Drug Guide
Acetaminophen; Dexbrompheniramine Maleate; Pseudoephedrine Sulfate
Classification
Therapeutic: Combination cold and allergy remedy
Pharmacological: Analgesic, Antihistamine, Decongestant
FDA Approved Indications
- Relief of cold, allergy, sinus, and upper respiratory symptoms such as nasal congestion, cough, and headache
Mechanism of Action
Acetaminophen works centralally to inhibit prostaglandin synthesis, reducing pain and fever; Dexbrompheniramine is an antihistamine that blocks H1 receptors, reducing allergy symptoms; Pseudoephedrine is a sympathomimetic that constricts blood vessels in the nasal passages, decreasing nasal congestion.
Dosage and Administration
Adult: Follow package instructions, typically 2 tablets every 4-6 hours as needed, not exceeding 8 tablets in 24 hours.
Pediatric: Consult pediatric guidelines; generally, use weight-based dosing and avoid in children under 6 years older children doses vary.
Geriatric: Use with caution, start at lower end of dosing range, monitor closely for adverse effects.
Renal Impairment: Adjust dosage accordingly; avoid in severe impairment.
Hepatic Impairment: Careful with acetaminophen; dose reduction may be necessary.
Pharmacokinetics
Absorption: Well absorbed from the gastrointestinal tract.
Distribution: Widely distributed; crosses the blood-brain barrier.
Metabolism: Acetaminophen undergoes hepatic conjugation; dextromethorphan is metabolized in the liver; pseudoephedrine is minimally metabolized.
Excretion: Renally excreted mainly as conjugates and unchanged pseudoephedrine.
Half Life: Acetaminophen: 2-3 hours; Dextromethorphan: about 3-6 hours; Pseudoephedrine: about 6-8 hours.
Contraindications
- Hypersensitivity to any component
- Use with MAO inhibitors within 14 days (pseudoephedrine)
- Narrow-angle glaucoma (dextromethorphan)
- Severe hepatic impairment (acetaminophen)
Precautions
- Use caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or prostatic hypertrophy.
Adverse Reactions - Common
- Drowsiness, dizziness (Common)
- Nausea, dry mouth (Common)
Adverse Reactions - Serious
- Hepatotoxicity (acetaminophen) (Rare with overdose)
- Anticholinergic effects (dry mouth, urinary retention) (Less common)
- Hypertension, palpations (pseudoephedrine) (Less common)
Drug-Drug Interactions
- Monoamine oxidase inhibitors (danger of hypertensive crisis with pseudoephedrine)
- Other CNS depressants (enhanced sedative effect)
Drug-Food Interactions
- Caution with alcohol (enhanced hepatotoxicity with acetaminophen)
Drug-Herb Interactions
- St. John's Wort (potential interaction with liver metabolism)
Nursing Implications
Assessment: Monitor for allergy symptoms, blood pressure, signs of CNS depression, and liver function in long-term use.
Diagnoses:
- Risk for activity intolerance related to sedative effects.
- Risk for liver damage related to acetaminophen use.
Implementation: Administer with food if gastrointestinal upset occurs, monitor patient response, instruct patient to adhere to dosing instructions.
Evaluation: Assess symptom relief, monitor for adverse reactions, especially hepatic and cardiovascular effects.
Patient/Family Teaching
- Advise against exceeding recommended dose of acetaminophen to prevent hepatotoxicity.
- Caution about drowsiness and operating machinery.
- Instruct on reading labels to avoid accidental overdose.
- Notify healthcare provider of any new or worsening symptoms.
Special Considerations
Black Box Warnings:
- Hepatotoxicity risk with high doses or chronic use of acetaminophen.
Genetic Factors: Ultra-rapid metabolizers of pseudoephedrine may experience exaggerated effects.
Lab Test Interference: None reported.
Overdose Management
Signs/Symptoms: Nausea, vomiting, anorexia, sweating, abdominal pain, hepatotoxicity in overdose.
Treatment: Administer acetylcysteine within 8-10 hours of overdose; supportive care; activated charcoal if diagnosis is prompt.
Storage and Handling
Storage: Store at room temperature, away from moisture and light.
Stability: Stable for the shelf life indicated on the package.