Indications
Alatrol is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis. It is also effective in treating the uncomplicated skin manifestations of chronic idiopathic urticaria and asthma triggered by allergens.
Use as directed by a registered healthcare professional.

Pharmacology
Cetirizine Hydrochloride is a potent H1 receptor antagonist, which does not exhibit significant anticholinergic or antiserotonic effects. At therapeutic doses, cetirizine causes minimal sedation and does not lead to behavioral changes. It works by inhibiting the early histamine-mediated phase of allergic reactions and by reducing the migration of inflammatory cells, as well as the release of mediators associated with the late phase of these reactions.

Pharmacokinetics:
A 10 mg dose of cetirizine reaches peak plasma concentrations of 257 mcg/L within one hour (980 mcg/L in children). While food does not significantly affect the extent of absorption, it may slightly reduce the rate of absorption. Peak blood levels of 0.3 mcg/mL are attained within 30 to 60 minutes after a 10 mg dose. The plasma half-life is approximately 11 hours, with renal clearance of 30 mL/min and an excretion half-life of around 9 hours. Cetirizine’s absorption is highly consistent among individuals.

Dosage & Administration
For Cetirizine Oral Tablets:

• Adults and Children 6 years and older: Take 1 tablet or 2 teaspoonfuls once daily, or 1 teaspoonful twice daily.
• Children 2-6 years: Take 1 teaspoonful once daily, or 1/2 teaspoonful twice daily.
• Children 6 months to 2 years: Take 1/2 teaspoonful once daily. The dose for children aged 12 to 23 months may be increased to 1/2 teaspoonful every 12 hours, as required.

For Cetirizine Injectable Form:
Cetirizine injectable is used only for intravenous administration. It is typically given once every 24 hours as needed for treating acute urticaria. The injection should be given slowly over 1 to 2 minutes. Cetirizine is not recommended for pediatric patients under 6 years of age with impaired renal or liver function.

• Adults and adolescents (12 years and older): 10 mg via intravenous injection.
• Children (6 to 11 years): 5 mg or 10 mg intravenously, depending on the severity of symptoms.
• Children (6 months to 5 years): 2.5 mg intravenously.

Always follow the dosage instructions provided by your healthcare provider.

Interactions
Cetirizine has not shown any clinically significant interactions with drugs such as Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole, or Erythromycin, among others.

Contraindications
Cetirizine is contraindicated in patients who have a known hypersensitivity to cetirizine or hydroxyzine.

Side Effects
The most commonly reported side effect of Alatrol is somnolence (drowsiness).

Pregnancy & Lactation
Cetirizine is classified as Pregnancy Category B by the US FDA, indicating that no adequate and well-controlled studies are available for pregnant women. As animal reproduction studies do not always predict human outcomes, cetirizine should only be used during pregnancy when absolutely necessary. Cetirizine is excreted in human milk, so caution is advised when administered to breastfeeding women.

Precautions & Warnings
Patients should exercise caution when driving or operating heavy machinery as cetirizine may cause drowsiness in some individuals.

Use in Special Populations

• Hepatic or Renal Impairment: In patients with mild to moderate liver or kidney impairment, the clearance of Alatrol is reduced, and its AUC (area under the curve) and half-life increase by about 2 to 3 times. In hemodialysis patients, plasma levels are unaffected, but the elimination half-life increases to about 20 hours, and AUC is increased threefold.
• Pediatric Use: The safety of Alatrol has been demonstrated for children aged 6 months to 5 years.
• Elderly Use: The clearance of Alatrol is reduced in elderly patients, but this is proportional to any decrease in creatinine clearance.

Therapeutic Class
Sedating antihistamine.

Storage Conditions
Store in a dry place, away from light and heat. Keep out of the reach of children.