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Empirin Codeine

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Empirin Codeine

Warnings
Precautions

WARNINGS

Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. A history of allergy is often lacking.

Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Results from pilot epidemiologic studies suggest an association between aspirin and Reye-Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.

PRECAUTIONS

General

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, gallbladder disease or gallstones, respiratory impairment, cardiac arrhythmias, inflammatory disorders of the gastrointestinal tract, hypothyroidism, Addison†s disease, prostatic hypertrophy or urethral stricture, coagulation disorders, head injuries, or acute abdominal conditions. Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets should not be prescribed for long-term therapy unless specifically indicated.

Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.

Laboratory Tests

Hypersensitivity to aspirin cannot be detected by skin testing or radioimmunoassay procedures. The primary screening tests for detecting a bleeding tendency are platelet count, bleeding time, activated partial thromboplastin time and prothrombin time. In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate long-term studies have been conducted in animals to determine whether codeine has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with aspirin and codeine. It is also not known whether aspirin and codeine (aspirin and codeine (aspirin and codeine) ) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) should be given to a pregnant woman only if clearly needed.

Reproductive studies in rats and mice have shown aspirin to be teratogenic and embryocidal at four to six times the human therapeutic dose. Studies in pregnant women, however, have not shown that aspirin increases the risk of abnormalities when administered during the fist trimester of pregnancy. In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight. In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.

Reproduction studies have been performed in rabbits and rats at doses at up to 150 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to codeine.

Nonteratogenic Effects: Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last six months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.

Labor and Delivery

Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate. Use of codeine during labor may lead to respiratory depression in the neonate.

Nursing Mothers

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from aspirin and codeine (aspirin and codeine (aspirin and codeine) ) , 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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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