Generics: Cetirizine hydrochloride.
Dosage Form: Paediatric Drops.
It is suitable for alleviating symptoms associated with seasonal and perennial allergic rhinitis. It is also suitable for the treatment of simple skin manifestations of chronic idiopathic urticaria and allergen-induced asthma.
Cetirizine hydrochloride is an effective H1 receptor antagonist without any significant anticholinergic or antiserum effects. At the pharmacologically active dose level, it produces almost no drowsiness and does not cause behavioral changes. It inhibits the early stages of histamine-mediated allergic reactions and also reduces the migration of inflammatory cells and the release of mediators related to the later stages of allergic reactions.
Pharmacokinetics: Cetirizine 10 mg reaches a maximum plasma concentration of 257 mcg / L (980 mcg / L in children) within 1 hour after administration. Food does not affect the degree of absorption, but may slightly slow down the rate. A maximum blood concentration of 0.3 µg / ml was reached between 30 and 60 minutes after administration of a 10 mg dose of cetirizine. Its plasma half-life is approximately 11 hours. The absorption from one topic to another is very consistent. Its renal clearance rate is 30 ml / min and its excretion half-life is approximately 9 hours.
Dosage guideline: Twice daily.
- 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. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.
Route of administration: Orally.
No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.
It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.
The most common side effects that occurred more frequently on Cetirizine is somnolence.
Pregnancy & Lactation:
The US FDA classifies cetirizine hydrochloride as pregnancy classification B. However, there are no adequate and well-controlled studies on pregnant women. Because animal reproduction research does not always predict human response, the drug should be used during pregnancy only when clearly necessary. Cetirizine hydrochloride has been shown to be excreted from human milk. Therefore, care should be taken when administering cetirizine hydrochloride to lactating women.
Precautions & Warnings:
Caution should be exercised when driving a car or operating a heavy machinery.
Keep in a dry place away from light and heat. Keep out of the reach of children.
Manufactured by: Square pharmaceuticals Ltd.