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APO-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: APO-SUMATRIPTAN (sumatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura. APO-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 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ...................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.................................................................................................................. 5 Post-Market Adverse Reactions ..................................................................................
16 9 DRUG INTERACTIONS ................................................................................................... 4 Drug-Drug Interactions ................................................................................................
5 Drug-Food Interactions ............................................................................................... 6 Drug-Herb Interactions................................................................................................
7 Drug-Laboratory Test Interactions .............................................................................. 18 10 CLINICAL PHARMACOLOGY ..........................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics .....................................................................................................
3 Pharmacokinetics ........................................................................................................ 21 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 24 PART II: SCIENTIFIC INFORMATION .....................................................................................
25 13 PHARMACEUTICAL INFORMATION ............................................................................... 25 14 CLINICAL TRIALS ...........................................................................................................
). 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 APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) Page 7 of 41 unknown.
For management of a suspected drug overdose, contact your regional poison control centre. 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) carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red (100 mg), hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
Availability of Dosage Forms APO-SUMATRIPTAN 25 mg Tablets:
Each white, triangular, film-coated tablet, engraved “APO” on one side, "SUM" over “25" on the other side, contains 25 mg sumatriptan (base) as the succinate salt. Available in cartons containing one blister card of 6 tablets.
APO-SUMATRIPTAN 50 mg Tablets:
Each white, triangular, biconvex, film-coated tablet, engraved “APO” on one side, "SUM" over “50" on the other side, contains 50 mg sumatriptan (base) as the succinate salt. Available in cartons containing one blister card of 6 tablets.
APO-SUMATRIPTAN 100 mg Tablets:
Each pink, triangular, biconvex, film-coated tablet, engraved “APO” on one side, "SUM" over “100" on the other side, contains 100 mg sumatriptan (base) as the succinate salt. Available in cartons containing one blister card of 6 tablets.
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ...................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.................................................................................................................. 5 Post-Market Adverse Reactions ..................................................................................
16 9 DRUG INTERACTIONS ................................................................................................... 4 Drug-Drug Interactions ................................................................................................
5 Drug-Food Interactions ............................................................................................... 6 Drug-Herb Interactions................................................................................................
7 Drug-Laboratory Test Interactions .............................................................................. 18 10 CLINICAL PHARMACOLOGY ..........................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics .....................................................................................................
3 Pharmacokinetics ........................................................................................................ 21 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 24 PART II: SCIENTIFIC INFORMATION .....................................................................................
). 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 APO-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 APO- 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 APO-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sumatriptan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1 Clinical Trials by Indication .......................................................................................... 2 Comparative Bioavailability Studies ............................................................................
27 15 MICROBIOLOGY ........................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY ........................................................................................
28 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 34 PATIENT MEDICATION INFORMATION ................................................................................ 35 APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) Page 4 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-SUMATRIPTAN (sumatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura.
APO-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 2 CONTRAINDICATIONS). 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 APO-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
7 WARNINGS AND PRECAUTIONS General APO-SUMATRIPTAN 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.
APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) Page 8 of 41 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. APO-SUMATRIPTAN should not be given to patients who have documented ischemic or vasospastic coronary artery disease (CAD) (see 2 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, APO-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 APO-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 APO-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 APO-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 APO-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 APO-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 APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) Page 9 of 41 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following APO-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 […]
25 13 PHARMACEUTICAL INFORMATION ............................................................................... 25 14 CLINICAL TRIALS ...........................................................................................................
1 Clinical Trials by Indication .......................................................................................... 2 Comparative Bioavailability Studies ............................................................................
27 15 MICROBIOLOGY ........................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY ........................................................................................
28 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 34 PATIENT MEDICATION INFORMATION ................................................................................ 35 APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) Page 4 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-SUMATRIPTAN (sumatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura.
APO-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 2 CONTRAINDICATIONS). 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 APO-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 APO- 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 APO-SUMATRIPTAN may increase blood pressure (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 3 Pharmacokinetics, Absorption/Metabolism). g. dihydroergotamine, methysergide).
Ergot-containing drugs have […]