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
