Dosing & Uses
Dosage Forms & Strengths
acetaminophen/caffeine/dihydrocodeine
capsule: Schedule III
- 320.5mg/30mg/16mg
Moderate-to-Severe Pain
2 capsules PO q4-6hr prn; not to exceed 5 doses/24 hr (ie, 10 capsules/24 hr)
Adjust dose according to pain severity and patient response
Dosage Modifications
Renal and hepatic impairment: Use with caution and reduce dose
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
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
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
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
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
Cautions
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
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
Caution with a history of drug abuse
Caffeine may produce CNS/CV stimulation and GI irritation
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Distributed in breast milk in small amounts, caution advised
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
Mechanism of Action
Acetaminophen: Acts on hypothalamus to produce analgesia and antipyresis
Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches
Dihydrocodeine: Semisynthetic opioid agonist analgesic related to codeine
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
