CZ 10 mg (Tablet)

Indications

• Relief of symptoms associated with seasonal allergic rhinitis
• Relief of symptoms associated with perennial allergic rhinitis
• Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria
• Treatment of allergen-induced asthma

Pharmacology

• Potent H1 receptor antagonist
• No significant anticholinergic and antiserotonic effects
• Inhibits histamine-mediated early phase of allergic reaction
• Reduces migration of inflammatory cells
• Reduces release of mediators associated with late phase of allergic reaction
• Peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children)
• Peak blood levels 0.3 micrograms/ml reached between thirty & sixty minutes after administration of 10 mg dose
• Plasma half-life approximately 11 hours
• Renal clearance 30 ml/minute
• Excretion half-life approximately nine hours

Dosage & Administration

• Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily)
• Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily
• Children 6 months to 2 years: 1/2 teaspoonful once daily
• Cetirizine injectable dosage form: for intravenous administration only
• Adults and adolescents 12 years of age and older: recommended dosage is 10 mg administered by intravenous injection
• Children 6 to 11 years of age: recommended dosage is 5 mg or 10 mg depending on symptom severity administered by intravenous injection
• Children 6 months to 5 years of age: recommended dosage is 2.5 mg administered by intravenous injection

Interaction

• No clinically significant drug interactions found with Theophylline
• No clinically significant drug interactions found with Azithromycin
• No clinically significant drug interactions found with Pseudoephedrine
• No clinically significant drug interactions found with Ketoconazole
• No clinically significant drug interactions found with Erythromycin

Contraindications

• Contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine

Side Effects

• The most common side effect is somnolence

Pregnancy & Lactation

• US FDA Pregnancy Category B
• No adequate and well-controlled studies in pregnant women
• Caution should be exercised when administered to a nursing woman

Precautions & Warnings

• Caution should be exercised when driving a car or operating heavy machinery

Use in Special Populations

• Hepatic or renal insufficiency: Total body clearance of CZ is reduced, AUC and half-life increased by about 2 to 3 fold
• Safety demonstrated in pediatric patients aged 6 months to 5 years
• Clearance of CZ reduced in elderly patients

Therapeutic Class

• Sedating Anti-histamine

Storage Conditions

• Keep in a dry place away from light and heat
• Keep out of the reach of children

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