PENTAZOCINE AND NALOXONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENTAZOCINE (UNII: RP4A60D26L) (PENTAZOCINE - UNII:RP4A60D26L), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentazocine and Naloxone Hydrochloride Tablets are 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, reserve Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Pentazocine and Naloxone Hydrochloride Tablets, are contraindicated in patients with: Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance. Pentazocine and Naloxone Tablets contain pentazocine, a substance with a high potential for abuse similar to other opioids including tramadol. Pentazocine and Naloxone Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the ri

Product summary:

Pentazocine and Naloxone Hydrochloride Tablets, USP are capsule-shaped, light yellow tablets, debossed with "M118" on one side and a score line on the other side, each containing pentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base. Bottles of 100 (NDC 63304-506-01). Store at controlled room temperature 15˚ C to 30˚ C (59˚ F to 86˚ F). Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 July 2018

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PENTAZOCINE AND NALOXONE- PENTAZOCINE AND NALOXONE TABLET
Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Pentazocine and Naloxone (pen tazʹ oh seen and nal oxʹ one)
Tablets, CIV
Rx only
Pentazocine and Naloxone Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
moderate to severe pain, when other pain treatments such as non-opioid
pain medicines do not treat
your pain well enough or you cannot tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Pentazocine and Naloxone Tablets:
•
Get emergency help right away if you take too many Pentazocine and
Naloxone Tablets (overdose).
When you first start taking Pentazocine and Naloxone Tablets, when
your dose is changed, or if you
take too much (overdose), serious or life-threatening breathing
problems that can lead to death may
occur. Taking Pentazocine and Naloxone Tablets with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your Pentazocine and Naloxone Tablets. They
could die from taking them.
Store Pentazocine and Naloxone Tablets away from children and in a
safe place to prevent stealing
or abuse. Selling or giving away Pentazocine and Naloxone Tablets are
against the law.
Do not take Pentazocine and Naloxone Tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
previously had an allergic reaction to pentazocine or naloxone.
•
known or suspected gastrointestinal obstruction, including paralytic
ileus.
Before taking Pentazocine and Naloxone Tablets, tell your healthcare
provider if you have a history of:
● h

Summary of Product characteristics

PENTAZOCINE AND NALOXONE- PENTAZOCINE AND NALOXONE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
PENTAZOCINE AND NALOXONE HYDROCHLORIDE TABLETS USP ANALGESIC FOR ORAL
USE ONLY RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
PENTAZOCINE AND NALOXONE TABLETS EXPOSES PATIENTS AND OTHER USERS TO
THE RISKS OF OPIOID
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS EACH PATIENT’S
RISK PRIOR TO PRESCRIBING PENTAZOCINE AND NALOXONE TABLETS, AND
MONITOR ALL PATIENTS
REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE
WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
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 REMS FOR
THESE PRODUCTS
_[SEE WARNINGS]_. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF PENTAZOCINE
AND NALOXONE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF
PENTAZOCINE AND NALOXONE TABLETS OR FOLLOWING A DOSE INCREASE [SEE
WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF PENTAZOCINE AND NALOXONE
TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF PENTAZOCINE [SEE
WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF PENTAZOCINE AND NALOXONE TABLETS DURING PREGNANCY CAN
RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT RECOGNIZED AND
TREATED, AND REQUIRES MANAGEMENT