y 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:
CENTUSSIN DHC Liquid should be given with caution to the elderly.
Hepatic Impairment: CENTUSSIN 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: CENTUSSIN DHC Liquid 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
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 CENTUSSIN DHC Liquid
include, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations,
flushing, increase irritability or excitement (especially in children).
DRUG ABUSE AND DEPENDENCE
This combination product is subject to the provisions of the Controlled Substances Act and has
been placed in Schedule V. 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 CENTUSSIN 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 Reference.
Signs and Symptoms: Symptoms of overdosage include pinpoint pupils, respiratory depression,
