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warnings
WARNINGS 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 judgement 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.
ADVERSE REACTIONS THE MAJOR HAZARDS OF CODEINE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSOR DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED. The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable. Some adverse reactions may be alleviated in the ambulatory patient if he lies down. Other adverse reactions include the following: Central Nervous System – Euphoria, dysphoria, weakness, headache, insomnia, agitation, disorientation, and visual disturbances. Gastrointestinal – Dry mouth, anorexia, constipation, and biliary tract spasm. Cardiovascular – Flushing of the face, bradycardia, palpitation, faintness, and syncope. Genitourinary – Urinary retention or hesitancy, anti-diuretic effect, and reduced libido and/or potency. Allergic – Pruritus, urticaria, other skin rashes, edema, and, rarely, hemorrhagic urticaria.