Brompheniramine/Pseudoephedrine/Dextromethorphan HBr syrup is used to treat individuals who are suffering from cough and cold allergy symptoms.
As with any medication, it may have side effects and you do need a doctor’s prescription. In this article, we will let you know the uses, pros & cons, and other additional information regarding Brompheniramine/Pseudoephedrine/Dextromethorphan HBr syrup.
Table of Contents
What is Brompheniramine/Pseudoephedrine/Dextromethorphan HBr Syrup?
It is light pink colored, clear syrup with a grape flavor. It typically contains three active ingredients:
Brompheniramine: An antihistamine that helps alleviate symptoms like sneezing, runny nose, and watery eyes. Each teaspoonful (5 mL) contains Brompheniramine Maleate, USP – 2 mg.
Pseudoephedrine: A decongestant that reduces nasal congestion and swelling in the nasal passages. Each 5 mL (1 teaspoonful) contains Pseudoephedrine Hydrochloride, UPS – 30 mg.
Dextromethorphan HBr: A cough suppressant that helps alleviate coughing. Each 5 mL (1 teaspoonful) contains Dextromethorphan Hydrobromide UPS – 10 mg.
Also, there is Alcohol 0.95% v/v
Pseudoephedrine and Brompheniramine work by contracting the B.D. (blood-vessels) in the nose.
This sources less mucus production & dry out the nose.
At the same time, dextromethorphan works to reduce the physique’s cough impulse.
These drugs work hand in hand to help relieve allergy symptoms or colds.
Artificial grape flavor, glycerin, sucrose, ethyl alcohol, sodium benzoate propylene glycol, methylparaben, sodium citrate dehydrate, citric acid, and FD&C Red No. 40. It may contain a 10% sodium citrate or 10% citric acid solution for pH adjustment. The pH range is amid 3.0 and 6.0.
- C 16H 19BrN 2•C 4H 4O 4 M.W. 435.31
Brompheniramine Maleate, USP(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)
- C 10H 15NO•HCl M.W. 201.69
Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride
- C 18H 25NO•HBr•H 2O M. W. 32
Dextromethorphan HBr, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate
Uses of Brompheniramine/Pseudoephedrine/Dextromethorphan HBr Syrup
This syrup relieves upper respiratory symptoms and coughs, including nasal congestion, associated with allergies or the common cold.
Don’t dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOI).
Antihistamines should not be used to treat people with asthma or lower respiratory tract conditions.
In small children and infants, antihistamines overdosage may cause death, hallucinations, and convulsions.
Antihistamines may weaken mental alertness. In the young child, they may harvest excitation.
Precautions to be Taken
Because of its antihistamine component, brompheniramine/pseudoephedrine/dextromethorphan hBr syrup should be used carefully in patients with a history of narrow-angle glaucoma, bronchial asthma, urinary bladder neck obstruction, or gastrointestinal obstruction.
Because of its sympathomimetic component, brompheniramine/pseudoephedrine/dextromethorphan hBr syrup should be used carefully in patients with thyroid, diabetes, heart disease, thyroid disease, or hypertension.
Patients should be warned and educated about engaging in activities requiring alertness, such as operating dangerous machinery or driving a car.
Overdose Symptoms & Signs
- Dextromethorphan in toxic doses will cause ataxia, drowsiness, nystagmus, convulsive seizures, and opisthotonos.
- Central nervous system possessions from an overdose of Brompheniramine may vary from depression to stimulation, particularly in children.
- Anticholinergic effects may be prominent. Toxic doses of pseudoephedrine may result in cardiac arrhythmias, hypertension, tachycardia, and CNS stimulation. Signs of Central Nervous System Depressants
- Depression may occasionally be seen.
Administration & Dosage
- Adults and pediatric patients twelve years and over 10 mL (2 teaspoonfuls) every 4 hours.
- Children six to under twelve years – 5 mL (1 teaspoonful) every 4 hours.
- Children two to under six years – 2.5 mL (½ teaspoonful) every 4 hours.
- Infants six months to under two years – Dosage to be established by a physician.
Do not exceed six doses during 24 hours.
The most common adverse reactions to brompheniramine/pseudoephedrine/dextromethorphan hBr syrup are
- Nose and Throat
- Dryness of Mouth
- Thickening of Bronchial Secretions
Few other Adverse Reactions
- Hemolytic Anemia.
Central Nervous System depressants – CNS
- Disturbed Co-ordination
- Visual Disturbances
System of G.I.
- Epigastric Discomfort
- Drug Rash
System of G.U.
- Difficult Urination
- Urinary Frequency
- Shortness of Breath,
- Tightness of chest
Interaction with the Drug
MAO – Monoamine Oxidase Inhibitors
Death, hypotension, and hyperpyrexia have been informed coincident with the co-administration of Monoamine Oxidase Inhibitors and products having dextromethorphan.
In addition, Monoamine Oxidase Inhibitors extend and increase the anticholinergic effects of antihistamines and may enhance the development of pseudoephedrine.
Associated administration of brompheniramine/pseudoephedrine/dextromethorphan hBr syrup and Monoamine Oxidase Inhibitors should be avoided.
CNS – Central Nervous System Depressant
Antihistamines have additive properties with alcohol and other Central Nervous System depressants (antianxiety agents, hypnotics, tranquilizers, sedatives, etc.).
Sympathomimetics may reduce the effects of anti-hypertensive drugs.
Impairment of Fertility, Mutagenesis, Carcinogenesis
Animal education of brompheniramine/pseudoephedrine/dextromethorphan hBr syrup has not been accomplished to assess the mutagenic potential and carcinogenic or the effect on fertility.
It is not known whether brompheniramine/pseudoephedrine/dextromethorphan hBr syrup cause fetal harm when directed to a pregnant female or can affect reproduction capability.
It should be given to a pregnant woman only if needed.
Reproduction revisions of brompheniramine maleate in mice and rats at doses up to sixteen times the maximum human amounts have discovered no evidence of weakened fertility or damage to the fetus.
Nursing – Mother
Because of the threat of intolerance of antihistamines in infants generally, and in newborns and premature in particular, brompheniramine/pseudoephedrine/dextromethorphan hbr syrup is contraindicated in nursing mothers.
Effectiveness and safety in pediatric patients below six months have not been proven.
Scientific studies of brompheniramine/pseudoephedrine/dextromethorphan hbr syrup did not include adequate numbers of people aged sixty-five and over to determine whether they react similarly to younger subjects.
However, antihistamines are more likely to cause hypotension, sedation, and dizziness in elderly patients. Older adults are also more likely to experience adverse responses to sympathomimetics.
In general, dose selection for an old patient should be vigilant, usually starting at the low end of the dosing array, replicating the greater frequency of decreased cardiac function, renal or hepatic, and other drug therapy or concomitant disease.
How is Brompheniramine/Pseudoephedrine/Dextromethorphan HBr Syrup Supplied?
Brompheniramine/Pseudoephedrine/Dextromethorphan HBr Syrup is available in the following sizes:
- 4 fl oz (118 mL) NDC 62135-302-48
- 16 fl oz (473 mL) NDC 62135-302-47
- Store the medication at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature.
- Keep tightly closed and dispense in a tight, light-resistant container as defined in the USP.
The syrup is commonly used to relieve cold and allergy symptoms.
Still, using it according to the prescribed dosage and following any precautions your healthcare provider provides is essential.
As with any medication, it may have side effects or interactions with other drugs, so it’s best to consult a healthcare professional before use, especially if you have any underlying health conditions or are taking other medications.