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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Brand Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Generic Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Active Ingredient
BrompheniramineCategory
Other
Salt Form
Maleate
Variants
4
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide, you must consult a qualified healthcare professional.
| 2 mg/5mL | SYRUP | ORAL | 68999-302 |
Detailed information about Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Brompheniramine is a first-generation antihistamine of the alkylamine class used to treat symptoms of allergic rhinitis and the common cold. It works by competitively inhibiting H1 receptors to reduce sneezing, rhinorrhea, and ocular itching.
For the treatment of allergic rhinitis or symptoms of the common cold, the standard adult dosage for Brompheniramine maleate is as follows:
Pediatric dosing must be calculated carefully based on age and, in some cases, weight. Parents should always use the measuring device provided with the medication.
Patients with significant renal (kidney) impairment may experience decreased clearance of Brompheniramine metabolites. While specific GFR-based dosing scales are not standardized for this drug, healthcare providers may recommend longer dosing intervals or a reduced total daily dose to prevent accumulation.
Since Brompheniramine is extensively metabolized by the liver, patients with hepatic cirrhosis or liver failure should use this medication with extreme caution. A lower starting dose is often warranted to avoid toxicity.
According to the Beers Criteria (a guideline for safe medication use in seniors), first-generation antihistamines like Brompheniramine should generally be avoided in the elderly. This is due to the high risk of anticholinergic side effects, including confusion, dizziness, blurred vision, and increased fall risk. If use is necessary, the lowest effective dose should be initiated.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Do not double the dose to catch up, as this significantly increases the risk of CNS depression and anticholinergic toxicity.
Signs of a Brompheniramine overdose may include extreme drowsiness, dilated pupils, flushed skin, fever, hallucinations, tremors, or seizures. In severe cases, respiratory failure or cardiovascular collapse may occur. In the event of a suspected overdose, contact a poison control center immediately or seek emergency medical attention. Anticholinergic toxicity is often managed in a hospital setting with supportive care and, occasionally, the administration of physostigmine in life-threatening cases.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or frequency without medical guidance.
Because Brompheniramine is a first-generation antihistamine, side effects are relatively common, particularly those affecting the central nervous system and the autonomic nervous system. The most frequently reported side effect is somnolence (drowsiness). Patients often describe this as a "heavy" or "foggy" feeling that can impair mental alertness. This effect typically begins within 30 to 60 minutes of ingestion and may last for several hours.
Other common side effects include:
Brompheniramine is a potent medication that requires careful use. The most critical safety point is the risk of Central Nervous System (CNS) depression. This medication significantly impairs the ability to perform tasks requiring mental alertness. Patients should not drive, operate heavy machinery, or engage in hazardous activities until they are certain how Brompheniramine affects them. This impairment can occur even if the patient does not feel subjectively "sleepy."
No FDA black box warnings for Brompheniramine. However, clinicians emphasize that it should never be used in premature infants or neonates due to an increased susceptibility to the anticholinergic effects and the potential for respiratory distress.
Brompheniramine must NEVER be used in the following circumstances:
Brompheniramine is generally categorized as FDA Pregnancy Category B or C depending on the specific manufacturer and formulation. This means that while animal studies may not have shown a risk, there are no adequate, well-controlled studies in pregnant women. Some epidemiological data have suggested a possible association between first-trimester antihistamine exposure and certain congenital malformations, though the evidence is not definitive. Healthcare providers typically recommend avoiding Brompheniramine during the third trimester, as antihistamines may cause seizures or irritability in the newborn.
Brompheniramine is known to be excreted in human breast milk. Because of the risk of antihistamines in infants (particularly CNS stimulation or unusual excitability), and because the anticholinergic effects may inhibit lactation (reduce milk supply), use in breastfeeding mothers is generally discouraged. If an antihistamine is required, second-generation options like loratadine are often preferred by pediatricians.
Brompheniramine is approved for use in children 6 years and older. However, the FDA and major pediatric associations warn against the use of multi-symptom cough and cold medicines in children under age 4 (and many manufacturers label for age 6+). In children, Brompheniramine can cause
Brompheniramine is an H1-receptor antagonist. It works by competing with free histamine for binding at H1-receptor sites on effector cells. It is specifically an inverse agonist, meaning it binds to the inactive state of the H1 receptor and stabilizes it, thereby preventing the receptor from shifting to its active state. This inhibits the typical allergic response, including capillary permeability and smooth muscle contraction. Its secondary mechanism involves the competitive inhibition of muscarinic acetylcholine receptors, which provides the drying effect on the nasal mucosa.
