Patients receiving other opioid analgesics,
sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics,
phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product
may exhibit additive depressant effects on the central nervous system. When such combined
therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use
of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an
additive effect.
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 intensify the anticholinergic effects of antihistamines.
Information for Patient/Caregivers:
Patients receiving POLY HIST DHC Liquid should be given the following information:
1. Patients should be advised that POLY HIST DHC Liquid may impair the mental or
physical abilities required for the performance of potentially hazardous tasks such
as driving a car or operating machinery.
2. Patients should be advised to report adverse experiences occurring during therapy.
3. Patients should be advised not to adjust the dose of POLY HIST DHC Liquid without
consulting the prescribing professional.
4. Patients should not combine POLY HIST DHC Liquid with alcohol or other central
nervous system stimulants.
5. 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 POLY HIST DHC Liquid is a potential drug of abuse. They
should protect if 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 POLY HIST DHC 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:
POLY HIST DHC 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