Pentazocine Combinations

Pronunciation: pen-TAZ-oh-seen
Class: Opioid agonist-antagonist analgesic

Trade Names

Pentazocine / Acetaminophen
- Tablets pentazocine 25 mg/acetaminophen 650 mg

Pentazocine / Naloxone
- Tablets pentazocine 50 mg/naloxone 0.5 mg

Pharmacology

Produces analgesia by an agonistic effect at the kappa opioid receptor. Weakly antagonizes effects of opiates at mu opioid receptor.

Indications and Usage

Relief of mild to moderate pain (pentazocine/acetaminophen); management of moderate to severe pain (pentazocine/naloxone).

Contraindications

Hypersensitivity to pentazocine, acetaminophen, or naloxone.

Dosage and Administration

Adults and Children 12 y of age and older Pentazocine/Acetaminophen

PO pentazocine 25 mg/acetaminophen 650 mg every 4 h (max, 150 mg/3,900 mg per day).

Pentazocine/Naloxone

PO pentazocine 50 mg/naloxone 0.5 mg every 3 to 4 h; increase to pentazocine 100 mg/naloxone 1 mg if necessary (max, 600 mg/6 mg per day).

General Advice

  • For oral use only.
  • May administer pentazocine/naloxone with aspirin if needed.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Alcohol

Causes additive CNS depression. Use with caution.

Barbiturate anesthetics and any other CNS depressants (eg, antidepressants, benzodiazepines)

Causes increased CNS and respiratory depression.

Adverse Reactions

Cardiovascular

Hypotension, syncope, tachycardia.

CNS

Confusion, depression, disorientation, disturbed dreams, dizziness, euphoria, excitement, hallucinations, headache, insomnia, irritability, light-headedness, paresthesia, sedation, tremor, weakness.

Dermatologic

Dermatitis including pruritus, erythema multiforme, flushed skin including plethora, rash, Stevens-Johnson syndrome, sweating, TEN, urticaria.

EENT

Tinnitus, visual blurring and focusing difficulty.

GI

Abdominal distress, anorexia, constipation, diarrhea, nausea, vomiting.

Hematologic

Eosinophilia, granulocytopenia.

Respiratory

Respiratory depression.

Miscellaneous

Allergic reactions (eg, agranulocytosis, edema of the face, hemolytic anemia, skin rashes, thrombocytopenic purpura), chills, urinary retention.

Precautions

Warnings

Pentazocine / Acetaminophen

This product contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.

Pentazocine / Naloxone

For oral use only. Severe, potentially lethal reactions (eg, pulmonary emboli, vascular occlusion, ulcerations and abscesses, withdrawal symptoms in narcotic-dependent individuals) may result from misuse of this drug by injection or in combination with other substances.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 y of age.

Elderly

Use caution in dose selection, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Labor and Delivery

Use drug with caution in women delivering premature infants.

Special Risk Patients

Use with caution in patients with MI who have cyanosis, decreased respiratory reserve, head injury, increased intracranial pressure, nausea and vomiting, obstructive pulmonary conditions, respiratory depression, seizure, or severe bronchial asthma.

Sulfite Sensitivity

Some of these products may cause allergic-type reactions (eg, anaphylaxis, hives, itching, wheezing) in susceptible persons.

Abuse/Dependence/Withdrawal

Abuse potential exists. Abrupt discontinuation after long-term use may cause withdrawal symptoms. Do not substitute other opiates in pentazocine withdrawal syndrome. Pentazocine may induce withdrawal symptoms in narcotic-dependent patients.

Acute CNS manifestations

Confusion, disorientation, hallucinations, and seizures.

Biliary surgery

May elevate biliary tract pressure.

Renal or hepatic function impairment

Duration of action may be prolonged; dosage reduction may be required.

Overdosage

Symptoms

Hypertension, respiratory depression, tachycardia.

Patient Information

  • For maximum effectiveness, instruct patient to take medication before intolerable pain develops.
  • Tell patient to take medication exactly as prescribed to minimize dependence.
  • Caution patient not to stop taking drug abruptly without consulting health care provider.
  • Advise patient to avoid sudden position changes to prevent orthostatic hypotension.
  • Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
  • Advise patient that drug may cause dizziness and to use caution while driving or performing other tasks requiring mental alertness.
  • Inform patient that aspirin may be taken concurrently with pentazocine/naloxone for additive analgesics, as well its anti-inflammatory and antipyretic effects.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web1)