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TARO-SUMATRIPTAN is a brand name for Sumatriptan, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Taro-Sumatriptan (sumatriptan succinate) is indicated for the acute treatment of migraine attacks, with or without aura. Taro-Sumatriptan is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar or ophthalmoplegic migraine (see
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Adults: • Taro-Sumatriptan (sumatriptan succinate), is indicated for the acute treatment of migraine headache with or without aura. • Taro-Sumatriptan should not be used prophylactically. • Sumatriptan may be given subcutaneously.
• The safety of treating an average of more than four headaches in a 30-day period has not been established. • The recommended dose of Taro-Sumatriptan should not be exceeded. • In selecting the appropriate formulation for individual patients, consideration should be given to the patient’s preference for formulation and the patient’s requirement for rapid onset of relief.
Significant relief begins about 10-15 minutes following subcutaneous injection. • In addition to relieving the pain of migraine, sumatriptan has also been shown to be effective in relieving associated symptoms of migraine (nausea, vomiting, phonophobia, photophobia).
• Sumatriptan is equally effective when administered at any stage of a migraine attack. • Long term (12-24 months) clinical studies with maximum recommended doses of sumatriptan indicate that there is no evidence of the development of tachyphylaxis, or medication induced (rebound) headache.
2 Recommended Dose and Dosage Adjustment Taro-Sumatriptan should be injected subcutaneously (on outer part of the thigh or back of the upper arm) using an autoinjector. The recommended adult dose of sumatriptan is a single 6 mg subcutaneous injection.
The recommended dose should not be exceeded. Clinical trials have shown that approximately 70-72 % of patients have headache relief within one hour after a single subcutaneous injection. This number increases to 82% by 2 hours. If the migraine headache returns, or if a patient has a partial response to the initial dose, the dose may be repeated after 1 hour.
Not more than 12 mg (two 6 mg injections) should be taken in any 24 hour period. If a patient does not respond to the first dose of Taro-Sumatriptan, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit.
Taro-Sumatriptan may be taken for subsequent attacks. Administration during migraine aura prior to other symptoms occurring may not prevent the development of a headache. Geriatrics (> 65 years of age) No differences have been observed between the pharmacokinetic parameters in healthy elderly volunteers compared with younger volunteers (less than 65 years old).
). If over dosage with sumatriptan occurs, the patient should be monitored and standard supportive treatment applied as required. Toxicokinetic data are not available. The effect of hemodialysis or peritoneal dialysis on the serum concentration of sumatriptan is unknown.
For management of a suspected drug overdose, contact your regional Poison Control Centre. 5 mL and Autoinjector Sodium Chloride, Water for injection. The needle shield contains dry natural rubber (a latex derivative).
Availability of Dosage Forms:
Subcutaneous injection Composition: Sumatriptan succinate (6 mg sumatriptan), sodium chloride and water for injection. The needle shield contains dry natural rubber (a latex derivative). 5 mL each, and each with a single -use auto- injector device, packed in a carton.
5mL Product Monograph 7 WARNINGS AND PRECAUTIONS General Taro-Sumatriptan (sumatriptan succinate) should only be used where a clear diagnosis of migraine has been established.
Cluster Headache:
There is insufficient information on the efficacy and safety of sumatriptan succinate in the treatment of cluster headache, which is present in an older, predominantly male population. The need for prolonged use and the demand for repeated medication in this condition renders the dosing information inapplicable for cluster headache.
Medication Overuse Headache:
Overuse of acute headache treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.
Latex Allergy:
The needle shield of the Taro-Sumatriptan pre-filled syringe contains dry natural rubber (a latex derivative) that has the potential to cause allergic reactions in latex sensitive individuals. Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events: Sumatriptan succinate has been associated with transient chest and/or neck pain, pressure, heaviness and tightness, which may resemble angina pectoris.
, Cardiovascular). 5mL Product Monograph • Patients with uncontrolled or severe hypertension because Taro-Sumatriptan may increase blood pressure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 3 Pharmacokinetics, Absorption/Metabolism).
g. dihydroergotamine, methysergide). Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. 4 Drug- Drug Interactions, Ergot -Containing Drugs; Other 5-HT1 agonists). 2 Recommended Dose and Dosage Adjustment, Hepatic Insufficiency).
• Patients with hemiplegic, basilar or ophthalmoplegic migraine. Taro-Sumatriptan should not be given intravenously because of its potential to cause coronary vasospasm. 1 Dosing Considerations Adults: • Taro-Sumatriptan (sumatriptan succinate), is indicated for the acute treatment of migraine headache with or without aura.
• Taro-Sumatriptan should not be used prophylactically. • Sumatriptan may be given subcutaneously. • The safety of treating an average of more than four headaches in a 30-day period has not been established. • The recommended dose of Taro-Sumatriptan should not be exceeded.
• In selecting the appropriate formulation for individual patients, consideration should be given to the patient’s preference for formulation and the patient’s requirement for rapid onset of relief. Significant relief begins about 10-15 minutes following subcutaneous injection.
• In addition to relieving the pain of migraine, sumatriptan has also been shown to be effective in relieving associated symptoms of migraine (nausea, vomiting, phonophobia, photophobia). • Sumatriptan is equally effective when administered at any stage of a migraine attack.
• Long term (12-24 months) clinical studies with maximum recommended doses of sumatriptan indicate that there is no evidence of the development of tachyphylaxis, or medication induced (rebound) headache. 2 Recommended Dose and Dosage Adjustment Taro-Sumatriptan should be injected subcutaneously (on outer part of the thigh or back of the upper arm) using an autoinjector.
