ng the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
Patients should be advised that Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Pregnancy
Teratogenic Effects - Pregnancy Category C.
Animal reproduction studies have not been conducted with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to a pregnant woman only if clearly needed, especially during the first trimester.
Labor and Delivery
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.
Nursing Mothers
Dihydrocodeine bitartrate, acetaminophen and caffeine 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.
Pediatric Use
Safety and effectiveness of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets in pediatric patients have not been established.
Geriatric Use
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets should be given with caution to the elderly.
Hepatic Impairment
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.
Renal Impairment
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets should be used with caution and at reduced dosage in the presence of impaired renal function.
Pancreatic/Biliary Tract Disease
Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease including acute pancreatitis.
ADVERSE REACTIONS
Dihyrocodeine
The most frequently observed reactions include lightheadedness, 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
Acetam
