. 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 ch8ildren may be more sensitive to the effects, especially the vasopressor effects of sympathomimetic amines.
Geriatric Use
ENDACOF-DH Oral Liquid should be given with caution to the elderly.
Hepatic Impairment
ENDACOF-DH Oral 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
ENDACOF-DH Oral 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 sued 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, pruritus, 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, sever narcosis and acute renal failure have been reported rarely during dihydrocodeine administration. Other adverse reactions observed with the ingredients in ENDACOF-DH Oral 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 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 ENDACOF-DH Oral 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, extreme somnolence progressing to stupor, loss of consciousness, or coma, skeletal muscle, flaccidity, cold and clammy skin and other symptoms common w
