International generic name
Drug form and composition
Tablets. One tablet (for children) contains 100 mg Aminophenazone. One tablet
(for adults) contains 300 mg Aminophenazone.
Febrile states; pain of different origin - headache, migraine, neuralgia, radiculitis,
neuritis, pain associated with arthritis; in rheumatism as an anti-inflammatory
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.
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).
The effects of Amidophen are potentiated by analgin, phenacetin, codein, phenobarbital,
and oral contraceptive agents. Aspirin increases the nephrotoxicity of Amidophen
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.
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.
20 or 800 tablets of 100 mg. 10 or 500 tablets of 300 mg.