Download Pretin D Prescribing Information

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Pretin® D
Tablet
Description
Pretin D tablet is a preparation of Loratadine INN and Pseudoephedrine
Hydrochloride BP. Each uniquely formulated extended release Pretin D
tablet contains 10 mg Loratadine INN for immediate release and 240 mg
Pseudoephedrine Hydrochloride BP which is released slowly allowing for
once daily administration. Loratadine is selective peripheral histamin H1
receptor antagonist.
Pseudoephedrine is an orally active
sympathomimetic amine, which exerts a decongestant action on the nasal
mucosa.
Indications
Pretin D is indicated for the relief of symptoms of seasonal and
perennial allergic rhinitis. Pretin D tablet should be administered when
both the antihistaminic properties of Loratadine and the nasal
decongestant activity of Pseudoephedrine are desired in patients 12 years
of age and older. Pretin D tablet also temporarily relieves running nose,
sneezing; itchy, watery eyes; nasal congestion; itching of the nose or
throat due to allergic rhinitis or other upper respiratory allergies;
symptoms of common cold; and nasal congestion and sinus pressure
associated with sinusitis.
Dosage and Administration
In adults and children 12 years of age and over : The recommended dose of
Pretin D tablet is once daily. As Pretin D contains Pseudoephedrine
which may cause agitation and insomnia as side effects, it is best
recommended to be taken in the morning instead of night.
Contraindications
Pretin D tablet is contraindicated in patients who are hypersensitive to
this medication or to any of its ingredients. This product, due to its
Pseudoephedrine component, is contraindicated in patients with narrowangle glaucoma or urinary retention, and in patients receiving monoamine
oxidase (MAO) inhibitor therapy or within fourteen days of stopping
such treatment. It is also contraindicated in patients with severe
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hypertension, severe coronary artery disease, and in those who have
shown hypersensitivity or idiosyncrasy to adrenergic agents, or to other
drugs of similar chemical structures.
Precautions
Loratadine/Pseudoephedrine combination tablets should be used with
caution in patients with hypertension, diabetes mellitus, ischaemic heart
disease, increased intraocular pressure, hyperthyroidism, renal
impairment, or prostatic hypertrophy. Central nervous system stimulation
with convulsions or cardiovascular collapse with accompanying
hypotension may be produced by sympathomimetic amines.
Drug Interactions
Pretin D tablet is contraindicated in patients taking MAO inhibitors and
for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive
effects of β adrenergic blocking agents, Methyldopa, Reserpine, and
Veratrum alkaloids may be reduced by sympathomimetics. Increased
ectopic pacemaker activity can occur when Pseudoephedrine is used
concomitantly with digitalis.
Concomitant administration of Erythromycin, Ketoconazole, and
Cimetidine increased the plasma concentration of both Loratadine and
Descarboethoxyloratadine. But there were no clinically relevant changes
in the safety profile of Loratadine.
Side Effects
In general it is well tolerated. Clinical trials suggest a very low rate of
adverse effects associated with its administration. Among the very few
adverse effects commonly reported are dry mouth, somnolence, insomnia,
pharyngitis, dizziness, cough, fatigue, nausea, nervousness, anorexia,
dysmenorrhoea and headache. Other less common side effects may include
increased sweating, thirst, back pain, chest pain, malaise, palpitations,
hypertension, tachycardia, abdominal distension, altered taste, flatulence,
myalgia, dry throat, agitation, frequency of micturition etc.
Use in Special Populations
Geriatric use : The safety and efficacy in patients above 60 years old have
not been investigated in placebo-controlled clinical trials. The elderly are
more likely to have adverse reactions to sympathomimetic amines.
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Pregnancy Category B : No evidence of risk in humans is reported.
Lactation : It is not known if this combination product is excreted in
human milk. However, both Loratadine and Pseudoephedrine when
administered alone passes into breast milk, therefore a decision should be
made whether to discontinue nursing or to discontinue the drug taking
into account the importance of the drug to the mother.
Paediatric use : Safety and effectiveness in children below the age of 12
years have not been established.
Commercial Pack
Pretin®D Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each
tablet contains Loratadine INN 10 mg and Pseudoephedrine
Hydrochloride BP 240 mg .
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