Levocetirizine dihydrochloride is the generic equivalent of the brand-name drug Levocetirizine Dihydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Levocetirizine dihydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Somnolence [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years…
Drug Interactions
7 DRUG INTERACTIONS 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. 7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic ce…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption. Chronic Idiopathic Urticaria ( 2.2 ) • Adults and children 12 years of age and older: 5 mg once daily in the evening • Children 6 to 11 years of age: 2.5 mg once daily in the evening • Renal Impairment Adjust the dose in patients 12 years of…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Somnolence Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride [see Warnings and Precautions ( 5.1 )]. Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur [see Warnings and Precautio…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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