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pentazocine/acetaminophen (Talacen)

 

Classes: Analgesics, Opioid Combos; Analgesics, Opioid Partial Agonist

Dosing and uses of Talacen (pentazocine/acetaminophen)

 

Adult dosage forms and strengths

FDA is asking manufacturers to limit acetaminophen in prescription products to 325 mg/dosage unit; manufacturers have until January 14, 2014 to comply

pentazocine/acetaminophen

tablet: Schedule IV

  • 25mg/650mg

 

Pain

Dose determined by pain severity and patient response

1 tablet PO q4hr; not to exceed 6 tablets/day

 

Renal Impairment

Caution; may need to reduce either dose or frequency of administration

 

Hepatic Impairment

Caution; may need to reduce either dose or frequency of administration

 

Pediatric dosage forms and strengths

FDA is asking manufacturers to limit acetaminophen in prescription products to 325 mg/dosage unit; manufacturers have until January 14, 2014 to comply

pentazocine/acetaminophen

tablet: Schedule IV

  • 25mg/650mg

 

Pain

Dose determined by pain severity and patient response

<12 years: Safety & efficacy not established

12 years or older: 1 tablet PO q4hr; not to exceed 6 tablets/day

 

Geriatric dosage forms and strengths

Use caution

 

Pain

Dose determined by pain severity and patient response

1 tablet PO q4hr; not to exceed 6 tablets/day

 

Talacen (pentazocine/acetaminophen) adverse (side) effects

Frequency not defined

Pentazocine

  • Circulatory depression, increased blood pressure, shock, tachycardia
  • Apprehension, confusion and hallucinations (especially in elderly), depression, disturbed dreams, dizziness, euphoria, floating feeling, headache, insomnia lightheadedness, nervousness, sedation, syncope, weakness or faintness
  • Diaphoresis, flushed skin (including plethora), rash, pruritus, urticaria, edema of the face
  • Abdominal distress, anorexia, constipation, cramps, diarrhea, nausea, vomiting
  • Depression of leukocytes (especially granulocytes), moderate transient eosinophilia
  • Cutaneous depression, stinging, soft tissue induration, nodules, , ulceration, severe sclerosis of the skin
  • Blurred vision, focusing difficulty, nystagmus, diplopia, miosis

Acetaminophen

  • Laryngeal edema
  • Angioedema
  • Pruritic maculopapular, rash, urticaria
  • Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
  • Hepatotoxicity
  • Anaphylactoid reaction

 

Warnings

Black box warnings

Contains acetaminophen

Hepatotoxicity may occur with acetaminophen doses that exceed 4 grams/day (ie, 4,000 mg/day)

Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death

Most cases of liver injury are associated with the use of acetaminophen at doses that exceed 4 grams/day, and often involve more than 1 acetaminophen-containing product

New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

Healthcare professionals can direct patients to take 1 or 2 tablets, capsules or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times a day (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

 

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Toxin-mediated diarrhea

Pseudomembranous enterocolitis

Respiratory depression

 

Cautions

May cause physical and psychological dependence

Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black box warnings)

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

G6PD deficiency

Acute asthma

Bradycardia

Chronic respiratory disease, cardiac conduction disorder

Head injury, intracranial hypertension

Inflammatory bowel disease, acute abdominal pain

Benign prostatic hypertrophy

Biliary spasm

Liver disease

Drug dependence, substance abuse

Epilepsy

Gallbladder disease

Hypotension

Hypothyroidism

Mood changes

Urinary system procedure

Renal disease

Urethral stricture

Less risk of respiratory sedation than with pure opioid agonist (dose dependent); highest incidence of psychotomimetic effects of all opioid agonist/antagonists

May produce withdrawal in opioid dependent patients

 

Pregnancy and lactation

Pregnancy category: (pentazocine) C; D if used for prolonged periods or near term

Lactation: Unknown if excreted in breast milk, use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Talacen (pentazocine/acetaminophen)

Mechanism of action

Pentazocine: Opioid agonist; inhibits ascending pain pathways, which causes alteration in response to pain; produces analgesia, respiratory depression, and sedation  

Acetaminophen: Nonopiate, nonsalicylate analgesic: may work peripherally to block pain impulse generation; acts on hypothalamus to produce antipyresis