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Anotic
Flupentixol + Melitracen
Anotic
Flupentixol + Melitracen
Indications
Psychosis
Indication detailsView
Flupentixol and Melitracen tablet is indicated in-
- Anxiety
- Depression
- Apathy
- Psychogenic depression.
- Depressive neurosses.
- Masked depression.
- Psychosomatic affections accompanied by anxiety and apathy.
- Menopausal depressions.
- Dysphoria and depression in alcoholics and drug addicts.
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
DosageView
Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Side effectsView
In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
ContraindicationsView
- The immediate recovery phase after myocardial infarction.
- Defects in bundle-branch conduction.
- Untreated narrow-angle glaucoma.
- Acute alcohol, barbiturate and opiate intoxications.
- This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
- Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
PrecautionsView
If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
InteractionsView
This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
Pregnancy & lactationView
This tablet should preferably not be given during pregnancy and lactation.
Overdose effectsView
In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.
Anoxa
Oxazepam
Anoxa
Oxazepam
Indications
Anxiety
Indication detailsView
Oxazepam is used in the treatment of anxiety disorders, including anxiety associated with depression. This drug seems to be particularly effective for anxiety, tension, agitation and irritability in older people. It is also prescribed to relieve symptoms of acute alcohol withdrawal.
Therapeutic classView
Tricyclic Anti-depressant
PharmacologyView
Oxazepam belongs to a class of drugs called "Benzodiazepine" which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effect of a natural chemical in the brain (GABA).
DosageView
Adult:
- Mild to Moderate Anxiety with Tension, Irritability and Agitation: The usual dose is 10 to 15 milligrams 3 or 4 times per day.
- Severe Anxiety, Depression with Anxiety, or Alcohol Withdrawal: The usual dose is 15 to 30 milligrams, 3 or 4 times per day.
- Safety and effectiveness have not been established for children less than 6 years of age,
- Nor have dosage guidelines been established for children 6 to 12 years. The doctor will adjust the dosage to fit the child's needs.
Side effectsView
Side effects cannot be anticipated. If any develop or change in intensity, doctor should be informed immediately. Doctor will determine if it is safe for a patient to continue taking Oxazepam. More common side effect includes drowsiness. Less common or rare side effects include: Blood disorders, change in libido, dizziness, excitement, fainting, headache, liver problems, loss or lack of muscle control, nausea, skin rashes or eruptions, sluggishness or unresponsiveness, slurred speech, swelling due to fluid retention, tremors, vertigo, yellowed eyes and skin. Side effects due to rapid decrease or abrupt withdrawal from Oxazepam: Abdominal and muscle cramps, convulsions, depressed mood, inability to fall or stay asleep, sweating, tremors, vomiting.
ContraindicationsView
The drug is contraindicated in individuals who have an allergic reaction to Oxazepam or other benzodiazepines such as diazepam. Oxazepam should not be prescribed if any patient is being treated for mental disorders which are more serious than anxiety.
PrecautionsView
This drug may make dizzy, drowsy or cause blurred vision; caution should be taken while engaging in activities requiring alertness such as driving or using machinery. The limit should be maintained while taking alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the drowsiness effect.
InteractionsView
Oxazepam may intensify the effects of alcohol. It may be best to avoid alcohol while taking this medication. If Oxazepam is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with a doctor before combining Oxazepam with the following: Antihistamines such as Diphenhydramine Narcotic painkillers such as Oxycodone and Pethidine Sedatives such as Secobarbital and Triazolam Tranquilizers such as Diazepam and Alprazolam.
Pregnancy & lactationView
This medication is not recommended for use during pregnancy due to the potential possible fetal harm. Based on information from related drugs, this drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breastfeeding while using this medication is not recommended.
StorageView
Store in a cool and dry place, protected from light and moisture. Keep out of reach of children.
Anoxiv
Betacarotene + Vitamin C + Vitamin E
Anoxiv
Betacarotene + Vitamin C + Vitamin E
Indications
Vitamin deficiency
Indication detailsView
Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
Therapeutic classView
Anti-oxidant Multivitamin preparations
PharmacologyView
Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
DosageView
This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.
Side effectsView
β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
ContraindicationsView
Carocet is contraindicated in patients with hypersensitivity to any of its components.
PrecautionsView
There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.
InteractionsView
Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.
Pregnancy & lactationView
β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.
StorageView
Should be stored in a dry place below 30˚C.
Anpar
Terbinafine Hydrochloride
Anpar
Terbinafine Hydrochloride
Indication detailsView
Terbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Therapeutic classView
Other Antifungal preparations, Topical Antifungal preparations
PharmacologyView
Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.
DosageView
Terbinafine tablet:
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
- For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
- The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.
