Brompheniramine maleate, phenylephrine hydrochloride.
Per 5 mL Brompheniramine maleate 4 mg, phenylephrine hydrochloride 10 mg.
Pharmacotherapeutic group: Antihistamine (H1-Receptor)/Decongestant.
Pharmacology: Antihistamine (H1-receptor): Antihistamine used in the treatment of allergy act by competing with histamine for H1-receptor sites on effector cells. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal and oral mucosa.
Decongestant: Sympathomimetic amines act on alpha-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages.
Pharmacokinetics: Absorption: Phenylephrine has reduced bioavailability (about 38%) from gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver.
Biotransformation: Antihistamines - Hepatic (cytochrome P-450 system); some renal.
Sympathomimetic amines - Phenylephrine: Extensive in the intestinal wall and in the liver. Sulfate conjugates are formed largely in the intestinal wall. Also, undergoes oxidative deamination by monoamine oxidase.
Half-life: Brompheniramine - 25 hours; Phenylephrine - 2.1 to 3.4 hours.
Onset of action: Most first generation antihistamines: 15 to 60 minutes.
Time to peak concentration: Brompheniramine - 2 to 5 hours; Phenylephrine - 0.75 to 2 hours (to achieve peak levels ranging from 0.9 to 298 ng/mL, respectively).
Time to peak effect: Brompheniramine - 3 to 9 hours
Elimination: Antihistamines - Renal. Most of the antihistamines studied are excreted as metabolites within 24 hours; Phenylephrine: 2.6% of the administered oral dose is excreted unchanged; 80 to 86% of unchanged Phenylephrine and metabolites are recovered in 48 hours after oral administration.
For the symptomatic relief of nasal congestion due to cough and cold and allergic conditions, mainly rhinitis.
Oral.
Adults: 5 mL (1 teaspoonful) every 4 to 6 hours.
Children: 6 - 12 years: 2.5 mL (1/2 teaspon) every 4 to 6 hours.
Symptoms: Nervousness, tremor, insomnia, agitation, irritability, abdominal pain, severe headache, nausea and vomiting.
Treatment: Stomach should be emptied by aspiration and lavage. Diazepam can be given to control CNS stimulation and convulsions. Alpha-adrenergic blockers are useful to manage hypertension.
A history of hypersensitivity to the substance or substances of similar chemical structure (or any of the other ingredients in the product).
Not recommended for children below 2 years of age.
Exercise caution and follow the instruction of doctor or pharmacist when giving to children between 2 to 6 years of age.
Unihist Syrup may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided. Use with caution in patients with renal or hepatic impairment and in patients with epilepsy. Phenylephrine has an excessive vasopressor response that may cause a prolonged rise in blood pressure. It induces tachycardia or reflect bradycardia and should therefore be avoided in severe hyperthyroidism and used with caution in severe ischaemic heart disease. Patients with diabetes mellitus or prostatic hyperplasia should also avoid Phenylephrine.
Unihist Syrup should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the fetus. It is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.
Central Nervous System (CNS): CNS depressive effects include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose. CNS stimulatory effects may include anxiety, hallucinations, appetite stimulation, muscle dyskinesia and activation of epileptogenic foci.
Anticholinergic effects: Side effects associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.
Others: Skin rashes and urinary retention in children and elderly are more likely to experience adverse effects than other age groups.
The following interactions have been noted: Central Nervous System (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics); May cause an increase in sedation effects monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs); May prolong and intensify the anticholinergic and CNS depressive effects other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like pyschostimulants; May cause an increase in blood pressure and additive effects methyldopa and β-blockers; May cause an increase in blood pressure.
Store at temperature of not more than 30°C.
R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Sign Out
