Номигрен®

General characteristics. Structure:

Active agent:
Propyphenazone            of 200,000 mg
Caffeine                        of 80,000 mg
Kamilofina chloride     of 25,000 mg
Mecloxamine citrate   of 20,000 mg
Ergotamine tartrate        of 0,750 mg
Excipients: starch corn, lactoses monohydrate, кросповидон, talc, magnesium stearate, gelatin, silicon dioxide colloid, tartaric acid, dye ferrous oxide red, titanium dioxide, macrogoal 6000, polyacrylate dispersion, polysorbate 80, karmelloza of sodium.

Description. Tablets, coated round form, biconvex, dark pink color.

Pharmacological properties:

Pharmacodynamics. The combined drug, has protivomigrenozny, spasmolytic and analgeziruyushchy effect.
Ergotamine - ergot alkaloid; is a partial serotonin receptor agonist, not selectively blocks 5-HT1A-ID-receptors. Alpha and adrenoceptor blocking activity in combination with the expressed direct vasoconstrictive action on smooth muscles of peripheral and brain vessels is characteristic of ergotamine. In this regard against the background of effect of ergotamine tonic influence on peripheral and brain vessels prevails that has therapeutic value when stopping attacks of migraine. Propyphenazone possesses analgeziruyushchy action.
Caffeine accelerates absorption of ergotamine and strengthens its therapeutic effect. Also caffeine has tonic effect on brain vessels.
Kamilofin has spasmolytic effect, eliminating an initial vasospasm in a prodromal phase of an attack of migraine.
Mecloxamine renders anticholinergic, antihistaminic, moderately sedative and antiemetic action.

Pharmacokinetics. After intake ergotamine in small degree is soaked up from digestive tract. Bioavailability low owing to intensive metabolism at "primary passing" through a liver.
The main metabolites are allocated through intestines with bile. About 4% are removed by kidneys in not changed look. Removal of ergotamine has two-phase character. An elimination half-life (Т½) in a final phase - 21 h.
Caffeine is well soaked up in intestines (including thick). Т½ makes about 5 h. About 10% are allocated with kidneys in not changed look.
After intake about 25% of propyphenazone are exposed to metabolism at "primary passing" through a liver, the volume of distribution makes 0,4 l/kg, the maximum concentration in a blood plasma is reached within 30-40 minutes, the maximum effect - in 90 minutes, Т½ - of 2,1 - 2,4 h, removed by kidneys.
Т½ mecloxamine and a kamilofin - 1,5-2 h, are brought by kidneys.

Indications to use:

Bad attacks of migraine (including followed by aura) and migrenepodobny headaches of vascular genesis.

Route of administration and doses:

Inside.
Номигрен® it is necessary to accept at the very beginning of an attack.
For the first reception the recommended dose - 1-2 tablets inside, washing down with water if in 30 min. improvement of a state does not come, it is necessary to take 1-2 more pill. The maximum daily dose no more than 4 tablets, the maximum dose within 1 week no more than 10 tablets.
Drug is not recommended to be used it is long: after 7 days of use in the cases demanding more prolonged treatment do a break for 3-4 days.

Features of use:

Not to use drug for the purpose of prevention of an attack of migraine! The patients accepting Nomigren® need to control a blood pattern periodically.
At systematic reception of the drugs containing ergotamine it is necessary to warn the patient about need to strictly adhere to the appointed doses in - avoidance of development of the phenomena of an ergotism: a spasm of peripheral vessels - an anesthesia, paresthesias, feeling of "pricking" in extremities, the lower extremity pains, cyanosis (especially fingers), the expressed reduction of a pulsation, and also disturbances from TsNS-dizziness, a stupor, a coma, spasms.
At emergence of such symptoms as numbness of finger-tips of brushes or feet, pains in heart, acceleration or delay of heart rate, administration of drug it is necessary to stop and see a doctor immediately.

Influence on ability to manage motor transport and other mechanisms
Номигрен® can influence psychophysical abilities of the patient, especially at a concomitant use with alcohol or drugs, the oppressing TsNS. It is impossible to manage vehicles and to work with potentially dangerous mechanisms for 2-3 h after administration of drug of Nomigren®.

Side effects:

From the central nervous system (цнс): sleep disorders, hyperexcitability; at prolonged use accustoming development is possible.
From cardiovascular system: tranzitorny tachycardia, changes on an ECG, increase in the arterial pressure (AP), pain in heart, bradycardia, muscle pains, reduction of a pulsation in extremities, paresthesia in extremities (the majority of the specified effects is connected with increase in a tone of peripheral vessels).
From the alimentary system: nausea, vomiting; seldom - diarrhea.
Others: weakness in legs; seldom - peripheral hypostases, a skin itch.

Interaction with other medicines:

Amantadin, quinidine and tricyclic antidepressants exponentiate effect of drug.
Номигрен® strengthens effect of ethanol and sedatives.
Alpha адреностимуляторы, beta adrenoblockers and nicotine strengthen vasoconstrictive effect of drug.
It is impossible to appoint along with vasoconstrictors since can lead to life-threatening arterial hypertension.
At simultaneous use with serotonin agonists { including with sumatriptany) raises. risk of development of the prolonged vasospastic reactions.
At simultaneous use with antibiotics of group of makrodid (including with erythromycin) increase in concentration of ergotamine in a blood plasma is possible.

Contraindications:

Hypersensitivity to drug components, organic diseases of cardiovascular system (including an acute myocardial infarction, stenocardia, the expressed atherosclerosis, a Bouveret's disease, frequent ventricular premature ventricular contraction, arterial hypertension), the expressed obliterating diseases of peripheral vessels, glaucoma, a benign hyperplasia of a prostate with an ischuria, a thyrotoxicosis, the expressed liver and/or renal failure, sepsis, pregnancy and the period of a lactation, age is younger than 15 years, a lactose intolerance, deficit of lactase or glyukozo-galaktozny malabsorption (drug contains lactose).
With care: sleep disorders, alarming frustration (agoraphobia, panic frustration), megacolon, advanced age, concomitant use of glucocorticosteroids; the migraine which is followed by focal neurologic disturbances.

Use at pregnancy and in the period of a lactation
Use of the drug Nomigren® is contraindicated at pregnancy (owing to its effect of stimulation of a uterus).
Use of drug in the period of a lactation as ergotamine and caffeine get into breast milk in enough is not recommended (there is a risk of development of an ergotism in the child). In need of use of drug in the period of a lactation, breastfeeding needs to be stopped.

Overdose:

Symptoms: nausea, vomiting, the general weakness, paresthesias, a sonitus, pain and cyanosis of the lower extremities (with decrease or total absence of a pulsation on peripheral arteries), increase or decrease in the ABP, tachycardia, drowsiness, a stupor, spasms, uneasiness. Treatment: a gastric lavage if there passed no more than 4 hours after administration of drug, reception of absorbent carbon, if necessary - performing symptomatic therapy.

Storage conditions:

At a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets are coated.
On 10 or 20 tablets, coated in the white propylene tuba corked by a white plastic cover with control of the first opening.
Each tuba together with the application instruction is placed in a cardboard pack.