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Toza
Nitazoxanide
Toza
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Toza
Nitazoxanide
Toza
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Tplase
Tenecteplase
Tplase
Tenecteplase
Indications
Myocardial infarction
Indication detailsView
Tenecteplase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of acute myocardial infarction symptoms.
Therapeutic classView
Fibrinolytics (Thrombolytics)
PharmacologyView
Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that Tenecteplase conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. Following administration of 30, 40, or 50 mg of Tenecteplase, there are decreases in circulating fibrinogen (4%-15%) and plasminogen (11%-24%). The clinical significance of fibrinspecificity on safety (e.g., bleeding) or efficacy has not been established. Biological potency is determined by an in vitro clot lysis assay and is expressed in Tenecteplase-specific units. The specific activity of Tenecteplase has been defined as 200 units/mg.
DosageView
Tenecteplase is for intravenous administration only. The recommended total dose should not exceed 50 mg and is based upon patient weight. A single bolus dose should be administered over 5 seconds based on patient weight. Treatment should be initiated as soon as possible after the onset of AMI symptoms.
- Patient Weight <60 kg: 30 mg Tenecteplase
- Patient Weight ≥60 to <70 kg: 35 mg Tenecteplase
- Patient Weight ≥70 to <80 kg: 40 mg Tenecteplase
- Patient Weight ≥80 to <90 kg: 45 mg Tenecteplase
- Patient Weight ≥90 kg: 50 mg Tenecteplase
AdministrationView
- The product should be visually inspected prior to administration for particulate matter and discoloration. Tenecteplase may be administered as reconstituted at 5 mg/mL.
- Precipitation may occur when Tenecteplase is administered in an IV line containing dextrose. Dextrose-containing lines should be flushed with a saline-containing solution prior to and following single bolus administration of Tenecteplase.
- Reconstituted Tenecteplase should be administered as a single IV bolus over 5 seconds.
- Because Tenecteplase contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted Tenecteplase is not used immediately, refrigerate the Tenecteplase vial at 2-8°C and use within 8 hours.
- Although the supplied syringe is compatible with a conventional needle, this syringe is designed to be used with needleless IV systems. From the information below, follow the instructions applicable to the IV system in use.
Side effectsView
The most frequent adverse reaction associated with Tenecteplase is bleeding. Should serious bleeding occur, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes. For Tenecteplase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9% and any stroke was 1.8%. The incidence of all strokes, including intracranial bleeding, increases with increasing age
ContraindicationsView
Tenecteplase therapy in patients with acute myocardial infarction is contraindicated in the following situations because of an increased risk of bleeding:
- Active internal bleeding
- History of cerebrovascular accident
- Intracranial or intraspinal surgery or trauma within 2 months
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Known bleeding diathesis
- Severe uncontrolled hypertension
PrecautionsView
General: Standard management of myocardial infarction should be implemented concomitantly with Tenecteplase treatment. Arterial and venous punctures should be minimized. Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from the noncompressible sites. In the event of serious bleeding, heparin and antiplatelet agents should be discontinued immediately. Heparin effects can be reversed by protamine.
Readministration: Readministration of plasminogen activators, including Tenecteplase, to patients who have received prior plasminogen activator therapy has not been systematically studied. Three of 487 patients tested for antibody formation to Tenecteplase had a positive antibody titer at 30 days. The data reflect the percentage of patients whose test results were considered positive for antibodies to Tenecteplase in a radioimmunoprecipitation assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Tenecteplase with the incidence of antibodies to other products may be misleading. Although sustained antibody formation in patients receiving one dose of Tenecteplase has not been documented, readministration should be undertaken with caution.
Hypersensitivity: Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Tenecteplase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with Tenecteplase during and for several hours after infusion. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.
Readministration: Readministration of plasminogen activators, including Tenecteplase, to patients who have received prior plasminogen activator therapy has not been systematically studied. Three of 487 patients tested for antibody formation to Tenecteplase had a positive antibody titer at 30 days. The data reflect the percentage of patients whose test results were considered positive for antibodies to Tenecteplase in a radioimmunoprecipitation assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Tenecteplase with the incidence of antibodies to other products may be misleading. Although sustained antibody formation in patients receiving one dose of Tenecteplase has not been documented, readministration should be undertaken with caution.
Hypersensitivity: Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Tenecteplase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with Tenecteplase during and for several hours after infusion. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.
