Airacof

Name: Airacof

Airacof Description

A Strawberry-Flavored, clear, alcohol-free, sugar-free, dye-free, liquid for oral administration.

Each 5 mL (teaspoonful) contains:
Codeine phosphate 7.5 mg
(WARNING: May be habit forming)
Phenylephrine hydrochloride 7.5 mg
Diphenhydramine hydrochloride 12.5 mg

The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The chemical name is Morphinan-6-ol,7,8-didehydroxy-4,5-eposy-3methoxy-17-methyl-, (5α,6α)-, phosphate (1:1) (salt), hemihydrate.

Phenylephrine hydrochloride is a mydriatic and a decongestant and occurs as bitter crystals. The chemical name is: (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride.

Diphenhydramine hydrochloride is an antihistaminic. The chemical name is 2-(diphenylmethoxy)-N, N-dimethylethylamine hydrochloride.

Inactive Ingredients: Sodium benzoate, Citric acid, Saccharin sodium, Propylene glycol, Sorbitol, Flavor and Purified water.

Airacof - Clinical Pharmacology

Codeine Phosphate

Codeine is a narcotic analgesic and antitussive whose effects are due to central action. It is well absorbed via oral administration. Following absorption, codeine is metabolized primarily by enzymes in the liver into morphine and other metabolites. These are excreted primarily in the urine with negligible amounts in the feces.

Phenylephrine Hydrochloride

Phenylephrine is an alpha-adrenergic receptor agonist, and acts predominantly by a direct action on alpha (α) adrenergic receptors. It causes Constriction of blood vessels in the nasal mucosa, which may relieve nasal congestion, after oral ingestion. In therapeutic doses the drug causes little, if any, central nervous system stimulation, and has no significant stimulant effect on the beta (β) adrenergic receptors of the heart.

Diphenhydramine hydrochloride

is an ethanolamine antihistamine with anticholinergic (drying), anti-inflammatory and sedative effects. It does not prevent the release of histamine, but competitively antagonizes histamine at H1, histamine receptors and thus blocks it in the central nervous system and in the periphery. Its antihistaminic effects thus relieve and block such allergic reactions as increased capillary permeability and dilation, edema formation, "flare" and "itch" response, vasoconstriction and vasodilatation, and gastrointestinal and smooth-muscle constriction.

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.

Adverse Reactions

Antitussives: may include drowsiness, dizziness, nausea or vomiting, constipation, dry mouth, headache, nervousness or restlessness, feeling of well-being, confusion, urinary disturbances, increased sweating, skin rash, hives, itching, swelling of face, flushing, weakness, visual disturbances, change in heart rate, difficulty breathing, loss of appetite, or general feeling of illness or discomfort. Possible allergic reaction to material if inhaled, ingested, or contacts with skin.

Sympathomimetic Amines: Hyperactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias and cardiovascular collapse with hypotension.

Antihistamines: Patients sensitive to antihistamines may experience mild sedation. Possible side effects of antihistamines are drowsiness, restlessness, dizziness, weakness, dry mouth, anorexia, nausea, vomiting, headache, nervousness, blurring of vision, polyuria, heartburn, dysuria and, very rarely, dermatitis.

Other adverse reactions include

Central Nervous System: Drowsiness, metal clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: The antiemetic phenothiazines are useful in suppressing the nausea and vomiting which may occur (see above); however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia.

Genitourinary System: Ureteral spasms, spasm of vesical sphincters and urinary retention have been reported.

Respiratory Depression: Codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. Apply other supportive measures when indicated.

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.

Airacof Dosage and Administration

Individuals 12 years of age and over

2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSOIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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