Dihydrocodeine bitartrate, acetaminophen and caffeine tablets are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from this combination product, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets in pediatric patients have not been established.

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets should be given with caution to the elderly.

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets should be given with caution to patients with hepatic insufficiency. Since dihydrocodeine is metabolized by the liver and since acetaminophen potentially causes hepatotoxicity, the effects of this combination product should be monitored closely in such patients.

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets should be used with caution and at reduced dosage in the presence of impaired renal function.

Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease including pancreatitis.

Dihydrocodeine:

The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration.

Acetaminophen:

Acetaminophen in therapeutic doses rarely causes adverse reactions.

The most serious adverse reaction is hepatoxicity from overdosage (see OVERDOSAGE ). Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, and agranulocytosis have been reported in patients receiving acetaminophen or p-aminophenol derivatives. Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema, or anaphylactoid reactions are rare.

Caffeine:

Adverse reactions associated with caffeine use include anxiety, anxiety neurosis, excitement, headaches, insomnia, irritability, lightheadedness, restlessness, tenseness, tremor, extrasystoles, palpitations, tachycardia, diarrhea, nausea, stomach pain, vomiting, diuresis, urticarcia, scintillating scotoma, and tinnitus.

This combination product is subject to the provisions of the Controlled Substance Act, and has been placed in Schedule III.

Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused.

Like other opioid analgesics, dihydroc