Bromphen/pseudo/dextro Hbr Syrup

Brompheniramine is a first-generation antihistamine that competitively blocks H1-receptors, thereby preventing the effects of histamine (e.g., sneezing, rhinorrhea, itching, watery eyes). It also possesses anticholinergic properties, contributing to its drying effects. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on alpha-adrenergic receptors in the respiratory mucosa, causing vasoconstriction, which reduces swelling and congestion. Dextromethorphan is a non-opioid antitussive that acts centrally on the cough center in the medulla oblongata, elevating the cough threshold. It is also a sigma-1 receptor agonist and an NMDA receptor antagonist.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Changes in eyesight
Difficulty passing urine
Mood changes
Balance problems
Shortness of breath

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dizziness, drowsiness, tiredness, or weakness
Nervousness or excitability
Sleep disturbances
Dry mouth, nose, or throat
Thickened mucus in the nose or throat
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions like asthma or emphysema.
If you have a history of heart disease or high blood pressure.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication.
* If the patient is a premature infant or newborn, as this formulation of the medication should not be administered to these individuals.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not exceed the recommended treatment duration.

Until you are aware of how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.

This medication may increase your susceptibility to sunburn. Exercise caution when exposed to sunlight, and notify your doctor if you experience unusual sunburn sensitivity while taking this medication. Ingesting excessive amounts of this medication or accidental ingestion can lead to severe consequences, including hallucinations, seizures, and even death, particularly in infants and young children. Therefore, it is crucial to keep this medication out of reach of children. If an overdose occurs or the medication is taken accidentally, immediately contact the poison control center and seek medical attention.

If you are 65 years or older, use this medication with caution, as you may be more prone to experiencing side effects. When administering this medication to children, exercise caution, as they may have a higher risk of excitability. This medication may not be suitable for all ages, so consult with your doctor before giving it to a child. Furthermore, do not use this medication as a means to induce sleep in children; instead, discuss alternative solutions with your doctor.

If you are pregnant or planning to become pregnant, inform your doctor, as it is necessary to discuss the potential benefits and risks associated with using this medication during pregnancy.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, tranylcypromine, linezolid, methylene blue) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis (pseudoephedrine) and serotonin syndrome (dextromethorphan).

• CNS Depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids, benzodiazepines) - additive CNS depression (brompheniramine, dextromethorphan).
• Other Sympathomimetics (e.g., phenylephrine, ephedrine, amphetamines, decongestants) - additive cardiovascular effects (pseudoephedrine).
• Anticholinergics (e.g., tricyclic antidepressants, atropine, some antipsychotics) - additive anticholinergic effects (brompheniramine).
• Beta-blockers (e.g., propranolol, metoprolol) - pseudoephedrine may reduce antihypertensive effect and increase risk of hypertension.
• Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol) - increased risk of serotonin syndrome with dextromethorphan.
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone) - increased dextromethorphan exposure and risk of toxicity.

• Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - pseudoephedrine may reduce their effectiveness.
• Digoxin - pseudoephedrine may increase risk of ectopic pacemaker activity.
• Oral Contraceptives - may reduce clearance of pseudoephedrine.
• Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may increase pseudoephedrine absorption.

• None specifically critical.

• Drowsiness
• Dizziness
• Nervousness
• Insomnia
• Dry mouth
• Blurred vision
• Urinary retention
• Palpitations
• Increased blood pressure
• Tremor
• Hallucinations (rare, especially with overdose)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine use in the first trimester has been associated with a small increased risk of gastroschisis and other vascular disruption defects, though data are conflicting. Brompheniramine and dextromethorphan are generally considered low risk but should be used cautiously.

L3 (Moderate Concern). All components are excreted into breast milk. Brompheniramine can cause drowsiness, irritability, or anticholinergic effects in the infant. Pseudoephedrine can decrease milk supply, especially in the early postpartum period. Dextromethorphan is generally considered low risk but can cause sedation. Avoid if possible, or use with caution and monitor infant for adverse effects.

Not recommended for children under 6 years of age due to potential for serious side effects and lack of proven efficacy. Use with extreme caution and precise dosing in children 6-12 years. Overdose can be fatal in young children.

Increased sensitivity to CNS effects (sedation, dizziness, confusion) and anticholinergic effects (dry mouth, urinary retention, constipation, blurred vision) of brompheniramine. Increased risk of cardiovascular effects (hypertension, tachycardia) from pseudoephedrine. Start with lower doses and monitor closely.

• This combination product is designed for multi-symptom relief, but it's important to ensure all symptoms being treated are present to avoid unnecessary drug exposure.
• Advise patients to avoid concurrent use of other cold/flu medications to prevent accidental overdose of similar ingredients.
• Educate patients about the potential for both sedating (brompheniramine, dextromethorphan) and stimulating (pseudoephedrine) effects, which can be confusing.
• Pseudoephedrine is often behind the counter due to its use in illicit methamphetamine production; patients may need to ask the pharmacist for it.
• Patients with underlying conditions like hypertension, heart disease, glaucoma, or prostate enlargement should consult a healthcare provider before using due to pseudoephedrine and brompheniramine effects.

• Single-ingredient antihistamines (e.g., loratadine, fexofenadine, cetirizine for allergies)
• Single-ingredient decongestants (e.g., pseudoephedrine, phenylephrine)
• Single-ingredient antitussives (e.g., dextromethorphan, guaifenesin)
• Nasal saline sprays (for congestion)
• Humidifiers (for cough/congestion)
• Honey (for cough relief)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.