CLARINASE 5/MG TAB 14/TAB

Indications

Approved Uses

Seasonal allergic rhinitis with nasal congestion, perennial allergic rhinitis with nasal congestion, relief of symptoms associated with allergic rhinitis including sneezing, rhinorrhea, nasal congestion, and itchy/watery eyes

Dosage & Administration

Dosing by Condition

Allergic rhinitis with nasal congestion (adults and children ≥12 years): 1 tablet orally every 12 hours; maximum 2 tablets/day; not recommended for <12 years.

Initial Dose

1 tablet twice daily (every 12 hours)

Maintenance Dose

1 tablet twice daily (every 12 hours)

Maximum Dose

Maximum: 2 tablets in 24 hours (1 tablet every 12 hours).

Children's Dosage

Children 12 years of age and over: One tablet every 12 hours. Not recommended for children under 12 years.

Dose Adjustment Notes

Severe renal impairment (CrCl <30 mL/min) or hepatic impairment: reduce to 1 tablet once daily (instead of every 12 hours); use caution in elderly and in cardiovascular disease.

How to Take

Swallow tablet whole with water. Can be taken with or without food. Do not crush or chew the tablet.

Side Effects

Common Side Effects

Insomnia, headache, dry mouth, nervousness, dizziness, palpitations, tachycardia, fatigue, somnolence, nausea

Side Effect Frequency

For loratadine 5 mg + pseudoephedrine 120 mg (Clarinase): Common (≥1/100 to <1/10): insomnia, dry mouth, headache, nervousness. Uncommon (≥1/1,000 to <1/100): dizziness, fatigue/asthenia, nausea. Rare/very rare (<1/1,000): palpitations/tachycardia, hypertension, urinary retention, hypersensitivity reactions (e.g., rash/angioedema), elevated hepatic enzymes.

Safety & Warnings

Contraindications

Hypersensitivity to ingredients, patients receiving MAO inhibitor therapy (or within 14 days of discontinuation), narrow-angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, hyperthyroidism.

Warnings & Precautions

Use with caution in hypertension, ischemic heart disease/arrhythmias, diabetes, hyperthyroidism, increased intraocular pressure/narrow-angle glaucoma, prostatic hypertrophy/urinary retention risk, and in renal or hepatic impairment; avoid with MAOIs (and within 14 days of stopping); may cause insomnia/nervousness-avoid late dosing; elderly may be more sensitive.

Age Restriction

Not recommended for children under 12 years (use in ≥12 years and adults).

Driving Warning

No driving warning; loratadine is non-sedating and does not impair driving ability. Pseudoephedrine may cause nervousness or insomnia but not drowsiness

Drug Interactions

Drug Interactions

MAO inhibitors (contraindicated/avoid within 14 days), other sympathomimetics/decongestants/stimulants (additive CV/CNS effects), antihypertensives (may reduce antihypertensive effect), tricyclic antidepressants (potentiate pressor/CNS effects), ergot alkaloids (increased vasoconstriction/ischemia risk), CYP inhibitors that increase loratadine exposure (e.g., ketoconazole, erythromycin/clarithromycin, cimetidine).

Interaction Severity

MAJOR/Contraindicated: MAO inhibitors (and within 14 days of stopping) due to risk of hypertensive crisis. MODERATE: other sympathomimetics/decongestants and tricyclic antidepressants (additive pressor/CV stimulation); antihypertensives (may reduce BP control); strong CYP3A4/2D6 inhibitors such as ketoconazole/erythromycin/cimetidine (may increase loratadine exposure).

Food Interaction

May be taken with or without food; food may delay absorption but does not meaningfully change overall clinical effect.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Children 12 years of age and over: One tablet every 12 hours. Not recommended for children under 12 years.

Elderly

Use with caution; consider reduced dosing frequency (once daily) due to increased sensitivity to sympathomimetic effects and potential renal/hepatic impairment

Kidney Impairment

Severe renal impairment (CrCl <30 mL/min): 1 tablet once daily.

Liver Impairment

Severe hepatic impairment: 1 tablet once daily (instead of every 12 hours).

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep in original packaging. Keep out of reach of children.

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime when symptoms resolve. Treatment should be kept as short as possible.

Overdose

Symptoms: CNS stimulation (insomnia, agitation/anxiety, tremor, hallucinations/psychosis, seizures), or less commonly somnolence; cardiovascular effects (tachycardia, palpitations, hypertension, arrhythmias); GI upset (nausea/vomiting); urinary retention. Management: urgent medical evaluation, supportive/symptomatic care with cardiovascular monitoring; consider activated charcoal if early after ingestion per poisoning guidance.

Patient Counseling

Take 1 tablet every 12 hours (max 2/day); swallow whole (do not crush/chew). May cause insomnia/nervousness-avoid late-evening dosing; avoid other decongestants/stimulants. Can raise blood pressure-seek advice if you have hypertension/heart disease. Do not use with MAOIs or within 14 days of stopping. Seek medical advice if symptoms persist ~7-10 days, worsen, or are accompanied by fever/severe headache.

Monitoring Requirements

No routine laboratory monitoring in healthy patients; monitor blood pressure/heart rate and symptom response in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or prostatic hypertrophy.

Pharmacology

Mechanism of Action

Loratadine: second-generation selective peripheral H1-antagonist (minimal CNS penetration). Pseudoephedrine: sympathomimetic with primarily alpha-adrenergic vasoconstriction in nasal mucosa reducing congestion.

Onset of Action

Clinical onset is typically within about 1-3 hours (decongestant effect may be noticed earlier in some patients).

Duration of Effect

12 hours.

Half-Life

Loratadine: ~8-12 hours; active metabolite (desloratadine): ~17-24 hours (can be longer in some sources). Pseudoephedrine: ~5-8 hours, prolonged with alkaline urine/renal impairment.

Bioavailability

Loratadine: not reliably stated as an absolute % (extensive first-pass metabolism; absolute bioavailability not well established). Pseudoephedrine: high oral absorption (often cited ~90% or higher).

Metabolism

Loratadine: extensive hepatic metabolism via CYP3A4 and CYP2D6 to active metabolite (desloratadine). Pseudoephedrine: minimal/incomplete hepatic metabolism; largely excreted unchanged in urine.

Excretion

Loratadine: eliminated as metabolites in urine and feces (roughly similar proportions across both routes). Pseudoephedrine: primarily renal excretion largely unchanged; extent is urine pH dependent.

Protein Binding

Loratadine: 97-99% protein bound; desloratadine: ~73-76% protein bound; pseudoephedrine: low protein binding (commonly reported ~0-20%).

Product Information

Available Dosage Forms

Tablet (immediate-release); extended-release formulations exist but are separate products

Composition per Dose

Each tablet: Loratadine 5mg + Pseudoephedrine hydrochloride 120mg

Generic Availability

Yes

OTC Alternatives

For allergy symptoms: loratadine 10 mg, cetirizine 10 mg, or fexofenadine (e.g., 120 mg) as single-ingredient antihistamines. For congestion: saline nasal spray/irrigation; short-term topical nasal decongestant (e.g., oxymetazoline) or oral decongestant where appropriate.

Symptom Target

Congestion, Runny Nose, Allergy, Multi-symptom

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 23-06-2026