Sumatriptan-Teva, 50 mg 2 pcs

Indications

Active ingredient

Composition

How to take, the dosage

Sumatriptan should not be used prophylactically.

The drug should be used at the first signs of a migraine attack. Sumatriptan is equally effective at any stage of a migraine attack.

The drug is taken orally by swallowing the whole tablet with water.

The recommended dose is 50 mg (1 tablet). Some patients may need a higher dose, 100 mg.

If a migraine attack does not resolve after the first dose, a second dose of the drug should not be taken to resolve the same migraine attack. In such cases, paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs may be used to stop the attack. However, sumatriptan may be used to control subsequent migraine attacks.

If the patient felt improvement after the first dose of the drug, and then the symptoms resumed, a second dose may be taken within the next 24 hours. In this case, the maximum dose of sumatriptan should not exceed 300 mg over a 24-hour period.

Sumatriptan can be used no sooner than 24 hours after taking ergotamine-containing medications; conversely, ergotamine-containing medications can be used no sooner than 6 hours after taking sumatriptan.

Particular patient groups

Patients of advanced ageElderly patients

The experience with sumatriptan in patients older than 65 years is limited. Pharmacokinetics in patients in this population are not significantly different from those in younger patients, but until further clinical data are available, the use of sumatriptan in patients over 65 years is not recommended.

Patients with hepatic impairment

In patients with hepatic impairment, doses should be lower (25-50 mg).

Interaction

No interaction of sumatriptan with propranololol, flunarizine, pizotifen and ethyl alcohol has been noted.

In concomitant administration with ergotamine, prolonged vasospasm was noted.

There are limited data on interactions with drugs containing ergotamine or other 5-HT1 receptor triptans/agonists, there is theoretically a possible increased risk of coronary vasospasm, and co-administration of these drugs is contraindicated.

The period of time between the use of sumatriptan and ergotamine-containing drugs or another 5-NT1 receptor triptan/agonist is unknown. It will depend, among other things, on the dose and type of medication administered. The action may be additive in nature. It is recommended that you wait at least 24 hours after using ergotamine or another 5-NT1 receptor tryptan/agonist before using sumatriptan. Conversely, it is recommended to wait at least 6 hours after using sumatriptan before using ergotamine-containing medications and at least 24 hours before using another tryptan/5-NT1 receptor agonist.

Possible interaction between sumatriptan and MAO inhibitors, their simultaneous use is contraindicated.

There have been rare reports from post-registration surveillance of the development of serotonin syndrome (including mental disorders, autonomic lability, and neuromuscular disorders) as a result of concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. The development of serotonin syndrome has also been reported with concomitant use of triptans with selective serotonin and norepinephrine reuptake inhibitors (SSRIs).

Indesirable reactions may occur more frequently during concomitant use of triptans and herbal preparations containing St. John’s Wort.

Special Instructions

Sumatriptan should be prescribed only if the diagnosis of migraine is beyond doubt.

Sumatriptan should not be used prophylactically.

Sumatriptan is contraindicated for use in hemiplegic, basilar and ophthalmoplegic forms of migraine. As with the use of other drugs for the treatment of acute migraine attacks, other types of neurological pathology should be excluded before treating a headache attack in patients with previously undiagnosed migraine or in patients with an atypical form of migraine. It should be noted that patients with migraine have an increased risk of developing certain cerebrovascular disorders (e.g., stroke or transient ischemic attacks).

The administration of sumatriptan may be associated with the occurrence of transient symptoms such as chest pain and tightness extending to the neck region; symptoms may be intense. If these symptoms are suspected to be a manifestation of CHD, appropriate diagnostic evaluation should be performed.

Sumatriptan should not be used in patients at risk for cardiovascular disease without prior evaluation to rule it out (these patients include postmenopausal women, men over 40 years of age, and patients with risk factors for CHD). However, the examination does not always allow detecting a heart disease in every patient. In very rare cases, patients with no history of cardiovascular disease may have serious adverse cardiovascular reactions.

Sumatriptan should be used with caution in patients with controlled arterial hypertension, as transient increases in blood pressure and peripheral vascular resistance have been observed in a small number of patients.

