ACETAMINOPHEN - Suppository 125 mg & 325 mg

CATEGORY :
Analgesic-Antipyretic.

MECHANISM OF ACTIONS :
The mechanism of analgesic action has not been fully determined. Acetaminophen may act predominantly by inhibiting prostaglandin synthesis in CNS and, to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or action of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Antipyretic action of Acetaminophen probably produces antipyresis by acting centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating, and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

PHARMACOKINETICS :
The rate and extent of absorption from the suppository dosage form may vary , depending on the composition of the base .

INDICATIONS :
Acetaminophen is used as an analgesic and antipyretic in the presence of Aspirin allergy, hemostatic disturbances, bleeding diatheses, upper GI disease and gouty arthritis, variety of arthritic and rheumatic conditions involving musculoskeletal pain, and other painful disorders, diseases accompanied by discomfort and fever such as common cold, flu and other bacterial and viral infections.

DRUG INTERACTIONS :
Acetaminophen interacts with alcohol, Barbiturates , Anticoagulants, Anti-inflammatory drugs.
Acetaminophen interacts with some laboratory tests (Glucose blood determination, 5-HIAA serum determination, pancreatic function test using bentiromide , uric acid serum determination, Bilirubin concentration, lactate dehydrogenase activity, prothrombin time).

ADVERSE EFFECTS :
If used as directed, Acetaminophen rarely causes severe toxicity or side effects .The side effects are usually mild, though haematological reactions have been reported. Skin rashes and allergic reactions occur occasionally . Local irritation and occasionally bleeding may occur with Acetaminophen suppositories .

W   A   R   N   I   N   G   S    :
• Usage in pregnancy : Acetaminophen crosses the placenta . It is routinely used during all stages of pregnancy .
• Usage in lactation : No adverse effects in nursing infants were reported

DOSAGE :
Usual adult and adolescent dose :
Analgesic and Antipyretic-Rectal , 325 mg to 500 mg every three hours , 325 to 650 mg every four hours , or 650 mg to 1 gram every six hours as needed , while symptoms persist . For short-term therapy ( up to ten days ) – up to 4 grams daily .For long-term therapy-up to 2.6 grams daily , unless chronic treatment with higher doses is prescribed and monitored by physician .
Usual pediatric dose :
Analgesic and Antipyretic : Rectal , 1.5 grams per square meter of body surface a day in divided doses . For children up to 2 years of age – dosage must be individualized by physician . Children 2 to 4 years of age – Rectal , 160 mg every 4 hours as needed .While symptoms persist .
Children 4 to 6 years of age : Rectal , 240 mg every 4 hours as needed . While symptoms persist . Children 6 to 9 years of age – Rectal , 320 mg every 4 hours as needed . While symptoms persist . Children 9 to 11 years of age – Rectal , 320 mg to 400 mg every 4 hours as needed . While symptoms persist Children 11 to 12 years of age – Rectal , 320 mg to 480 mg every 4 hours as needed . While symptoms persist .
NOTE : It is recommended that children up to 12 years of age receive no more than 5 doses in each 24 hours period , unless directed by physician .

HOW SUPPLIED :
Acetaminophen as 125 mg and 325 mg suppositories . 10 suppositories in one box .

STORAGE :
Store below 30º C .