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 Clarinase
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. |
