Acitrin®

Cetirizine Dihydrochloride

Prescribing Details



Description

Acitrin ® is a preparation of Cetirizine dihydrochloride. It is a piperazine derivative and metabolite of Hydroxyzine, which is long acting and has some mast-cell stabilizing activity. Principal actions of Cetirizine are mediated by selective inhibition of peripheral H 1 -receptors.


Uses

No Data


Indications

Acitrin ® is indicated for the symptomatic treatment of

  • Seasonal Allergic Rhinitis such as sneezing, rhinorrhea, pruritus, ocular pruritus, tearing and redness of the eyes.
  • Perennial Allergic Rhinitis sneezing, rhinorrhea, post-nasal discharge, nasal pruritus, ocular pruritus and tearing.
  • Chronic Idiopathic Urticaria such as uncomplicated skin manifestations, severity and duration of hives, pruritus and allergen induced asthma.

 


Dosage and administration

Adults and children aged 6 years and over
Acitrin ® Tablet10 mg once daily or 5 mg twice daily.
Acitrin ® Syrup: 2teaspoonfuls once daily or 1 teaspoonful twice daily. In patients with decreased renal function (creatinine clearance 11-31 mL/min), patients on hemodialysis (creatinine clearance less than 7 mL/min) and in hepatically impaired patients, a dose of 1/2 tablet or 1 teaspoonful once daily is recommended.

Children aged 2 to 6 years
Acitrin ® Tablet: 5 mg once daily or 2.5 mg twice daily
Acitrin ® Syrup: 1 teaspoonful once daily or 1/2 teaspoonful twice daily. Children aged 6 months to <2 years
Acitrin ®> Syrup: 1/2 teaspoonful once daily, increased to a maximum of 1/2 teaspoonful twice daily
Acitrin ® Paediatric Drops: 1ml once daily, increased to a maximum of 1ml twice daily.


Use in pregnancy & lactation

Cetirizine dihydrochloride is pregnancy category B. There are no adequate and well controlled studies in pregnant women. Cetirizine should be used during pregnancy only if clearly needed. Cetirizine has been reported to be excreted in human breast milk. As large amount of drugs are excreted in human milk, use of Cetirizine in nursing mother is not recommended.


Geriatric use
No Data

Precautions

Could be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of Cetirizine with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.


Side effects
Cetirizine dihydrochloride is well tolerated. Lower incidence of sedation, headache, dry mouth, and gastrointestinal disturbances may occur. It does not produce anticholinergic effects.

Contraindications

Cetirizine Dihydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.


Drug interactions

No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin.


Overdose
Only limited information is available regarding overdosage in humans although the most likely effect of overdosage is hypotension. If overdosage is occurred, the patient should be carefully monitored and treatment should be symptomatic and supportive.

Preparation

No Data


Pharmaceutical precautions

Store in a cool and dry place, protect from light.


Presentation
Acitrin ® Tablet: Each tablet contains Cetirizine Dihydrochloride BP 10 mg
Acitrin ® Syrup: Each 5 ml syrup contains Cetirizine Dihydrochloride BP 5 mg
Acitrin ® Paediatric Drops: Each ml contains Cetirizine Dihydrochloride BP 2.5 mg

Package quantities
Acitrin ® Tablet: Carton of 100 tablets in blister
Acitrin ® Syrup: Bottle of 60 ml
Acitrin ® Paediatric Drops: Bottle of 15 ml with food grade dropper