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Tramp
Paracetamol + Tramadol Hydrochloride
Tramp
Paracetamol + Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
This tablet is indicated for-
- The management of moderate to moderately severe pain in adults.
- The short-term (five days or less) management of acute pain.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
DosageView
For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
Side effectsView
The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
ContraindicationsView
Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.
PrecautionsView
- This combination preparation may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- This combination preparation should not be taken with alcohol containing beverages.
- The patient should be instructed not to take this combination preparation in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations.
- This combination preparation should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Pediatric usageView
pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
StorageView
Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.
Tramp CR
Ketoprofen (oral & injection)
Tramp CR
Ketoprofen (oral & injection)
Indications
Rheumatic disorders
Indication detailsView
The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
- Rheumatoid arthritis
- Degenerative joint diseases
- Musculoskeletal and joint disorders such as tendinitis, sprain
- Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.
Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
DosageView
Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.
Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
AdministrationView
The oral forms should be taken with fluids, preferably with food.
Side effectsView
- Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
- Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
- Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
- Eye disorders- Rare: vision blurred
- Ear and labyrinth disorders- Rare: tinnitus
- Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
- Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
- Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
- Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
- Hepatobiliary disorders- Rare: hepatitis, transaminases increased
- Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
- General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
ContraindicationsView
Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
- Severe heart failure
- Active or history of peptic ulcer/hemorrhage
- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
- Severe hepatic insufficiency
- Severe renal insufficiency
- Third trimester of pregnancy
- Rectitis or history of proctorrhagia (rectal administration)
PrecautionsView
Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.
Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.
If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.
If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
InteractionsView
Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
- Heparin
- Vitamin K antagonists (such as warfarin)
- Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
- Thrombin inhibitors (such as dabigatran)
- Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
- Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
- Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
- Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
- Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
- Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
- ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
- Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
- Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
- Cyclosporin: Increased risk of nephrotoxicity.
- Tacrolimus: Increased risk of nephrotoxicity.
- Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
- Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
- Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
- Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
- Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
- Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Pregnancy & lactationView
During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
Pediatric usageView
Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.
Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.
Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Overdose effectsView
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
StorageView
Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Tranal
Tramadol Hydrochloride
Tranal
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tranal
Tramadol Hydrochloride
Tranal
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tranal
Tramadol Hydrochloride
Tranal
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tranbit
Tenofovir Alafenamide
Tranbit
Tenofovir Alafenamide
Indications
Liver disease
Indication detailsView
Tenofovir Alafenamide is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
Therapeutic classView
Hepatic viral infections (Hepatitis B)
PharmacologyView
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). Tenofovir alafenamide as a lipophilic cell-permeant compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is then converted to tenofovir through hydrolysis primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of toxicity to mitochondria in cell culture.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of toxicity to mitochondria in cell culture.
DosageView
Testing Prior To Initiation Of Tenofovir Alafenamide: Prior to initiation of Tenofovir Alafenamide, patients should be tested for HIV-1 infection. Tenofovir Alafenamide alone should not be used in patients with HIV infection
It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating Tenofovir Alafenamide and during therapy in all patients as clinically appropriate
Recommended Dosage In Adults: The recommended dosage of Tenofovir Alafenamide is 25 mg (one tablet) taken orally once daily with food
It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating Tenofovir Alafenamide and during therapy in all patients as clinically appropriate
Recommended Dosage In Adults: The recommended dosage of Tenofovir Alafenamide is 25 mg (one tablet) taken orally once daily with food
Side effectsView
The following adverse reactions are discussed in other sections of the labeling:
- Lactic Acidosis/Severe Hepatomegaly with Steatosis
- Severe Acute Exacerbation of Hepatitis B
- New Onset or Worsening of Renal Impairment
ContraindicationsView
None
InteractionsView
Tenofovir is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in Tenofovir absorption. Consult the full prescribing information prior to and during treatment for potential drug drug interactions.
Pregnancy & lactationView
Before you take Tenofovir Alafenamide, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if Tenofovir Alafenamide will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Tenofovir Alafenamide.
Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Tenofovir Alafenamide in pediatric patients less than 18 years of age have not been established.
