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Oxyir (Oxycodone Hydrochloride) - Warnings and Precautions

 
 



WARNINGS

RESPIRATORY DEPRESSION

Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

HYPOTENSIVE EFFECT

OxyIR® Capsules and OXYFAST® CONCENTRATE Solution, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. OxyIR and OXYFAST may produce orthostatic hypotension in ambulatory patients. OxyIR and OXYFAST, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Drug Dependence:    Oxycodone 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, this drug is subject to the Federal Controlled Substances Act.

USAGE IN AMBULATORY PATIENTS

Oxycodone may impair the mental and/or physical abilities required for the performance of potential 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 oxycodone hydrochloride 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, this drug should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

USAGE IN CHILDREN

This drug should not be administered to children.

PRECAUTIONS

SPECIAL PRECAUTIONS REGARDING OXYFAST ORAL CONCENTRATE 20 MG/1 ML SOLUTION

OXYFAST 20 mg/1 mL solution is a highly concentrated solution. Care should be taken in the prescription and dispensing of this solution strength. Patients should be instructed against use by individuals other than the patient, as inappropriate use may cause acute overdosage.

GENERAL

Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Use of OxyIR® and OXYFAST® is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.

The administration of oxycodone, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

INTERACTIONS WITH MIXED AGONIST/ANTAGONIST OPIOID ANALGESICS

Agonist/antagonist and partial agonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

USE IN PANCREATIC/BILIARY TRACT DISEASE

Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

HEAD INJURY AND INCREASED INTRACRANIAL PRESSURE

The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

ACUTE ABDOMINAL CONDITIONS

The administration of this drug or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

INFORMATION FOR PATIENTS/CAREGIVERS

If clinically advisable, patients receiving OxyIR (immediate-release) Capsules or OXYFAST CONCENTRATE Solution or their caregivers should be given the following information by the physician, nurse, pharmacist or caregiver:

  1. Patients should be advised not to adjust the dose of this drug without consulting the prescribing professional.
  2. Patients should be advised that this drug may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
  3. Patients should not combine this drug with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
  4. Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
  5. Patients should be advised that this drug is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
  6. Patients should be advised that if they have been receiving treatment with this drug for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper this drug dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

LABORATORY MONITORING

Due to the broad range of plasma concentrations seen in clinical populations, the varying degrees of pain, and the development of tolerance, plasma oxycodone measurements are usually not helpful in clinical management. Plasma concentrations of the active drug substance may be of value in selected, unusual, or complex cases.

USE IN DRUG AND ALCOHOL ADDICTION

OxyIR and OXYFAST are opioids with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

DRUG-DRUG INTERACTIONS

The CNS depressant effects of oxycodone hydrochloride may be additive with that of other CNS depressants. See WARNINGS.

Opioid analgesics, including OxyIR and OXYFAST may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Oxycodone is metabolized in part to oxymorphone via CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. Clinicians should be aware of this possible interaction, however.

MUTAGENICITY/CARCINOGENICITY

Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. Coli test with and without metabolic activation at doses of up to 5000 µg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 µg/mL and with activation 48 hours after exposure at doses of up to 5000 µg/mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 µg/mL). Mutagenic results occurred in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 µg/mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 µg/mL or greater with metabolic activation and at 400 µg/mL or greater without metabolic activation. The data from these tests indicate that the genotoxic risk to humans may be considered low.

Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted owing to the length of clinical experience with the drug substance.

PREGNANCY

Teratogenic Effects--Category B:   Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg (48 mg/m2) and 125 mg/kg (1375 mg/m2), respectively. These doses are 3 and 47 times a human dose of 160 mg/day (90 mg/m2), based on mg/kg of a 60 kg adult (0.5 and 15 times this human dose based upon mg/m2). The results did not reveal evidence of harm to the fetus due to oxycodone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects--Neonates whose mothers have been taking oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

LABOR AND DELIVERY

OxyIR® and OXYFAST® are not recommended for use in women during and immediately prior to labor and delivery because oral opioids may cause respiratory depression in the newborn.

NURSING MOTHERS

Low concentrations of oxycodone have been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving OxyIR or OXYFAST since oxycodone may be excreted in the milk.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established.

SPECIAL RISK PATIENTS

This drug should be given with caution to certain patients such 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.

Page last updated: 2006-01-21

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