Drug Dependence

Codeine Sulfate 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 this drug and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, the drug is subject to the Federal Controlled Substances Act.

Usage in Ambulatory Patients

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Interaction with Other Central Nervous System Depressants

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with codeine may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Usage in Pregnancy

Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore codeine should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Pediatric Use

Safe dosage of this drug has not been established in children below the age of three.

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 pre- existing 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 codeine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients

Codeine should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepaticorrenalfunction, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

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