Geriatric Use: Clinical trials of Tenofovir Alafenamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Renal Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild, moderate, or severe renal impairment. Tenofovir Alafenamide is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)
Hepatic Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of Tenofovir Alafenamide in patients with decompensated cirrhosis (Child-Pugh B or C) have not been established; therefore Tenofovir Alafenamide is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment
Geriatric Use: Clinical trials of Tenofovir Alafenamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Renal Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild, moderate, or severe renal impairment. Tenofovir Alafenamide is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)
Hepatic Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of Tenofovir Alafenamide in patients with decompensated cirrhosis (Child-Pugh B or C) have not been established; therefore Tenofovir Alafenamide is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment
Overdose effectsView
If overdose occurs, monitor patient for evidence of toxicity. Treatment of overdosage with Tenofovir Alafenamide consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysiswith an extraction coefficient of approximately 54%
StorageView
Store below 86°F (30°C). Keep in its original container. Keep the container tightly closed.
Traneta
Linagliptin
Traneta
Linagliptin
Indications
Type 2 DM
Indication detailsView
Linagliptin is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.
- As monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance or contraindicated due to renal impairment.
- As combination therapy: in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Therapeutic classView
Dipeptidyl Peptidase-4 (DPP-4) inhibitor
PharmacologyView
Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
DosageView
Linagliptin 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulfonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Patients with renal impairment: No dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.
Patients with renal impairment: No dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.
Side effectsView
There may be hypoglycaemia, nasopharyngitis, cough and pancreatitis in combination with metformin and sulfonylurea.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients.
PrecautionsView
Hypersensitivity to the active substance or to any of the excipients.
InteractionsView
Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well controlled studies in pregnant women. So, Linagliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Linagliptin passes into breast milk or not.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Traneta M
Linagliptin + Metformin Hydrochloride
Traneta M
Linagliptin + Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Linagliptin & Metformin immediate release tablet: The dosage of Linagliptin & Metformin should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin Hydrochloride use.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Side effectsView
Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.
ContraindicationsView
Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.
PrecautionsView
In a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linagliptin & Metformin. Temporarily discontinue Linagliptin & Metformin in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.
InteractionsView
Cationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.
Overdose effectsView
In the event of an overdose with this combination the usual supportive measures (i.e. remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Linagliptin by hemodialysis or peritoneal dialysis is unlikely but Metformin Hydrochloride is dialyzable.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Traneta M
Linagliptin + Metformin Hydrochloride
Traneta M
Linagliptin + Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Linagliptin & Metformin immediate release tablet: The dosage of Linagliptin & Metformin should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin Hydrochloride use.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Side effectsView
Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.
ContraindicationsView
Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.
PrecautionsView
In a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linagliptin & Metformin. Temporarily discontinue Linagliptin & Metformin in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.
InteractionsView
Cationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.
Overdose effectsView
In the event of an overdose with this combination the usual supportive measures (i.e. remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Linagliptin by hemodialysis or peritoneal dialysis is unlikely but Metformin Hydrochloride is dialyzable.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Traneta M
Linagliptin + Metformin Hydrochloride
Traneta M
Linagliptin + Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Linagliptin & Metformin immediate release tablet: The dosage of Linagliptin & Metformin should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin Hydrochloride use.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
Side effectsView
Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.
ContraindicationsView
Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.
PrecautionsView
In a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linagliptin & Metformin. Temporarily discontinue Linagliptin & Metformin in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.
InteractionsView
Cationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.
Overdose effectsView
In the event of an overdose with this combination the usual supportive measures (i.e. remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Linagliptin by hemodialysis or peritoneal dialysis is unlikely but Metformin Hydrochloride is dialyzable.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Tranexil
Tranexamic Acid
Tranexil
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Tranexil
Tranexamic Acid
Tranexil
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Trangina MR
Trimetazidine Dihydrochloride
Trangina MR
Trimetazidine Dihydrochloride
Indications
Meniere’s disease
Indication detailsView
Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs
PharmacologyView
Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.
DosageView
The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.
Side effectsView
Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia
ContraindicationsView
Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.
PrecautionsView
Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.
InteractionsView
No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.
Pregnancy & lactationView
There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Trangit MR
Trimetazidine Dihydrochloride
Trangit MR
Trimetazidine Dihydrochloride
Indications
Meniere’s disease
Indication detailsView
Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs
PharmacologyView
Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.
DosageView
The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.
Side effectsView
Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia
ContraindicationsView
Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.
