Sudolor..... ( Loratadine & Pseudoephedrine )

Sudolor (Loratadine & Pseudoephedrine)

Therapeutic Group: Anti Histamine

Presentation

Sudolor 120: Each extended release tablet contains Loratadine USP 5 mg and Pseudoephedrine Hydrochloride USP 120 mg.

Sudolor 240: Each extended release tablet contains Loratadine USP 10 mg and Pseudoephedrine Hydrochloride USP 240 mg.

Descriptions

Sudolor tablet is a preparation of Loratadine and Pseudoephedrine Hydrochloride. Loratadine is a non-sedative histamine H1-receptor antagonist with anti-allergic properties. Loratadine is a long acting tricyclic anti-histamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anti-cholinergic effect. Pseudoephedrine is a stereoisomer of Ephedrine with similar but less potent pharmacological activity. It has nasal and bronchial decongestant activity.

Indications

Sudolor is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis. Sudolor should be administered when both the anti-histaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine are desired. Sudolor also temporarily relieves runny nose, sneezing, itchy watery eyes, nasal congestion, itching of nose or throat due to allergic rhinitis or other upper respiratory allergies, symptoms of common cold and sinus pressure associated with sinusitis.

Dosage & Administration

Adults and Children 12 years of age and over:
Sudolor 120: One tablet twice a day (every 12 hours).
Sudolor 240: One tablet once daily.
(Safety and effectiveness of this drug in children below the age of 12 years have not been established).

Side Effects

Loratadine - Pseudoephedrine Hydrochloride tablet is usually 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 headache, nausea, dizziness, insomnia, dry mouth, somnolence, nervousness, fatigue, dyspepsia, anorexia, thirst etc. Serious adverse effects associated with the use of this drug are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and, rarely, hallucinations have been reported.

Precautions

Loratadine - Pseudoephedrine Hydrochloride tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. It should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (one Loratadine 5 mg - Pseudoephedrine Hydrochloride 120 mg tablet per day and one Loratadine 10 mg - Pseudoephedrine Hydrochloride 240 mg tablet every other day).

Contraindications

Loratadine - Pseudoephedrine Hydrochloride tablet is contraindicated in patients who are hypersensitive to this medication or any of its ingredients. It is also contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown hypersensitivity to its components, to adrenergic agents, or to other drugs of similar chemical structures.

Use in Pregnancy & Lactation

Pregnancy: There was no evidence of animal teratogenicity in reproduction studies. Loratadine - Pseudoephedrine Hydrochloride tablets should be used during pregnancy only if clearly needed.
Lactation: It is not known if this combination product is excreted in human milk. However, caution should be exercised when Loratadine - Pseudoephedrine Hydrochloride tablets are administered to a nursing woman.

Overdose

In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired conciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents.

Commercial Packaging

Sudolor 120: Each box contains 5 blister strips of 10 extended release tablets.
Sudolor 240: Each box contains 5 blister strips of 10 extended release tablets.