Bromesep

Syrup: Each 5 mL (1 teaspoonful) contains Brompheniramine maleate 2 mg, Phenylephrine HCl 5 mg.
Elixir: Each 5 mL (1 teaspoonful) contains Brompheniramine maleate 4 mg, Phenylephrine HCl 5 mg.
Expectorant: Each 5 mL (1 teaspoonful) contains Brompheniramine maleate 2 mg, Phenylephrine HCl 5 mg, Glyceryl guaiacolate (INN: Guaifenesin) 100 mg.

Pharmacology: BROMESEP contains Brompheniramine maleate, an antihistamine agent used for the relief of manifestations of immediate-type hypersensitivity reactions and Phenylephrine HCl, a nasal decongestant used for temporary relief of nasal congestion, and Glyceryl guaiacolate (for expectorant only), an expectorant used for phlegm loosening and easy phlegm expectoration.
Pharmacodynamics: Brompheniramine maleate, an alkylamine (propylamine)-derivative first-generation antihistamine (sedating antihistamine) agent is competitive, but reversible H₁-receptor antagonist. Antihistamine effects include inhibition of respiratory, vascular, and GI smooth muscle constriction; decreased capillary permeability, which reduces the wheal, flare, and itch response. Brompheniramine is sedating antihistamine with anticholinergic and moderate sedative actions.
Phenylephrine HCl is a nasal decongestant that binds to the adrenergic receptors in nasal mucosa resulting in increased blood vessels' sympathetic tone and provoking vasoconstriction. Constriction in the mucous membranes results in their shrinkage; this promotes drainage, thus improving ventilation and the stuffy feeling.
Expectorant: Glyceryl guaiacolate is an expectorant, which increases respiratory tract fluid secretions resulting in phlegm loosening and easy phlegm expectoration. As a result, productive cough is relieved.
Pharmacokinetics: Brompheniramine maleate appears to be well absorbed from the GI tract. The antihistamine effect of Brompheniramine, as determined by suppression of responses induced by intradermal administration of histamine, that include suppression of the wheal and flare responses and antipruritic effect. The suppression of the wheal and flare responses appear to be maximal within 3-9 hours after a single oral dose of the drug, but suppression of the flare response may persist for up to at least 48 hours. Following 2 mg oral administration of dexbrompheniramine maleate every 4 hours, mean peak plasma concentration of the drug were approximately 22 ng/mL on the sixth and seventh days of dosing and mean trough concentration were about 17-18 ng/mL on the sixth and seventh days respectively. The antipruritic effect appears to be maximal within 9-24 hours. Distribution of the drug appears to be widely distributed. The apparent volume of distribution reportedly average 11.7 L/kg, and the half-life of Brompheniramine reportedly ranges from 11.8-34.7 hours. Brompheniramine undergoes N-dealkylation forming metabolite namely, monodesmethylbrompheniramine and didesmethylbrompheniramine. About 40% of Brompheniramine and its metabolites are excreted principally in urine, about 5-10% as unchanged, about 6-10% as monodesmethylbrompheniramine and about 6-10% as didesmethylbrompheniramine. And about 2% of drug is excreted in feces within 72 hours.
Following oral administration Phenylephrine is completely absorbed and undergoes extensive first-pass metabolism in the intestinal wall. The relative bioavailability of Phenylephrine is approximately 38%. Following oral administration, nasal decongestion may occur within 15 or 20 minutes. Phenylephrine undergoes rapid distribution into peripheral tissues. But does not appear to be distributed into breast milk. Phenylephrine undergoes extensive first pass metabolism in the intestinal wall and in the liver. The principal routes of metabolism involve sulfate conjugation (primarily in the intestinal wall) and oxidative deamination by monoamine oxidase. Approximately 80% of Phenylephrine and its metabolites are excreted mainly in urine, about 2.6% as unchanged. The elimination half-life of Phenylephrine is 2-3 hours following oral administration.
Expectorant: Glyceryl guaiacolate is readily absorbed from the gastrointestinal tract. The plasma half-life reportedly average 1 hour. It is rapidly metabolized and excreted primarily in the urine. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

BROMESEP is used for temporary relief of cough (for expectorant only), allergic symptoms, rhinorrhea, nasal congestion associated with common cold, rhinitis or other upper respiratory allergies.