PrecautionsView
Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.
InteractionsView
No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.
Pregnancy & lactationView
There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Tranquil
Clobazam
Tranquil
Clobazam
Indications
Tension
Indication detailsView
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Therapeutic classView
Benzodiazepine hypnotics
PharmacologyView
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
DosageView
General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
Treatment of anxiety states-
Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Treatment of epilepsy in combination with one or more other anticonvulsants-
Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
AdministrationView
The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
Side effectsView
Metabolism and nutrition disorders: Common: decreased appetite
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
ContraindicationsView
Clobazam must not be used-
- In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
- In patients with myasthenia gravis (risk of aggravation of muscle weakness).
- In patients with severe respiratory insufciency (risk of deterioration).
- In patients with sleep apnoea syndrome (risk of deterioration).
- In patients with severe impairment of liver function (risk of precipitating encephalopathy).
- In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
- Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
PrecautionsView
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
InteractionsView
Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Pregnancy & lactationView
Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called "floppy infant syndrome"). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
StorageView
Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.
Trapost
Travoprost
Trapost
Travoprost
Indications
Open angle glaucoma
Indication detailsView
Travoprost Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
DosageView
Use in adults: The recommended dose is one drops of Travoprost in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Travoprost, discontinue the other agent and start the following day with Travoprost.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Side effectsView
The most frequently reported treatment-related side-effect is ocular hyperaemia.
ContraindicationsView
Travoprost eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of this preparation.
PrecautionsView
Travoprost should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Travoprost should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travoprost.
InteractionsView
Reduced therapeutic effect with NSAIDs.
Pregnancy & lactationView
There are no adequate and well-controlled clinical study En pregnant women. Travoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
StorageView
Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.
Trapost OSD
Travoprost
Trapost OSD
Travoprost
Indications
Open angle glaucoma
Indication detailsView
Travoprost Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
DosageView
Use in adults: The recommended dose is one drops of Travoprost in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Travoprost, discontinue the other agent and start the following day with Travoprost.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Side effectsView
The most frequently reported treatment-related side-effect is ocular hyperaemia.
ContraindicationsView
Travoprost eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of this preparation.
PrecautionsView
Travoprost should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Travoprost should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travoprost.
InteractionsView
Reduced therapeutic effect with NSAIDs.
Pregnancy & lactationView
There are no adequate and well-controlled clinical study En pregnant women. Travoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
StorageView
Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.
Trastunix
Trastuzumab
Trastunix
Trastuzumab
Indication detailsView
Adjuvant Breast Cancer: Trastuzumab is indicated for adjuvant treatment of HER2 overexpressing node-positive or node-negative ER/PR negative or with one high-risk feature breast cancer
capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing
metastatic gastric or gastroesophageal junction adenocarcinoma who have not received
prior treatment for metastatic disease.
- as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- as part of a treatment regimen with docetaxel and carboplatin
- as a single agent following multi-modality anthracycline-based therapy.
- In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast cancer in a patient who has received one or more chemotherapy regimens for metastatic disease. overexpressing breast cancer in patient.
capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing
metastatic gastric or gastroesophageal junction adenocarcinoma who have not received
prior treatment for metastatic disease.
PharmacologyView
The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro, Trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
DosageView
Recommended Doses and Schedules: Do not administer as an intravenous push or bolus. Do not mix Trastuzumab with other drugs.
Adjuvant Treatment, Breast Cancer: Administer according to one of the following doses and schedules for a total of 52 weeks of Trastuzumab therapy:
During and following paclitaxel, docetaxel, or docetaxel/carboplatin:
Metastatic Gastric Cancer: Administer Trastuzumab at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks until disease progression. Or, as directed by the registered physician.
Adjuvant Treatment, Breast Cancer: Administer according to one of the following doses and schedules for a total of 52 weeks of Trastuzumab therapy:
During and following paclitaxel, docetaxel, or docetaxel/carboplatin:
- Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
- One week following the last weekly dose of Trastuzumab, administer Trastuzumab at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.
- Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes
- Subsequent doses at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.
- Extending adjuvant treatment beyond one year is not recommended
Metastatic Gastric Cancer: Administer Trastuzumab at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks until disease progression. Or, as directed by the registered physician.
