PMS-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.
Verbatim from this product's HC label. Tap a section to expand.
). 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 the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669). 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 Tablet / 25 mg, 50 mg and 100 mg 25 mg and 50 mg: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl Alcohol, Sodium Starch Glycolate, Talc and Titanium Dioxide.
100 mg: Colloidal Silicon Dioxide, Fractionated coconut oil, Hypromellose, Iron oxide red, Lactose Monohydrate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polydextrose, Sodium Starch Glycolate, Talc and Titanium Dioxide.
Availability of Dosage Forms pms-SUMATRIPTAN Tablets 25 mg are white to off-white, coated round tablets, debossed with “P” logo on one side and “S25" on the other side. Available in blister packs of 6 tablets (1 x 6 tablets) in a box.
pms-SUMATRIPTAN (sumatriptan tablets) Page 8 of 42 pms-SUMATRIPTAN Tablets 50 mg are white to off-white, coated triangular tablets, debossed with “S50” on one side and plain on the other side. Available in blister packs of 6 tablets (1 x 6 tablets) in a box.
pms-SUMATRIPTAN Tablets 100 mg are pink, coated triangular tablets, debossed with “S100” on one side and plain on the other side. Available in blister packs of 6 tablets (1 x 6 tablets) in a box. Each tablet contains 25 mg or 50 mg or 100 mg sumatriptan (base) as the succinate salt.
7. Warnings and Precautions General pms-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.
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.
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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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. pms-SUMATRIPTAN should not be given to patients who have documented ischemic or vasospastic coronary artery disease (CAD) (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, pms-SUMATRIPTAN (sumatriptan tablets) Page 9 of 42 coronary artery vasospasm or myocardial ischemia, pms-SUMATRIPTAN should not be administered (2 Contraindications).
For patients with risk factors predictive of CAD who are considered to have a satisfactory cardiovascular evaluation, the first dose of pms-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 pms-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 pms-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 pms-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 pms-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 pms-SUMATRIPTAN should be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses, and should be monitored […]