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Paracetamol/Caffeine/Dihydrocodeine

    Brands

    DEA Class;  Rx

    Common Brand Names; Trezix

    Analgesics, Opioid combo

    Multi-ingredient products of acetaminophen and caffeine combined with dihydrocodeine, an opioid analgesic
    Used for acute moderate to severe pain; not for chronic, persistent pain
    Tablets and capsules not directly interchangeable; as with all opioids, may cause sedation and respiratory depression

    For the treatment of moderate pain to severe pain.

    Hypersensitivity

    Any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus

    Acetaminophen

    • Pruritic maculopapular rash
    • Urticaria
    • Laryngeal edema
    • Angioedema
    • Anaphylactoid reaction
    • Thrombocytopenia
    • Leukopenia

    Caffeine

    • Insomnia
    • Restlessness
    • Nervousness
    • Tremor
    • Tinnitus
    • Irritability
    • Nausea

    Dihydrocodeine

    • Light-headedness
    • Dizziness
    • Drowsiness
    • Headache
    • Fatigue
    • Sedation
    • Confusion

    May impair mental/physical abilities required for hazardous tasks (eg, driving, operating machinery)

    May cause respiratory depression

    Caution is used with head injury or increased ICP

    May cause hypotension

    Dihydrocodeine can produce drug dependence

    Caution in elderly or debilitated patients, or in patients with following conditions: adrenocortical insufficiency (Addison disease), asthma, central nervous system depression or coma, chronic obstructive pulmonary disease, decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis), delirium tremens, head injury, hypotension, increased intracranial pressure, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, and toxic psychosis

    Use opioids with caution with MAOIs

    Pregnancy Category: C

    Lactation: Distributed in breast milk in small amounts, caution advised

    Adults

    Capsules containing acetaminophen 320.5 mg: acetaminophen 3,205 mg/24 hours PO; caffeine 300 mg/24 hours PO; dihydrocodeine 160 mg/24 hours PO. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.
    Tablets containing acetaminophen 325 mg: acetaminophen 3,250 mg/24 hours PO; caffeine 300 mg/24 hours PO; dihydrocodeine 160 mg/24 hours PO. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.

    Geriatric

    Capsules containing acetaminophen 320.5 mg: acetaminophen 3,205 mg/24 hours PO; caffeine 300 mg/24 hours PO; dihydrocodeine 160 mg/24 hours PO. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.
    Tablets containing acetaminophen 325 mg: acetaminophen 3,250 mg/24 hours PO; caffeine 300 mg/24 hours PO; dihydrocodeine 160 mg/24 hours PO. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.

    Adolescents

    Safety and efficacy have not been established.

    Children

    12 years: Safety and efficacy have not been established.
    1 to 11 years: Use is contraindicated.

    Infants

    Use is contraindicated.

    acetaminophen/caffeine/dihydrocodeine

    capsule: Schedule III

    • 320.5mg/30mg/16mg