Classes
DEA Class; Rx
Common Brand Names; Trezix
Analgesics, Opioid combo
Description
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
Indications
Contraindications
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
Adverse Effects
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
Warnings
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 and Lactation
Pregnancy Category: C
Lactation: Distributed in breast milk in small amounts, caution advised
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
12 years: Safety and efficacy have not been established.
1 to 11 years: Use is contraindicated.
Use is contraindicated.
How supplied
acetaminophen/caffeine/dihydrocodeine
capsule: Schedule III
- 320.5mg/30mg/16mg