). Safety and efficacy have not been established for cluster headache which is present in an older, predominantly male population. 3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): Experience of the use of sumatriptan succinate in patients aged over 65 years is limited.
4 Geriatric s). 2 CONTRAINDICATIONS Taro-Sumatriptan (sumatriptan succinate) is contraindicated in: • Patients with hypersensitivity to sumatriptan or to any of the ingredients of the formulations, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGI NG.
• Patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias). g. atherosclerotic disease, congenital heart disease) should not receive Taro-Sumatriptan.
g. stable angina of effort and vasospastic forms of angina such as the Prinzmetal’s variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks (TIAs).
Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, or Raynaud’s syndrome (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 5mL Product Monograph • Patients with uncontrolled or severe hypertension because Taro-Sumatriptan may increase blood pressure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
3 Pharmacokinetics, Absorption/Metabolism). g. dihydroergotamine, methysergide). Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. 4 Drug- Drug Interactions, Ergot -Containing Drugs; Other 5-HT1 agonists).
2 Recommended Dose and Dosage Adjustment, Hepatic Insufficiency). • Patients with hemiplegic, basilar or ophthalmoplegic migraine. Taro-Sumatriptan should not be given intravenously because of its potential to cause coronary vasospasm.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pediatrics).
Hepatic Insufficiency Adults with Mild to Moderate Hepatic Impairment:
The pharmacokinetic parameters of 6 mg subcutaneous sumatriptan do not differ statistically between normal volunteers and moderately hepatically impaired subjects (see 7 WARNINGS AND PRECAUTIONS Hepatic/Biliary/Pancreatic). No dosage adjustment is necessary for patients with mild to moderate hepatic impairment.
5mL Product Monograph CONTRAINDICATIONS). 4 Administration Patients should be advised to read the patient instruction leaflet regarding the safe disposal of syringes and needles.
In rare cases, the symptoms have been identified as being the likely result of coronary vasospasm or myocardial ischemia. Rare cases of serious coronary events or arrhythmia have occurred following use of sumatriptan succinate. Taro-Sumatriptan should not be given to patients who have documented ischemic or vasospastic coronary artery disease (CAD) (see 2 CONTRAINDICATIONS).
g. hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, female who is surgically or physiologically postmenopausal, or male who is over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease.
The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is unknown. If, during the cardiovascular evaluation, the patient’s medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, Taro-Sumatriptan should not be administered (see 2CONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are considered to have a satisfactory cardiovascular evaluation, the first dose of Taro-Sumatriptan should be administered in the setting of a physician’s office or similar medically staffed and equipped facility.
5mL Product Monograph ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining electrocardiograms in patients with risk factors during the interval immediately following administration of Taro-Sumatriptan on the first occasion of use.
However, an absence of drug-induced cardiovascular effects on the occasion of the initial dose does not preclude the possibility of such effects occurring with subsequent administrations. Intermittent long term users of Taro-Sumatriptan who have or acquire risk factors predictive of CAD as described above, should receive periodic interval cardiovascular evaluations over the course of treatment.
If symptoms consistent with angina occur after the use of Taro-Sumatriptan, ECG evaluation should be carried out to look for ischemic changes. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to Taro- Sumatriptan.
Discomfort in the chest, neck, throat, and jaw (including pain, pressure, heaviness, tightness, and dyspnea) has been reported after administration of sumatriptan succinate. Because 5-HT1 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following Taro-Sumatriptan succinate administration, should be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.
2 Clinical Trial Adverse Reactions).
Cardiac Events and Fatalities Associated with 5-HT1 Agonists:
Taro-Sumatriptan can cause coronary artery vasospasm. Serious […]
The recommended adult dose of sumatriptan is a single 6 mg subcutaneous injection. The recommended dose should not be exceeded. Clinical trials have shown that approximately 70-72 % of patients have headache relief within one hour after a single subcutaneous injection.
This number increases to 82% by 2 hours. If the migraine headache returns, or if a patient has a partial response to the initial dose, the dose may be repeated after 1 hour. Not more than 12 mg (two 6 mg injections) should be taken in any 24 hour period.
If a patient does not respond to the first dose of Taro-Sumatriptan, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit. Taro-Sumatriptan may be taken for subsequent attacks. Administration during migraine aura prior to other symptoms occurring may not prevent the development of a headache.
Geriatrics (> 65 years of age) No differences have been observed between the pharmacokinetic parameters in healthy elderly volunteers compared with younger volunteers (less than 65 years old). 3 Pediatrics).
Hepatic Insufficiency Adults with Mild to Moderate Hepatic Impairment:
The pharmacokinetic parameters of 6 mg subcutaneous sumatriptan do not differ statistically between normal volunteers and moderately hepatically impaired subjects (see 7 WARNINGS AND PRECAUTIONS Hepatic/Biliary/Pancreatic). No dosage adjustment is necessary for patients with mild to moderate hepatic impairment.
5mL Product Monograph CONTRAINDICATIONS). 4 Administration Patients should be advised to read the patient instruction leaflet regarding the safe disposal of syringes and needles. 5 OVERDOSAGE There have been some reports of overdosage with sumatriptan succinate.
Patients have received single injections of up to 12 mg subcutaneously without significant adverse effects. Doses up to 16 mg subcutaneously were not associated with side effects other than those mentioned (see