Claritin Reditabs

Claritin Reditabs

loratadine

Manufacturer:

Catalent UK

Distributor:

Bayer
Full Prescribing Info
Contents
Loratadine.
Description
Each LORATADINE (CLARITIN) Reditabs tablet contains Loratadine 10 mg that can be taken orally without water.
Loratadine orally disintegrating tablets contain loratadine (SCH 29851), a tri-cyclic antihistamine with selective peripheral H1-receptor antagonistic activity, which is currently used for the relief of symptoms associated with allergic rhinitis, and urticaria and other dermatologic disorders.
Its chemical names are: 1-Piperidinecarboxylic acid 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-ethylester, and ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidine carboxylate. The empirical formula is C22H23CIN2O2 and Molecular Weight (MW) is 382.89.
Action
Pharmacology: Pharmacodynamics: In comparative clinical studies, the sedation profile of loratadine 10 mg once daily is comparable to that of placebo. In studies with loratadine tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed.
In a study in which loratadine tablets were administered at 4 times the clinical dose for 90 days, no clinically significant increase in the QTc was seen on ECGs.
Pharmacokinetics: After oral administration of loratadine in the conventional tablet formulation, the drug is rapidly and well absorbed and undergoes extensive first pass metabolism. In normal subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The mean elimination half-lives found in normal 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 (descarboethoxyloratadine). In nearly all patients, exposure (AUC) to the metabolite is greater than exposure to parent loratadine.
Pharmacokinetic studies showed that LORATADINE (CLARITIN) Reditabs provides plasma concentrations of loratadine and its active metabolite, descarboethoxyloratadine, that are similar to those achieved with loratadine in conventional formulations.
Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.
Approximately 40% of the dose is excreted in the urine and 42% in the feces over a 10-day period and that mainly in the form of conjugated metabolites.
The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult volunteers and in healthy geriatric volunteers.
In patients with chronic renal impairment both the AUC and peak plasma concentrations (Cmax) increased for loratadine and its metabolite as compared to the AUCs and Cmax of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Hemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
In patients with chronic alcoholic liver disease, the AUC and 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 metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Loratadine and its active metabolite are excreted in the breast milk of lactating women. Forty-eight hours after dosing, only 0.029% of the loratadine dose is detected in the milk as unchanged loratadine and its active metabolite.
The bioavailability parameters of loratadine and of the active metabolite are dose proportional.
The effect of food on the pharmacokinetic profile of loratadine and its metabolite is not regarded as clinically significant. Consumption of food with LORATADINE (CLARITIN) Reditabs may delay the time and increase the extent of absorption without influencing clinical effects.
The bioavailability of loratadine or its active metabolite was not compromised when a 10 mg LORATADINE (CLARITIN) Reditabs was placed on the tongue and swallowed without water.
Preclinical Information: Loratadine, the active ingredient in Loratadine tablets, syrup and Loratadine (Claritin) Reditabs tablets, is a tri-cyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and in vivo radioligand studies in mice have shown that neither loratadine nor its metabolites readily cross the blood-brain barrier. Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors.
Carcinogenesis, Mutagenesis and Impairment of Fertility: No significant findings were noted.
LORATADINE (CLARITIN) Reditabs Mucous Membrane Irritation: No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of LORATADINE (CLARITIN) Reditabs tablets into the hamster cheek pouch for five days.
Indications/Uses
LORATADINE (CLARITIN) Reditabs Tablet is 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.
LORATADINE (CLARITIN) Reditabs Tablet is also indicated for the relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
Dosage/Direction for Use
Adults and children 12 years of age and over: One LORATADINE (CLARITIN) Reditabs tablet placed in the mouth once daily. Tablet disintegration occurs rapidly and water or other liquid is not required.
Overdosage
Somnolence, tachycardia, and headache have been reported with overdoses. In the event of overdosage, general symptomatic and supportive measures should be instituted and maintained for as long as necessary.
Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.
Contraindications
LORATADINE (CLARITIN) Reditabs tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.
Special Precautions
Patients with liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. Therefore, the following dosing is recommended: One half the recommended dose every day or the full recommended dose every other day.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with loratadine.
Use In Pregnancy & Lactation
No teratogenic effect was observed in animals. The safe use of Loratadine tablets, syrup and LORATADINE (CLARITIN) Reditabs tablets during pregnancy and lactation has not been established. Loratadine should only be used if the potential benefit justifies the potential risk to fetus or newborn. Loratadine is excreted in breastmilk. Therefore, in lactating females a decision should be made whether to discontinue nursing or discontinue the drug.
Adverse Reactions
Loratadine has no clinically significant sedative properties at the recommended dosage.
The most frequently reported adverse effects were headache, somnolence, fatigue and dry mouth and gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
In addition, the following spontaneous adverse events have been reported very rarely during the marketing of loratadine: abnormal hepatic function, alopecia, anaphylaxis, tachycardia, palpitations, and dizziness.
Drug Interactions
Increase in plasma concentrations of this drug has been reported with concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic).
Other drugs known to inhibit hepatic metabolism should be coadministered with caution until definitive interaction studies can be completed.
Storage
Store at temperatures not exceeding between 30°C, and protect from excessive moisture.
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
OD tab 10 mg x 10's.
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