Nomigren, 10 pcs.

Nomigren is a combination drug, it has antimigraine, antispasmodic and analgesic effects.

Ergotamine is an ergot alkaloid, a partial agonist of serotonin receptors, non-selectively blocks 5-HT1A-1D receptors. Ergotamine is characterized by alpha-adrenoblocking activity in combination with a pronounced direct vasoconstrictor effect on the smooth muscle of peripheral and cerebral vessels.

In this regard, against the background of ergotamine action the tonic effect on peripheral and cerebral vessels prevails, which is of therapeutic importance in relieving migraine attacks.

Propiphenazone has analgesic effects.

Caffeine accelerates absorption of ergotamine and increases its therapeutic effect. Caffeine also has a tonic effect on the cerebral vessels.

Camilofin has an antispasmodic effect, eliminating the initial vasospasm in the prodromal phase of a migraine attack.

Mecloxamine has anticholinergic, antihistamine, moderate sedative and antiemetic effects.

Pharmacokinetics

Ergotamine is slightly absorbed from the gastrointestinal tract after oral administration.

The bioavailability is low due to intense metabolism during primary passage through the liver.

The main metabolites are excreted through the intestine with bile. About 4% is excreted unchanged by the kidneys. Excretion of ergotamine is biphasic. T_1/2 in the final phase is 21 hours.

Caffeine is well absorbed in the intestine (including the colon). T_1/2 is about 5 h. About 10% is excreted unchanged by the kidneys.

After oral administration, about 25% of propifenazone is metabolized by primary passage through the liver, V_d is 0.4 L/kg, C_max in plasma is reached within 30-40 min, maximum effect in 90 min, T_1/2 is 2.1-2.4 h, excreted by the kidneys.

The T_1/2 of mecloxamine and camilofin is 1.5-2 h, excreted by the kidneys.

Indications

Acute attacks of migraine (including those accompanied by an aura).
Migraine-like headaches of vascular origin.

Pharmacological effect

Nomigren is a combination drug that has anti-migraine, antispasmodic and analgesic effects.

Ergotamine is an ergot alkaloid, a partial agonist of serotonin receptors, indiscriminately blocks 5-HT1A-1D receptors. Ergotamine is characterized by alpha-adrenergic blocking activity in combination with a pronounced direct vasoconstrictor effect on the smooth muscles of peripheral and cerebral vessels.

In this regard, against the background of the action of ergotamine, the tonic effect on peripheral and cerebral vessels predominates, which has therapeutic significance in relieving migraine attacks.

Propyphenazone has an analgesic effect.

Caffeine accelerates the absorption of ergotamine and enhances its therapeutic effect. Caffeine also has a tonic effect on brain vessels.

Kamilofin has an antispasmodic effect, eliminating the initial vasospasm in the prodromal phase of a migraine attack.

Mecloxamine has anticholinergic, antihistamine, moderate sedative and antiemetic effects.

Pharmacokinetics

After oral administration, ergotamine is absorbed to a small extent from the gastrointestinal tract.

Bioavailability is low due to intensive metabolism during the first pass through the liver.

The main metabolites are excreted through the intestines with bile. About 4% is excreted unchanged by the kidneys. Elimination of ergotamine is biphasic. T1/2 in the final phase – 21 hours.

Caffeine is well absorbed in the intestines (including the colon). T1/2 is about 5 hours. About 10% is excreted unchanged by the kidneys.

After oral administration, about 25% of propyphenazone is metabolized during the initial passage through the liver, Vd is 0.4 l/kg, Cmax in blood plasma is achieved within 30–40 minutes, the maximum effect is after 90 minutes, T1/2 is 2.1–2.4 hours, excreted by the kidneys.

T1/2 of mecloxamine and camilofin is 1.5–2 hours, excreted by the kidneys.

Special instructions

Do not use the drug to prevent a migraine attack!

Patients taking Nomigren need to periodically monitor their blood count.

When systematically taking drugs containing ergotamine, the patient should be warned about the need to strictly adhere to the prescribed doses in order to avoid the development of ergotism phenomena: peripheral vascular spasm – loss of sensitivity, paresthesia, tingling sensation in the extremities, pain in the lower extremities, cyanosis (especially of the fingers), a marked decrease in pulsation, as well as disorders of the central nervous system – dizziness, stupor, coma, convulsions.

