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TEVA-SUMATRIPTAN DF 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: TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF (sumatriptan succinate) tablets are indicated for the acute treatment of migraine attacks with or without aura. TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF (sumatriptan succinate) tablets are not intended for the prophylactic therapy of migraine or for use in the management of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Adults TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are indicated for the acute treatment of migraine headache with or without aura. TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF should not be used prophylactically.
TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are 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 TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF 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 (12-24 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 Page 6 of 44 The minimum effective single adult dose is 25mg. 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. TEVA-SUMATRIPTAN is only available in 100mg strength. TEVA-SUMATRIPTAN DF is available in 25 mg, 50 mg and 100 mg strengths.
Clinical trials have shown that approximately 50 - 75% of patients have headache relief within two hours after oral dosing with 100 mg, and that a further 15 - 25% have headache relief by 4 hours. Comparator studies have shown similar efficacy rates with the 50mg 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 TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF Tablets, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit.
). 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. 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 100 mg sumatriptan (as sumatriptan succinate) Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
The film-coating consists of hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, synthetic red iron oxide, titanium dioxide and triacetin. Page 8 of 44 Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral DF Tablets 25mg, 50 mg and 100 mg sumatriptan as (sumatriptan succinate) Colloidal silicon dioxide, crospovidone, lactose, magnesium stearate and microcrystalline cellulose.
The film-coating for the 25 mg and 50 mg tablets consists of hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. The film-coating for the 100 mg tablet consists of hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, synthetic red iron oxide, titanium dioxide and triacetin.
Availability of Dosage Forms TEVA-SUMATRIPTAN is available as a pink, triangular, film coated tablet engraved with N on one side and 100 on the other, supplied in blister pack boxes of 6 and 24 tablets. TEVA-SUMATRIPTAN DF is available as: 25 mg – White to off white, triangular, film-coated tablet, engraved with "N" on one side and "25" on the other side, supplied in bottles of 50 and blister packs of 6 (1 sheet o f 6 unit dose tablets), 24 (4 sheets of 6 unit dose tablets) & 100 (10 sheets of 10 unit dose tablets).
, Cardiovascular). Page 5 of 44 Patients with uncontrolled or severe hypertension because TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF may increase blood pressure (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 3 Pharmacokinetics, Absorption/Metabolism).
Within 24 hours before or after treatment with other 5HT1 receptor agonists, or ergotamine-containing drugs or their derivatives (eg. 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. 1 Dosing Considerations Adults TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are indicated for the acute treatment of migraine headache with or without aura.
TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF should not be used prophylactically. TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are 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 TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF 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 (12-24 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 Page 6 of 44 The minimum effective single adult dose is 25mg. 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.
). Safety and efficacy have not been established for cluster headache which is present in an older, predominantly male population. 1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of sumatriptan succinate in pediatric patients has not been established and their use in this age group is not recommended.
2 Geriatrics Geriatrics (>65 years of age): Experience of the use of sumatriptan succinate in patients aged over 65 years is limited. Therefore the use of TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF in patients over 65 years is not recommended.
4 Geriatrics) 2 CONTRAINDICATIONS TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are 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 TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF.
, 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). Page 5 of 44 Patients with uncontrolled or severe hypertension because TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF may increase blood pressure (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF may be taken to treat subsequent migraine attacks. 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: TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are 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.
50 mg – White to off white, triangular, film-coated tablet, engraved with "N" on one side and "50" on the other side, supplied in bottles of 50 and bli ster packs of 6 (1 sheet of 6 unit dose tablets), 24 (4 sheets of 6 unit dose tablets) & 100 (10 sheets of 10 unit dose tablets).
100 mg - Pink, triangular, film-coated tablet, engraved with "N N" on one side and "100" on the other side, supplied in bottles of 50 and blister packs of 6 (1 sheet of 6 unit dose tablets), 24 (4 sheets of 6 unit dose tablets) & 100 (10 sheets of 10 unit dose tablets).
7 WARNINGS AND PRECAUTIONS General TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF 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 Page 9 of 44 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. TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF 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. I f, 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, TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF 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 TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF 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 TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF 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 TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF who have or acquire risk factors predictive of CAD, as described above, should receive period ic interval cardiovascular evaluations over the course of treatment.
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2 Clinical Trial Adverse Reactions). The maximum recommended single dose is 100 mg, which should not be exceeded. TEVA-SUMATRIPTAN is only available in 100mg strength. TEVA-SUMATRIPTAN DF is available in 25 mg, 50 mg and 100 mg strengths.
Clinical trials have shown that approximately 50 - 75% of patients have headache relief within two hours after oral dosing with 100 mg, and that a further 15 - 25% have headache relief by 4 hours. Comparator studies have shown similar efficacy rates with the 50mg 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 TEVA-SUMATRIPTAN or TEVA-SUMATRIPTAN DF Tablets, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit.
TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF may be taken to treat subsequent migraine attacks. 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: TEVA-SUMATRIPTAN and TEVA-SUMATRIPTAN DF are 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 sumatripan succinate. Doses up to 400 mg orally were not associated with side effects other than those mentioned (see
3 Pharmacokinetics, Absorption/Metabolism). Within 24 hours before or after treatment with other 5HT1 receptor agonists, or ergotamine-containing drugs or their derivatives (eg. 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.