Mode of Administration: BROMESEP contains Brompheniramine maleate, Phenylephrine HCl and Glyceryl guaiacolate (for expectorant only). Dosage of product should be within the range of the usual therapeutic dosage of each active ingredient.
Recommended Dose: Dosage in pediatric patients: There is no adequate safety and efficacy information, and recommended dose for the symptomatic treatment of cold and cough in children younger than 2 years of age. It is suggested that this product should not be used in children younger than 2 years of age as it may cause serious and potentially life-threatening adverse effects. Used with cautions in children older than 2 years of age.
Dosage in geriatric patients: Drug used in geriatric patients (60 years of age and older) may cause confusion, dizziness, sedation, hypotension, hyperexcitability, anticholinergic effects (e.g. dry mouth, urinary retention [particularly in men]) and paradoxical reaction. Dosage reduction may be required.
Dosage in hepatic impairment: There is no information of dosage adjustment for the use in patients with hepatic impairment. However, caution is needed when drug is used in hepatic impairment patients.
Dosage in renal impairment: There is no information of dosage adjustment for the use in patients with renal impairment. However, since drug and metabolites are excreted primarily in the urine so that dosage reduction may be necessary in renal impairment.
Syrup: Dosage in adults: Adults: Administer 10 mL (2 teaspoonfuls) orally every 4-6 hours or follow physician's instruction.
Dosage in children: Children 6 to 12 years of age: Administer 7.5 mL (1½ teaspoonfuls) orally every 4-6 hours or follow physician's instruction. Children 2 to 6 years of age: Administer 2.5-5 mL (½-1 teaspoonful) orally every 4-6 hours or follow physician's instruction.
Note: Do not exceed 4 doses in a 24-hour period.
Elixir: Dosage in adult: Adult: administer 10 mL (or 2 teaspoonfuls) orally, 2-3 times daily or follow physician's instruction.
Dosage in children: Older than 12 years of age: administer 10 mL (or 2 teaspoonfuls) orally, 2-3 times or follow physician's instruction.
6 to 12 years of age: administer 5 mL (or 1 teaspoonful) orally, 2-3 times or follow physician's instruction.
2 to 6 years of age: administer 2.5 mL (or ½ teaspoonful) orally, 2-3 times or follow physician's instruction.
Note: BROMESEP ELIXIR should not be administered to children under 2 years of age.
BROMESEP ELIXIR should not be administered exceed the recommended dosage.
Expectorant: Dosage in adults: Adults: administer 10 mL (or 2 teaspoons) orally, 4 times daily or follow physician's instruction.
Dosage in children: Older than 12 years of age: administer 10 mL (or 2 teaspoons) orally, 4 times daily or follow physician's instruction.
6 to 12 years of age: administer 5 mL (or 1 teaspoon) orally, 4 times daily or follow physician's instruction.
2 to 6 years of age: administer 2.5 mL (or ½ teaspoon) orally, 4 times daily or follow physician's instruction.
Note: BROMESEP EXPECTORANT should not be administered to children under 2 years of age.
BROMESEP EXPECTORANT should not be administered exceed 4 times daily of recommended dosage.

Symptoms: Symptoms of this product overdosages are not clear. However, symptoms of antihistamines and nasal decongestant overdosage may cause vary effects.
Central nervous system: drowsiness, dizziness, ataxia, tinnitus, blurred vision.
Children often manifest CNS stimulation and may have hallucinations, toxic psychosis, delirium tremens, excitement, ataxia, incoordination, muscle twitching, athetosis, hyperthermia, cyanosis, convulsion, and hyperreflexia followed by postictal depression and cardiorespiratory arrest.
Cardiovascular system: hypotension, hypertension, bradycardia, drowsiness, rebound hypotension, anticholinergic effects e.g. dilated pupils, flushing, dry mouth, ECG changes (less common), shock-like syndrome.
Treatment: Protect against aspiration, especially in infants and children. Administer activated charcoal as a slurry with water and a cathartic to minimize absorption. Correct acidosis and electrolyte imbalances. Do not induce emesis in unconscious patients. Gastric lavage may be considered within 3 hours after ingestion and even later if large amounts were taken. Continue supportive treatment as needed.

Do not use BROMESEP in patients with hypersensitivity to Brompheniramine maleate and/or Phenylephrine HCl and/or Glyceryl guaiacolate (for expectorant only) or any components of the formulation.
Because BROMESEP contains Phenylephrine HCl in the formulation, use this product with or within 14 days of monoamine oxidase inhibitor (MAOI) is contraindicated.
Because BROMESEP contains Brompheniramine in the formulation, therefore this product is contraindicated in patients with asthmatic attacks.

