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 produces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in upper respiratory areas.
INDICATIONS :
Kold Off is indicated for the relief of symptoms associated with allergic rhinitis and the common cold including nasal congestion, sneezing, rhinorrhea, pruritus and lacrimation. Kold Off is recommended when both the antihistaminic properties of Loratadine and the decongestant effect of Pseudoephedrine Hydrochloride are desired.
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 their components or to adrenergic agents.
- It is also contraindicated in patients receiving MAO inhibitors 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 or diabetes mellitus, and in patients receiving digitalis.
- Sympathomimetics should be used with caution in 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 capsule daily is recommended. Use in pregnancy and lactation
Should be used only if the potential benefit justifies the potential risk to the fetus.
DRUG INTERACTIONS :
- Ketoconazole, Erythromycin and Cimetidine increase plasma concentration of loratadine but without clinically significant changes.
- Coadminstration of sympathomimetic drugs with monoamine oxidase inhibitors (MAO) 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 and there are the other side effects which are rare 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.
PRESENTATIONS :
Kold Off capsule : pack of 10 capsules and hospital packs of different sizes.
INSTRUCTIONS TO THE PATIENT
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children Mfd. By
P.O. Box : 4265 Sana’a /Yemen.
Council of Arab Health Ministers Union of Arab Pharmacists
012-06-060 7/13