Bromesep

Bromesep

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Per 5 mL syr Brompheniramine maleate 2 mg, phenylephrine HCl 5 mg. Per 5 mL elixir Brompheniramine maleate 4 mg, phenylephrine HCl 5 mg. Per 5 mL expectorant Brompheniramine maleate 2 mg, phenylephrine HCl 5 mg, glyceryl guaiacolate (guaifenesin) 100 mg
Indications/Uses
Symptomatic relief of cough, nasal congestion, rhinorrhea, associated w/ allergies, common cold, rhinitis or upper resp allergies.
Dosage/Direction for Use
Syr Adult 10 mL every 4-6 hr. Childn 6-12 yr 7.5 mL every 4-6 hr, 2-6 yr 2.5-5 mL every 4-6 hr. Not to exceed 4 doses in 24-hr period. Elixir Adult & childn >12 yr 10 mL bid to tid. Childn 6-12 yr 5 mL bid to tid, 2-6 yr 2.5 mL bid to tid. Expectorant Adult & childn >12 yr 10 mL qid. Childn 6-12 yr 5 mL qid, 2-6 yr 2.5 mL qid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ asthma, glaucoma, benign prostatic hyperplasia, difficulty in urination; HTN, CV disease, diabetes, hyperthyroidism. Concomitant use w/ MAOI. Childn <1 yr.
Special Precautions
Convulsions in patients taking antihistamines; seizure (paradoxical reaction). Dry mouth, urinary retention, viscid mucus, blurred vision, dizziness, confusion & blood cell disorders. Patients w/ narrow-angle glaucoma, stenosing peptic ulcer, ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, bronchial asthma, increased IOP, hyperthyroidism, CV disease, HTN, & diabetes; epilepsy; history of asthma & pulmonary emphysema. Avoid concomitant use w/ alcohol or alcohol-containing product. Concomitant use w/ CNS depressant eg, benzodiazepines, anticholinergic & antidepressant. May impair ability to drive & operate machinery. Hepatic impairment. 1st trimester of pregnancy & lactation. Not to be used in childn <2 yr. Elderly. Expectorant: Not to be used in patients w/ persistent or chronic cough or breathing problems eg, smoking, asthma, chronic bronchitis or emphysema. Identify underlying cause of cough prior to treatment.
Adverse Reactions
Anaphylactic shock, angioneurotic, laryngeal & peripheral edema, asthma, dermatitis, drug rash, lupus erythematosus-like syndrome, urticaria; bradycardia, cardiac arrest, ECG change including blunting of T-wave & QT interval prolongation, excitability, extrasystoles, HTN, hypotension, palpitation, postural hypotension, reflex tachycardia & bradycardia, tachycardia, precordial pain or discomfort, pallor, severe peripheral & visceral vasoconstriction, severe decreased cardiac output; anxiety, disturbed coordination, dizziness, drowsiness, faintness, sedation, acute labyrinthitis, blurred vision, catatonic-like states, confusion, convulsion, diplopia, disorientation, nightmare, euphoria, excitation, fatigue, hallucination, headache, hysteria, insomnia, lassitude, neuritis, oculogyric crisis, paresthesia, pseudoschizophrenia, restlessness, tinnitus, tongue protrusion, torticollis, tremor, vertigo, weakness, extrapyramidal reactions; epigastric distress, anorexia, constipation, diarrhea, increased appetite, nausea, stomatitis, vomiting, wt gain, stomach pain; metabolic acidosis; pilomotor response, weakness; decreased renal perfusion, reduced urine output; resp distress.
Drug Interactions
Additive CNS depression w/ other CNS depressants eg, barbiturates, tranquilizers, alcohol. Decreased vasopressor response w/ prior α-adrenergic blocker eg, phentolamine mesylate. Blocked cardiostimulating effect w/ prior β-blocker eg, propranolol. Potentiated vasopressor effects w/ TCA eg, imipramine. Additive anticholinergic action w/ other anticholinergic drugs eg, atropine & antidepressants (TCA, MAOI). Suppressed cutaneous histamine response to allergen extr. Expectorant: Increased renal clearance for urate.
MIMS Class
Cough & Cold Preparations
ATC Classification
R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.
Presentation/Packing
Form
Bromesep elixir
Packing/Price
60 mL x 1's
Form
Bromesep expectorant
Packing/Price
60 mL x 1's
Form
Bromesep syr
Packing/Price
60 mL x 1's
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