Instruction for use: Zomig

Dosage form: Coated tablets; Film-coated tablets

Active substance: Zolmitriptan*

ATX

N02CC03 Zolmitriptan

Pharmacological group:

Serotonergic agents

The nosological classification (ICD-10)

G43 Migraine: The pain of migraine; Migraine; hemiplegic migraine; Migraine headache; A migraine attack; Continuous headache; hemicranias

Composition and release form

Tablets, coated with a coating.

Zolmitriptan 2.5 mg; 5 mg

In blistere 3 pcs .; In a pack of cardboard 1 or 2 blisters.

Pharmachologic effect

Mode of action - antimigraine.

Selectively excites 5HT1B / 1D receptors, causes vasoconstriction, inhibits the release of neuropeptides (vasoactive intestinal peptide, substance P, etc.).

Pharmacodynamics

It relieves a painful attack with migraine, relieves nausea, vomiting, photo and phonophobia.

Pharmacokinetics

Quickly absorbed by at least 64% and regardless of food intake. Absolute bioavailability is 40%. It is converted into N-desmethyl metabolite, 2-6 times more active than zolmitriptan, and inactive derivatives (indoleacetic acid and N-oxide-metabolite). 75% Cmax is achieved within 1 hour and is maintained in the plasma for the next 4-6 hours. The average half-life of zolmitriptan and its metabolites is 2.5-3 hours. More than 60% is excreted urine mainly in the form of indoleacetic metabolite and 30% With feces (mostly unchanged drug).

Clinical Pharmacology

The effect is manifested within 1 h after administration.

Indication for the Zomig

Migraine (relief of seizures).

Contraindications

Hypersensitivity, uncontrolled arterial hypertension.

Application in pregnancy and breastfeeding

Perhaps, if the expected effect of therapy exceeds the potential risk for the fetus (no studies have been conducted in pregnant women, there are no data on teratogenic properties from the results of animal experiments). Be wary of prescribing to nursing women, since there is no evidence of penetration of the drug into breast milk.

Side effects

Often: nausea, dry mouth, asthenia, dizziness, drowsiness, paresthesia and dysesthesia, a feeling of warmth, heaviness and compression in the throat, neck, limbs and chest (in the absence of ischemic changes on the ECG), muscle weakness, myalgia.

Interaction

Moclobemide (MAO-A inhibitor) increases the concentration in tissues, cimetidine - T1 / 2.

Dosing and Administration

Inside, the recommended dose for relieving a migraine attack is 2.5 mg; If symptoms persist or reappear within 24 hours, can be taken repeatedly, but not earlier than 2 hours after the first dose; If necessary, the dose can be increased to 5 mg. Clinically significant effect is manifested within 1 hour after taking Zomig. Effectiveness does not depend on the time after the onset of an attack, a pill is taken, but it is recommended to take Zomig as early as possible after the onset of migraine headache. In case of repeated attacks it is recommended that the total dose of Zomig taken within 24 hours does not exceed 15 mg.

There is no need for dose adjustments in patients with impaired renal function, as well as in patients with mild and moderate impairment of liver function. In patients with severe impairment of liver function, the recommended maximum dose taken within 24 hours is 5 mg.

Overdose

Symptoms: sedation.

Treatment: symptomatic therapy, incl. Ensuring airway patency, monitoring and maintaining the function of the cardiovascular system.

Precautionary measures

It is not recommended to appoint with symptomatic WPW-syndrome or arrhythmias associated with other additional ways of impulses, in patients with IHD. The concomitant administration of other 5HT1D agonists within 12 hours after taking Zomig should be ruled out. With caution apply during work drivers of vehicles and people whose profession is associated with increased concentration of attention (should take into account the possibility of development of the factor).

Special instructions

Safety and efficacy in children and people over 65 years of age have not been established.

Storage conditions of the drug Zomig

At temperatures below 30 ° C.

Keep out of the reach of children.

Shelf life of the drug Zomig

2 years.

Do not use after the expiry date printed on the package.