Migrepam pills 2.5 №2

Tablets, film coated.

Packaging

2 pcs.

pharmachologic effect

Zolmitriptan is a selective serotonin 5HT1B / 1D receptor agonist, stimulation of which leads to vasoconstriction. It has high affinity for recombinant human serotonin 5HT1B / 1D receptors and moderate affinity for serotonin 5HT1A receptors. Zolmitriptan does not have affinity and does not show significant pharmacological activity with respect to serotonin 5HT2, 5HT3, 5HT4, adrenergic, histamine, muscarinic and dopaminergic receptors.

The introduction of zolmitriptan to laboratory animals resulted in vasoconstriction in the carotid artery pool. In addition, the results of studies on laboratory animals suggest that zolmitriptan blocks the central and peripheral activity of the trigeminal nerve by inhibiting the release of the peptide associated with the calcitonin gene, the vasoactive intestinal peptide and substance P.

In clinical studies, the effect of zolmitriptan on headaches and other migraine symptoms (such as nausea, photophobia, phonophobia) was observed 1 hour later and increased from 2 to 4 hours after taking the drug.

Zolmitriptan is equally effective for migraine with aura, migraine without aura, and migraine associated with menstruation.Taking zolmitriptan during aura did not prevent migraine headache, so the drug should be taken after the onset of a pain attack.

Indications and usage

Relief of migraine attacks with and without aura.

Contraindications

• Hypersensitivity to zolmitriptan and other components of the drug.
• Age up to 18 years.
• Older age - over 65 years old (efficacy and safety of application has not been studied).
• Pregnancy period (safety of use has not been studied).
• Hemiplegic, basilar and ophthalmoplegic migraine.
• Uncontrolled arterial hypertension.
• Coronary heart disease.
• Coronary vasospasm / Prinzmetal angina pectoris.
• Peripheral arterial disease.
• Cerebrovascular accident (including stroke or transient ischemic attack) in history.
• Wolff-Parkinson-White syndrome or arrhythmias associated with other additional impulse pathways.
• Severe renal failure (creatinine clearance less than 15 ml / min).
• Simultaneous use with other agonists of serotonin 5HT1B / 1D receptors (for example, Sumatriptan, naratriptan), ergotamine or its derivatives (including metisergid), and also within 24 hours after their cancellation.
• Simultaneous use with MAO-A inhibitors and within 14 days after their cancellation.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (lactose is part of the drug).

Severe abnormal liver function.

Pregnancy and Breastfeeding

Pregnancy

The safety of zolmitriptan during pregnancy has not been studied. The results of animal studies revealed no direct teratogenic effects. However, some data from studies of embryotoxicity suggest a possible decrease in the viability of embryos. Use of the drug is contraindicated during pregnancy.

Breastfeeding period

Zolmitriptan penetrates the milk of lactating animals. It is not known whether zolmitriptan passes into the breast milk of women during breastfeeding. It is therefore necessary with caution to approach the issue of the appointment of the drug to women during breastfeeding. The termination of breastfeeding for 24 hours allows minimizing the effect of zolmitriptan on the infant.

Special notes

Migrepam® can be used only in cases of clearly diagnosed migraine. Before prescribing zolmitriptan, as well as other means for the relief of migraine, it is necessary to exclude other possible serious neurological diseases in patients with previously undetermined migraine, as well as in patients with established diagnosis of migraine in the presence of atypical symptoms.

Zolmitriptan is not indicated for the treatment of hemiplegic, basilar, and ophthalmoplegic migraines.

In patients taking serotonin 5HT1B / 1D receptor agonists, cerebral circulation disorders were observed,including strokes. Patients with migraines may be at risk of developing certain disorders of cerebral circulation.

Zolmitriptan should not be used in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other additional pathways for impulse conduction.

Very rarely, when using this class of drugs (serotonin 5HT1B / 1D receptor agonists), coronary angiospasm, angina pectoris, and myocardial infarction were noted.

