Monoamine Oxidase Inhibitors
Dihydrocodeine, like all opioids interact with monoamine oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors and beta-adrenergic blockers increase the effects of sympathomimetics. They may also prolong and intensity the anticholinergic effects of antihistamines.

Information for Patient/Caregivers
Patients receiving ENDACOF-DH Oral Liquid should be given the following information:

Patients should be advised that ENDACOF-DH Oral Liquid may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Patients should be advised to report adverse experiences occurring during therapy.
Patients should be advised not to adjust the dose of ENDACOF-DH Oral Liquid without consulting the prescribing professional.
Patients should not combine ENDACOF-DH Oral Liquid with alcohol or other central nervous system stimulants.
Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child
Patients should be advised that ENDACOF-DH Oral Liquid is 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 ENDACOF-DH Oral Liquid. 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.

Nonteratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7-1.0 mg/kg q6h, Phenobarbital 2 mg/kg q6h, and paregoric 24 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.

Labor and delivery
ENDACOF-DH Oral Liquid is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.

Pediatric Use
This product is not recommended for use in children under 6 years of age. Children under two years may be more susceptible to the respiratory arrest, coma and death. Use of antihistamines is not recommended in infants