CETIRIZINE HYDROCHLORIDE SYRUP For Oral Use Rx only
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Actions
Pharmacokinetics
Distribution
Metabolism
Elimination
Interaction Studies
Special Populations
Effect of Gender
Effect of Race
Pharmacodynamics
Clinical Studies
INDICATIONS AND USAGE
Perennial Allergic Rhinitis
Chronic Urticaria
CONTRAINDICATIONS
PRECAUTIONS
Activities Requiring Mental Alertness
Drug-Drug Interactions
Carcinogenesis, Mutagenesis and Impairment of Fertility
Pediatric Use
ADVERSE REACTIONS
| Headache | 12.3% | 11.0% | 14.0% |
| Pharyngitis | 2.9% | 6.2% | 2.8% |
| Abdominal pain | 1.9% | 4.4% | 5.6% |
| Coughing | 3.9% | 4.4% | 2.8% |
| Somnolence | 1.3% | 1.9% | 4.2% |
| Diarrhea | 1.3% | 3.1% | 1.9% |
| Epistaxis | 2.9% | 3.7% | 1.9% |
| Bronchospasm | 1.9% | 3.1% | 1.9% |
| Nausea | 1.9% | 1.9% | 2.8% |
| Vomiting | 1.0% | 2.5% | 2.3% |
Autonomic Nervous System
Cardiovascular
Central and Peripheral Nervous Systems
Gastrointestinal
Genitourinary
Hearing and Vestibular
Metabolic/Nutritional
Musculoskeletal
Psychiatric
Respiratory System
Reproductive
Reticuloendothelial
Skin
Special Senses
Vision
Body as a Whole
Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine hydrochloride has been reported.