Sumatriptan 100 mg 2 coated tablets

indication of migraine attack with or without aura

Section: Method of administration and doses

Take orally, the tablet should be swallowed whole with water. Treatment should begin 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 taking the first dose, the medication should not be used again to relieve the same attack.
To relieve subsequent attacks (when symptoms decrease or disappear and then resume), a second dose can be taken within the next 24 hours, provided that the interval between doses is at least 2 hours.
The maximum daily dose is 300 mg.

Composition

sumatriptan succinate 100mg;
Excipients: MCC, lactose monohydrate, povidone or sodium carboxymethyl starch, magnesium stearate

Tablets coated with a film shell

Contraindications

• hemiplegic, basilar, or ophthalmoplegic forms of migraine;

• ischemic heart disease or the presence of symptoms suggesting its presence;

• myocardial infarction in the medical history;

• pharmacologically uncontrolled arterial hypertension;

• occlusive diseases of peripheral vessels;

• stroke or transient ischemic attack (including in the medical history);

• severe liver and kidney function disorders;

• simultaneous use with ergotamine or its derivatives and within 24 hours after their use;

• use against the background of monoamine oxidase inhibitors or earlier than 2 weeks after discontinuation of these drugs;

• age under 18 and over 65 years (efficacy and safety not established);

• pregnancy;

• breastfeeding (breastfeeding is possible no earlier than 24 hours after taking the drug);

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

Special Instructions

Do not use for the prevention of migraine attacks. Treatment should not be initiated in patients at risk for cardiovascular issues without prior examination (women in the postmenopausal period, men over 40 years of age, individuals with risk factors for the development of coronary heart disease). Before prescribing sumatriptan to patients with newly diagnosed or atypical migraine, other potentially dangerous neurological diseases should be ruled out. After taking sumatriptan, chest pain and a feeling of tightness may occur. The pain can be intense and radiate to the neck. If there is reason to believe that these symptoms are manifestations of coronary heart disease, appropriate examination must be conducted.
Effect on the ability to drive vehicles and operate machinery
During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased attention and quick psychomotor reactions.

Section: Side Effects

The frequency of the side effects listed below was determined as follows: very common - more than 1/10; common - from more than 1/100 to less than 1/10; uncommon - from more than 1/1000 to less than 1/100; rare - from more than 1/10,000 to less than 1/1000; very rare - less than 1/10,000, including individual cases.
Nervous system: common - dizziness, drowsiness, sensory disturbances, including paresthesia and decreased sensitivity.
Cardiovascular system: common - transient increase in blood pressure (observed shortly after taking the medication), "flushing."
Respiratory system and organs of the cell group: common - dyspnea, mild, transient irritation of the mucous membrane or burning sensation in the nasal cavity or throat, nasal bleeding.
Gastrointestinal tract: common - nausea, vomiting.
Musculoskeletal system and connective tissue: common - 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: common - pain sensations, feeling of cold or heat, feeling of pressure or tightness (usually transient, can be intense and occur in any part of the body, including the chest and throat), weakness, fatigue (usually mild or moderately expressed, transient).
Laboratory indicators: very rare - minor deviations in liver function tests.
Post-marketing surveillance

Interaction

When administered simultaneously with ergotamine and ergotamine-containing medications, prolonged vasospasm may occur.

There may be an interaction between sumatriptan and MAO inhibitors (decreased metabolism of sumatriptan, increased concentration).

When sumatriptan is used concurrently with selective serotonin reuptake inhibitors, weakness, hyperreflexia, and coordination disturbances may develop.

No interaction of sumatriptan with propranolol, flunarizine, pizotifen, and ethanol has been noted.

Section: Pharmacodynamics

Sumatriptan is a specific selective agonist of 5-HT1 serotonin receptors, predominantly located in the blood vessels of the brain, and their stimulation leads to the constriction of these vessels. It does not affect other subtypes of 5-HT serotonin receptors (5-HT2-7). It activates the sensitivity of trigeminal nerve receptors. The therapeutic effect usually occurs within 30 minutes after administration.

Section: Pharmacokinetics

After oral administration, it is rapidly absorbed. 70% of the maximum plasma concentration is reached within 45 minutes. Cmax in plasma is 54 ng/ml. Bioavailability is 14% (due to presystemic metabolism and incomplete absorption). Binding to plasma proteins is 14-21%.
It is metabolized by oxidation involving monoamine oxidase (primarily isoenzyme A), resulting in metabolites, the main ones being the indoleacetic acid analogue of sumatriptan, which has no pharmacological activity regarding 5-HT1 serotonin receptors, and its glucuronide. It is excreted by the kidneys, primarily in the form of metabolites.