International generic name

Aminophenazone

Drug form and composition

Tablets. One tablet (for children) contains 100 mg Aminophenazone. One tablet (for adults) contains 300 mg Aminophenazone.

Indications

Febrile states; pain of different origin - headache, migraine, neuralgia, radiculitis, neuritis, pain associated with arthritis; in rheumatism as an anti-inflammatory agent.

Dosage and administration

In adults Amidophen is administered orally in the following dose: 300 mg 3 or 4 times daily. In the cases of acute rheumatism the dose can reach 2 grams daily, divided in four equal doses. In children Amidophen is used orally 3 to 4 times daily with the following single doses: for 2 to 5 years old - 50 - 100 mg for the single dose; for 6 to 12 years old - 100-150 mg for the single dose.

Contraindications

Hypersensitivity to some of the product components or to pyrazolone preparations, hematological diseases (agranulocytosis, leucopenia), kidney diseases with oliguria and edema, pregnancy and breast feeding.

Special warnings and precautions

In cases of prolonged treatment, regular checks of blood count and kidney function are necessary. When prolonged treatment with Amidophen is necessary in patients suffering from peptic ulcer, a H2-blocker should be administered concurrently. During the treatment with this drug a change in urine colour may be observed (dark yellow to red colour).

Drug interactions

The effects of Amidophen are potentiated by analgin, phenacetin, codein, phenobarbital, and oral contraceptive agents. Aspirin increases the nephrotoxicity of Amidophen

Adverse reactions

Skin rash, urticaria, more rarely angioneurotic edema; in great doses - collapse, cyanosis. Amidophen stimulates the central nervous system and in toxic doses can lead to seizures. In the small children Amidophen can provoke hyperthermic convulsions. After prolonged usage it can induce granulocytopenia or agranulocytosis, especially in people with increased sensitivity. Rarely observed reactions are nausea, loss of appetite, vomiting, diarrhea, jaundice, hyperglycemia.

Pharmacological mechanisms

Amidophen is a preparation of the group of pyrazolone derivatives. It posesses antipyretic, analgesic, and relatively weaker anti-inflammatory activity. The antipyretic activity of the drug is related to the inhibition of cyclooxygenase and blocking of the synthesis of endogenous pyrogens. The analgesic effect is due mainly to the inhibition of the production of prostaglandins in the periphery. Some role also plays the inhibition of the brain cyclooxygenase, and respective decrease of the quantity of prostaglandin E, which leads to increase in the threshold of pain sensitivity at the level of the thalamus. The anti-inflammatory action of Amidophen is related to the inhibition of the prostaglandin production by cyclooxygenase inhibition.

Supplied

20 or 800 tablets of 100 mg. 10 or 500 tablets of 300 mg.

Expiry

2 years.