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Pentazocine/Paracetamol

    Discontinued

    DEA Class;  Discontinued

    Common Brand Names; Talacen

    • Analgesics, Opioid Combos; 
    • Analgesics, Opioid Partial Agonist

    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

    Hypersensitivity

    Hepatitis or severe hepatic/renal impairment

    Toxin-mediated diarrhea

    Pseudomembranous enterocolitis

    Respiratory depression

    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

    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

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

    Lactation: Unknown if excreted in breast milk, use caution

    Adults

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

    Pediatric

    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

    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