Avoid driving, operating machinery, or performing other hazardous activities including risk of falling while working in a high place because this product may cause drowsiness.
Avoid concomitant use with alcohol or other alcohol-containing product.
Contraindicated in children under 1 years of age, patients with asthma, glaucoma, benign prostatic hyperplasia or difficulty urinating unless physician directed.
Use with caution in the first trimester pregnant women or breast feeding women.
This product may cause dry mouth, urinary retention, viscid mucus, blurred vision, dizziness, confusion and blood cell disorders.
Children and elderly are more sensitive to effects of this product which may cause drowsiness, dizziness, hallucination, dry mouth, urine retention, hypotension, irritability, insomnia. Seizure may occur in some patients (paradoxical reaction).
Use with caution when take this product concomitantly with CNS depressant including benzodiazepines, anticholinergic and antidepressant.
This product should be used with caution in patients with a history of asthma and pulmonary emphysema.
Contraindicated in patients with a hypertension, cardiovascular disease, diabetes or hyperthyroidism unless physician directed.
Elixir: This product contains 4.37% v/v of alcohol. Use with caution.
Expectorant: This product contains 3.325% v/v of alcohol. Use with caution.

BROMESEP should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension, and diabetes, unless directed by a physician.
There are reports of convulsions in patients taking antihistamines. It is suggested that BROMESEP should be used with caution in patients with epilepsy.
Expectorant: BROMESEP EXPECTORANT should not be used in patients with persistent or chronic cough or breathing problems such as smoking, asthma, chronic bronchitis, or emphysema, unless directed by a physician.
Before prescribing BROMESEP EXPECTORANT to suppress or modify cough, it may be important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Pregnancy: Pregnancy category C.
Administration of Brompheniramine and Phenylephrine in late pregnancy, show possible harms to the fetus, and there are the risks of severe reactions (e.g. seizure) of antihistamine use in neonates. There is no adequate safety and efficacy information in pregnancy. Hence, use this product during pregnancy only if the potential benefit justifies the risk to the mother and fetus.
Lactation: It is not known whether Brompheniramine and Glyceryl guaiacolate (for expectorant only) are distributed into milk. However, Phenylephrine does not appear to be distributed into breast milk. There is no adequate safety and efficacy information in lactation. Therefore, physician should carefully consider discontinuing nursing during drug use or discontinuing the drug. Taking into account the importance of the drugs to the nursing women and possible risks to infants nursing.

Allergic: anaphylactic shock, angioneurotic, laryngeal, and peripheral edema, asthma, dermatitis, drug rash, lupus erythematosus-like syndrome, urticaria.
Cardiovascular: bradycardia, cardiac arrest, ECG change including blunting of T-wave and prolongation of the QT interval, excitability, extrasystoles, hypertension, hypotension, palpitation, postural hypotension, reflex tachycardia, tachycardia, reflex bradycardia, arrhythmia (rare), precordial pain or discomfort, pallor, severe peripheral and visceral vasoconstriction, severe decreased cardiac output.
Central nervous system: 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 (usually in association with excessive dosage), torticollis, tremor, vertigo, weakness, extrapyramidal reactions may occur with high doses.
Gastrointestinal: epigastric distress, anorexia, constipation, diarrhea, increased appetite, nausea, stomatitis, vomiting, weight gain, stomach pain.
Endocrine & metabolic: metabolic acidosis.
Neuromuscular & skeletal: pilomotor response, weakness.
Renal: decreased renal perfusion, reduced urine output.
Respiratory: respiratory distress.
Expectorant: Dermatologic: rash.

Additive CNS depression may occur when BROMESEP is administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. Thus, concomitantly use is not recommended. Patients already receiving another CNS depressant should not undertake self-medication with this product without first consulting a physician. Patients should be advised to avoid alcoholic beverages during this product therapy.
The vasopressor response to this product is decreased by prior administration of an α-adrenergic blocking agent such as phentolamine mesylate.
The cardiostimulating effect of this product is blocked by prior administration of β-adrenergic blocking agents such as propranolol. Propranolol may be used to treat cardiac arrhythmias occurring during administration of Phenylephrine-containing product.
Concomitant use of tricyclic antidepressants (e.g. imipramine) or guanethidine and this product may also potentiate the vasopressor effects of Phenylephrine in this product.
This product may suppress the cutaneous histamine response to allergen extracts and should be discontinue this product 4 days prior to skin testing.
This product has an additive anticholinergic action with other anticholinergic drugs, such as atropine and some antidepressants (both tricyclic antidepressants and MAOIs).
Expectorant: This product may increase renal clearance for urate, thereby lower serum uric acid levels.

Store below 30°C.

Cough & Cold Preparations

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.

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