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:

Lannett Company, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride Capsules are 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]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxycodone Hydrochloride capsule is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.3 )] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7 )] - Known or suspected gastrointestinal obstruction, including paralytic ileu

Product summary:

Oxycodone Hydrochloride Capsule 5 mg is a hard gelatin size #4 ivory opaque/reddish orange opaque capsule, imprinted with logo “LANNETT” on the cap and “1774” on the body available in one strength as follows: NDC# 0527-1774-01:                                                      Bottle of 100 Capsules Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Protect from moisture and light. Store Oxycodone Hydrochloride Capsules securely and dispose of properly [see Patient Counseling Information 17)].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE CAPSULE
LANNETT COMPANY, 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, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION
AND MITIGATION STRATEGY (REMS); 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._
OXYCODONE HYDROCHLORIDE CAPSULES EXPOSE 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)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE
FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND
MITIGATION STRATEGY (REMS)
FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE CAPSULES, ESPECIALLY
BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYCODONE. (5.3)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE CAPSULES DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.4)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.5, 7, 12.3)
CONCOMI