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HISDEC (REFORMULATED) Phenylephrine Hydrochloride / Brompheniramine Maleate 6.25mg / 2mg Syrup (Oral Drops) 15mL

RXDRUG-DRP-XY37698
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Features

Brand
Hisdec (Reformulated)
Full Details
Dosage Strength
6.25mg / 2mg perml
Drug Ingredients
  • Brompheniramine Maleate
  • Phenylephrine
Drug Packaging
Syrup (Oral Drops) 15ml
Generic Name
Phenylephrine Hydrochloride / Brompheniramine Maleate
Dosage Form
Syrup (Oral Drops)
Registration Number
DRP-XY37698
Drug Classification
Prescription Drug (RX)
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Description

Indications/Uses

It is indicated for the symptomatic relief of nasal congestion and cough and cold symptoms. It is also used for allergic conditions, mainly rhinitis and conjunctivitis.
 

Dosage/Direction for Use

Syrup: Adults: 5 mL - 10 mL (1 to 2 teaspoonful) every 6 to 8 hours, or as prescribed by the physician.
Children: 1 - 6 months: 1.25 mL (¼ teaspoonful).
7 months - 2 years: 2.5 mL (½ teaspoonful).
2 - 4 years: 3.75 mL (¾ teaspoonful).
4 - 12 years: 5 mL (1 teaspoonful).
To be given every 6 to 8 hours or as prescribed by the physician.
Drops: Infants 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.
 

Administration

May be taken with or without food: May be taken w/ food or milk to reduce GI discomfort.
 

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).
 

Drug Interactions

Phenylephrine HCl: Increased effects w/ MAOIs & β adrenergic blockers. May reduce hypertensive effects of methyldopa, mecamylamine, reserpine & veratrum alkaloids. Brompheniramine maleate: May exhibit additive effects w/ other CNS depressants, including alcohol.
 

Storage

Store at temperatures not exceeding 30°C.
 

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 (CNS) stimulation.
 

MedsGo Class

Cough & Cold Preparations
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