Before zolmitriptan is prescribed to patients with risk factors for coronary heart disease (CHD) (for example, smoking, hypertension, hyperlipidemia, diabetes, burdened family history of CHD), an examination of the cardiovascular system is necessary, it is necessary to monitor blood pressure and electrocardiogram. Particular attention should be paid to postmenopausal women and men over 40 years of age with these risk factors. However, not all patients during examination can detect cardiovascular diseases, and in very rare cases serious cardiovascular complications can develop in patients who have not had indications of a cardiovascular disease in history.

As with the use of other serotonin 5HT1B / 1D receptor agonists, with zolmitriptan, sensations of heaviness, pressure or tightness in the region of the heart have been reported.If you experience pain in the chest or symptoms of coronary heart disease, stop taking zolmitriptan before conducting an appropriate medical examination.

As in the case of other serotonin 5HT1B / 1D receptor agonists, a transient increase in blood pressure was noted in patients regardless of the history of hypertension (a very rare increase in blood pressure was clinically pronounced). Do not exceed recommended doses of zolmitriptan.

Side effects may be more frequent while taking triptans and herbal preparations containing St. John's wort (Hypericum perforatum). It was noted the development of serotonin syndrome with the simultaneous use of triptans and SSRIs or SSRIs. Serotonin syndrome may include the following signs and symptoms: changes in mental status, autonomic and neuromuscular symptoms. Careful observation of the simultaneous prescription of Migrepam® and SIOZS or SIOZSiN is recommended, especially during the initiation of therapy, increasing the dose or adding another drug that affects serotonin metabolism to therapy (see the section "Interaction with Other Drugs").

Excessive use of antifungal drugs can lead to an increase in the incidence of headache, which potentially requires discontinuation of treatment.If a patient has frequent or daily headaches, despite the regular use of drugs to treat this condition, you should be aware of the possibility of developing headaches with excessive use of drugs for the treatment of headaches.

Impact on the ability to drive trans. Wed and fur.:

There was no significant deterioration in the performance of psychomotor tests while taking zolmitriptan at a dose of up to 20 mg. Patients whose activities require a high rate of psychomotor reactions (for example, driving a vehicle or mechanisms) are advised to use caution because of the possible development of drowsiness and other symptoms of migraine.

Composition

1 pill contains:

Active ingredient: zolmitriptan 2,5 mg;

Excipients: anhydrous lactose 98.0 mg, microcrystalline cellulose 15.0 mg, sodium carboxymethyl starch (sodium starch glycolate) 3.0 mg, Magnesium stearate 1.5 mg;

Shell auxiliary substances: hypromellose (hydroxypropyl methylcellulose 2.4 mg, macrogol 6000 (polyethylene glycol 6000) 0.55 mg, titanium dioxide 0.6 mg, talc 0.39 mg, iron yellow oxide 0.06 mg.

Tablets are taken entirely inside with water.

The recommended dose of the drug to relieve a migraine attack is 2.5 mg (1 tablet). It is recommended to take the drug as soon as possible after the onset of a headache, but the drug is also effective when taken at a later time after the onset of an attack.If migraine symptoms reappear within 24 hours, you can take a repeated dose of Migrepam®. It is not necessary to accept the repeated dose earlier than in 2 hours after reception of the first dose. If there is no clinical effect after taking the first dose, it is unlikely that the drug will be taken again during the same attack.

If a patient has not achieved a therapeutic effect after taking a dose of 2.5 mg, Migrepam® can be used at a dose of 5 mg (2 tablets) to relieve subsequent migraine attacks.

You should not take more than 2 doses of Migrepam® per day. The total dose of zolmitriptan, taken during the day, should not exceed 10 mg (4 tablets).

Migrepam® is not indicated for the prevention of migraine.

Adverse reactions with zolmitriptan, as a rule, occur within 4 hours after taking the drug, are transient in nature and resolved spontaneously without treatment. The frequency of adverse reactions does not increase with repeated doses.

The incidence of adverse reactions is according to the WHO classification: very often (≥1 / 10 cases), often (≥1 / 100 and <1/10 cases), infrequently (≥1 / 1000 and <1/100 cases), rarely (≥ 1/10000 and <1/1000 cases) and very rarely (<1/10000 cases).

