4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
In some cases, children under two may also be prescribed this drug, although this typically only occurs in severe cases. About two thirds of the dose are excreted unchanged in urine. Carcinogenesis, Mutagenesis and Impairment of Fertility:Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine Hydrochloride Group, and More Frequently Than in the Placebo GroupChildren 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F); [See USP Controlled Room Temperature].Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.We comply with the HONcode standard for trustworthy health information -
In rare cases, this medication can have the opposite effect, and cause a child to become rambunctious shortly after taking the recommended dose.
Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid).The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with cetirizine hydrochloride were mild or moderate.
In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on cetirizine hydrochloride vs. 1.0% on placebo).Table 1 lists adverse experiences which were reported for cetirizine hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with cetirizine hydrochloride than placebo.
Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine hydrochloride has been reported.In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.There is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.Overdosage has been reported with cetirizine hydrochloride. Cetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
Cetirizine hydrochloride oral solution is available as:Use these dosage charts for infants and children under 12 years old:The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In a study of 1 week duration in children 6 to 11 months of age, patients who received cetirizine exhibited greater irritability/fussiness than patients on placebo. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride.
There is no known specific antidote to cetirizine hydrochloride. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the cetirizine and placebo treatment groups in each study.
The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/mCetirizine hydrochloride oral solution can be taken without regard to food consumption.Cetirizine hydrochloride oral solution is a clear, colorless to pale yellow solution with a grape flavor. Cetirizine hydrochloride is an orally active and selective HCetirizine hydrochloride is a white, crystalline powder and is water soluble. In the third trial, also a crossover study, cetirizine hydrochloride 20 mg and ketoconazole (400 mg per day) were given alone and in combination. - Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. FOSAMAX Once Weekly 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis. While cetirizine for children is generally considered to be safe, it is potentially dangerous for children who are allergic to it or As with most medications, even those considered safe, there is a chance of side effects when taking cetirizine for children. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received cetirizine compared to patients who received placebo (9.0% v. 5.3%). These studies support the safety of administering cetirizine hydrochloride to pediatric and adult allergic rhinitis patients with mild to moderate asthma.Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.Cetirizine was not mutagenic in the Ames test, and not clastogenic in the human lymphocyte assay, the mouse lymphoma assay, and In a fertility and general reproductive performance study in mice, cetirizine did not impair fertility at an oral dose of 64 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/mThe effectiveness of cetirizine hydrochloride for the treatment of allergic rhinitis and chronic idiopathic urticaria in pediatric patients aged 6 to 5 years is based on an extrapolation of the demonstrated efficacy of cetirizine hydrochloride in adults with these conditions and the likelihood that the disease course, pathophysiology and the drug’s effect are substantially similar between these two populations. Elimination.