8/13/2019 pretin-d

1/3

PretinDTablet

DescriptionPretin 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 H1receptor 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 nasaldecongestant 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 narrow-

angle glaucoma or urinary retention, and in patients receiving monoamine

oxidase (MAO) inhibitor therapy or within fourteen days of stoppingsuch treatment. I t is also contraindicated in patients with severe

8/13/2019 pretin-d

2/3

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 withcaution 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 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 includeincreased 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 havenot been investigated in placebo-controlled clinical trials. The elderly are

more likely to have adverse reactions to sympathomimetic amines.

8/13/2019 pretin-d

3/3

Pregnancy Category B :No evidence of risk in humans is reported.

L actation :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 takinginto 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 PackPretinD Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each

tablet contains Loratadine INN 10 mg and Pseudoephedrine

Hydrochloride BP 240 mg .