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The information provided in this commentary is intended solely for educational and professional reference purposes and does not replace medical advice, diagnosis, or treatment. Clinical decisions should always rely on the officially approved prescribing information and the judgment of qualified healthcare professionals.
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2. Summary
Clarinase® Repetabs is an extended-release oral combination product containing loratadine, a second-generation peripherally selective H1-antihistamine, and pseudoephedrine sulfate, a systemic sympathomimetic nasal decongestant. It is indicated for the symptomatic relief of allergic rhinitis and upper respiratory tract congestion when both antihistaminic and decongestant effects are required. The Repetabs® technology allows rapid onset of antihistaminic action with sustained decongestant activity for up to 12 hours.
3. Brand Name
Clarinase® Repetabs
4. Category
- Antihistamine / Decongestant combination
- Anti-allergic agent
- Upper respiratory tract symptom reliever
5. Active Ingredient
- Loratadine
- Pseudoephedrine sulfate
6. Pharmaceutical Form & Strength
Extended-release (modified-release) tablets
Each tablet contains:
- Loratadine 5 mg
- Pseudoephedrine sulfate 120 mg
7. Manufacturer & Marketing Authorization Holder
Original manufacturer: Bayer HealthCare
Local marketing authorization / distributor (Egypt): Egyptian Pharmaceutical Trading Company (EPTCO)
(Authorization and availability may vary by country and over time.)
8. Mechanism of Action
- Loratadine selectively blocks peripheral histamine H1-receptors, reducing histamine-mediated symptoms such as sneezing, itching, rhinorrhea, and lacrimation, with minimal penetration of the blood–brain barrier.
- Pseudoephedrine sulfate is a sympathomimetic amine that stimulates α-adrenergic receptors in nasal mucosal vessels, producing vasoconstriction and reducing mucosal edema and nasal congestion.
- The Repetabs® bilayer system enables immediate release of loratadine and delayed, sustained release of pseudoephedrine.
9. Spectrum of Activity
Not applicable.
Clarinase Repetabs has no antimicrobial activity and provides symptomatic relief only.
10. Pharmacokinetics
Loratadine
- Well absorbed orally
- Extensive hepatic metabolism via CYP3A4 and CYP2D6
- Active metabolite: desloratadine
- Elimination half-life: approximately 8–24 hours (prolonged in hepatic impairment)
Pseudoephedrine
- Rapid gastrointestinal absorption
- Minimal hepatic metabolism
- Primarily excreted unchanged in urine
- Duration of decongestant effect: up to 12 hours in extended-release formulation
11. Indications
Indicated for relief of symptoms associated with:
- Seasonal and perennial allergic rhinitis
- Upper respiratory tract congestion due to common cold
Including:
- Nasal congestion
- Sneezing
- Rhinorrhea
- Nasal and ocular pruritus
- Lacrimation
12. Administration
Adults and adolescents ≥12 years:
- One tablet twice daily (every 12 hours)
- Tablets must be swallowed whole with water and must not be crushed or chewed.
13. Method of Preparation
Not applicable.
(Commercially available ready-to-use oral tablets.)
14. Contraindications
- Hypersensitivity to loratadine, pseudoephedrine, or excipients
- Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation
- Severe or uncontrolled hypertension
- Severe coronary artery disease
- Narrow-angle glaucoma
- Urinary retention
- Hyperthyroidism
- Severe renal impairment
15. Warnings & Precautions
- Use with caution in patients with cardiovascular disease, diabetes mellitus, prostatic hypertrophy, or increased intraocular pressure
- Elderly patients are more susceptible to sympathomimetic adverse effects
- Dose reduction recommended in severe hepatic impairment
- Pseudoephedrine may cause CNS stimulation, insomnia, anxiety, or elevated blood pressure
- Rare but serious cerebrovascular adverse events (e.g., PRES/RCVS) have been reported with pseudoephedrine; discontinue immediately if severe headache or neurological symptoms occur
16. Drug Interactions
- MAO inhibitors: risk of hypertensive crisis
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): increased loratadine plasma levels (usually not clinically significant)
- Antihypertensives: reduced efficacy
- Digitalis glycosides: increased risk of arrhythmias
- Other sympathomimetics: additive cardiovascular and CNS effects
- Antacids may increase pseudoephedrine absorption
- Antihistamines should be discontinued before allergy skin testing
17. Side Effects
Common
- Insomnia
- Dry mouth
- Headache
- Nervousness
Uncommon / Rare
- Dizziness
- Palpitations
- Hypertension
- Gastrointestinal discomfort
- Skin rash or urticaria
- Rare reports of alopecia, hypersensitivity reactions, and transient liver enzyme elevation
18. Use in Special Populations
- Pregnancy: Use only if potential benefit outweighs potential risk
- Lactation: Both components are excreted in breast milk; decision required to discontinue nursing or therapy
- Pediatrics: Not recommended for children under 12 years
- Elderly: Increased sensitivity to sympathomimetic effects; close monitoring advised
- Renal impairment: Avoid in severe cases
19. Storage Conditions
- Store below 30°C
- Protect from moisture
- Keep out of reach of children
20. Additional Sections
Overdose:
May result in CNS stimulation or depression, cardiovascular instability, hypertension, arrhythmias, seizures, or coma. Treatment is symptomatic and supportive.
Drug Abuse & Dependence:
Pseudoephedrine has stimulant properties; abuse is uncommon at therapeutic doses but possible at high doses.
21. Frequently Asked Questions (FAQ)
Q: Does Clarinase Repetabs cause drowsiness?
A: Loratadine is non-sedating, but pseudoephedrine may cause insomnia or restlessness.
Q: Can it be used long-term?
A: It is intended for short-term or seasonal use; prolonged use should be medically supervised.
Q: Is it suitable for hypertensive patients?
A: It is contraindicated in uncontrolled hypertension and should only be used under medical supervision in controlled cases.
22. References
- Approved prescribing information for loratadine/pseudoephedrine extended-release tablets
- EMA Pharmacovigilance Risk Assessment Committee (PRAC) safety communications on pseudoephedrine
- FDA DailyMed drug labeling database
- WHO ATC/DDD Classification System (R01BA52)
- Standard clinical pharmacology and drug reference texts
