Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic.

CLINICAL PHARMACOLOGY:

Acetaminophen is a peripherally acting analgesic and is well absorbed orally. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness.

The plasma elimination half-life ranges from 1 to 4 hours for acetaminophen. Acetaminophen is distributed throughout most fluids of the body, and is metabolized primarily in the liver. Little unchanged drug is excreted in the urine, but most metabolic products appear in the urine within 24 hours.

WARNINGS:

Do not use the maximum dosage of this product for more than 10 days or for fever for more than 3 days except under the advice and supervision of a physician. If you are pregnant or nursing A baby, seek the advice of a health professional before using this product.

ALCOHOL WARNING: If you generally consume 3 or more alcohol- containing drinks per day, you should consult your physician for advice on when and how you should take acetaminophen and other pain relievers.

PRECAUTIONS:

If a rare sensitivity reaction occurs, the drug should be stopped.

DRUG INTERACTIONS: No information provided.

SIDE EFFECTS: No information provided.

OVERDOSE:

Signs And Symptoms: In acute acetaminophen over dosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

Treatment: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals. The antidote, N-acetylcysteine, should be administered as early as possible, preferably within 16 hours of the overdose ingestion for optimal results, but in any case, within 24 hours.

ALCOHOL INFORMATION: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older: Two tablets every 6 hours. No more than a total of 8 tablets in any 24 hour period or as directed by a physician. Children under 12 years of age 1.5 gram/m² of body surface in divided dose.

How Supplied:

Each package of RUZ-Acetaminophen contains 10 blisters and each blister contains 10 tablets.

Store below 30°C.

Reference: PDR 2000, page 1693-4

                  USPDI for Professional Health Care, 2004, Page 9-15

                  Martindale 2005, Page 76-9

* Ruzaphen® is the trade name of Acetaminophen 500 mg tablet.