e experiences occurring during therapy.
Patients should be advised not to adjust the dose of Acetaminophen, caffeine and dihydrocodeine bitartrate tablet without consulting the prescribing professional.
Patients should not combine Acetaminophen, caffeine and dihydrocodeine bitartrate tablet with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding 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 pregnant women 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 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.
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 pancreatitis.
ADVERSE REACTIONS:
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 d
