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Clarinase RepetabsClarinase Repetabs Tablets


Long-acting, Non-Sedating Antihistamine/Decongestant Tablets

DESCRIPTION : Each CLARINASE REPETABS Tablet contians 5 mg loratadine in the tablet coating and 120 mg pseudoephedrine sulfate equally distributed between the tablet coating and the barrier-coated core. The two active components in the coating are quickly liberate; release of the decongestant in the core is delayed for several hours. Inactive ingredients : acacia, calcium sulfate, carnauba wax, gum rosin, microcrystalline cellulose, oleic acid, medicinal soap, sucrose, talc, titanium dioxide, white wax, zein, lactose anhydrous, corn starch, povidone, magnesium stearate and purified water.


ACTION : Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.


Pseudoephedrine sulfate, one of the naturally occurring alkaloids of the Ephedra and an orally administered vasoconstrictor, produces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in upper respiratory areas.


The mucuos membrane of the respiratory tract is decongested through the action of the sympathetic nerves.


INDICATIONS AND USAGE : CLARINASE REPETABS Tablets are indicated for the relief of symptoms associated with allergic rhinitis and the common cold including nasal congestion, sneezing, rhinorrhea, pruritus and lacrimation.


CLARINASE REPETABS Tablets are recommended when both the antihistaminic properties of loratadine and the decongestant effect of pseudoephedrine sulfate are desired.


DOSAGE AND ADMINISTRATION : Adults and Children 12 years of age and over : One CLARINASE REPETABS Tablet twice a day.


DRUG INTERACTIONS : When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.


Increase in plasma concentrations of loratadine have been reported after 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 co-administered with caution until definitive interaction studies can be completed.


When sympathomimetics are given to patients receiving monoamine oxidase ( MAO ) inhibitors, hypertensive reactions, including hypertensive crises may occur. The antihypertensive effects of methyldopa, mecamylamine, reserpine and veratum alkaloids may be reduced by sympathomimetics. Beta-adrenergic blocking agents may also interact with sympathomimetics. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Antacids increase the rate of pseudoephedrine absorption; kaolin decreases it.


Drug/Laboratory Test Interactions : Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.


The in vitrol addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatinine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over six hours.


ADVERSE REACTIONS : During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with CLARINASE REPETABS Tablets was comparable to that of placebo, with the exception of insomnia and dry mouth, both of which were commonly reported. Other reported adverse reactions associated with both CLARINASE REPETABS Tablets and placebo included headache and somnolence.


Rare adverse reactions in decreasing order of frequency incldued nervousness, dizziness, fatigue, nausea, abdominal distress, anorexia, thirst, tachycardia, pharyngitis, rhinitis, acne, pruritus, rash, urticaria, arthralgia, confusion, dysphonia, hyperkinesia, hypoesthesia, decreased libido, paraesthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, eeydisordes, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, paroneiria, increased appetite, change in bowel habits, dyspepsia, eructation, hemorrhoids, tongue discolouration, tongue disorder, vomiting, transient abnormal hepatic function, dehydration, creased weight, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnea, epitaxis, nasal congestion, sneezing, nasal irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps, malaise and rigors.


During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.


CONTRAINDICATIONS : CLARINASE REPETABS Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components, to adrenergic agents or to other drugs of similar chemical structure. CLARINASE REPETABS Tablets also are contraindicated in patients receiving MAO therapy or within fourteen days of discontinuing such treatment and in patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.


PRECAUTIONS : Sympathomimetics should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hyperthrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitus.


Sympathomimetics should be used with caution in patients receiving digitalis.


Sympathomimetics may cause central nervous system ( CNS ) stimulation, excitability, convulsions, and/or cardiovascular collapse with accompanying hypotension.


In patients 60 years of age or older, sympathomimetics are also more likely to cause adverse reactions such as confusion, hallucination, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a repeat-action formulation to elderly patients.


Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of one tablet daily is recommended.


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