- Body Weight: <25 kg: 125 mg/day up to 6 weeks
- Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
- Body Weight: >35 kg: 250 mg/day up to 6 weeks
- Tinea corporis, cruris: 1 to 2 weeks
- Tinea pedis: 1 week
- Cutaneous candidiasis: 2 weeks
- Pityriasis versicolor: 2 weeks
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- Tinea pedis: once a day,1 week
- Tinea corporis/cruris: once a day,1 week
- Pityriasis versicolor: twice a day, 1 week
Side effectsView
The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.
ContraindicationsView
Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
PrecautionsView
Warnings-
- Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
- Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.
InteractionsView
In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.
Pregnancy & lactationView
Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Pediatric usageView
Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Overdose effectsView
Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
StorageView
Store in a cool and dry place, below 30°C, protect from light.
Anplat
Clopidogrel Bisulphate
Anplat
Clopidogrel Bisulphate
Indications
Unstable angina
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
DosageView
Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Side effectsView
Clopidogrel is generally well tolerated drug.
- Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
- Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
ContraindicationsView
Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
- As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
- Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
InteractionsView
- NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose effectsView
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
StorageView
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
Anquil
Midazolam
Anquil
Midazolam
Indications
Status epilepticus
Indication detailsView
Midazolam is indicated in-
- Short-term treatment of insomnia.
- Sedation in premedication before surgical or diagnostic procedures.
Therapeutic classView
Benzodiazepine hypnotics, Benzodiazepine sedatives
PharmacologyView
The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.
DosageView
Oral dosage:
- For adults: 7.5-15 mg daily.
- In elderly and debilitated patients: The recommended dose is 7.5 mg.
- In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.
- Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
- Induction of Anesthesia: The dose is 10-15 mg.
- Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
- Children: 0.15-0.20 mg/kg
- Elderly and debilitated patients: 0.025-0.05 mg/kg
- For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.
Side effectsView
At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.
ContraindicationsView
Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product
PrecautionsView
Midazolam IV should be administered very slowly.
InteractionsView
Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.
Pregnancy & lactationView
Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.
Overdose effectsView
Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.
StorageView
Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.
Anquil
Midazolam
Anquil
Midazolam
Indications
Status epilepticus
Indication detailsView
Midazolam is indicated in-
- Short-term treatment of insomnia.
- Sedation in premedication before surgical or diagnostic procedures.
Therapeutic classView
Benzodiazepine hypnotics, Benzodiazepine sedatives
PharmacologyView
The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.
DosageView
Oral dosage:
- For adults: 7.5-15 mg daily.
- In elderly and debilitated patients: The recommended dose is 7.5 mg.
- In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.
- Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
- Induction of Anesthesia: The dose is 10-15 mg.
- Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
- Children: 0.15-0.20 mg/kg
- Elderly and debilitated patients: 0.025-0.05 mg/kg
- For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.
Side effectsView
At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.
ContraindicationsView
Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product
PrecautionsView
Midazolam IV should be administered very slowly.
InteractionsView
Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.
Pregnancy & lactationView
Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.
Overdose effectsView
Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.
StorageView
Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.
Anquil
Midazolam
Anquil
Midazolam
Indications
Status epilepticus
Indication detailsView
Midazolam is indicated in-
- Short-term treatment of insomnia.
- Sedation in premedication before surgical or diagnostic procedures.
Therapeutic classView
Benzodiazepine hypnotics, Benzodiazepine sedatives
PharmacologyView
The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.
DosageView
Oral dosage:
- For adults: 7.5-15 mg daily.
- In elderly and debilitated patients: The recommended dose is 7.5 mg.
- In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.
- Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
- Induction of Anesthesia: The dose is 10-15 mg.
- Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
- Children: 0.15-0.20 mg/kg
- Elderly and debilitated patients: 0.025-0.05 mg/kg
- For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.
Side effectsView
At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.
ContraindicationsView
Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product
PrecautionsView
Midazolam IV should be administered very slowly.
InteractionsView
Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.
Pregnancy & lactationView
Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.
Overdose effectsView
Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.
StorageView
Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.
Anreb
Losartan Potassium
Anreb
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Anreb
Losartan Potassium
Anreb
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Anreb Plus
Losartan Potassium + Hydrochlorothiazide
Anreb Plus
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Anreb Plus
Losartan Potassium + Hydrochlorothiazide
Anreb Plus
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Anril
Nitroglycerin (IV Infusion)
Anril
Nitroglycerin (IV Infusion)
Indications
Angina pectoris
Indication detailsView
Nitroglycerin Injection is indicated for the treatment of peri-operative hypertension; for controlling of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta blockers and for induction of Intraoperative hypotension.
Therapeutic classView
Nitrates: Coronary vasodilators
PharmacologyView
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance,systolic arterial pressure, and mean arterial pressure (after load). Dilatation of the coronary arteries also occurs.