There have been rare post-registration reports of the development of serotonin syndrome (including mental disorders, autonomic lability, and neuromuscular disorders) as a result of concomitant use of SSRIs and sumatriptan. Serotonin syndrome has also been reported with concomitant use of triptans with SSRIs.

If a patient is indicated for concomitant use of SSRIs and/or SSRIs, the patient’s condition should be monitored carefully.

The concomitant use of any triptan (5-HT1 agonist) with sumatriptan is not recommended.

Sumatriptan should be used with caution in patients whose absorption, metabolism, or excretion of sumatriptan may be significantly altered (e.g., patients with impaired renal or hepatic function).

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors for decreased seizure threshold.

In patients with known hypersensitivity to sulfonamides, administration of sumatriptan may cause allergic reactions that range from skin hypersensitivity to anaphylaxis. There are limited data on cross-sensitivities, but caution should be exercised when using sumatriptan in such patients.

Misuse of medications intended to relieve migraine attacks is associated with an increase in headaches in sensitive patients (drug abuse-related headache). In this case, withdrawal of the drug should be considered.

The recommended dose of sumatriptan should not be exceeded.

Influence on driving and operating ability

Migraine patients may experience somnolence associated both with the disease itself and with taking sumatriptan. Patients should be especially cautious when driving or operating moving machinery.

Synopsis

Contraindications

Side effects

The undesirable reactions presented below are listed according to organ system involvement and frequency of occurrence. The frequency is defined as follows: very common (> 1/10); frequent (> 1/100 and < 1/10); not common (> 1/1000 and < 1/100); rare (> 1/10,000 and < 1/1000); very rarely (< 1/10,000); unknown (frequency cannot be estimated from available data).

Data from clinical studies

Nervous system disorders: frequent – dizziness, somnolence, sensory disturbances (including paresthesias and decreased sensitivity).

Vascular disorders: frequent – transient increase in blood pressure (soon after taking the drug), hot flashes.

Disorders of the respiratory system, thorax and mediastinum: often – shortness of breath.

Gastrointestinal disorders: frequently – nausea, vomiting (causal relationship of adverse reactions with taking the drug is not proven).

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

General disorders and disorders at the site of administration: Frequently, 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 the chest and throat), weakness, fatigue (usually mild to moderate, transient).

Laboratory and instrumental findings: very rarely, minor abnormalities in hepatic test values.

Data from post-registration observations

Immune system disorders: unknown- hypersensitivity reactions that range from cutaneous manifestations of hypersensitivity to anaphylaxis.

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

Visual disturbances:unknown – flickering, diplopia, decreased visual acuity. Visual loss (usually transient). However, visual disturbances may be due to the migraine attack itself.

Cardiac disorders: unknown – bradycardia, tachycardia, palpitations, arrhythmias, ECG signs of transient myocardial ischemia, coronary vasospasm, angina, myocardial infarction.

Vascular disorders: unknown – decreased blood pressure, Raynaud’s syndrome.

Gastrointestinal tract disorders: unknown – ischemic colitis, diarrhea.

Muscular and connective tissue disorders: frequently – myalgia; unknown – neck stiffness, arthralgia.

Mental disorders: unknown – anxiety.

Skin and subcutaneous tissue disorders: unknown – hyperhidrosis.

Overdose

Pregnancy use

Pregnancy

Caution should be exercised when using the drug during pregnancy and the potential benefits to the mother and possible risks to the fetus should be assessed.

Post-registration follow-up data are available for more than 1000 women taking sumatriptan during the first trimester of pregnancy. Due to insufficient information, it is premature to draw definitive conclusions about an increased risk of birth defects. There is limited experience with the drug in women in the second and third trimesters of pregnancy.

The evaluation of experimental animal studies showed no direct teratogenic or adverse effects of the drug on prenatal and postnatal development. However, in rabbits, effects on embryonic and fetal viability were observed.

Breastfeeding

Sumatriptan has been shown to be excreted into breast milk following subcutaneous administration. Exposure to the newborn can be minimized by avoiding breastfeeding for 12 h after taking the drug.

Similarities