OXYCODONE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570)

Available from:

Glenmark Pharmaceuticals, Inc

INN (International Name):

Oxycodone Hydrochloride

Composition:

Oxycodone Hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone hydrochloride capsule is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.1)], reserve Oxycodone hydrochloride capsules for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Oxycodone Hydrochloride capsule is contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)]. Available data with Oxycodone Hydrochloride Capsules are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 ti

Product summary:

Oxycodone hydrochloride capsule 5 mg is a hard gelatin capsule with an opaque yellow cap imprinted in black ink with "LV" and an opaque white body imprinted in black ink with "901" supplied as: NDC# 68462-204-01: Bottle of 100 Capsules Dispense in a tight, light-resistant container. Protect from moisture and light. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE CAPSULE
GLENMARK PHARMACEUTICALS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OXYCODONE HYDROCHLORIDE
CAPSULES.
OXYCODONE HYDROCHLORIDE CAPSULES CII
INITIAL U.S. APPROVAL: 1950
WARNING : RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-
THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL
OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Boxed Warning
12/2016
Indications And Usage
12/2016
Dosage And Administration
12/2016
Warnings And Precautions
12/2016
INDICATIONS AND USAGE
Oxycodone hydrochloride capsule is an opioid agonist indicated for the
management of pain severe enough to require an
opioid analgesic and for which alternative treatments are inadequate.
(1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve Oxycodone
hydrochloride capsules for use in patients for whom alternative
treatment options [e.g., non-opioid analgesics or opioid
combination products];
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DOSAGE AND ADMINISTRATION
OXYCODONE HYDROCHLORIDE CAPSULES EXPOSES USERS TO RISKS OF ADDICTION,
ABUSE, AND MISUSE, WHICH CAN
LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING
AND MONITOR REGULARLY FOR THESE
BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE CAPSULES, ESPECIALLY
BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYCODONE. (5.2)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE CAPSULES DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWA