See Supplemental Patient Information
- Therapy is intended for oral use only. Severe, potentially lethal, reactions may occur from misuse of therapy by injection either alone or in combination with other substances
- Therapy may cause a physical and psychological dependence
- Pentazocine component of this combination drug is associated with elevation of cerebrospinal fluid pressure that may be attributed to CO2 retention due to respiratory depressant effects of the drug. Such effects may be markedly exaggerated in the presence of head injury, intracranial lesions, or a preexisting increase in intracranial pressure. This drug may obscure the clinical course of patients with head injuries. Use this drug with extreme caution and only if its use is deemed essential in such patients
- Use alcohol with extreme caution in patients receiving pentazocine due to the potential for increased CNS depressant effects
- Withdrawal symptoms have been observed after receiving pentazocine in certain patients who have been given narcotics previously, including methadone for the daily treatment of narcotic dependence. Avoid abrupt withdrawal
- Rare cases of respiratory depression have been reported after oral administration of pentazocine; use cautiously in patients with respiratory depression from any cause, severely limited respiratory reserve, severe bronchial asthma, and other obstructive respiratory conditions, or cyanosis
- Hallucinations (usually visual), disorientation, and confusion may occur in patients receiving therapeutic doses of pentazocine. Closely observe such patients and check their vital signs. Exercise caution during reinstitution of this drug as acute CNS manifestations may recur
- Seizures may occur in certain susceptible patients in association with the use of this combination drug
- Therapy may differ from other marketed narcotics in their respect to elevate biliary tract pressure
- Use cautiously in patients with myocardial infarction who have nausea or vomiting
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Substance abuse
- Pulmonary impairment
- CNS depression
- CNS depressant use
- Seizure disorder
- Cor pulmonale
- Porphyria
- Cardiovascular disorder
- Post-MI
- Hypothyroidism
- Obstructive GI disorder
- Acute abdomen
- Biliary disorder
- Pancreatitis
- Adrenal insufficiency
- Prostatic hypertrophy
- Inflammatory bowel disease
- Delirium tremens
- Elderly or debilitated patients
Supplemental Patient Information
- Advise ambulatory patients not to operate machinery, drive cars, or unnecessarily expose themselves to hazards since sedation, dizziness, and occasional euphoria have been noted during therapy
- Inform patients that pentazocine component of this combination drug may cause physical and psychological dependence when taken alone and may have additive CNS depressant properties when taken in combination with alcohol or other CNS depressants
Pregnancy Category:C
Breastfeeding: Since no information is available on the use of pentazocine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.Naloxone: No information is available on the excretion of naloxone into breastmilk. Because it is not orally bioavailable, it is unlikely to affect the breastfed infant. Studies in nursing mothers have shown that naloxone does not affect lactation hormone levels. If naloxone is required by the mother, it is not a reason to discontinue breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 June 2011). Manufacturer advises caution.
US Trade Name(s)
US Availability
naloxone/pentazocine (generic)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
