Description
PROPERTIES:
DECONGESS SR capsules contain pseudoephedrine HCl, a sympathomimetic agent which stimulates adrenergic receptors in the mucous membranes of the upper respiratory tract, specially the nasal mucosa and sinuses causing rapid nasal decongestion, relief of nasal mucosal edema and reduction of sinus secretion. DECONGESS SR capsules exert prolonged effect due to continuous release of the active ingredient which achieves optimal steady blood level. The twice-daily dose regimen ensures patient’s compliance with excellent tolerability.
INDICATIONS:
Nasal congestion due to common cold, influenza or sinusitis.
Nasopharyngeal congestion and rhinitis (allergic and vasomotor).
DOSAGE:
One capsule every 12 hours.
CONTRAINDICATIONS:
DECONGESS SR capsules are contraindicated in case of:
1. Individuals with known hypersensitivity to the product or any of the components.
2. In patients with severe hypertension or coronary artery disease.
3. In patients who are taking or have taken, monoamine oxidase inhibitors and the antibacterial agent furazolidone within preceding two weeks.
SIDE EFFECTS:
Serious adverse effects associated with the use of pseudoephedrine are extremely rare. Symptoms of central nervous system excitation may occur including sleep disturbance and rarely, hallucinations.
Skin rashes, with or without irritation, have occasionally been reported with pseudoephedrine. Urinary retention has been reported occasionally in men receiving
pseudoephedrine, prostatic enlargement could have been an important predisposing factor.
Drug interactions:
• Concomitant use of Decongess SR capsules with other pseudoephedrine-containing products, tricyclic antidepressants, monoamine oxidase inhibitors and furazolidone, which interfere with the catabolism of sympathomimetics amines, may occasionally cause a rise in blood pressure.
• A rise in blood pressure may also occur with the concomitant use of other sympathomimetic agents such as decongestants, appetite suppressants and amfetamine-like psychostimulants.
• Because of pseudoephedrine content, Decongess SR capsules may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta- adrenergic blocking agents
Pregnancy & LACTATION:
• Insufficient available informations about the effects of administration of Decongess SR capsules during human pregnancy.
• Pseudoephedrine is excreted in breast milk in small amounts but its effect on breast-fed infants is not known.
• It has been estimated that approximately 0.4 to 0.7% of a single 60 mg ( non-controlled release) dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours.
• Decongess SR capsules, like most medicines, should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs any possible risk.
WARNING & Precautions:
As with other products containing sympathomimetics, it should be used with caution in patients with hypertension, heart disease, diabetes mellitus, hyperthyroidism, glaucoma, prostatic enlargement in elderly and hepatic or renal impairment.
PACKING:
A carton box containing 14 capsules in 2 PVC/Aluminium strips.
STORAGE:
Keep at temperature not exceeding 30C, in dry place.
Keep out of reach of children.
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