Alargin

Description

💊 Alargin – Cetirizine Hydrochloride

Manufacturer: SinoHealth Pharmaceuticals LTD

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1. Presentation:

• Oral Dosage Form: Tablets and oral syrup

• Injectable Dosage Form: Single-use intravenous injection

• Strength: 10 mg per tablet / per 5 ml syrup / as specified for injection

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2. Description:

Alargin contains Cetirizine Hydrochloride, a potent H1 receptor antagonist with minimal anticholinergic and antiserotonergic effects.

At therapeutic doses, Cetirizine is non-sedating in most patients and does not cause behavioral changes.

It inhibits the histamine-mediated early phase of allergic reactions and reduces the migration of inflammatory cells and the release of mediators associated with the late phase of allergic reactions.

Pharmacokinetics:

• Oral Cetirizine 10 mg achieves peak plasma concentration (257 mcg/L) within 1 hour (980 mcg/L in children).

• Food does not affect the extent of absorption but may slightly reduce the rate.

• Peak blood levels (~0.3 μg/mL) occur 30–60 minutes after a 10 mg dose.

• Plasma half-life is approximately 11 hours; renal clearance ~30 mL/min.

• Excretion half-life ~9 hours; absorption is consistent among subjects.

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3. Indications:

Alargin is indicated for the relief of symptoms associated with:

• Seasonal and perennial allergic rhinitis

• Chronic idiopathic urticaria (uncomplicated skin manifestations)

• Allergen-induced asthma

Use only under the supervision of a registered physician.

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4. Dosage & Administration:

Oral Dosage Form:

• Adults and children ≥6 years: 1 tablet or 2 teaspoonfuls once daily, or 1 teaspoonful twice daily

• Children 2–6 years: 1 teaspoonful once daily, or ½ teaspoonful twice daily

• Children 6 months–2 years: ½ teaspoonful once daily (may increase to ½ teaspoonful every 12 hours for children 12–23 months)

Injectable Dosage Form:

• Adults & adolescents ≥12 years: 10 mg IV once daily

• Children 6–11 years: 5–10 mg IV depending on symptom severity

• Children 6 months–5 years: 2.5 mg IV once daily

Administer IV over 1–2 minutes. Not recommended in pediatric patients <6 years with renal or hepatic impairment.
Use only under registered physician guidance.

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5. Interaction:

No clinically significant drug interactions have been found with:

• Theophylline

• Azithromycin

• Pseudoephedrine

• Ketoconazole

• Erythromycin

• Other commonly used drugs

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6. Contraindications:

• Hypersensitivity to Cetirizine or Hydroxyzine

• Avoid in patients using ergot derivatives simultaneously

• Patients with severe liver disorders

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7. Side Effects:

• Most common: somnolence

• Other rare effects: headache, mild gastrointestinal discomfort, dry mouth

• Generally well-tolerated; reversible upon discontinuation

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8. Pregnancy & Lactation:

• Pregnancy: FDA Category B; use only if clearly needed

• Lactation: Excreted in human milk; exercise caution when administered to nursing mothers

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9. Precautions & Warnings: