Congestap

Congestap

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Phenylpropanolamine HCl, brompheniramine maleate.
Description
Each 5 mL (1 teaspoonful) syrup contains: Phenylpropanolamine HCl 12.5 mg and Brompheniramine Maleate 4 mg.
Each mL of syrup for oral drops contains: Phenylpropanolamine HCl 6.25 mg and Brompheniramine Maleate 2 mg.
Action
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 (vasodilatation, 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.
Indications/Uses
Treatment of common colds and allergic rhinitis.
Dosage/Direction for Use
Syrup: Adults: 5-10 mL (1 to 2 teaspoonful) every 6 to 8 hours, or as prescribed by the physician.
Children 5 to 12 years: 5 mL (1 teaspoonful);
3 to 4 years: 3.75 mL (¾ teaspoon);
7 months to 2 years: 2.5 mL (½ teaspoon);
1 to 6 months: 1.25 mL (¼ teaspoon).
To be given every 6 to 8 hours, or as prescribed by the physician.
Infant Drops: 7 months-2 years: 1 mL;
Up to 6 months: 0.5 mL.
To be given every 6 to 8 hours, or as prescribed by the physician.
Contraindications
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.
Special Precautions
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 veratrum 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.
Adverse Reactions
Adverse reactions include drowsiness, lassitude, nausea giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability, or excitement (especially in children).
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
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.
Presentation/Packing
Syrup 60 mL. Oral drops 15 mL.
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