Amigrenin pills 100mg №2

Active ingredient and dosage form

Amigrenin coated tablets: 1 pill contains Sumatriptan (as succinate) 50 or 100 mg;
Excipients: MCC; milk sugar; potato starch; sodium carboxymethyl starch; Magnesium stearate; hydroxypropylcellulose or hydroxypropylmethylcellulose; PVP; polyethylene glycol 4000; talc; titanium dioxide;
2 or 10 pcs. in a blister strip packaging, in a carton pack 1 packaging.

Mechanism of action

- antimigraine drug. Specific selective serotonin 5HT agonist_1D-receptors (5-hydroxytryptamine-1-like), located mainly in the smooth muscles of the blood vessels of the brain. Stimulation 5HT_1D-receptors leads to selective narrowing of blood vessels in the carotid artery system, without having a significant effect on cerebral blood flow. In addition, it was experimentally established that sumatriptan inhibits the activity of the trigeminal nerve.
It is believed that these effects contribute to reducing the severity of pain in migraine.
The clinical effect is observed 30 minutes after oral administration of the drug.

Indications and usage

- relief of acute migraine attacks, with or without aura.

Contraindications

- hemiplegic, basilar and ophthalmoplegic forms of migraine;
- IHD (including angina);
- occlusive peripheral artery disease;
- uncontrolled arterial hypertension;
- stroke or transient cerebral circulation (including in history);
- severe liver dysfunction;
- simultaneous administration of preparations containing ergotamine or its derivatives;
- simultaneous administration of MAO inhibitors and a period of up to 14 days after their cancellation;
- pregnancy;
- lactation period (breastfeeding);
- The age of patients under 18 years and over 65 years;
- Hypersensitivity to the drug.

Dosage and administration

Amigrenin is not intended to be used for the purpose of prophylaxis.
For adults administered in 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 Amigrenin, then the drug should not be prescribed again to relieve an ongoing attack. If the symptoms have decreased or disappeared, and then resumed, you can take a second dose over the next 24 hours. The interval between doses of the drug should be at least 2 hours.

Adverse reactions

Cardiovascular: hyperemia of the skin and mucous membranes, arterial hypotension, tachycardia, palpitations, angina, transient increase in blood pressure, transient changes of ischemic type ECG, bradycardia; in isolated cases - manifestations of Raynaud's syndrome.
From the side of the central nervous system: dizziness, weakness, drowsiness, feeling tired; visual impairment (diplopia, scotoma, reduced visual acuity).
Gastrointestinal: abdominal discomfort, dysphagia, nausea, vomiting; rarely - ischemic colitis, increased activity of liver enzymes.
Allergic reactions: rash, itching, erythema, urticaria, anaphylaxis.
Other: possible tingling sensations, heat, heaviness, pressure or compression in different parts of the body, myalgia.

Pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Special notes

WITH extra care Amigrenin should be prescribed for epilepsy (including in any conditions with a decrease in the convulsive readiness threshold), as well as in patients with controlled arterial hypertension.
When Amigrenin is prescribed to patients with newly diagnosed migraine or with migraine that occurs with atypical symptoms, other potentially dangerous neurological diseases should be excluded. It must be borne in mind that in patients with migraine there is a risk of cerebrovascular complications (including stroke or transient cerebral circulatory disorders).
The drug should not be prescribed to patients at risk of developing the pathology of the cardiovascular system, without prior examination to exclude the disease.The first 2-3 doses should be taken under the supervision of a physician (as a spasm of the coronary arteries is possible).
In patients with hypersensitivity to sulfonamides when receiving Amigrenin 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 with younger patients).
Influence on ability to drive motor transport and control mechanisms
Against the background of Amigrenin therapy, drowsiness may develop. Therefore, during the period of use of the drug, patients should be extremely careful to drive a car and engage in other potentially hazardous activities that require high-speed psychomotor reactions.

Overdosage

Treatment: in the event of an overdose, observe the patient for 10 hours, conducting symptomatic therapy as needed.

Drug Interactions

When taken concomitantly with ergotamine, prolonged vasospasm was observed. Amigrenin can be prescribed no earlier than 24 hours after taking medications containing ergotamine.
Interaction between sumatriptan and MAO inhibitors is possible, their simultaneous use is contraindicated.
There are separate reports of the development of weakness, hyperreflexia and impaired coordination in patients after simultaneous administration of sumatriptan and selective serotonin reuptake inhibitors. Do not simultaneously appoint Amigrenin and drugs in this group.
Do not simultaneously appoint Amigrenin and lithium preparations.

Storage conditions

List B. The drug should be stored in a dry, dark place.