SUMAMIGREN

Active material: Sumatriptan
When ATH: N02CC01
CCF: Serotoninovыh agonist 5-HT₁-receptors. Protivomigrenoznoy drug with activity
ICD-10 codes (testimony): G43
When CSF: 02.16.05.01
Manufacturer: Pharmaceutical Works POLPHARMA S.A. (Poland)

Pharmaceutical form, composition and packaging

Pills, coated Pink colour, round, lenticular, with a slightly rough surface.

Excipients: lactose, microcrystalline cellulose, natrievaya soly kroskarmellozы, magnesium stearate, talc, Colloidal anhydrous silica.

The composition of the shell: gipromelloza, macrogol 6000, talc, Titanium dioxide, triэtiltsitrat, cochineal red lacquer (E124).

2 PC. – blisters (1) – packs cardboard.

Pills, coated orange, round, lenticular, with a slightly rough surface.

Excipients: lactose, microcrystalline cellulose, natrievaya soly kroskarmellozы, magnesium stearate, talc, Colloidal anhydrous silica.

The composition of the shell: gipromelloza, macrogol 6000, talc, Titanium dioxide, triэtiltsitrat, nail orange-yellow (E110).

2 PC. – blisters (1) – packs cardboard.

Pharmacological action

Protivomigrenozny drug. Specific serotonin 5HT selective agonist_1D-receptors, no effect on other subtypes of serotonin receptors 5HT-. Serotonin 5HT_1D-receptors are located primarily in the blood vessels of the brain, their stimulation leads to a narrowing of these vessels. Sumatriptan reduces the sensitivity of the trigeminal nerve. Both of these effects are the basis of the drug protivomigrenoznogo. The clinical effect observed after 30 min after oral administration.

Pharmacokinetics

Absorption

When receiving the drug inside sumatriptan is rapidly absorbed from the gastrointestinal tract, while through 45 minutes in plasma is reached 70% from C_max. Before the drug at a dose of 100 mg C_max averages 54 ng / ml. Oral bioavailability averages 14% due to first-pass metabolism and incomplete absorption.

Distribution

Plasma protein binding is 14-21%.

Metabolism

Biotransformed by MAO Type A. The main metabolite is indoleacetic analogue sumatriptan, had no activity at serotonin 5HT₁– and 5NT₂-receptors.

Deduction

T_1/2 is 2 no. The major metabolite of sumatriptan excreted mainly in the urine as free acid or glucuronide conjugate. Migraine attacks have no significant effect on the pharmacokinetics of sumatriptan, ingestable.

Testimony

- Relief of migraine attacks with or without aura.

Dosage regimen

The tablets are taken orally entirely, drinking water.

The recommended single dose of 50 mg (1 tab.), in some cases it may require a higher drug dose 100 mg. If migraine symptoms do not disappear or decrease after the first dose, the drug should not be prescribed for the relief of the ongoing re-attack. The drug can be used for subsequent migraine relief.

If the symptoms have been reduced or, and then resumed, You can take a second dose for the next 24 no. The maximum dose is 300 mg for 24 no.

Side effect

From the body as a whole: pain, hot flashes, tingling, the feeling of compression or gravity (usually transient, but may be intense and occur in various parts of the body, incl. in the chest or throat); also possible flushes, dizziness, a feeling of weakness, feeling tired, drowsiness (usually slightly or moderately expressed, wear prehodyashtiy character).

Cardio-vascular system: decrease in blood pressure, bradycardia, tachycardia, transient increase in blood pressure; rarely – arrhythmias, transient ischemic ECG changes such as, spasm of the coronary arteries, myocardial infarction; in a few cases – Raynaud's syndrome.

From the digestive system: nausea, vomiting, ishemicheskiy colitis (the relationship of these phenomena with the reception of sumatriptan is not certain); abdominal discomfort, dysphagia, increase in liver transaminases.

CNS: dizziness; rarely – convulsive seizures (in some cases it has been observed in patients with a history of seizures or conditions, predisposing to seizures); sometimes – diplopia, scotoma, nistagmo, reduced visual acuity; rarely – partial transient loss of vision (should be considered, that impairment may be associated with a migraine attack).

Allergic reactions: rash, itch, эritema, hives; in a few cases – anaphylactic reactions.

Contraindications

- Hemiplegic, basilar migraine and oftalmoplegicheskaya form;

- CHD (incl. Prinzmetal angina, myocardial infarction, postinfarktnыy kardioskleroza), as well as the presence of symptoms, to suggest ischemic heart disease;

- Peripheral arterial occlusive disease;

- A stroke or transient ischemic attack (incl. history);

- Uncontrolled hypertension;

- Expressed human liver;

- Expressed by the human kidney;

- Concomitant use of drugs, containing ergotamine or a derivative thereof (incl. metisegrid);

- Simultaneous reception of MAO inhibitors and the period up to 14 days after their cancellation;

- Pregnancy;

- Lactation (breast-feeding);

- Before the age of the patients 18 and older 65 years;

- Hypersensitivity to the drug.

FROM caution prescribe the drug to patients with controlled hypertension, Disease, where absorption may vary, metabolism or excretion of sumatriptan (abnormal liver function or kidney), epilepsy (incl. any state with a reduction in the threshold of convulsive readiness), hypersensitivity to sulfonamides (the use of sumatriptan may cause allergic reactions of varying severity; from skin to anaphylactic reactions.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breast-feeding).

Cautions

Sumamigren^® It should be prescribed only, when the diagnosis of migraine is not in doubt. Apply the drug should be as soon as possible after symptom onset, although it is equally effective when used at any stage of attack.

The preparation is not intended for the prevention of migraine.

In appointing sumamigren^® patients with previously diagnosed with migraine or patients with atypical migraine is necessary to exclude other potentially serious neurological conditions. It should be noted, that migraine patients are at increased risk of cerebrovascular complications (stroke or transient ischemic).

Sumamigren^® should not be used in patients with suspected heart disease without prior inspection. This category includes patients in postmenopausal women, Men over the age of 40 years, Patients with risk factors for coronary heart disease. Use of the drug is possible only after eliminating cardiovascular system. If the background of the drug in such patients develop symptoms of the cardiovascular system, and there is reason to CHD, it is necessary to conduct an appropriate examination.

Do not exceed the recommended dose.

Effects on ability to drive vehicles and management mechanisms

The therapy may develop drowsiness sumatriptan (both related to the disease itself, and drug-). Therefore, during the use of the drug, patients should be with extreme caution to drive and engage in other potentially hazardous activities, requiring a high rate of psychomotor reactions.

Overdose

Admission sumatriptan oral dose above 400 mg did not cause any additional side effects.

Treatment: in the case of an overdose the patient should be monitored for 10 no, symptomatic therapy as needed.

Drug Interactions

There was no drug interactions with propranolol sumatriptan, flunarizinom, pizotifenom and ethanol.

When concomitantly with ergotamine long vasospasm observed. Sumatriptan may be administered no earlier than 24 hours after ingestion, containing ergotamine, and drugs, containing ergotamine, It can be administered no earlier than 6 hours after administration of sumatriptan.

Interoperability between sumatriptan and MAOIs, their concurrent use is contraindicated.

There are some reports about the development of weakness, hyperreflexia and incoordination in patients after simultaneous reception of sumatriptan and selective serotonin reuptake inhibitors (this combination is not recommended, and if necessary, use of such a combination should be carefully monitored condition of the patient).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.