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DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.
Usage in Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with AIRACOF™. It is also not known whether AIRACOF™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AIRACOF™ should be given to a pregnant woman only if clearly needed. Codeine has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. AIRACOF™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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OVERDOSAGE
Overdose effects of Codeine phosphate may include cold, clammy skin; confusion; convulsions; severe dizziness; drowsiness; nervousness or restlessness; heartbeat; slow or troubled breathing; and unconsciousness. Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.
TREATMENT
Recommended treatment of opioid analgesic overdose may consist of the following: Induced vomiting or perform gastric lavage (if the opioid was taken orally). Administer naloxone (an opioid antagonist) as a single dose of between 400 micrograms and 2 mg, preferably by intravenous infusion. Administer intravenous fluids and/or vasopressors and use of he supportive measures as needed. Continuously monitor patient (mandatory because the duration of action of the opioid may exceed naloxone as needed. Alternatively, initial treatment may be followed by continuous intravenous infusion of naloxone.
Gastric emptying may be useful in removing unabsorbed drug.
Diphenhydramine Hydrochloride Mild overdose of diphenhydramine leads to sedation. Moderate to severe diphenhydramine overdose produces predictable anticholinergic effects: agitated delirium, mydriasis, dry mouth, decreased gastrointestinal motility, urinary retention, and erythema. Rarely, diphenhydramine overdose may cause rhabdomyolysis. Life-threatening overdose is characterized by hyperthermia (from a combination of musculoskeletal action in an agitated patient who is unable to lose heat because of an inability to sweat), seizures, and ventricular tachycardia. Mild to moderate overdoses can be treated supportively. Sedation for severe agitation can be accomplished by intravenous benzodiazepines or physostigmine. Ventricular arrhythmia is treated with intravenous sodium bicarbonate or hypertonic saline.
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CONTRAINDICATIONS
Contraindicated in patients with severe hypertension or severe coronary artery disease, in patients on MAO inhibitor therapy, in patients with narrow-angle glaucoma, urinary retention, or peptic ulcer, during an asthmatic attack, in nursing mothers, and in premature or newborn infants. Contraindicated in patients with hypersensitivity to phenylephrine, codeine, sympathomimetic, amines, diphenhydramine, or other antihistamines of similar chemical structure. Because of its drying effect on lower respiratory secretions, AIRACOF™ is not recommended in the treatment of bronchial asthma.
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DRUG ABUSE AND DEPENDENCE
AIRACOF™ is subject to the Federal Controlled Substance ACT (Schedule V).
May be habit forming. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of AIRACOF™, and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs.
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