"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Interactions with Other Central Nervous System Depressants
Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics or other CNS depressants (including alcohol) concomitantly with NUMORPHAN (oxymorphone) may exhibit an additive CNS depression (see PRECAUTIONS: DRUG INTERACTIONS).
NUMORPHAN (oxymorphone) should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma.
Head Injury and Increased Intracranial Pressure
The possible respiratory depressant effects of potent analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated in the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, NUMORPHAN (oxymorphone) should be used in these circumstances only when essential, and then should be administered with extreme caution.
Acute Abdominal Conditions
The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
NUMORPHAN (oxymorphone) , as with other opioid drugs, can produce tolerance, psychological dependence, and physical dependence and has the potential for being abused (see Drug Abuse And Dependence).
Safe use in pregnancy has not been established (relative to possible adverse effects on fetal development). As with other analgesics, the use of NUMORPHAN (oxymorphone) in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child (see PRECAUTIONS).
Special Risk Patients: NUMORPHAN (oxymorphone) should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal or hepatic disease. Caution should also be exercised in patients with hypothyroidism, acute alcoholism, delirium tremens, convulsive disorders, Addison's disease, gallbladder disease or gallstones, prostatic hypertrophy or urethral stricture, recent gastrointestinal or genitourinary tract surgery, inflammatory bowel disease, diarrhea secondary to poisoning until the toxin is eliminated, diarrhea secondary to pseudomembranous colitis, cardiac arrhythmias, increased ocular pressure, and toxic psychosis. Debilitated and elderly patients and those with severe liver disease should receive smaller doses of NUMORPHAN (oxymorphone) .
Hypotensive Effect: Opioid analgesics may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or coadministration of drugs such as phenothiazines or general anesthetics. Administer with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure. Orthostatic hypotension may occur in ambulatory patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies have not been performed in animals to evaluate the carcinogenic potential of NUMORPHAN (oxymorphone) . Studies to evaluate the mutagenic potential of NUMORPHAN (oxymorphone) have not been conducted. There have been no studies to evaluate the effect of NUMORPHAN (oxymorphone) on fertility.
Usage in Pregnancy
Teratogenic Effects: Pregnancy Category C: NUMORPHAN (oxymorphone) was reported to produce malformations in offspring of hamsters that received 1,500 times the recommended human dose on Day 8 of gestation. There have been no adequate and well-controlled studies of reproductive toxicity in other laboratory animals or in pregnant women. It is not known whether NUMORPHAN (oxymorphone) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. As with other opioid analgesics, the use of NUMORPHAN (oxymorphone) in pregnancy or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.
Non-teratogenic Effects: Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence. Neonatal withdrawal may occur. Symptoms usually appear during the first days of life and may include convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate.
Labor and Delivery
NUMORPHAN (oxymorphone) should be used with caution during labor. Sinusoidal fetal heart rate patterns may occur with the use of opioid analgesics.
Opioid analgesics in therapeutic doses may prolong labor. Generally, the effect of opioids on the pregnant uterus appears to depend on the time of administration; administration of the drugs during the latent phase of the first stage of labor, or before cervical dilation of 4-5 cm has occurred, may hamper the progress of labor.
Opioid analgesics, including NUMORPHAN (oxymorphone) , may cause respiratory depression in the newborn. The effect of NUMORPHAN (oxymorphone) , if any, on the later growth, development, and functional maturation of the child is unknown.
It is not known whether NUMORPHAN (oxymorphone) is excreted in human milk. Because many drugs, including some opioids, are excreted in human milk, caution should be exercised when NUMORPHAN (oxymorphone) is administered to a nursing woman.
Safety and effectiveness of NUMORPHAN (oxymorphone) in pediatric patients below the age of 18 years have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2008
Additional Numorphan Information
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