Phenylephrine hydrochloride, brompheniramine maleate.
Each 5 mL (1 teaspoonful) syrup contains: Phenylephrine HCl 12.5 mg, brompheniramine maleate 4 mg.
Each mL contains: Phenylephrine HCl 6.25 mg, brompheniramine maleate 2 mg.
Pharmacology: Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells.
Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistamine effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue.
Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single oral dose of 4 mg reached in 5 hours, urinary excretion is the major route of elimination mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.
Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation.
Treatment of common colds and allergic rhinitis.
Syrup: Adults: 5-10 mL (1 to 2 teaspoonfuls) every 6 to 8 hours, or as prescribed by the physician.
Children: 1-6 months: 1.25 mL (¼ teaspoon); 7 months-2 years: 2.5 mL (½ teaspoon); 3-4 years: 3.75 mL (¾ teaspoon); 5-12 years: 5 mL (1 teaspoon).
To be given every 6 to 8 hours, or as prescribed by the physician.
Infant Drops: Up to 6 months: 0.5 mL; 7 months-2 years: 1 mL.
To be given every 6 to 8 hours, or as prescribed by the physician.
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase (MAO) inhibitors.
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol.
Antihistamine may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.
MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the hypertensive effects of methyldopa, mecamylamine, reserpine and veratum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. The safety of use of this product in pregnancy has not been established.
The safety of use of this product in pregnancy has not been established.
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of the mouth, blurred vision, cardiac palpitations, flushing, increased irritability, or excitement (especially in children).
Store at temperatures not exceeding 30°C.
R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
R06AB51 - brompheniramine, combinations ; Belongs to the class of substituted alkylamines used as systemic antihistamines.
Iruden oral drops
15 mL x 1's
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