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Numorphan (Oxymorphone Hydrochloride) - Warnings and Precautions

 
 



WARNINGS

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 may exhibit an additive CNS depression (see PRECAUTIONS; Drug Interactions).

Respiratory Depression

NUMORPHAN 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 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.

Drug Dependence

NUMORPHAN, 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).

Pregnancy

Safe use in pregnancy has not been established (relative to possible adverse effects on fetal development). As with other analgesics, the use of NUMORPHAN 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).

PRECAUTIONS

General

Special Risk Patients

NUMORPHAN 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.

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.

Information for Patients

Patients should be cautioned regarding the following:

Drowsiness, dizziness, or lightheadedness related to the use of this medication may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car, operating machinery, etc.

This medication, like other opioid analgesics, will add to the effect of alcohol and other CNS depressants [such as antihistamines, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, tricyclic antidepressants, and monoamine oxidase (MAO) inhibitors]. Alcohol should not be consumed while taking NUMORPHAN.

Withdrawal side effects may be precipitated by suddenly stopping this drug after prolonged use (regular use for several weeks or more). The medication should be gradually reduced before completely discontinuing use.

Elderly patients are more sensitive to opioid analgesics, especially the respiratory depressant effects and opioid induced urinary retention. Lower doses or longer dosing intervals may be required.

Orthostatic hypotension may occur with the use of this medication, especially in ambulatory patients. Patients should get up slowly from a lying or sitting position.

NUMORPHAN (oxymorphone hydrochloride, USP) may be habit forming and has the potential for being abused. Tolerance, psychological and physical dependence can occur.

Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence, and neonatal withdrawal may occur.

Laboratory Tests

Opioids may increase biliary tract pressure with resultant increases in plasma amylase or lipase.

Drug Interactions

The concomitant use of other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, and alcohol may produce additive CNS depressant effects. When such combined therapy is contemplated, the dose of one or both agents should be reduced (see WARNINGS).

Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

It has been reported that the incidence of bradycardia was increased when oxymorphone was combined with propofol for induction of anesthesia.

In addition, CNS toxicity has been reported (confusion, disorientation, respiratory depression, apnea, seizures) following coadministration of cimetidine with opioid analgesics; no clear-cut cause and effect relationship was established.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies have not been performed in animals to evaluate the carcinogenic potential of NUMORPHAN. Studies to evaluate the mutagenic potential of NUMORPHAN have not been conducted. There have been no studies to evaluate the effect of NUMORPHAN on fertility.

Usage in Pregnancy

Teratogenic Effects: Pregnancy Category C: NUMORPHAN 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 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. As with other opioid analgesics, the use of NUMORPHAN 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 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, may cause respiratory depression in the newborn. The effect of NUMORPHAN, if any, on the later growth, development, and functional maturation of the child is unknown.

Nursing Mothers

It is not known whether NUMORPHAN is excreted in human milk. Because many drugs, including some opioids, are excreted in human milk, caution should be exercised when NUMORPHAN is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of NUMORPHAN in pediatric patients below the age of 18 years have not been established.

Page last updated: 2006-05-18

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