Amigraine ADCO is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so-called “histaminic cephalalgia”. Amigraine ADCO contains a combination of Ergotamine, Caffeine and Analgin. This combination medication used to treat or prevent certain types of headaches (vascular headaches including migraine and cluster headaches). Headache pain can sometimes be caused by widened blood vessels in the head. Ergotamine works by narrowing these widened blood vessels. Caffeine increases the absorption of ergotamine and also narrows widened blood vessels.

Composition

Active Ingredients: Each Tablet contains:

• Ergotamine Tartarate 1 mg.
• Caffeine 100 mg.
• Analgin 300 mg.

Inactive ingredients: Talc, Magnesium Stearate, Starch.
Pharmaceutical form: Oral tablets.

Indications

Amigraine ADCO is used for the symptomatic treatment and prevention of migraine attacks and other types, thrombing vascular headaches. Histaminic cephalgia, and occipital neuralgia.

Dosage and Administration

• To avert or arrest an acute attack, 1 to 4 tablets daily is taken.
• A single dose of 1 to 2 tablets is sufficient in most cases to avert the attack (or according to physician’s order).

Contraindications

• Peripheral vascular diseases.
• coronary heart diseases.
• renal or hepatic dysfunction.
• and in pregnancy.

Side effects

• Increased risk or agranulocytosis and shock.
• Cardiovascular:  Transient changes in heart rate.
• GI: Nausea, vomiting are common side effects.
• Miscellaneous: Weakness of legs, limb muscle pain; numbness and tingling of the fingers and toes: localized edema, itching.

Drug interactions

• There s an increased risk of Peripheral vasoconstriction during concomitant administration of ergotamine with beta-blockers.
• Administeration of ergotamine with macrolid antibiotics such as erythromycin has produced ergotism.
• Ergotamine should not be given to patients receiving sumatriptan until 6 hours have elapsed since stopping sumatriptan-containing preparation.

Pregnancy & Lactation

It must not be taken by a pregnant woman and a breast feeding mother as it is excreted in breast milk.

Precautions & Warnings

• Dependence can develop insidiously when ergotamine tartrate is used for more than 2 days each week, even if total daily or weekly dosage recommendations are observed.
• Hypersensitivity and disturbance of white blood cells may occur during treatment with this preparation as with other pyrazolone derivatives, if during prolonged treatment the well being of the patient is impaired, the leucocytic count should be checked and in case of granulocytopenia the drug must be discontinued.
• Drug contains analgin which may cause agranulocytosis.
• Amigraine ADCO should not be given to children.

Pharmacological action

Ergotamine Tartarate is the most effective material for relieving the pain of migraine caused by increased pulsation of the dilated cerebral arterioles. The pain-relieving effect of ergotamine is ascribed to a specific vasoconstrictor action on the ensuring reduction of the pathologically raised pulse amplitude of the extracranial arteries. Its effect is further enhanced by its marked absorption caused by caffeine. Analgin has analgesic action, which helps in relieving the pain attacks.

Pharmacokinetics

Ergotamine

• Absorption: Ergotamine is poorly absorbed following GI administration but caffeine is included to improve the absorption.
• Metabolism : Ergotamine is metabolized by the liver.
• Elimination: The elimination of ergotamine is biphesic: half-lives of about 2 and 21 hours have been reported for the 2 phases, respectively. 90% of metabolites are excreted in the bile, about 4% of a dose is excreted in the urine. Some of the metabolites are pharmacologically active. Ergotamine or its metabolites have been detected in breast milk.

Caffeine

• Absorption : absorbed readily after oral doses and is widely distributed throughout the body.
• Metabolism: In adults, caffeine is metabolised almost completely in the liver.
• Elimination : excreted in the urine with only about 1% unchanged. Elimination half-lives are about 3 to 7 hours in adults but may be in excess of 100 hours in neonates.

Analgin

• Absorption : Analgin is rapidly hydrolysed in gastric juice to the active metabolite 4-methyl-amino-antipyrine which is absorbed from the intestine.
• Metabolism: 4-methyl-amino-antipynne. which after absorption undergoes metabolism to 4-formyl-amino-antipyrine and other metabolites.
• Elimination: after absorption 4-methyl-amino-antipyrine undergoes metabolism to 4-formyl-amino-antipyrine and other metabo-lites. Most of a dose is excreted in the urine as metabolites. Dipyrone metabolites are also distributed into breast milk.

Package and storage

• Storage: Keep at temperature not exceeding 30°C in dry place.
• Package: Strips of 10 tablets.
• Produced by: The Arab Drug Company, Cairo – A.R.E.

Amigraine ADCO – Information Leaflet

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