Drug Guide
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Classification
Therapeutic: Antihistamine, Decongestant combination
Pharmacological: Antihistamine (selective) and Sympathomimetic decongestant
FDA Approved Indications
- Relief of allergy symptoms including nasal congestion, sneezing, runny nose, and itchy eyes due to seasonal allergic rhinitis.
- Relief of nasal congestion associated with allergic rhinitis.
Mechanism of Action
Fexofenadine is a selective peripheral H1 antihistamine that inhibits the effects of histamine at H1 receptor sites. Pseudoephedrine is a sympathomimetic agent that stimulates alpha-adrenergic receptors in the nasal mucosa, resulting in vasoconstriction and decreased nasal congestion.
Dosage and Administration
Adult: Typically, 60 mg twice daily or as prescribed. For 12-hour formulations: 60 mg twice a day. For 24-hour formulations: once daily 180 mg.
Pediatric: Safety and efficacy not established for children under 12; consult specific product label.
Geriatric: Adjust dosage if needed; no specific changes recommended but monitor for anticholinergic and cardiovascular effects.
Renal Impairment: Reduce dose in patients with severe renal impairment; consult dosing guidelines.
Hepatic Impairment: No specific adjustment recommended, but caution advised.
Pharmacokinetics
Absorption: Fexofenadine is well absorbed; pseudoephedrine is also rapidly absorbed.
Distribution: Fexofenadine binds extensively to plasma proteins; pseudoephedrine has minimal plasma protein binding.
Metabolism: Fexofenadine undergoes minimal metabolism; pseudoephedrine is primarily excreted unchanged.
Excretion: Excreted mainly in feces (fexofenadine) and urine (pseudoephedrine).
Half Life: Fexofenadine: approximately 14 hours; Pseudoephedrine: approximately 4-6 hours.
Contraindications
- Known hypersensitivity to any components.
- Use caution in patients with hypertension or cardiovascular disease (pseudoephedrine).
Precautions
- Use with caution in patients with hyperthyroidism, glaucoma, and prostatic hypertrophy.
- Avoid in patients taking monoamine oxidase inhibitors (MAOIs).
Adverse Reactions - Common
- Headache (Common)
- Nausea (Common)
- Nervousness or restlessness (Common)
Adverse Reactions - Serious
- Hypertension or arrhythmias (pseudoephedrine) (Serious but less common)
- Allergic reactions, angioedema (rare) (Rare)
Drug-Drug Interactions
- Concurrent use with other vasoconstrictors or monoamine oxidase inhibitors (MAOIs).
Drug-Food Interactions
- Avoid alcohol, which can increase sedation.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood pressure, especially in hypertensive patients. Observe for allergic reactions and CNS effects.
Diagnoses:
- Risk for hypertension or cardiovascular effects.
- Ineffective airway clearance due to nasal congestion.
Implementation: Administer with water, caution against alcohol and CNS depressants.
Evaluation: Assess relief of allergy and congestion symptoms after administration.
Patient/Family Teaching
- Take medication as prescribed. Do not exceed recommended doses.
- Report any signs of increased blood pressure or allergic reactions.
- Avoid alcohol and activities requiring alertness if sedated.
Special Considerations
Black Box Warnings:
- Pseudoephedrine may increase blood pressure; use with caution in hypertensive patients.
Genetic Factors: None specific.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Excessive stimulation, hypertension, CNS excitation, nausea, vomiting.
Treatment: Supportive care; monitor cardiac status; activated charcoal may be administered if ingestion is recent.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable if stored properly; protect from moisture and light.