📌 COMPOSITION

• Each capsule contains: Pseudoephedrine Hydrochloride B.P. 120 mg (as coated pellets) – Loratadine 5 mg (as coated pellets).

📌 DESCRIPTION

Kold Off contains Loratadine, which is a potent, long‑acting, tricyclic antihistamine with selective peripheral H1‑receptor antagonistic activity. Pseudoephedrine Hydrochloride is one of the naturally occurring alkaloids of Ephedra and an orally administered vasoconstrictor that produces a gradual but sustained decongestant effect, facilitating shrinkage of congested mucosa in the upper respiratory areas. Kold Off is recommended when both the antihistaminic properties of Loratadine and the decongestant effect of Pseudoephedrine Hydrochloride are desired.

📌 INDICATIONS

Kold Off is indicated for the relief of symptoms associated with allergic rhinitis and the common cold, including nasal congestion, sneezing, rhinorrhoea, pruritus and lacrimation.

📌 DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over: one Kold Off capsule twice a day.

📌 RESTRICTIONS ON USE

Contraindications

• Kold Off is contraindicated in those who have shown sensitivity or idiosyncrasy to its components or to adrenergic agents.
• It is also contraindicated in patients receiving MAO inhibitor 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 (Pseudoephedrine Hydrochloride) should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure, diabetes mellitus, and in patients receiving digitalis.
• Sympathomimetics should be used with caution in elderly patients.
• Patients with severe hepatic impairment should be given a lower initial dose because they may have reduced clearance of Loratadine; an initial dose of one capsule daily is recommended.

Use in Pregnancy and Lactation

Should be used only if the potential benefit justifies the potential risk to the foetus and infant.

📌 DRUG INTERACTIONS

• Ketoconazole, Erythromycin and Cimetidine increase the plasma concentration of Loratadine, but without clinically significant changes.
• Co‑administration of sympathomimetic drugs with MAO inhibitors may cause hypertensive crises.
• The antihypertensive effect of Methyldopa, Mecamylamine, Reserpine and Veratrum alkaloids may be reduced by sympathomimetics.
• Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis.
• Antacids increase the rate of absorption of Pseudoephedrine; kaolin decreases it.

📌 ADVERSE EFFECTS

The most common side effects are insomnia and dry mouth. Other rare side effects include: dizziness, fatigue, nausea, abdominal disturbances, thirst, tachycardia, and other side effects caused by sympathomimetics.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Kold Off capsules: Pack of 10 capsules and hospital packs of different sizes.