OXYCODONE HYDROCHLORIDE (Page 8 of 10)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
Long-term studies have not been performed in animals to evaluate the carcinogenic potential of Oxycodone Hydrochloride or oxycodone.

Mutagenesis
Oxycodone hydrochloride was genotoxic in an in vitro mouse lymphoma assay in the presence of metabolic activation. There was no evidence of genotoxic potential in an in vitro bacterial reverse mutation assay ( Salmonella typhimurium and Escherichia coli) or in an assay for chromosomal aberrations ( in vivo mouse bone marrow micronucleus assay).

Impairment of Fertility
Studies in animals to evaluate the potential impact of oxycodone on fertility have not been conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING

Oxycodone hydrochloride tablets, USP are available as follows:

Oxycodone hydrochloride tablets, USP 5 mg are supplied as white round biconvex tablets debossed “K” on left and “18” on right of the bisect on one side and plain on the other side.
Unit dose packages of 100 (10 x 10) NDC 68084-354-01

Oxycodone hydrochloride tablets, USP 10 mg are supplied as pink round biconvex tablets debossed “K” on left and “56” on right of the bisect on one side and plain on the other side.
Unit dose packages of 100 (10 x 10) NDC 68084-968-01

Oxycodone hydrochloride tablets, USP 15 mg are supplied as green round biconvex tablets debossed “K” on left and “8” on right of the bisect on one side and plain on the other side.
Unit dose packages of 100 (10 x 10) NDC 68084-975-01

Oxycodone hydrochloride tablets, USP 30 mg are supplied as blue round biconvex tablets debossed “K” on left and “9” on right of the bisect on one side and plain on the other side.
Unit dose packages of 100 (10 x 10) NDC 68084-983-01

Protect from moisture.

Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse and Misuse
Inform patients that the use of oxycodone hydrochloride tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions ( 5.1)]. Instruct patients not to share oxycodone hydrochloride tablets with others and to take steps to protect oxycodone hydrochloride tablets from theft and misuse.

Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxycodone hydrochloride tablets or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions ( 5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions ( 5.2]. Instruct patients to take steps to store oxycodone hydrochloride tablets securely and to dispose of unused oxycodone hydrochloride tablets by flushing the tablets down the toilet or disposing of in accordance with local state guidelines and/or regulations.

Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone hydrochloride tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.5), Drug Interactions ( 7)].

Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions ( 7)].

MAOI Interaction
Inform patients to avoid taking oxycodone hydrochloride tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking oxycodone hydrochloride tablets [see Drug Interactions ( 7)].

Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions ( 5.7)].

Important Administration Instructions
Instruct patients how to properly take oxycodone hydrochloride tablets. Patients should be advised not to adjust the dose of oxycodone hydrochloride tablets without consulting the prescribing healthcare provider [see Dosage and Administration ( 2), Warnings and Precautions ( 5.12)].

Hypotension
Inform patients that oxycodone hydrochloride tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from sitting or lying position) [see Warnings and Precautions ( 5.8)].

Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in oxycodone hydrochloride tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications ( 4), Adverse Reactions ( 6.2)].

Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of oxycodone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.1)].

Embryo-Fetal Toxicity
Inform female patients of reproductive potential that oxycodone hydrochloride tablets can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1)].

Lactation
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see Use in Specific Populations ( 8.2)].

Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations ( 8.3)].

Driving or Operating Machinery
Inform patients that oxycodone hydrochloride tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating dangerous machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions ( 5.13)].

Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions ( 6), Clinical Pharmacology ( 12.1)].

Disposal of Unused Oxycodone Hydrochloride Tablets
Advise patients to dispose of unused oxycodone hydrochloride tablets by flushing the tablets down the toilet or disposing of in accordance with local state guidelines and/or regulations.

DEA Order Form Required.

PACKAGING INFORMATION
American Health Packaging unit dose blisters (see How Supplied section) contain drug product from KVK Tech, Inc. as follows:
(5 mg / 100 UD) NDC 68084-354-01 packaged from NDC 10702-018
(10 mg / 100 UD) NDC 68084-968-01 packaged from NDC 10702-056
(15 mg / 100 UD) NDC 68084-975-01 packaged from NDC 10702-008
(30 mg / 100 UD) NDC 68084-983-01 packaged from NDC 10702-009

Distributed by:
American Health Packaging
Columbus, OH 43217 8235401/1022F

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