Pentazocine-Naloxone Hcl (pentazocine HCl/naloxone HCl)

Dosage of pentazocine hydrochloride and naloxone hydrochloride is expressed in terms of pentazocine and naloxone.

Pentazocine/naloxone is administered orally.

Pentazocine/naloxone is commercially available as a fixed-combination tablet preparation.

Store pentazocine/naloxone tablets in a tight, light-resistant container at 20-25degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Significant respiratory depression.

*Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.

*Known or suspected GI obstruction, including paralytic ileus.

*Hypersensitivity (e.g., anaphylaxis) to pentazocine, naloxone, or any ingredients in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

See Full Prescribing Information for a list of adverse effects of pentazocine/naloxone.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of pentazocine/naloxone have not been established in pediatric patients <12 years of age.

There are no available data with pentazocine/naloxone in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, pentazocine administered subcutaneously to pregnant hamsters during early gestation produced neural tube defects (i.e., exencephaly and cranioschisis) at 2.6 times the maximum daily dose (MDD). In pregnant rats that received pentazocine during organogenesis, there was an increased incidence of resorptions and extra ribs at 0.2 times the MDD. There was no evidence of malformations in rats or rabbits. Based on data in animals, advise pregnant women of the potential risk to the fetus.

Use of opioid analgesics for an extended period of time during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly.

Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Pentazocine/naloxone is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including pentazocine/naloxone, can prolong labor through actions, which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Pentazocine is distributed into human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pentazocine/naloxone and any potential adverse effects on the breast-fed infant from the drugs or from the underlying maternal condition. Use caution when pentazocine/naloxone is administered to a nursing woman. Infants exposed to pentazocine/naloxone should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is discontinued, or when breastfeeding is stopped.

Use caution when selecting a dosage of pentazocine/naloxone for a geriatric patient, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Geriatric patients may have increased sensitivity to pentazocine/naloxone. Respiratory depression is the chief risk for geriatric patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant and when opioids were administered concomitantly with other agents that depress respiration.