Sensitrin

Levocetirizine hydrochloride.

Each film-coated tablet contains: Levocetirizine hydrochloride 5 mg.

For the symptomatic relief of allergic conditions including rhinitis and chronic urticaria.

Adults and Children 12 Years of Age and Older: The recommended dose of Levocetirizine hydrochloride is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
Children 6 to 11 Years of Age: The recommended dose of Levocetirizine hydrochloride is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults.
Dosage Adjustment for Renal and hepatic Impairment: In adults and children 12 years of age and older with: Mild renal impairment (creatinine clearance [CL_CR=50-8 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CL_CR=30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CL_CR=10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CL_CR < 10 mL/min) and patients undergoing hemodialysis should not receive Levocetirizine hydrochloride.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic and renal impairment, adjustment of the dose is recommended.

Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Levocetirizine hydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

The use of Levocetirizine hydrochloride is contraindicated in: Patients with known hypersensitivity to Levocetirizine hydrochloride or any of the ingredients. Observed reactions range from urticaria to anaphylaxis.
Patients with end-stage renal disease (CL_CR <10 mL/min) and patients undergoing hemodialysis.
Pediatric patients with impaired renal function. Children 6 months to 11 years of age with impaired renal function.

General: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Levocetirizine hydrochloride. Avoid concurrent use of alcohol or other central nervous system depressants with Levocetirizine.
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, Levocetirizine hydrochloride should be used during pregnancy only if clearly needed.
Use in Lactation: Levocetirizine has been reported to be excreted in human breast milk, therefore it is not recommended during lactation.

Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, Levocetirizine hydrochloride should be used during pregnancy only if clearly needed.
Use in Lactation: Levocetirizine has been reported to be excreted in human breast milk, therefore it is not recommended during lactation.

The use of Levocetirizine hydrochloride has been associated with somnolence, fatigue, nasopharyngitis, dry mouth, and pharyngitis.

In vitro data indicate that Levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes. No in vivo drug-drug interaction studies have been performed with Levocetirizine. Drug interaction studies have been performed with racemic cetirizine.
Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine: Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease (-16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect.
Ritonavir: Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine. The disposition of ritonavir was not altered by concomitant cetirizine administration.

Store at temperatures not exceeding 30°C.

Antihistamines & Antiallergics

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

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