General: Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur.
Usage in Ambulatory Patients: Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Respiratory Depression: Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. This combination product should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression.
Hypertensive Effect: Dihydrocodeine, like all opioid analgesics, may cause hypotention in patients whose ability to maintain blood pressure has been compromised by depleted blood volume or who received concurrent therapy with drugs such as phenothiazine or other agents which compromise vasomotor tone. This product may produce orthostatic hypotension in ambulatory patients. This combination product should be administered with caution to patients with circulatory shock since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Dependence: Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused. This product should be prescribed and administered with the appropriate degree of caution (See Drug Abuse and Dependence section).
There is currently no manufacturer warning information available for this drug.
This product is indicated for the temporary relief of cough and nasal congestion associated with upper respiratory tract infections and allergies.
CIII
J-COF DHC
Liquid
Antitussive · Antihistamine
Decongestant
Rx Only
DESCRIPTION
Each teaspoonful (5 mL) for oral administration contains:
Dihydrocodeine Bitartrate…………………………7.5 mg
(WARNING-May be habit forming)
Brompheniramine Maleate…………………………..3 mg
Pseudoephedrine Hydrochloride…………………..15 mg
This product contains the following inactive ingredients:
Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Grape Flavor, Purified Water.
Dihydrocodeine Bitartrate is an antitussive having the chemical name,Morphine-6-ol,4,5-epoxy-3-methoxy-17-methyl-,(5α,6α)-2,3-dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
Brompheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine,
γ-(4-bromophenyl)-N,N-dimethyl-, (±)-,(Z)-2-butenedioate (1:1). with the following structure:
Pseudoephedrine Hydrochloride is a decongestant having the chemical name, Benzenemethanol, α-[1-(methylamino) ethyl]-, [S-(R*,R*)-, hydrochloride. It has the following structural formula:
