Sumitran^® (Tablets) Instructions for Use

ATC Code

N02CC01 (Sumatriptan)

Active Substance

Sumatriptan (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Serotonin 5-HT₁ receptor agonist. Agent with antimigraine activity

Pharmacotherapeutic Group

Antimigraine agent

Pharmacological Action

An agent for the treatment of migraine; an agonist of serotonin 5-HT₁ receptors. The therapeutic effect of sumatriptan is apparently due to two mechanisms: the substance excites serotonin 5-HT₁ receptors of the smooth muscles of the carotid artery system vessels and causes their constriction.

The carotid arteries supply blood to the tissues of the head, including the meninges; the dilation of the vessels of the meninges is associated with the occurrence of migraine attacks.

Furthermore, Sumatriptan activates receptors on the endings of afferent fibers of the trigeminal nerve in the dura mater, resulting in reduced release of sensory neuropeptides.

Sumatriptan poorly penetrates the blood-brain barrier and, according to experimental data, does not possess intrinsic analgesic properties.

The effect of sumatriptan usually occurs within 30 minutes after oral administration and within 10-15 minutes after subcutaneous injection.

Indications

Relief of migraine attacks and Horton’s syndrome (histamine cephalgia).

ICD codes

Dosage Regimen

Tablets

To relieve a migraine attack for oral administration, the dose is 100 mg as a single dose; sometimes a dose of less than 100 mg may be effective; in case of recurrence of the attack, a repeated dose is possible, with the daily dose not exceeding 300 mg.

Subcutaneously, it is administered at a dose of 6 mg; if necessary, a repeated injection at the same dose can be performed no earlier than 1 hour after the first administration; the maximum daily dose for subcutaneous administration is 12 mg.

For Horton’s syndrome, it is administered subcutaneously at a dose of 6 mg as a single dose during an attack; the maximum daily dose is 12 mg; the interval between injections is at least 1 hour.

Adverse Reactions

From the central nervous system dizziness, weakness, drowsiness.

From the cardiovascular system arterial hypotension or short-term increase in blood pressure, bradycardia or tachycardia.

From the digestive system nausea, vomiting.

Dermatological reactions skin rash, erythema, itching.

Local reactions with subcutaneous administration – short-term pain at the injection site.

Other sensation of warmth, tingling, pain, pressure, or tightness in various parts of the body.

Contraindications

Ischemic heart disease, arterial hypertension; simultaneous use of drugs containing ergot alkaloids or related compounds, lithium preparations, serotonin reuptake inhibitors; simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; hypersensitivity to sumatriptan.

Use in Pregnancy and Lactation

Clinical experience with the use of sumatriptan during pregnancy is limited, therefore it is contraindicated for use.

It should be used with caution during lactation. It is not recommended to breastfeed the child for 24 hours after taking sumatriptan.

Use in Hepatic Impairment

Use with caution in cases of impaired liver function.

Use in Renal Impairment

Use with caution in cases of impaired renal function.

Pediatric Use

The safety and efficacy of use in children and adolescents under 18 years of age have not been established.

Special Precautions

Sumatriptan is not used to prevent migraine attacks.

Use with caution in cases of impaired liver and kidney function, as well as in patients with epilepsy or other brain function disorders.

When relieving attacks, it is advisable to start treatment as early as possible; however, administration of sumatriptan during the aura, before the appearance of other symptoms, may not prevent the occurrence of headache.

During treatment with sumatriptan, symptoms resembling angina attacks sometimes occur – pain, feeling of tightness in the chest. In this regard, Sumatriptan should not be used if undiagnosed heart and vascular diseases are suspected, until an appropriate examination is performed.

If there is no effect from the first dose of sumatriptan, the diagnosis should be verified.

The safety and efficacy of use in children and adolescents under 18 years of age have not been established.

Effect on the ability to drive vehicles and operate machinery

With migraine, as well as during therapy with sumatriptan, drowsiness may develop. Therefore, during the period of use, patients should exercise particular caution when driving a car and engaging in other potentially hazardous activities that require high speed of psychomotor reactions.

Drug Interactions

Cases of serotonin syndrome have been described with simultaneous use with lithium salts.

With simultaneous use with moclobemide, the bioavailability of moclobemide increases in the absence of clinical manifestations.

With simultaneous use with rizatriptan, there is a risk of additive hyperstimulation of serotonin 5-HT₁ receptors; with ergotamine – the possible development of vasospasm.

With simultaneous use of St. John’s wort preparations, an enhancement of serotonergic effects and the development of side effects are possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.