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TEVA-ALMOTRIPTAN is a brand name for Almotriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...................................................................................3 CONTRAINDICATIONS .........................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
and Hepatic Impairment in WARNINGS AND PRECAUTIONS). 2 L/h; creatinine clearance between 31 and 71 mL/min) compared to healthy volunteers. Maximum plasma concentrations of almotriptan increased by approximately 80% in these patients (see DOSAGE AND ADMINISTRATION and Renal Impairment in WARNINGS AND PRECAUTIONS).
Pharmacokinetic parameters of almotriptan have not been studied in adolescents 12 to17 years of age with renal insufficiency. STORAGE AND STABILITY Store 15- 30°C. 5 mg of almotriptan and is white to off white, round, biconvex, film coated tablet, debossed “AL” on one side and plain on the other.
Available in cartons of 6 tablets (2 blister strips of 3 tablets each). The non-medicinal ingredients are: carnauba wax, hydroxypropyl methylcellulose, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, and titanium dioxide.
55 Structural formula: Physicochemical properties: Physical Form: White to slightly yellow crystalline powder.
Solubility:
Soluble in water, slightly soluble in Methanol. 5 mg tablets (McNeil Consumer Healthcare, Canada) in healthy adult male and female volunteers (n=31) under fasting state. The results from measured data are summarized in the table below.
5 mg tablets (McNeil Consumer Healthcare, Canada) were purchased in Canada. § Expressed as the median (range) ψ Expressed as the arithmetic mean (CV%) The pharmacological activity of almotriptan in the treatment of migraine has been assessed in Phase II and Phase III clinical trials.
Study demographics and trial design Adults (> 18 years of age) The efficacy of almotriptan was established in 3 multi-center, randomized, double-blind, placebo-controlled trials. Patients enrolled in these studies were primarily female (86%) and Caucasian (more than 98%), with a mean age of 41 years (range of 18 to 72) (see Table 4).
Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients evaluated their headache pain. If the pain had not decreased in severity to mild or to no pain, the patient was allowed to take an escape medication.
If the pain had decreased to mild or to no pain at 2 hours but subsequently increased in severity Page 29 of 38 between 2 and 24 hours, it was considered a relapse and the patient was instructed to take a second dose of study medication.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Almotriptan in Canada.
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Associated symptoms of nausea, vomiting, photophobia, and phonophobia were also evaluated. 5 mg, compared with those who received placebo. 25 mg dose. 5 mg did not lead to significantly better response. These results are summarized in Tables 4 to 6.
Table 4- Summary of patient demographics for clinical trials in adult patients. 5 mg, oral over 24 hours 1602 (88% of subjects completed study) 41 (18-72) M/F Study results Adults The efficacy of almotriptan was established in 3 multi-center, randomized, double-blind, placebo-controlled European trials.
Patients enrolled in these studies were primarily female (86%) and Caucasian (more than 98%), with a mean age of 41 years (range of 18 to 72). Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients evaluated their headache pain.
If the pain had not decreased in severity to mild or to no pain, the patient was allowed to take an escape medication. If the pain had decreased to mild or to no pain at 2 hours but subsequently increased in severity between 2 and 24 hours, it was considered a relapse and the patient was instructed to take a second dose of study medication.
Associated symptoms of nausea, vomiting, photophobia, and phonophobia were also evaluated. In these three studies, the percentage of patients achieving a response (mild or no pain) 2 hours after […]