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AG-SUMATRIPTAN is a brand name for Sumatriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AG-Sumatriptan (sumatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura. AG-Sumatriptan (sumatriptan succinate) 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 • AG-Sumatriptan (sumatriptan succinate) is indicated for the acute treatment of migraine headache with or without aura. • AG-Sumatriptan should not be used prophylactically. • AG-Sumatriptan is for oral administration.
• The safety of treating an average of more than four headaches in a 30 day period has not been established. • The recommended dose of AG-Sumatriptan should not be exceeded. • Significant relief begins about 30 minutes following oral administration.
• 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 to 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 The minimum effective single adult dose of AG-Sumatriptan is 25 mg.
The optimal dose is a single 50 mg tablet although some patients did respond to a single 25 mg tablet (see 14 CLINICAL TRIALS). Depending on clinical response and tolerability, some patients may benefit from the 100 mg strength. 2 Clinical Trial Adverse Reactions).
The maximum recommended single dose is 100 mg, which should not be exceeded. Clinical trials have shown that approximately 50 to 75% of patients have headache relief within two hours after oral dosing with 100 mg, and that a further 15 to 25% have headache relief by 4 hours.
Comparator studies have shown similar efficacy rates with the 50 mg and 100 mg tablets. If the migraine headache returns, or if a patient has a partial response to the initial dose, the dose may be repeated after 2 hours. Not more than 200 mg should be taken in any 24-hour period.
If a patient does not respond to the first dose of AG-Sumatriptan, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit. AG-Sumatriptan may be taken to treat subsequent migraine attacks.
Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 6 of 39 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 overdosage 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. Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 7 of 39 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, and Composition Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablets 25 mg, 50 mg and 100 mg sumatriptan (as sumatriptan succinate) Croscarmellose sodium, hypromellose, lactose monohydrate, triacetin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, titanium dioxide (100 mg tablets: iron oxide red, iron oxide yellow).
Availability of Dosage Forms AG-Sumatriptan 25 mg:
Each white, triangular, biconvex, film-coated tablet, engraved “SUM” on one side and “25" on the other side, contains 25 mg sumatriptan (base) as the succinate salt.
AG-Sumatriptan 50 mg:
Each white, triangular, biconvex, film-coated tablet, engraved “SUM” on one side, and “50" on the other side, contains 50 mg sumatriptan (base) as the succinate salt.
AG-Sumatriptan 100 mg:
Each pink, triangular, biconvex, film-coated tablet, engraved “SUM” on one side, and “100" on the other side, contains 100 mg sumatriptan (base) as the succinate salt. AG-Sumatriptan is available in cartons containing one blister card of 6 tablets.
7 WARNINGS AND PRECAUTIONS General AG-Sumatriptan should only be used where a clear diagnosis of migraine has been established.
, Cardiovascular). • Patients with uncontrolled or severe hypertension because AG-Sumatriptan may increase blood pressure (See 7 WARNINGSAND PRECAUTIONS, Cardiovascular). 3 Pharmacokinetics, Absorption/Metabolism). , dihydroergotamine, methysergide).
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. 4 Drug- Drug Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 5 of 39 Interactions, Ergot-Containing Drugs; Other 5-HT1 agonists). 2 Recommended Dose and Dosage Adjustment, Hepatic Insufficiency).
• Patients with hemiplegic, basilar, or ophthalmoplegic migraine. 1 Dosing Considerations Adults • AG-Sumatriptan (sumatriptan succinate) is indicated for the acute treatment of migraine headache with or without aura. • AG-Sumatriptan should not be used prophylactically.
• AG-Sumatriptan is for oral administration. • The safety of treating an average of more than four headaches in a 30 day period has not been established. • The recommended dose of AG-Sumatriptan should not be exceeded. • Significant relief begins about 30 minutes following oral administration.
• 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 to 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 The minimum effective single adult dose of AG-Sumatriptan is 25 mg.
The optimal dose is a single 50 mg tablet although some patients did respond to a single 25 mg tablet (see 14 CLINICAL TRIALS). Depending on clinical response and tolerability, some patients may benefit from the 100 mg strength. 2 Clinical Trial Adverse Reactions).
). 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 Geriatrics). 2 CONTRAINDICATIONS AG-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 PACKAGING.
• Patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias). , atherosclerotic disease, congenital heart disease) should not receive AG-Sumatriptan.
, 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). • Patients with uncontrolled or severe hypertension because AG-Sumatriptan may increase blood pressure (See 7 WARNINGSAND PRECAUTIONS, Cardiovascular).
3 Pharmacokinetics, Absorption/Metabolism). , dihydroergotamine, methysergide). Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. 4 Drug- Drug Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 5 of 39 Interactions, Ergot-Containing Drugs; Other 5-HT1 agonists).
2 Recommended Dose and Dosage Adjustment, Hepatic Insufficiency). • Patients with hemiplegic, basilar, or ophthalmoplegic migraine.
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3 Pediatrics).
Hepatic Insufficiency • Adults with Mild to Moderate Hepatic Impairment:
In patients with mild or moderate hepatic impairment, plasma sumatriptan concentrations up to two times those seen in healthy subjects have been observed. Therefore, a 25 mg dose (single tablet) may be considered in these patients (Child Pugh grade A or B) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
• Adults with Severe Hepatic Impairment: AG-Sumatriptan is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). 4 Administration The tablet should be swallowed whole with water, not crushed, chewed or split.
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. 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.
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. AG-Sumatriptan should not be given to patients who have documented ischemic or vasospastic coronary artery disease (CAD) (see 2 Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 8 of 39 CONTRAINDICATIONS).
, 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, AG-Sumatriptan should not be administered (see 2 CONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are considered to have a satisfactory cardiovascular evaluation, the first dose of AG-Sumatriptan should be administered in the setting of a physician’s office or similar medically staffed and equipped facility.
Because cardiac 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 AG-Sumatriptan administration 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 AG-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 AG-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 AG-Sumatriptan.
Discomfort in the chest, neck, throat and jaw (including pain, pressure, heaviness, tightness, 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 AG- Sumatriptan 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.
Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following AG- Sumatriptan should be evaluated for atherosclerosis or predisposition to […]
The maximum recommended single dose is 100 mg, which should not be exceeded. Clinical trials have shown that approximately 50 to 75% of patients have headache relief within two hours after oral dosing with 100 mg, and that a further 15 to 25% have headache relief by 4 hours.
Comparator studies have shown similar efficacy rates with the 50 mg and 100 mg tablets. If the migraine headache returns, or if a patient has a partial response to the initial dose, the dose may be repeated after 2 hours. Not more than 200 mg should be taken in any 24-hour period.
If a patient does not respond to the first dose of AG-Sumatriptan, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit. AG-Sumatriptan may be taken to treat subsequent migraine attacks.
Product Monograph AG-Sumatriptan (Sumatriptan Tablets, BP) Page 6 of 39 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:
In patients with mild or moderate hepatic impairment, plasma sumatriptan concentrations up to two times those seen in healthy subjects have been observed. Therefore, a 25 mg dose (single tablet) may be considered in these patients (Child Pugh grade A or B) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
• Adults with Severe Hepatic Impairment: AG-Sumatriptan is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). 4 Administration The tablet should be swallowed whole with water, not crushed, chewed or split.
5 OVERDOSAGE There have been some reports of overdosage with sumatriptan succinate. Doses up to 400 mg orally were not associated with side effects other than those mentioned. (see