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dihydrocodeine/acetaminophen/caffeine (Rx)Brand and Other Names:Trezix

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

dihydrocodeine/acetaminophen/caffeine

capsule: Schedule III

  • 16mg/320.5.4mg/30mg
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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

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Adverse Effects

Frequency Not Defined

Dihydrocodeine

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

Acetaminophen

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

Caffeine

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

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

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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.

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Pharmacology

Mechanism of Action

Dihydrocodeine: Semisynthetic opioid agonist analgesic related to codeine

Acetaminophen: Acts on hypothalamus to produce analgesia and antipyresis

Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

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Images

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Formulary

FormularyPatient Discounts

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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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