nt of an overdosage of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes. Oral activated charcoal should follow. The first dose of charcoal should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotracheal intubation and artificial respiration may be necessary. Peritoneal or hemodialysis may be necessary. If hypoprothrombinemia occurs, Vitamin K should be administered.
A pure opioid antagonist, such as naloxone or nalmefene, is a specific antidote against respiratory depression which results from opioid overdose. Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.
In adults and adolescents, regardless of the quantity of acetaminophen reported to have been ingested, acetylcysteine should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion. It is not advisable to await the plasma concentration determination of acetaminophen before administering acetylcysteine. Serum liver enzyme levels should be measured. Therapy in children involves a similar treatment scheme; however, a regional Poison Control Center should be contacted.
No specific antidote is available for caffeine. In addition to the supportive measures above, administration of demulcents such as aluminum hydroxide gel may diminish gastrointestinal irritation. Seizures may be treated with intravenous diazepam or a barbiturate.
DOSAGE AND ADMINISTRATION
The usual adult dosage is one (1) Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablet orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than one tablet should be taken in a four hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.
HOW SUPPLIED
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine bitartrate* 32 mg, (*Warning: May be habit-forming), are supplied in bottles of 100 tablets NDC 0525-0032-01, and in bottles 500 tablets, NDC 0525-0032-05. Tablets are lavender, oval-shaped, single-scored and are debossed “PAL” on one side and “032” on the other side.
Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from moisture.
Dispense in a tight, light-resistant container with a child resistant closure.
Manufactured by:
MIKART, INC.
Atlanta, GA 30318
Rev. 02/99 Code 790Z00
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate (Acetaminophen, Caffeine and Dihydrocodeine Bitartrate)
PRODUCT INFO
P
