- active substance: sumatriptan;
- 1 capsule contains sumatriptan succinate in terms of sumatriptan 50 mg or 100 mg;
- excipients: lactose, monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate;
capsule shell composition: gelatin, titanium dioxide (E 171), ponso 4R (E 124).
Dosage form. Capsules.
Main physical and chemical properties: hard gelatin capsules № 1 cylindrical with hemispherical ends; the case – white color, a cover – red color. The contents of the capsules are white or almost white, odorless powder.
капсули 100 мг блістер у коробці, № 1, 3, 10
капсули 50 мг блістер у коробці, № 1, 3, 10
Indications for use.
For quick relief of migraine attacks, with or without aura.
Hypersensitivity to any component of the drug. History of myocardial infarction, coronary heart disease, Princemetal angina, peripheral vascular disease, or symptoms characteristic of coronary heart disease.
A history of stroke or transient cerebrovascular accident. Moderate or severe hypertension and mild uncontrolled hypertension. Severe hepatic failure. Concomitant use of ergotamine or its derivatives (including methysergide) (see section “Interaction with other medicinal products and other forms of interaction”). Concomitant use of a triptan / 5-hydroxytryptamine receptor agonist (5-HT1) (see section “Interaction with other medicinal products and other forms of interaction”). Competitive use of monoamine oxidase (MAO) and Amigren inhibitors. Amigren should not be used for 2 weeks after discontinuation of MAO inhibitors.
Method of application and dose.
Amigren capsules should not be used to prevent seizures. Amigren is recommended to be used as early as possible after the onset of a migraine attack, although it is equally effective at each stage of the attack.
The recommended dose of Amigren for adults is 50 mg (1 tablet). In some cases, the dose can be increased to 100 mg (2 capsules).
Amigren can be used for new migraine attacks, but if the first dose of the drug is ineffective, the drug should not be used again during the same attack. If the patient responds to the first dose but symptoms return, the second dose may be given within the next 24 hours, with a total daily dose not to exceed 300 mg. The capsules should be swallowed whole with water.
Elderly patients (age 65 years)
There is insufficient experience with sumatriptan in patients over 65 years of age. Although the pharmacokinetics of the drug do not differ from those in younger individuals, until additional clinical data are available, the use of Amigren in elderly patients is not recommended.
To date, the efficacy and safety of sumatriptan in children have not been established, so Amigren is not recommended for use in this patient population.