DosageView
Not for direct intravenous injection. Nitroglycerin injection is a concentrated, potent drug which must be diluted in dextrose (5%) injection or sodium chloride (0.9%) injection prior to its infusion. Nitroglycerin injection should not be mixed with other drugs.
Initial Dilution: Aseptically transfer the contents of one nitroglycerin ampoule (containing 50 mg of nitroglycerin) into a 500 ml glass bottle of either Dextrose (5%) Injection or Sodium Chloride Injection (0.9%).This yields a final concentration of 100 mcg/ml.
Maintenance Dilution: It is important to consider the fluid requirements of the patient as well as the expected duration of infusion in selecting the appropriate dilution of Nitroglycerin Injection. After the initial dosage titration, the concentration of the solution may be increased, if necessary, to limit fluids given to the patient. The nitroglycerin concentration should not exceed 400 mcg/ml.
Initial Dilution: Aseptically transfer the contents of one nitroglycerin ampoule (containing 50 mg of nitroglycerin) into a 500 ml glass bottle of either Dextrose (5%) Injection or Sodium Chloride Injection (0.9%).This yields a final concentration of 100 mcg/ml.
Maintenance Dilution: It is important to consider the fluid requirements of the patient as well as the expected duration of infusion in selecting the appropriate dilution of Nitroglycerin Injection. After the initial dosage titration, the concentration of the solution may be increased, if necessary, to limit fluids given to the patient. The nitroglycerin concentration should not exceed 400 mcg/ml.
Side effectsView
Adverse reactions to nitroglycerin are generally dose-related and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred.
ContraindicationsView
Allergic reactionsto organic nitrates are extremely rare,but they do occur. Nitroglycerin Injection is contraindicated in patients who are allergic to it. In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venousreturn. Intravenous nitroglycerin is contraindicated in patients with these conditions.
PrecautionsView
Severe hypotension and shock may occur with even small doses of nitroglycerin. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. As tolerance to other forms of nitroglycerin develops,the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitratesfrom these workers, demonstrating the existence of true physical dependence.
InteractionsView
The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Administration of nitroglycerin infusions through the same infusion set as blood can result in pseudoagglutination and hemolysis. More generally, nitroglycerin in 5% dextrose or sodium chloride 0.9% should not be mixed with any other medication of any kind. Intravenous nitroglycerin interferes, at least in some patients, with the anticoagulant effect of heparin. In patients receiving intravenous nitroglycerin, concomitant heparin therapy should be guided by frequent measurement of the activated partial thromboplastin time.
Pregnancy & lactationView
Pregnancy category C. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin injection is administered to a nursing mother.
Pediatric usageView
Safety and effectiveness in children have not been established.
Overdose effectsView
Homodynamic Effects: The ill effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitation; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anril
Nitroglycerin (Sublingual Spray)
Anril
Nitroglycerin (Sublingual Spray)
Indications
Angina pectoris
Indication detailsView
Nitroglycerin sublingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Therapeutic classView
Nitrates: Coronary vasodilators
PharmacologyView
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins with more prominent effects on the latter. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular enddiastolic pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load).
DosageView
At the onset of an attack, 1 or 2 metered sprays should be administered under the tongue. No more than 3 metered sprays are recommended within a 15 minute period. If the chest pain persists, prompt medical attention is recommended. Nitroglycerin spray may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
Side effectsView
A number of nitrate related adverse effects may occur including headache, facial flushing, dizziness, nausea, vomiting, feelings of weakness, postural hypotension and reflex tachycardia .
ContraindicationsView
Hypersensitivity to nitrates or any constituents of the formulation. Hypotension, hypovolaemia, severe anaemia, cerebral haemorrhage and brain trauma, mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy. Concomitant administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction.
PrecautionsView
The use of Nitroglycerin during the early days of acute myocardial infarction requires particular attention to monitoring hemodynamics and clinical status. Nitroglycerin should be used with caution in patients with severely impaired renal or hepatic function, hypothyroidism, malnutrition or hypothermia.
InteractionsView
Use of alcohol with Nitroglycerin may produce severe hypotension and collapse. Oral Nitroglycerin may enhance the bioavailability of dihydroergotamine. Orthostatic hypotension may occur with the combined use of calcium channel blocker, phenothiazines and tricyclic antidepressants.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Nitroglycerin should be given to pregnant women only if clearly needed. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nitroglycerin spray is administered to a nursing woman.
Pediatric usageView
Safety and effectiveness of nitroglycerin in pediatric patients have not been established.
Overdose effectsView
Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse, heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions and possibly death due to circulatory collapse.
Methemoglobinemia: Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.
Treatment of Overdosage: Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required. If an excessive quantity of Nitroglycerin spray has been recently swallowed, gastric lavage may be of use.
Methemoglobinemia: Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.
