pentazocine/acetaminophen (Rx)Brand and Other Names:Talacen

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & 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
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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

Dosage Forms & 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
more...

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

Use caution

Pain

Dose determined by pain severity and patient response

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

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Interactions

Interaction Checker

pentazocine/acetaminophen and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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
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            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

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            Pregnancy & 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.

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            Pharmacology

            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

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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