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Airacof (Codeine Phosphate / Phenylephrine Hydrochloride / Diphenhydramine Hydrochloride) - Warnings and Precautions



Antihistamines may cause drowsiness, dizziness, blurred vision, and otherwise impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

Sympathomimetic amines should be used cautiously, extremely carefully and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder-neck obstruction, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Products which contain diphenhydramine should not be used in combination with other diphenhydramine formulations; in rare cases toxic psychosis has occurred in children who received combinations of two or more diphenhydramine formulations by any route of administration including topically applied preparations.

Respiratory Depression

At high doses or in sensitive patients, 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.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Infants and Children

Diphenhydramine should not be administered to premature or full-term neonates. Infants may have greater susceptibility than adults to the toxic effects of diphenhydramine. Adults who administer diphenhydramine to children should be aware that children may be at increased risk for excitability and central nervous system stimulation. Antihistamine may impair mental alertness in children.


Information for Patients

This product may cause drowsiness or dizziness like other antihistamines and narcotic drug products, and accordingly do not drive, operate machinery, or perform other similar activities due to potential impairment, until your reaction to this medicine is known, or after consultation with your physician.

Special Risk Patients

Do not use concomitantly with other CNS depressants, including alcohol, or sleep aids, or appetite suppressants, which may increase or otherwise potentiate the sedative effects of diphenhydramine. As with any narcotic analgesic agent, AIRACOF™ should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Use diphenhydramine hydrochloride with precaution in patients with narrow-angle glaucoma, stenosing peptic ulcer disease, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladderneck obstruction, history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, or hypertension. Elderly are more susceptible to the side effects of diphenhydramine.

Cough Reflex

Codeine suppresses the cough reflex. As with all narcotics, caution should be exercised when AIRACOF™ is used postoperatively and in patients with pulmonary disease.

Drug Interactions

Use of this product with other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol), sleep aids, appetite suppressants and other such products. AIRACOF™ may result in an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with codeine preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of anticholinergics with codeine may produce paralyticileus.

Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

MAO inhibitors and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.

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.

Nonteratogenic Effects

Babies born to mother who have been taking opiods regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Chlorpromazine 0.7 to 1mg/kg q6h, and paregoric 2 to 4 drops kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosage decreased as tolerated.

Labor and Delivery

As with all narcotics, administration of AIRACOF™ to the mother shortly before delivery may result in some degree of respiratory depression in the newborn especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from AIRACOF™, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established, and should not be used in children under 6 years old. Children may be more sensitive to the effects of this product, and may exhibit, in particular, excitability, in addition to the potential adverse events noted above.

Surgery and Hospital Care

Inform your physician of the use of this product before undergoing any medical procedures, including surgery, any hospital, medical or emergency care.

Page last updated: 2010-01-08

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