Caffeine Drug Interactions:
Caffeine may enhance the cardiac inotropic effects of beta-adrenergic stimulating agents. Co-administration of caffeine and disulfiram may lead to a substantial decrease in caffeine clearance. Caffeine may increase the metabolism of other drugs such as phenobarbital and aspirin. Caffeine accumulation may occur when products or foods containing caffeine are consumed concomitantly with quinolones such as ciprofloxacin.

Information for Patients/Caregivers:
Patients receiving TREZIX™ capsules should be given the following information:
1. Do not take TREZIX™ if you are allergic to any of its ingredients.
2. If you develop signs of allergy such as a rash or difficulty breathing stop taking TREZIX™ and contact your healthcare provider immediately.
3. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
4. Patients should be advised that TREZIX™ capsules may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
5. Patients should be advised to report adverse experiences occurring during therapy.
6. Patients should be advised not to adjust the dose of TREZIX™ capsules without consulting the prescribing professional.
7. Patients should not combine TREZIX™ capsules with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
8. 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.
9. Patients should be advised that TREZIX™ capsules 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 TREZIX™ capsules. 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:
TREZIX™ capsules 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 dec