Sumatriptan-Vertex, 100 mg 2 pcs

An agonist of serotonin 5-HT1 receptors.

A drug with antimigraine activity

Indications

– migraine attack with or without aura.

Active ingredient

Composition

Tablets, film-coated 1 tablet sumatriptan 100 mg

How to take, the dosage

In the mouth, the tablet should be swallowed whole with water. Treatment should be started as soon as possible when a migraine attack occurs. The recommended dose is 50 mg, if necessary 100 mg.

If migraine symptoms do not disappear or decrease after the first dose, do not use the drug again to stop the same attack.

To control subsequent attacks (when symptoms decrease or disappear and then return), a second dose may be taken within the next 24 hours, provided that there is at least a 2-hour interval between doses.

The maximum daily dose is 300 mg.

Interaction

In concomitant administration with ergotamine and ergotamine-containing drugs prolonged vasospasm is possible.

Possible interaction between sumatriptan and MAO inhibitors (decreased intensity of sumatriptan metabolism, increased concentration).

In concomitant use of sumatriptan and drugs from the group of selective serotonin reuptake inhibitors, weakness, hyperreflexia and impaired coordination of movements may occur.

No interaction of sumatriptan with propranololol, flunirizine, pizotifen and ethanol has been noted.

Special Instructions

Do not use for the prevention of migraine attacks.

In patients of cardiovascular risk group the therapy should not be started without prior examination (women in the post-menopausal period, men over 40 years old, persons with risk factors for CHD).

Before administering sumatriptan to patients with newly diagnosed or atypical migraine, other potentially dangerous neurological diseases should be excluded. Chest pain and tightness may occur after taking sumatriptan. The pain may be intense and irradiate into the neck. If there is reason to believe that these symptoms are a manifestation of CHD, an appropriate evaluation should also be performed.

Influence on driving and operating machinery

At the time of treatment, caution must be exercised when driving motor transport and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

– hemiplegic, basilar, or ophthalmoplegic forms of migraine;

– CHD or presence of symptoms suggestive of it;

– history of myocardial infarction;

– pharmacologically uncontrolled arterial hypertension;

– peripheral vascular occlusive disease;

– stroke or transient cerebral circulation disorder (includingч. history);

– significant hepatic or renal impairment;

– concomitant use with and within 24 h after taking ergotamine or its derivatives;

– use while taking monoamine oxidase inhibitors or earlier than 2 weeks after discontinuation of these drugs;

– age under 18 and older than 65 years (efficacy and safety not established);

Pregnancy;

-Breastfeeding (breastfeeding not earlier than 24 hours after taking the drug;

– congenital galactosemia, glucose/galactose malabsorption syndrome, congenital lactose deficiency;

– hypersensitivity to any of the ingredients of the drug.

With cautiousness:epilepsy (including any condition with reduced epileptic threshold), pharmacologically controlled arterial hypertension, hepatic or renal dysfunction, hypersensitivity to sulfonamides (administration of sumatriptan may cause allergic reactions, with severity varying from skin manifestations to anaphylaxis).

Side effects

The incidence of adverse reactions listed below was determined accordingly as follows: very frequently over 1/10; frequently over 1/100 to less than 1/10; sometimes over 1/1000 to less than 1/100; rarely over 1/10 000 to less than 1/1000; very rarely less than 1/10 000, including individual cases.

Nervous system disorders:often – dizziness, somnolence, sensory disturbances, including parasthesias and decreased sensitivity.

Cardiovascular system disorders:often – transient increase in BP (observed soon after taking the drug), “hot flashes”.

Respiratory system and cage organs:often – dyspnea, mild, transient mucous membrane irritation or burning sensation in the nasal cavity or throat, nasal bleeding.

Gastrointestinal disorders:often – nausea, vomiting.

Musculoskeletal and connective tissue disorders:often – feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat).

General and local reactions:often–pain, feeling of cold or heat, feeling of pressure or tightness (usually transient, may be intense and occur in any part of the body, including chest and throat), weakness, fatigue (usually mild to moderate, transient).

Laboratory findings:very rarely, minor abnormalities in liver function tests.

Postmarketing surveillance

On the immune system:very rarely – hypersensitivity reactions, including skin manifestations, as well as anaphylaxis.

Nervous system disorders:very rarely – seizures (in some cases observed in patients with a history of seizures or concomitant conditions predisposing to the occurrence of seizures; in some patients no risk factors were identified), tremor, dystonia, nystagmus, scotoma.

Visual disorders:very rarely, flickering, diplopia, decreased visual acuity, blindness (usually transient). However, visual disturbances may be due to the migraine attack itself.

Cardiovascular system disorders:very rarely – bradycardia, tachycardia, flutter, arrhythmias, transient changes on ECG, coronary vasospasm, angina, myocardial infarction, hypotension, Raynaud’s syndrome.

Gastrointestinal disorders:very rarely – ischemic colitis, dysphagia, feeling of discomfort in the stomach.

Overdose

Symptoms: No adverse reactions other than those listed above are seen when taken orally up to 400 mg.

Treatment: gastric lavage, observation of the patient for 10 h, symptomatic therapy.

Similarities