Clear, colourless to light yellow syrup.
Each 5 ml of CLARITYNE Syrup contains 5 mg of micronized loratadine.
The quantity of sucralose in the loratadine syrup composition is 750 mg/ml. The amount of sucralose per 5 ml (5 mg) dose is 3.75 g.
Excipients/Inactive Ingredients: Edetate disodium, flavor, glycerol, maltitol, sodium dihydrogen phosphate dihydrate, phosphoric acid, propylene glycol, purified water, sorbitol, sucralose, sodium benzoate (0.05% w/v) as preservative.
Pharmacotherapeutic group: antihistamines - H1 antagonist. ATC code: R06A X13.
Pharmacology: Pharmacodynamics: Loratadine, the active ingredient in CLARITYNE products, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.
Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.
During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.
Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.
Pharmacokinetics: Absorption: Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters of loratadine and of the active metabolite are dose proportional.
Distribution: Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins. In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively.
Biotransformation: After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL) is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.
Elimination: Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Renal Impairment: In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its active metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
Hepatic impairment: In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Elderly: The pharmacokinetic profile of loratadine and its active metabolite is comparable in healthy adult volunteers and in healthy geriatric volunteers.
Toxicology: Preclinical safety data: Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.
No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of oral lyophilisates into the hamster cheek pouch for five days.
CLARITYNE Products are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration.
CLARITYNE Products are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
Adults and Children 12 years of age and over: Two 5 ml spoonfuls (10 mg) once daily.
Children 2 to 12 years of age: Body Weight >30 kg: Two 5 ml spoonfuls (10 mg) syrup once daily.
Body Weight ≤30 kg: One 5 ml spoonful (5 mg) syrup once daily.
Safety and efficacy of CLARITYNE have not been established in children younger than 2 years of age.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg or 5 ml once daily, or 10 mg or 10 ml every other day is recommended.
Overdosage with loratadine increases the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.
In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.
CLARITYNE Products are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.
CLARITYNE Products should be administered with caution in patients with severe liver impairment (see Dosage & Administration).
The administration of CLARITYNE Products should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Effects on ability to drive and use machines: In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Safe use of CLARITYNE Products during pregnancy has not been established; therefore, use only if the potential benefit justifies the potential risk to fetus. Since loratadine is excreted in breast milk, a decision should be made whether to discontinue nursing or discontinue the drug.
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table. (See table.)
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When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Pharmacology: Pharmacokinetics under Actions), which may cause an increase in adverse events.
Incompatibilities: No incompatibilities.
Store below 30°C. Syrup bottle should be protected from excessive moisture.
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Clarityne Syrup 5 mg/5 mL
(grape flavour) 60 mL x 1's
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