If symptoms such as numbness in the tips of the fingers or toes, pain in the heart, acceleration or deceleration of heart rate appear, you should immediately stop taking the drug and consult a doctor.

Influence on the ability to drive vehicles and other mechanisms.

The drug may affect the patient’s psychophysical abilities, especially when taken simultaneously with alcohol or drugs that depress the central nervous system. Do not drive vehicles or operate potentially dangerous mechanisms for 2–3 hours after taking Nomigren.

Active ingredient

Kamilofin, Caffeine, Mecloxamine, Propyphenazone, Ergotamine

Composition

1 film-coated tablet contains:

Active ingredients

Propyphenazone 200,000 mg.
Caffeine 80,000 mg.
Camilofin chloride 25,000 mg.
Mecloxamine citrate 20,000 mg.
Ergotamine tartrate 0.750 mg.

Excipients

Corn starch,

lactose monohydrate,

crospovidone,

talc,

magnesium stearate,

gelatin,

colloidal silicon dioxide,

tartaric acid,

iron oxide red dye,

titanium dioxide,

macrogol 6000,

polyacrylate dispersion,

polysorbate 80,

carmellose sodium.

Pregnancy

The use of Nomigren is contraindicated during pregnancy (due to its uterine stimulating effect).

Lactation

The use of the drug during lactation is not recommended, since ergotamine and caffeine pass into breast milk in sufficient quantities (there is a risk of developing ergotism in the child).

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Use in children

Contraindicated in children and adolescents under 15 years of age.

Contraindications

hypersensitivity to the components of the drug;
organic diseases of the cardiovascular system (including acute myocardial infarction, angina pectoris, severe atherosclerosis, paroxysmal tachycardia, frequent ventricular extrasystole, arterial hypertension);
severe obliterating diseases of peripheral vessels;
glaucoma;
benign prostatic hyperplasia with urinary retention;
thyrotoxicosis;
severe liver and/or kidney failure;
sepsis;
lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose);
pregnancy;
lactation period;
age under 15 years.

With caution: sleep disturbances; anxiety disorders (agoraphobia, panic disorders); megacolon; old age; simultaneous use of corticosteroids; migraine accompanied by focal neurological disorders.

Side Effects

From the side of the central nervous system: sleep disturbances, increased excitability; with prolonged use, addiction may develop.

From the cardiovascular system: transient tachycardia, ECG changes, increased blood pressure, pain in the heart, bradycardia, muscle pain, decreased pulsation in the extremities, paresthesia in the extremities (most of these effects are associated with an increase in peripheral vascular tone).

From the digestive system: nausea, vomiting; rarely – diarrhea.

Other: weakness in legs; rarely – peripheral edema, skin itching.

Interaction

Cannot be prescribed simultaneously with vasoconstrictors, because this can lead to life-threatening hypertension. When used simultaneously with serotonin agonists (including sumatriptan), the risk of developing prolonged vasospastic reactions increases.

When used simultaneously with macrolide antibiotics (including erythromycin), the concentration of ergotamine in the blood plasma may increase.

Amantadine, quinidine and tricyclic antidepressants potentiate the effect of the drug.

Nomigren enhances the effect of ethanol and sedatives.

Alpha adrenergic stimulants, beta blockers and nicotine enhance the vasoconstrictor effect of the drug.

Overdose

Symptoms: nausea, vomiting, general weakness, paresthesia, tinnitus, pain and cyanosis of the lower extremities (with decreased or complete absence of pulsation in the peripheral arteries), increased or decreased blood pressure, tachycardia, drowsiness, stupor, convulsions, anxiety.

Treatment: gastric lavage, if no more than 4 hours have passed after taking the drug, administration of activated charcoal, and, if necessary, symptomatic therapy.

Short product description

A combined drug for the treatment of migraine and migraine-like headaches of vascular origin. A drug with a unique composition of five components: ergotamine, kamilofin, caffeine, mecloxamine, propyphenazone. Effectively and quickly eliminates not only pain, but also other symptoms of a migraine attack (nausea, vomiting, photophobia).

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Bosnalek JSC, Bosnia and Herzegovina