Treatment of Overdosage: Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required. If an excessive quantity of Nitroglycerin spray has been recently swallowed, gastric lavage may be of use.
StorageView
Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
Anril SR
Nitroglycerin (Oral preparation)
Anril SR
Nitroglycerin (Oral preparation)
Indications
Severe hypertension
Indication detailsView
Nitroglycerin is indicated for the prophylaxis of angina pectoris. The onset of action is not sufficiently rapid for this form to be useful in aborting an acute anginal episode.
Therapeutic classView
Nitrates: Coronary vasodilators
PharmacologyView
Nitroglycerin causes relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins. Dilation of veins promote peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (preload) and relaxation of arteries reduce systemic vascular resistance and arterial pressure (afterload).
DosageView
Dosage should always to be adjusted according to the requirement and response obtained by the individual patient and the severity of the anginal pain. For adults, one Nitroglycerin 2.6 mg sustained released tablet or capsule in morning and evening. This should be taken empty stomach.
Side effectsView
Headache may occur at the onset of treatment but will usually subside after a few days. If the headache persists dosage should be decreased. Other side effects include tachycardia, postural hypotension and syncope, cyanosis and methaemoglobinaemia.
ContraindicationsView
Nitroglycerin is contraindicated in patients with a known hypersensitivity to nitroglycerin, other organic nitrates, or nitrites or to the excipients of the medicine. It is also contraindicated in patients with acute myocardial infarction, marked anaemia, head trauma, cerebral haemorrhage, or closed angle glaucoma.
PrecautionsView
Nitroglycerin should be used with caution in patients who are predisposed to closed-angle glaucoma. As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored. The use of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status to avoid the hazards of hypotension and tachycardia.
InteractionsView
Nitroglycerin dilates peripheral blood vessels and may increase the antihypertensive properties of vasodilators, calcium antagonists, beta-adrenergic blockers. Concomitant use of nitrates with tricyclic antidepressants and alcohol may cause high blood pressure. Concomitant use of nitrates with phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, vardenafil and tadalafil cause fall in blood pressure. Aspirin decreases the clearance and enhances the hemodynamic effects of nitroglycerin. Nitroglycerin may reduce the pharmacologic effects of heparin when used concomitantly. Nitrates increase the bioavailability of dihydroergotamine.
Pregnancy & lactationView
Nitroglycerin should not be used during pregnancy or lactation unless considered essential by the physician.
StorageView
Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
Anseng
Panax Ginseng
Anseng
Panax Ginseng
Indication detailsView
Panax Ginseng capsule is indicated to reduce fatigue and stress, increase vitality strengthens immunity, while recovering after long term fever and weakness, as a stimulant, enhance libido, increase physical endurance, prevents impotence, adjuvant therapy for diabetes. Posses antioxidant property.
Primary Uses-
Primary Uses-
- Adaptogen and general tonic
- Increased athletic performance and endurance
- Immunomodulatory effects
- Aphrodisiac; erectile dysfunction and fertility
- Menopausal symptoms
- Non-insulin dependent diabetes mellitus
- Improved pulmonary function in treatment of severe, chronic respiratory disease; additive effect of antibiotic treatment for respiratory tract infection
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Ginseng is an all-natural & clinically shown to increase body's oxygen uptake which is necessary to help make healthy energy. The pharmacological effects a) adaptogenic b) improvement of physical & mental performance. In human, some evidence suggests that ginseng can improve glycogen utilization, alcohol clearance, serum lipid level, and other metabolic parameters, which is taken as evidence of a pro-homeostasis, adaptogenic effect.
DosageView
Capsule: One Panax Ginseng capsule one or two times a day or advised by the physician.
Syrup: 2 teaspoonfuls 2 times daily after meal or as directed by the registered physician.
Syrup: 2 teaspoonfuls 2 times daily after meal or as directed by the registered physician.
Side effectsView
Over Ginseng's many years of use, no serious side effects or drug interactions have been reported.
ContraindicationsView
Ginseng can be taken with any other vitamin, minerals or herbal supplement. No known contraindications according to the German E Commission and World Health Organization (WHO). However, as with any supplement, consult with physician if you are taking prescription drugs.
PrecautionsView
Over stimulation and insomnia have also been reported with ginseng and anecdotal evidence suggests that excessive doses may mildly elevate blood pressure and/or cause hyper sexuality. Safety in young children or individuals with severe hepatic or renal disease is not known.
Pregnancy & lactationView
No known restrictions according to the American Herbal Products Association and the German E Commission, but controlled, long-term safety studies are lacking. In Traditional Chinese Medicine (TCM), ginseng root is included in prescriptions given during pregnancy, labor and postpartum.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anset
Ondansetron
Anset
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Anset
Ondansetron
Anset
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Anset
Ondansetron
Anset
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Anset
Ondansetron
Anset
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.