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. This age group may be at a higher risk than other age groups
because of an increased susceptibility to anticholinergic effects, such as CNS excitation, and an
increased tendency toward convulsions. In older children taking antihistamines, a paradoxical
reaction characterized by hyperexcitability may occur. Very young children may be more sensitive
to the effects, especially the vasopressor effects of sympathomimetic amines.
Geriatric Use:
POLY HIST DHC Liquid should be given with caution to the elderly.
Hepatic Impairment:
POLYHIST DHC Liquid should be given with caution to patients with hepatic insufficiency.
Since, dihydrocodeine is metabolized by the liver; the effects of this combination
product should be monitored closely in such patients.
Renal Impairment:
POLY HIST DHC Liquid should be used with caution and in 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
The most frequently observed adverse reactions with dihydrocodeine include light-headedness,
dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation,
pruritis, 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.
Other adverse reactions observed with the ingredients in POLY HIST DHC Liquid include, lassitude,
nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability
or excitement (especially in children).
DRUG ABUSE AND DEPENDENCE
This combination product is subject to the provisions of the Controlled Substance Act and
has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine
type and therefore has the potential of being abused. Psychological dependence, physical
dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and
it should be prescribed and administered with the same degree of caution appropriate to the
use of other oral opioid medications. Symptoms of dihydrocodeine withdrawal consist of
irritability, restlessness, insomnia, diaphoresis, anxiety and palpitations.
OVERDOSAGE
An overdose of POLY HIST DHC Liquid is a potentially lethal poly-drug overdose situation,
and consultation with a regional Poison Control Center is recommended. A listing of the
poison control centers can be found in standard references such as the Physician's Desk
