PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

PENTAZOCINE HYDROCHLORIDE

Composition:

PENTAZOCINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentazocine and Naloxone 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, which can occur at any dosage or duration [see Warnings], reserve Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia Pentazocine and Naloxone Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Pentazocine and Naloxone Tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ]. Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] - Patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ]. Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance. Controlled Substance Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance. Abuse Pentazocine and Naloxone Tablets contain pentazocine, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Pentazocine and Naloxone Tablets increases a risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of Pentazocine and Naloxone Tablets with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of Pentazocine and Naloxone Tablets abuse include those with a history of prolonged use of any opioid, including products containing Pentazocine, those with a history of drug or alcohol abuse, or those who use Pentazocine and Naloxone Tablets in combination with other abused drugs. "Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Pentazocine and Naloxone Tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Pentazocine and Naloxone Tablets Abuse of Pentazocine and Naloxone Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Pentazocine and Naloxone Tablets with alcohol and/or other CNS depressants. Parental drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue Pentazocine and Naloxone Tablets in a patient physically dependent on opioids. Rapid tapering of Pentazocine and Naloxone Tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing Pentazocine and Naloxone Tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Pentazocine and Naloxone Tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION, WARNINGS ]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Pregnancy].

Product summary:

Pentazocine and Naloxone Tablets USP are light yellow, capsule shaped tablets debossed "NL" on left side and "680" on the right side of the bisect and plain on the other side, supplied in bottles of 100 and 500. Bottles of 100 (NDC 43386-680-01). Bottles of 500 (NDC 43386-680-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store Pentazocine and Naloxone Tablets securely and dispose of properly [See PRECAUTIONS/Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 275346 Rev. 01/2024

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE - PENTAZOCINE
HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET
Lupin Pharmaceuticals,Inc.
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MEDICATION GUIDE
Pentazocine and Naloxone (pen tazʹ oh seen and nal oxʹ one) Tablets,
CIV
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 or call 911 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. Talk to your healthcare provider
about naloxone, a medicine for
the emergency treatment of an opioid.
•
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 it.
Selling or giving away Pentazocine and Naloxone Tablets is against the
law.
•
Store Pentazocine and Naloxone Tablets securely, out of sight and
reach of children, and in a
location not accessible by others, including visitors to the home.
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 p

Summary of Product characteristics

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE -
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET
LUPIN PHARMACEUTICALS,INC.
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PENTAZOCINE AND NALOXONE TABLETS, USP CIV
REVISED: JANUARY 2024
ANALGESIC FOR ORAL USE ONLY
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
PENTAZOCINE AND NALOXONE TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF 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 AND REASSESS ALL PATIENTS REGULARLY FOR THE DEVELOPMENT
OF
THESE BEHAVIORS AND CONDITIONS [SEE

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