InteractionsView
Formal interaction studies of Tenectaplase with other drugs have not been performed. Patients studied in clinical trials of Tenecteplase were routinely treated with heparin and aspirin. Anticoagulants (such as heparin and vitamin K antagonists) and drugs that alter platelet function. (such as acetylsalicylic acid, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of bleeding if administered prior to, during, or after Tenectaplase therapy.
Pregnancy & lactationView
Pregnancy: Tenectaplase has been shown to elicit maternal and embryo toxicity in rabbits given multiple IV administrations. In rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths. Subsequent embryonic deaths were secondary to maternal hemorrhage and no fetal anomalies were observed. Tenectaplase does not elicit maternal and embryo toxicity in rabbits following a single IV administration. Thus, in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of Tenectaplase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for AMI. There are no adequate and well controlled studies in pregnant women. Tenectaplase should be given to pregnant women only if the potential benefits justify the potential risk to the fetus.
Nursing Mothers: It is not known if Tenectaplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenectaplase is administered to a nursing woman.
Nursing Mothers: It is not known if Tenectaplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenectaplase is administered to a nursing woman.
Pediatric usageView
Pediatric Use: The safety and effectiveness of Tenecteplase in pediatric patients have not been established.
In elderly patients: The benefits of Tenecteplase on mortality should be carefully weighed against the risk of increased adverse events, including bleeding.
In elderly patients: The benefits of Tenecteplase on mortality should be carefully weighed against the risk of increased adverse events, including bleeding.
StorageView
Store lyophilized Tenecteplase at controlled room temperature not to exceed 30°C or under refrigeration 2-8°C. Do not use beyond the expiration date stamped on the vial.
Tracid
Tranexamic Acid
Tracid
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Tracid
Tranexamic Acid
Tracid
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Trado
Tramadol Hydrochloride
Trado
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Trado
Tramadol Hydrochloride
Trado
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Trado Plus
Paracetamol + Tramadol Hydrochloride
Trado Plus
Paracetamol + Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
This tablet is indicated for-
- The management of moderate to moderately severe pain in adults.
- The short-term (five days or less) management of acute pain.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
DosageView
For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
Side effectsView
The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
ContraindicationsView
Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.
PrecautionsView
- This combination preparation may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- This combination preparation should not be taken with alcohol containing beverages.
- The patient should be instructed not to take this combination preparation in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations.
- This combination preparation should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Pediatric usageView
pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
StorageView
Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.
Tralin
Sertraline Hydrochloride
Tralin
Sertraline Hydrochloride
Indications
Trichotillomania
Indication detailsView
Sertraline is indicated for the treatment of-
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Post-traumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
Obsessive-compulsive disorder:
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
Major depressive disorder:
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
- Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
- Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Tralin
Sertraline Hydrochloride
Tralin
Sertraline Hydrochloride
Indications
Trichotillomania
Indication detailsView
Sertraline is indicated for the treatment of-
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Post-traumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
Obsessive-compulsive disorder:
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
Major depressive disorder:
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
- Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
- Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Tralin
Sertraline Hydrochloride
Tralin
Sertraline Hydrochloride
Indications
Trichotillomania
Indication detailsView
Sertraline is indicated for the treatment of-
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Post-traumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
Obsessive-compulsive disorder:
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
Major depressive disorder:
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 50 mg
- Therapeutic Range: 50-200 mg
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
- Starting Dose: 25 mg
- Therapeutic Range: 50-200 mg
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
- Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
- Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Tram-K
Ketorolac Tromethamine
Tram-K
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Tramacid
Tramadol Hydrochloride
Tramacid
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tramadol
Tramadol Hydrochloride
Tramadol
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tramamax
Tramadol Hydrochloride
Tramamax
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tramatol
Paracetamol + Tramadol Hydrochloride
Tramatol
Paracetamol + Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
This tablet is indicated for-
- The management of moderate to moderately severe pain in adults.
- The short-term (five days or less) management of acute pain.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
DosageView
For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
Side effectsView
The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
ContraindicationsView
Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.
PrecautionsView
- This combination preparation may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- This combination preparation should not be taken with alcohol containing beverages.
- The patient should be instructed not to take this combination preparation in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations.
- This combination preparation should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Pediatric usageView
pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
StorageView
Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.
Tramavir
Tramadol Hydrochloride
Tramavir
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tramavir
Tramadol Hydrochloride
Tramavir
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Tramic
Tranexamic Acid
Tramic
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Tramic
Tranexamic Acid
Tramic
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.