Alenil™ IV injection: Each 1 ml ampoule contains Cetirizine Hydrochloride BP 10 mg.
Alenil™ is a preparation of Cetirizine Hydrochloride, a human metabolite of hydroxyzine. It is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1-receptors. The antihistaminic activity of Cetirizine Hydrochloride has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies however, dry mouth was more common with Cetirizine Hydrochloride than with placebo. In vitro receptor binding studies have shown no measurable affinity for receptors other than H1 receptors.
Cetirizine Hydrochloride IV Injection is a single use injectable product for intravenous administration only. The recommended dosage regimen is once every 24 hours as needed for treatment of acute urticaria. Administer Cetirizine Hydrochloride IV Injection as an intravenous push over a period of 1 to 2 minutes. Cetirizine Hydrochloride IV Injection is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.
Adults and adolescents 12 years of age and older: The recommended dosage is 10 mg administered by intravenous injection.
Children 6 to 11 years of age: The recommended dosage is 5 mg or 10 mg depending on symptom severity administered by intravenous injection.
Children 6 months to 5 years of age: The recommended dosage is 2.5 mg administered by intravenous injection.
Pediatric Use: The safety and efficacy of Cetirizine Hydrochloride IV Injection have been established in patients 6 months to 17 years of age. The efficacy of Cetirizine Hydrochloride IV Injection for the treatment of acute urticaria down to 6 months of age is based on extrapolation of the efficacy of Cetirizine Hydrochloride IV Injection in adults with acute urticaria and supported by pharmacokinetic data with oral Cetirizine Hydrochloride in patients 6 months to 17 years of age. Because of the absence of pharmacokinetic and safety information for Cetirizine Hydrochloride in children below 6 years of age with impaired renal or hepatic function, the use of Cetirizine Hydrochloride IV Injection in this impaired patient population is not recommended. The safety and efficacy of Cetirizine Hydrochloride IV Injection in patients less than 6 months of age has not been established.
Geriatric Use: In clinical trials with Cetirizine Hydrochloride IV Injection, 18 patients were 65 years and older, and 6 patients were 75 years and older. No overall differences in safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. With regard to efficacy, the clinical trials with Cetirizine Hydrochloride oral tablets and IV Injection did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
Hepatic and Renal Impairment: No dosage adjustment is required in patients with hepatic and severe renal impairment. Monitor for antihistaminic side effects in this patient population.
No clinically significant drug interactions with oral Cetirizine Hydrochloride, the active ingredient in Cetirizine Hydrochloride IV Injection, have been found with Theophylline at a low dose, Azithromycin, Pseudoephedrine, Ketoconazole, or Erythromycin. There was a small decrease in the clearance of oral Cetirizine Hydrochloride caused by a 400-mg dose of Theophylline; it is possible that larger theophylline doses could have a greater effect.
Use in Specific Populations:
Pregnancy: There are no adequate and well-controlled studies in pregnant women with Cetirizine Hydrochloride. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In a prenatal and postnatal development (PPND) study conducted in mice, Cetirizine Hydrochloride did not have any adverse effects on rat dams or offspring development at doses up to approximately 30 times the MRHD. Cetirizine Hydrochloride caused excessive maternal toxicity at an oral dose in dams that was approximately 180 times the MRHD.
Lactation: Cetirizine Hydrochloride has been reported to be present in human breast milk. In mice and beagle dogs, studies indicated that Cetirizine Hydrochloride was excreted in milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cetirizine Hydrochloride IV Injection and any potential adverse effects on the breastfed child from Cetirizine Hydrochloride IV Injection or from the underlying maternal condition.
There are no adequate and well-controlled studies in pregnant women with Cetirizine Hydrochloride. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In a prenatal and postnatal development (PPND) study conducted in mice, Cetirizine Hydrochloride did not have any adverse effects on rat dams or offspring development at doses up to approximately 30 times the MRHD. Cetirizine Hydrochloride caused excessive maternal toxicity at an oral dose in dams that was approximately 180 times the MRHD. Lactation: Cetirizine Hydrochloride has been reported to be present in human breast milk. In mice and beagle dogs, studies indicated that Cetirizine Hydrochloride was excreted in milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cetirizine Hydrochloride IV Injection and any potential adverse effects on the breastfed child from Cetirizine Hydrochloride IV Injection or from the underlying maternal condition.
Somnolence/Sedation: In clinical trials with Cetirizine Hydrochloride IV Injection and Cetirizine Hydrochloride tablets, the occurrence of somnolence/sedation has been reported in some patients. Exercise due caution when driving a car or operating potentially dangerous machinery. Avoid concurrent use of Cetirizine Hydrochloride IV Injection with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.
Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children.