Pentazocine and naloxone

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Manufacturer: Actavis Pharma, Inc.

Score: 143.0

Quick Summary

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. The drug is a mixed agonist-antagonist at opioid receptors, with pentazocine being a partial agonist at the mu opioid receptor and an agonist at the kappa opioid receptor, while naloxone is an opioid antagonist. Important safety information includes the risk of addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. The initial dosage is 1 tablet every 3-4 hours as needed for pain, with a total daily dosage not exceeding 12 tablets.

Key Clinical Findings and Indications

Management of pain severe enough to require an opioid analgesic
Alternative treatments are inadequate
Mixed agonist-antagonist at opioid receptors

Important Safety Information

Warning

Addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma
Known or suspected gastrointestinal obstruction
Hypersensitivity to pentazocine, naloxone, or formulation excipients

Adverse Reactions

Respiratory depression
Nausea
Vomiting
Constipation
Dizziness
Lightheadedness
Hallucinations
Sedation
Euphoria
Headache
Confusion
Disorientation

Dosing Recommendations

General Guidance

Titrate dosage slowly and frequently reevaluate patients, especially in geriatric patients

Pain management

Adult Dose

1 tablet every 3-4 hours as needed

Pediatric Dose

Not established for patients under 12 years

Special Population Considerations

Pregnancy

Use for an extended period may result in neonatal opioid withdrawal syndrome
Advise pregnant women of potential risk to fetus

Nursing Mothers

Pentazocine is excreted in breast milk, caution should be exercised when administering to nursing women

Pediatric Use

Safety and effectiveness not established for patients under 12 years

Geriatric Use

Elderly patients may have increased sensitivity, use caution when selecting dosage
Titrate dosage slowly and frequently reevaluate patients

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