Product Overview
Composition
- ergotamine tartrate 1 mg
- caffeine 100 mg
Excipients:
potato starch-0,0238,
talcum powder-0.0031g
calcium stearate - 0.0006g
Excipients of the shell;
refined sugar (sucrose) - 0.1346 g,
dextrose monohydrate-0.0207g,
potato starch -0.0647,
talc -0.0072 g
calcium stearate - 0.0028 g.
pharmachologic effect
Farmgroup:
anti-migraine agent.
Farm action:
Cofetamine is a combination drug.
Caffeine causes stimulation of the central nervous system, mainly the cerebral cortex, respiratory and vasomotor centers. Increases mental and physical performance, reduces drowsiness, fatigue. It has a pronounced cardiotonic effect: it increases the strength and heart rate, increases blood pressure with hypotension.
Ergotamine causes a vasoconstrictor effect. Caffeine accelerates the absorption of ergotamine.
Pharmacokinetics :
After taking Cofetamine orally, about 62% of ergotamine is absorbed in the gastrointestinal tract. The maximum plasma concentration is reached 2 hours after ingestion. Binding to plasma proteins - 98%.
Ergotamine is metabolized in the liver with the formation of pharmacologically active metabolites. Ergotamine is excreted mainly with bile both unchanged and in the form of metabolites. Excretion is biphasic, with a half-life of 2.7 hours and 21 hours for phases I and II, respectively.
After taking the drug inside, caffeine is absorbed quickly and almost completely. Plasma protein binding is 35%. Caffeine is almost completely metabolized in the body. Metabolites are excreted mainly in the urine.
The elimination half-life is about 3.5 hours.
Indications
Migraine, arterial hypotension.
Contraindications
Individual intolerance to the components of the drug, children under 12 years old.
With caution - sleep disorders, anxiety disorders (agoraphobia, panic disorders), organic diseases of the cardiovascular system (including acute myocardial infarction, angina pectoris, severe atherosclerosis, paroxysmal tachycardia, frequent ventricular extrasystole, arterial hypertension, obliterating diseases of the peripheral vessels) hepatic and / or renal failure, glaucoma, advanced age.
Side effects
From the side of the nervous system: agitation, anxiety, tremor, anxiety, headache, dizziness, cramps, paresthesia in the extremities, increased reflexes, tachypnea, insomnia; with sudden cancellation - increased inhibition of the central nervous system, increased fatigue, drowsiness.
From the cardiovascular system: palpitations, tachycardia, cardialgia, increased blood pressure.
From the digestive system: nausea, vomiting, diarrhea.
Allergic reactions: edema, pruritus.
Other: with prolonged use - addiction, drug dependence, weakness in the legs, myalgia, Lerish’s syndrome (severe cyanosis, lack of pulse on the lower extremities, pain, distal sensitivity).
Interaction
Enhances the pharmacological effect of other drugs containing ergot alkaloids and caffeine.
Caffeine is an antagonist of adenosine (large doses of adenosine may be required).
With the combined use of caffeine and barbiturates, primidone, anticonvulsants (derivatives of hydantoin, especially phenytoin), an increase in metabolism and an increase in clearance of caffeine are possible; cimetidine, oral contraceptive drugs, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing its excretion and increasing blood concentration).
Means that cause CNS stimulation - possible excessive stimulation of the central nervous system.
Mexiletine reduces caffeine excretion by up to 50%; nicotine increases the rate of excretion of caffeine.
MAO inhibitors, furazolidone, procarbazine and selegiline - large doses of caffeine can cause the development of dangerous cardiac arrhythmias or a marked increase in blood pressure.
Caffeine reduces the absorption of Ca2 + in the digestive tract.
Reduces the effect of narcotic analgesics and sleeping pills; increases - non-narcotic analgesics (increased absorption).
Increases urinary excretion of Li + drugs.
Accelerates absorption and enhances the action of cardiac glycosides, increases their toxicity.
The combined use of caffeine with beta-blockers and can lead to the mutual suppression of therapeutic effects; with adrenergic bronchodilator drugs - to additional stimulation of the central nervous system and other additive toxic effects.
Caffeine can reduce the clearance of theophylline and, possibly, other xanthines, increasing the possibility of additive pharmacodynamic and toxic effects.
The vasoconstrictor effect of the drug is enhanced by alpha-adrenostimulants, beta-blockers, serotonin agonists (including sumatriptan) and nicotine. Macrolides increase the toxicity of ergotamine (a decrease in hepatic clearance of caffeine).
How to take, course of administration and dosage
Inside, for adults and children over 12 years old, 1-2 tablets per reception during a headache attack, then 1 tablet 2-3 times a day for several days.
The maximum single dose of Cofetamine is 2 tablets, daily - 4 tablets.
It is not recommended to use for a long time (in order to avoid the phenomenon of ergotism): after 7 days of use, in cases requiring a longer treatment, take a break (for 3-4 days).
Overdose
Symptoms: increased severity of side effects, including nausea, vomiting, numbness of the fingers and toes, lethargy, drowsiness, epileptic seizures, stupor, coma.
Treatment: gastric lavage, intake of activated carbon, if necessary, symptomatic therapy.
Special instructions
Impact on the ability to drive vehicles
During treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require concentration and speed of psychomotor reactions.