On the part of the central nervous system: often - sensitivity disorders, dizziness, hyperesthesia, paresthesia, drowsiness, feeling of "warmth" or "cold", vertigo.

Since the cardiovascular system: often - a feeling of heartbeat; infrequently - tachycardia, a slight increase in blood pressure,transient increase in blood pressure; very rarely - myocardial infarction, angina, coronary angiospasm.

On the part of the gastrointestinal tract: often - abdominal pain, nausea, vomiting, dry mouth, dyspepsia, dysphagia; very rarely, ischemia or infarction (for example, ischemia or infarction of the intestine, infarction of the spleen), the symptoms of which may be diarrhea mixed with blood and abdominal pain.

On the part of the musculoskeletal system: often - muscular weakness, myalgia.

From the urinary system: infrequently - polyuria, frequent urination; very rarely - the imperative urge to urinate.

On the part of the immune system: rarely - hypersensitivity reactions, including urticaria, angioedema, and Anaphylactic reactions.

Common disorders: often - asthenia, inertness, tightness of breath, pain or tightness in the throat, neck, chest or limbs, increased sweating.

Some of the symptoms listed may be symptoms of a migraine.

In studies on the interaction of zolmitriptan with caffeine, ergotamine, dihydroergotamine, Paracetamol, Metoclopramide, pizothiphene, Fluoxetine, rifampicin and propranolol, there were no clinically significant changes in the pharmacokinetic parameters of zolmitriptan and its active metabolite.

The results of studies involving healthy volunteers indicate a lack of pharmacokinetic and clinically significant interaction of zolmitriptan and ergotamine.However, due to the theoretical risk of coronary angioscience, the simultaneous use of these drugs is contraindicated. It is recommended to use zolmitriptan not earlier than 24 hours after taking ergotamine or its derivatives.

After the application of moclobemide (MAO-A inhibitor), a slight increase (by 26%) in AUC of zolmitriptan and a threefold increase in the AUC of its active metabolite was noted.

After taking cimetidine, an inhibitor of cytochrome P450, there was an increase in the half-life of zolmitriptan by 44% and an increase in AUC by 48%. The half-life and AUC of the active N-desmethylated metabolite were doubled. Therefore, for patients taking cimetidine, the total dose of zolmitriptan taken during the day should not exceed 5 mg. Based on the general profile of the interaction of zolmitriptan, one cannot exclude the possibility of its interaction with inhibitors of the CYP1A2 isoenzyme of cytochrome P450. Therefore, for patients taking selective CYP1A2 isoenzyme inhibitors (for example, fluvoxamine, Ciprofloxacin and other quinolones), the total dose of zolmitriptan taken during the day should not exceed 5 mg.

The pharmacokinetic interaction of zolmitriptan with selegiline (an MAO-B inhibitor) and fluoxetine (a selective serotonin reuptake inhibitor (SSRI) has not been confirmed. However, the simultaneous use of triptans and SSRIs or SIOZSNN (selective serotonin and noradrenaline reuptake inhibitors used in the serotonine and serotonin and serotonin reuptake inhibitors) did not include confirmation of serotonin and noradrenaline) (see section "Special instructions"). Like other serotonin 5 HT1B / 1D receptor agonists, zolmitriptan can slow down the absorption of other drugs.

Side effects may be more frequent while taking triptans and herbal preparations containing St. John's wort (Hypericum perforatum).

Symptoms

A single dose of zolmitriptan at a dose of 50 mg by healthy volunteers usually showed a sedative effect. The elimination half-life of zolmitriptan is 2.5–3 hours; therefore, during an overdose, patient monitoring should continue for at least 15 hours or until an overdose is observed.

Treatment

For zolmitriptan there is no specific antidote. In the case of severe intoxication, intensive care measures are recommended, including the restoration and maintenance of the airway, ensuring adequate oxygenation and ventilation of the lungs, as well as monitoring and supporting the function of the cardiovascular system.

The effect of hemodialysis and peritoneal dialysis on serum zolmitriptan concentration has not been established.

At a temperature not higher than 25 ° С.

Keep out of the reach of children.

3 years.