"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
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 that may obscure the clinical course in patients with head injuries.
Special-Risk Patients: Codeine should be given with caution to certain patients, s.c. as the elderly or debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.
Information for the Patient
Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, s.c. as driving a car or operating machinery. Codeine in combination with other narcotic analgesics, phenothiazines, sedative hypnotics, and alcohol has additive depressant effects.
Pregnancy Category C Animal reproduction studies have not been conducted with codeine phosphate. It is also not known whether codeine phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. On the basis of the historical use of codeine phosphate during all stages of pregnancy, there is no known risk of fetal abnormality. Codeine phosphate should be given to a pregnant woman only if clearly needed.
Labor and Delivery
The use of codeine phosphate in obstetrics may prolong labor. It passes the placental barrier and may produce depression of respiration in the newborn. Resuscitation a.d. in severe depression, the administration of naloxone may be required.
Codeine appears in the milk of nursing mothers. Caution should be exercised when it is administered to a nursing woman.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Codeine Phosphate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.