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Pronunciation:

(pen TAZ oh seen & a seet a MIN oh fen)

U.S. Brand Names:

Talacen®

Synonyms:

Acetaminophen and Pentazocine; Pentazocine Hydrochloride and Acetaminophen

Generic Available:

Yes

Use:

Relief of mild to moderate pain

Restrictions:

C-IV

Pregnancy Risk Factor:

C/D (prolonged use or high doses at term)

Pregnancy Implications:

Pentazocine was not found to be teratogenic in animal studies. Pentazocine and acetaminophen cross the placenta in humans. Use should be avoided during labor and delivery of premature infants. Abstinence syndromes in the newborn have been reported after long-term use of pentazocine during pregnancy. Other adverse effects in the newborn have been reported following abuse of pentazocine during pregnancy; these effects may be due to pentazocine, other drugs abused, the mother's lifestyle, or a combination of all factors.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to pentazocine, acetaminophen, or any component of the formulation; pregnancy (prolonged use or high doses at term)

Warnings/Precautions:

Contains sodium metasulfite; may cause allergic-type reactions; potential for elevating CSF pressure due to respiratory effects which may be exaggerated in presence of head injury, intracranial lesions, or pre-existing increase in intracranial lesions. May experience hallucinations, disorientation, and confusion. May cause psychological and physical dependence. Use with caution in patients with myocardial infarction who have nausea or vomiting, patients with respiratory depression, severely limited respiratory reserve, severe bronchial asthma, other obstructive respiratory conditions or cyanosis, impaired renal or hepatic function, patients prone to seizures. Abrupt discontinuation may result in withdrawal symptoms. Pentazocine may precipitate opiate withdrawal symptoms in patients who have been receiving opiates regularly.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Tachycardia, hypotension, syncope, flushing

Central nervous system: Headache, dizziness, drowsiness, lightheadedness, sedation, insomnia, hallucinations, euphoria, depression, confusion, disorientation, chills, irritability, excitement

Dermatologic: Rash, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Gastrointestinal: Nausea, vomiting, biliary spasm, constipation, anorexia, diarrhea, abdominal distress

Genitourinary: Urinary retention

Hematologic: WBCs decreased, eosinophilia, thrombocytopenic purpura, hemolytic anemia, agranulocytosis

Neuromuscular & skeletal: Weakness, tremor, paresthesia

Ocular: Blurred vision

Otic: Tinnitus

Respiratory: Respiratory depression

Miscellaneous: Diaphoresis, facial edema, anaphylaxis

Overdosage/Toxicology:

See individual agents.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Stability:

Store at controlled room temperature of 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

Pentazocine: Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression; partial agonist-antagonist

Acetaminophen: Inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation

Pharmacodynamics/Kinetics:

See individual agents.

Dosage:

Oral: Adults: Analgesic: 1 caplet every 4 hours, up to a maximum of 6 caplets

Patient Education:

If self-administered, use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause hypotension, dizziness, drowsiness, confusion, or nervousness (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); nausea, dry mouth, decreased appetite, or gastric distress (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, consult prescriber about use of stool softeners). Report chest pain, rapid heartbeat, or palpitations; persistent dizziness; change in mental status; shortness of breath or respiratory difficulty; unusual bleeding (stool, mouth, urine) or bruising; unusual fatigue and weakness; pain on urination; change in elimination patterns or change in color of urine or stool; or unresolved nausea or vomiting. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nursing Implications:

Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation; observe for narcotic withdrawal

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Caplet (Talacen®): Pentazocine 25 mg and acetaminophen 650 mg [contains sodium metabisulfite]

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