The onset of action for Brompheniramine is typically 15 to 30 minutes, with the maximum therapeutic effect occurring at the same time as peak plasma levels (2-5 hours). The duration of the antihistaminic effect can last up to 24 hours in some individuals, though symptomatic relief usually necessitates dosing every 4 to 6 hours for immediate-release forms. Tolerance to the sedative effects may develop after several days of continuous use, but the anti-allergy effects generally persist.
| Parameter | Value |
Common questions about Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Brompheniramine is primarily used to relieve symptoms associated with the common cold and allergic rhinitis, such as hay fever. It is effective at reducing sneezing, a runny nose, and itchy or watery eyes by blocking the effects of histamine in the body. Additionally, its anticholinergic properties help dry up nasal secretions, which is helpful for those with a persistent "drippy" nose. Healthcare providers may also recommend it for the treatment of mild allergic skin reactions like hives. It is often found in combination with other medications to treat multi-symptom respiratory illnesses.
The most frequent side effect of Brompheniramine is significant drowsiness or sedation, which occurs because the drug easily enters the brain. Many patients also experience "anticholinergic" effects, which include a very dry mouth, blurred vision, and constipation. Dizziness and a feeling of mental cloudiness are also quite common, especially during the first few days of treatment. In some cases, it can cause a thickening of mucus in the lungs, making it harder to clear the throat. Because of these effects, it is often taken at night rather than during the day.
No, you should strictly avoid alcohol while taking Brompheniramine. Alcohol is a central nervous system depressant that acts synergistically with Brompheniramine, meaning it significantly intensifies the drug's sedative effects. This combination can lead to extreme lethargy, impaired motor skills, and even dangerous respiratory depression. Drinking alcohol while on this medication greatly increases the risk of accidents, falls, and severe over-sedation. Always check the labels of other liquid medications, as some may contain small amounts of alcohol that could also interact.
Brompheniramine should only be used during pregnancy if clearly needed and under the direct supervision of a healthcare provider. It is generally classified as Category B or C, meaning there is limited high-quality data on its safety in humans. Some studies have raised concerns about antihistamine use in the first trimester, though the risks are not fully established. It is especially important to avoid use in the third trimester, as it may cause adverse effects like irritability or seizures in the newborn. Most doctors prefer to recommend older, more studied antihistamines or saline nasal sprays for pregnant patients.
Brompheniramine typically begins to work within 15 to 30 minutes after oral administration. You will likely feel a reduction in sneezing and itching relatively quickly, though the peak effect of the medication usually occurs between 2 and 5 hours after the dose is taken. The duration of action is quite long compared to other first-generation antihistamines, often providing relief for 4 to 6 hours with immediate-release forms and up to 12 hours with extended-release versions. If you do not feel relief within an hour, do not take an extra dose; wait for the medication to reach its full effect.
Yes, for most people taking Brompheniramine for short-term allergy or cold relief, it can be stopped suddenly without significant withdrawal symptoms. Unlike some other classes of medication, it does not typically cause physical dependence. However, if you have been using it daily for a very long period, you might experience a temporary return of allergy symptoms, sometimes called "rebound" congestion or itching. If you are using a combination product that contains other ingredients, you should check with your doctor before stopping. It is always best to use the medication only for as long as symptoms persist.
If you miss a dose of Brompheniramine, take it as soon as you remember, provided it is not almost time for your next scheduled dose. If you are within an hour or two of your next dose, it is safer to skip the missed dose entirely and continue with your regular schedule. Never take two doses at the same time to make up for a missed one, as this can lead to an overdose and severe side effects like extreme drowsiness or heart palpitations. Setting a timer or using a pillbox can help you stay on track with your dosing schedule. If you are unsure, consult your pharmacist.
While weight gain is not a commonly reported side effect for short-term use of Brompheniramine, some antihistamines have been linked to increased appetite and weight gain with long-term use. This is thought to occur because histamine receptors in the brain play a role in regulating hunger and satiety. If the H1 receptor is blocked for long periods, it may lead to increased food intake. However, since Brompheniramine is usually used for short durations (days to weeks) for cold or allergy symptoms, significant weight gain is unlikely for most patients. If you notice unusual weight changes, discuss them with your doctor.
Brompheniramine has several significant drug interactions that require caution. It should never be taken with MAOIs, and it should be used very carefully with other sedating medications like opioids, sleep aids, or anti-anxiety drugs. Many over-the-counter cold and flu medicines already contain an antihistamine, so taking Brompheniramine alongside them could lead to an accidental overdose. It can also interact with certain antidepressants and blood pressure medications. Always provide your healthcare provider or pharmacist with a full list of all medications and supplements you are currently taking before starting Brompheniramine.