AdministrationView
- Using a sterile syringe, slowly inject the 20 ml of diluent into the vial containing the lyophilized powder of Trastuzumab, which has a cake-like appearance. The stream of diluent should be directed into the cake. The reconstituted vial yields a solution for multiple-dose use, containing 21 mg/ml Trastuzumab.
- Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
- Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed for approximately 5 minutes.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect visually for particulates and discoloration. The solution should be free of visible particulates, clear to slightly opalescent and colorless to pale yellow.
- Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion.
Side effectsView
The most serious adverse reactions caused by Trastuzumab includes Cardiomyopathy, Infusion Reactions, Embryo-Fetal Toxicity, Pulmonary Toxicity, Exacerbation of Chemotherapy-Induced Neutropenia. The most common adverse reactions in patients receiving Trastuzumab in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
PrecautionsView
Cardiomyopathy: Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4-6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Trastuzumab as a single agent or in combination therapy compared with those not receiving Trastuzumab. The highest absolute incidence occurs when Trastuzumab is administered with an anthracycline. Withhold Trastuzumab for ≥ 16% absolute decrease in LVEF from pre treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of Trastuzumab in patients with Trastuzumab-induced left ventricular cardiac dysfunction has not been studied.
Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
Embryo-Fetal Toxicity: Trastuzumab can cause fetal harm when administered to a pregnant woman. Use of Trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab.
Pulmonary Toxicity: Trastuzumab use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Trastuzumab and those who did not.
Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
- Baseline LVEF measurement immediately prior to initiation of Trastuzumab
- LVEF measurements every 3 months during and upon completion of Trastuzumab
- Repeat LVEF measurement at 4 week intervals if Trastuzumab is withheld for significant left ventricular cardiac dysfunction.
- LVEF measurements every 6 months for at least 2 years following completion of Trastuzumab as a component of adjuvant therapy.
Embryo-Fetal Toxicity: Trastuzumab can cause fetal harm when administered to a pregnant woman. Use of Trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab.
Pulmonary Toxicity: Trastuzumab use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Trastuzumab and those who did not.
InteractionsView
Patients who receive anthracycline after stopping Trastuzumab may be at increased risk of cardiac dysfunction because of Trastuzumab’s long washout period based on population PK analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Trastuzumab. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.
Pregnancy & lactationView
It can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab. Advise pregnant women and females of reproductive potential that exposure to Trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab. There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric usageView
Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
ReconstitutionView
Reconstitute each 440 mg vial of Trastuzumab with 20 ml of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative to yield a multi-dose solution containing 21 mg/ml Trastuzumab. In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 ml of Sterille Water for Injection (SWFI) without preservative to yield a single use solution.
StorageView
Store the vial in original carton at 2 o -8 o C. Protect from light. Keep out of the reach of children. Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze. The solution of Trastuzumab for infusion diluted in 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C for no more than 24 hours prior to use. Do not freeze.
Travagen Z
Travoprost
Travagen Z
Travoprost
Indications
Open angle glaucoma
Indication detailsView
Travoprost Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
DosageView
Use in adults: The recommended dose is one drops of Travoprost in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Travoprost, discontinue the other agent and start the following day with Travoprost.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Side effectsView
The most frequently reported treatment-related side-effect is ocular hyperaemia.
ContraindicationsView
Travoprost eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of this preparation.
PrecautionsView
Travoprost should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Travoprost should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travoprost.
InteractionsView
Reduced therapeutic effect with NSAIDs.
Pregnancy & lactationView
There are no adequate and well-controlled clinical study En pregnant women. Travoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
StorageView
Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.
Travast
Travoprost
Travast
Travoprost
Indications
Open angle glaucoma
Indication detailsView
Travoprost Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
DosageView
Use in adults: The recommended dose is one drops of Travoprost in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Travoprost, discontinue the other agent and start the following day with Travoprost.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Side effectsView
The most frequently reported treatment-related side-effect is ocular hyperaemia.
ContraindicationsView
Travoprost eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of this preparation.
PrecautionsView
Travoprost should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Travoprost should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travoprost.
InteractionsView
Reduced therapeutic effect with NSAIDs.
Pregnancy & lactationView
There are no adequate and well-controlled clinical study En pregnant women. Travoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
StorageView
Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.