Amigrenin pills, 100mg 6pcs

Composition

>of 1 tab. contains: Active ingredients:  sumatriptan succinate 140 mg, which corresponds to the sumatriptan content of 100 mg

Auxiliary substances:

microcrystalline cellulose – 32 mg,

lactose (milk sugar) – 123.7 mg,

potato starch-11.5 mg,

sodium carboxymethyl starch (primogel) – 9.6 mg,

magnesium stearate-3.2 mg.

Shell composition:  

hypromellose (hydroxypropylmethylcellulose) – 4.18 mg,

povidone (polyvinylpyrrolidone) – 2.8 mg,

macrogol 4000 (polyethylene glycol 4000) – 1.02 mg,

talc-1.12 mg,

titanium dioxide (E171) – 880 mcg.

Pharmacological action

Pharmacotherapy group: anti-migraine agent. ( №02CC01).

Pharmacological properties

Pharmacodynamics :

It interacts with 5-hydroxytryptamine type I receptors located in the smooth muscles of the blood vessel walls of the brain, selectively narrows the vessels in the carotid artery system, and inhibits the activity of the trigeminal nerve. All this helps to reduce the severity of pain in migraines. The clinical effect is noted after 30 minutes.

Pharmacokinetics:

When taken orally, sumatriptan is rapidly absorbed. 70% of the maximum serum concentration is reached in 45 minutes. The average absolute bioavailability is 14% due to presystemic metabolism and incomplete absorption. The degree of binding to plasma proteins is low (14-21%), and the half – life is 2 hours. The main metabolite (an indoleacetic analog of sumatriptan) is mainly excreted in the urine as a free acid and its glucuronide conjugate.

Indications

Relief of acute migraine attacks (with or without aura).

Contraindications

— hemiplegic, basilar and oftalmologicheskiy forms of migraine;

— ischemic heart disease (including angina);

— occlusive peripheral artery disease;

uncontrolled hypertension;

stroke or transient cerebrovascular accident (including in the anamnesis);

— pronounced violations of the liver;

— concomitant use of preparations containing ergotamine or its derivatives;

— simultaneous reception of MAO inhibitors and a period of 14 days after their cancellation;

— pregnancy;

— lactation (breastfeeding);

the age of patients under 18 and over 65 years;

— hypersensitivity to the drug.

Side effects

From the cardiovascular system: hyperemia of the skin and mucous membranes, hypotension, tachycardia, palpitation, angina attack, transient increase in blood pressure, transient ECG changes of the ischemic type, bradycardia; in isolated cases – manifestations of Raynaud’s syndrome.

From the central nervous system: dizziness, weakness, drowsiness, fatigue; visual disturbances (diplopia, scotoma, decreased visual acuity).

From the digestive system:  abdominal discomfort, dysphagia, nausea, vomiting; rarely-ischemic colitis, increased activity of liver enzymes.

Allergic reactions: rash, pruritus, erythema, urticaria, anaphylaxis.

Other services: possible sensations of tingling, heat, heaviness, pressure or compression in various parts of the body, myalgia.

Interaction

Long-term vasospasm was observed when taken concomitantly with ergotamine. Amigrenine can be prescribed no earlier than 24 hours after taking medications containing ergotamine. Possible interaction between sumatriptan and MAO inhibitors, their simultaneous use is contraindicated.

There have been isolated reports of weakness, hyperreflexia, and impaired coordination in patients after concomitant use of sumatriptan and selective serotonin reuptake inhibitors.

You should not simultaneously prescribe Amigrenin and drugs of this group. Amigrenine and lithium preparations should not be administered simultaneously.

How to take, course of use and dosage

Amigrenin is not intended for use for prevention purposes.

Adults are prescribed a single dose of 50 mg, in some cases-100 mg. The maximum daily dose is 300 mg.

If the symptoms of migraine do not disappear and do not decrease after taking the first dose of Amigrenine, then the drug should not be re-prescribed to stop the ongoing attack.

If symptoms have subsided or subsided and then resumed, you can take a second dose within the next 24 hours. The interval between doses of the drug should be at least 2 hours.

Overdose

Treatment:  in case of overdose, the patient should be monitored for 10 hours, carrying out symptomatic therapy as necessary.

Special instructions

Sumatriptan should be prescribed with extreme caution in patients with epilepsy (including any conditions with a reduced threshold of convulsive readiness), as well as in patients with controlled arterial hypertension. When prescribing Amigrenine to patients with newly diagnosed migraines or migraines with atypical symptoms, other potentially dangerous neurological diseases should be excluded. It should be borne in mind that patients with migraines are at risk of developing cerebrovascular complications (including stroke or transient cerebral circulatory disorders).

The drug should not be prescribed to patients who are at risk of developing pathology from the cardiovascular system, without a preliminary examination to exclude the disease. The first 2-3 doses of the drug should be carried out under the supervision of a doctor (since spasm of the coronary arteries is possible). In patients with hypersensitivity to sulfonamides, taking sumatriptan may develop allergic reactions that range from skin manifestations to anaphylactic shock.

If there is no effect on the first dose, the diagnosis should be clarified.

Clinical experience with the drug in patients over the age of 65 years is limited (there is no significant difference in pharmacokinetics compared to younger patients).

Influence on the ability to drive motor vehicles and manage mechanisms

Somnolence may occur during sumatriptan therapy. Therefore, during the period of use of the drug, patients should drive with extreme caution and engage in other potentially dangerous activities that require a high rate of psychomotor reactions.

Storage conditions

List B. Store in a dry place, protected from light and out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Sumatriptan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, For adults under 65 years of age as prescribed by a doctor

Indications

Migraine