Drug Guide
Loratadine and Pseudoephedrine Sulfate
Classification
Therapeutic: Nasal decongestant and antihistamine combination
Pharmacological: Antihistamine and sympathomimetic agent
FDA Approved Indications
- Relief of nasal congestion, sneezing, watery eyes, and runny nose associated with allergic rhinitis and chronic idiopathic urticaria
Mechanism of Action
Loratadine is a selective peripheral H1 antihistamine that blocks the effects of histamine. Pseudoephedrine is a sympathomimetic agent that constricts blood vessels in the nasal passages, decreasing nasal congestion.
Dosage and Administration
Adult: Loratadine 10 mg and pseudoephedrine 120 mg once daily. For 24-hour formulation, same doses every 24 hours.
Pediatric: Not generally recommended for children under 12; consult specific pediatric dosing guidance.
Geriatric: Adjust dose as needed; be cautious due to potential cardiovascular effects of pseudoephedrine.
Renal Impairment: Dose adjustment may be necessary; consult specific guidelines.
Hepatic Impairment: No specific adjustment necessary, but monitor patient.
Pharmacokinetics
Absorption: Both components are absorbed well from the gastrointestinal tract.
Distribution: Loratadine is extensively bound to plasma proteins; pseudoephedrine has minimal protein binding.
Metabolism: Loratadine is metabolized in the liver; pseudoephedrine undergoes minimal metabolism.
Excretion: Primarily excreted in urine; loratadine metabolites are also excreted via feces.
Half Life: Loratadine approximately 8 hours; pseudoephedrine about 6-12 hours.
Contraindications
- Hypersensitivity to loratadine, pseudoephedrine, or any component.
- Severe hypertension or coronary artery disease (due to pseudoephedrine).
- Use in patients with severe or uncontrolled hypertension.
- Use cautiously in patients with glaucoma, urinary retention, or hyperthyroidism.
Precautions
- Use with caution in patients with cardiovascular disease, diabetes, glaucoma, or hyperthyroidism. May cause insomnia, nervousness, or increase blood pressure.
Adverse Reactions - Common
- Headache (Common)
- Dry mouth (Common)
- Insomnia or nervousness (pseudoephedrine) (Common)
Adverse Reactions - Serious
- Hypertension or palpitations (pseudoephedrine) (Serious)
- Allergic reactions (rash, swelling) (Serious)
Drug-Drug Interactions
- MAO inhibitors (risk of hypertensive crisis), other sympathomimetics, CNS depressants.
Drug-Food Interactions
- Avoid excessive caffeine intake.
Drug-Herb Interactions
- Beware of herbal products that may elevate blood pressure or cause CNS effects.
Nursing Implications
Assessment: Monitor blood pressure, heart rate, and for signs of CNS stimulation. Assess for allergic symptoms.
Diagnoses:
- Ineffective airway clearance
- Risk for hypertension
- Insomnia
Implementation: Administer as prescribed, typically once daily. counsel patient on avoiding caffeine and other stimulants.
Evaluation: Monitor effectiveness in relieving allergy symptoms and adverse effect profile.
Patient/Family Teaching
- Take medication as directed. Do not exceed recommended dose.
- Report any increase in blood pressure, palpitations, or nervousness.
- Be aware that pseudoephedrine can cause sleeplessness; best taken earlier in the day.
Special Considerations
Black Box Warnings:
- Pseudoephedrine may elevate blood pressure and increase risk of cardiovascular events, especially in patients with pre-existing hypertension or cardiac disease.
Genetic Factors: No specific genetic markers affect response.
Lab Test Interference: Pseudoephedrine may interfere with urinary drug testing and cause false positives for amphetamines.
Overdose Management
Signs/Symptoms: Severe hypertension, tachycardia, agitation, hallucinations.
Treatment: Symptomatic and supportive care; consider antihypertensive agents if needed.
Storage and Handling
Storage: Store at room temperature, away from light and moisture.
Stability: Stable up to the expiration date on the package.