Yes, Brompheniramine maleate is widely available as a generic medication. It is often sold under various store brands as an "Allergy Relief" or "Cold Relief" liquid or tablet. Generic versions are required by the FDA to have the same active ingredient, strength, and dosage form as the brand-name versions, making them a cost-effective alternative. You can find it as a standalone ingredient, though it is very frequently found as part of a generic multi-symptom cold formula. Always check the "Drug Facts" label on the back of the package to confirm that Brompheniramine is the active ingredient.
Other drugs with the same active ingredient (Brompheniramine)
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Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphanhydrobromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride,
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Brompheniramine, Pseudoephedrine, Dextromethorphan
Careone Childrens Cold And Cough
> Warning: Stop taking Brompheniramine and call your doctor immediately if you experience any of the following serious reactions:
Prolonged use of Brompheniramine is generally discouraged without medical supervision. Chronic use of first-generation antihistamines has been investigated in epidemiological studies for a potential link to cognitive decline in older adults, though a direct causal relationship specifically for Brompheniramine requires further study. Additionally, chronic use can lead to tolerance, where the drug becomes less effective over time, or rebound congestion if used in combination with nasal decongestants.
There are currently no FDA black box warnings specifically for Brompheniramine maleate. However, it carries significant class-wide warnings regarding its use in neonates and young children due to the risk of fatal respiratory depression. Most manufacturers include prominent warnings against use in children under 2 to 6 years of age depending on the specific formulation and regional regulations.
Report any unusual symptoms or persistent side effects to your healthcare provider to ensure continued safety during treatment.
For short-term use of OTC Brompheniramine, routine lab monitoring is usually not required. However, for patients taking the medication long-term or those with underlying health conditions, healthcare providers may monitor:
As noted, Brompheniramine causes significant impairment. The sedative effect is often compared to alcohol consumption. Patients are strongly advised to avoid driving or operating dangerous equipment for at least 8 to 12 hours after a dose, or until the effects have completely worn off.
Alcohol must be strictly avoided while taking Brompheniramine. Alcohol acts as a synergistic CNS depressant, meaning it multiplies the sedative effects of the antihistamine. This combination can lead to severe respiratory depression, profound lethargy, and an increased risk of accidents.
While Brompheniramine does not typically require a tapering schedule for short-term use, stopping the medication after prolonged, high-dose use may occasionally result in mild "rebound" symptoms, such as increased nasal congestion or insomnia. If you have been taking this medication daily for several weeks, consult your doctor before stopping.
> Important: Discuss all your medical conditions, especially respiratory, ocular, or urinary issues, with your healthcare provider before starting Brompheniramine.
For each interaction, the primary management strategy is to avoid the combination or have a healthcare provider adjust the dosage and monitor for signs of excessive sedation or anticholinergic toxicity.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those purchased over-the-counter.
These conditions require a careful risk-benefit analysis by a physician:
Patients who have had a reaction to Chlorpheniramine, Dexchlorpheniramine, or Triprolidine may also react to Brompheniramine, as these all belong to the alkylamine chemical class. If you have a history of reacting to any "cold and allergy" liquid or tablet, verify the active ingredients with a pharmacist.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of breathing problems or eye disease, before prescribing Brompheniramine.
Patients over the age of 65 are at a significantly higher risk for adverse effects. The sedative properties increase the risk of falls and hip fractures. The anticholinergic properties can exacerbate pre-existing dementia or cause acute delirium. Furthermore, the long half-life of Brompheniramine (up to 35 hours in some studies) means the drug can stay in an elderly person's system much longer than in a younger adult.
In patients with a Glomerular Filtration Rate (GFR) below 50 mL/min, the clearance of the drug's metabolites is reduced. While it is not removed significantly by hemodialysis, the systemic effects may be prolonged. Dosing should be cautious, starting at the lowest possible range.
Because the liver is the primary site of metabolism via the CYP450 system, patients with Child-Pugh Class B or C hepatic impairment should be monitored closely. Reduced dosing frequency (e.g., every 8-12 hours instead of every 4-6) may be necessary to prevent CNS toxicity.
> Important: Special populations require individualized medical assessment. Always consult a specialist if you are pregnant, nursing, or over age 65.
|---|---|
| Bioavailability | ~70-80% |
| Protein Binding | 39% - 45% |
| Half-life | 24.9 hours (range 12-35) |
| Tmax | 2 - 5 hours |
| Metabolism | Hepatic (CYP2D6, N-dealkylation) |
| Excretion | Renal (primarily as metabolites) |
Brompheniramine belongs to the Alkylamine class of first-generation antihistamines. Related medications in this class include chlorpheniramine, dexchlorpheniramine, and triprolidine. These are characterized by having less sedative potential than the ethanolamine class (like diphenhydramine) but still significantly more than second-generation antihistamines.