Usage
Bromhexine + Pseudoephedrine is prescribed for the symptomatic relief of cough and nasal congestion associated with the common cold, flu, and other respiratory tract infections such as acute bronchitis and sinusitis. It combines a mucolytic (Bromhexine) and a decongestant (Pseudoephedrine).
Pharmacological Classification:
- Mucolytic expectorant and decongestant.
Mechanism of Action:
Bromhexine reduces the viscosity of mucus by breaking down mucopolysaccharides and mucoproteins, thereby facilitating expectoration. Pseudoephedrine acts as a sympathomimetic amine with predominantly alpha-adrenergic activity causing vasoconstriction in the nasal mucosa which shrinks swollen nasal membranes and opens up the airways.
Alternate Names
While there isn’t a universally recognized alternate name for this fixed-dose combination itself, the components have other names:
- Bromhexine: Bisolvon is a common alternate name, along with Bromhexin Hydrochloride.
- Pseudoephedrine: Sudafed, Drixoral are amongst the most commonly used brand names.
Brand Names:
Brand names may vary in different regions but may include combinations of the individual drug names or unique brand names specific to the formulation. Some examples include Ascoril D, Solvin Cold, and Bro-Zedex. Please note this is not an exhaustive list and new brand names may emerge.
How It Works
Pharmacodynamics:
- Bromhexine: Increases serous bronchial secretions, reducing mucus viscosity and improving mucociliary clearance.
- Pseudoephedrine: Stimulates alpha-adrenergic receptors in the respiratory tract, leading to vasoconstriction, reduced nasal congestion, and widening of the airways.
Pharmacokinetics:
- Bromhexine: Well absorbed orally. Metabolized in the liver with metabolites further conjugated and excreted primarily in urine.
- Pseudoephedrine: Readily absorbed from the gastrointestinal tract. Partially metabolized in the liver, and the remainder is excreted unchanged in the urine. Its elimination can be prolonged in individuals with renal impairment.
Mode of Action:
- Bromhexine: Depolymerizes mucopolysaccharide fibers in mucus, making it less viscous.
- Pseudoephedrine: Acts as a sympathomimetic amine activating alpha-adrenergic receptors.
Elimination Pathways:
- Bromhexine: Primarily renal excretion.
- Pseudoephedrine: Renal excretion (primarily unchanged drug).
Dosage
Standard Dosage
Adults:
Standard adult dosage is typically 8 mg bromhexine and 60 mg pseudoephedrine administered every 4-6 hours, not to exceed 4 doses in 24 hours. This may be in tablet or syrup form.
Children:
For children older than 12 years the adult dose is typically prescribed. It is generally not recommended for children under 12 years of age unless under specific guidance and monitoring by a physician. If prescribed for children 6-12 years old, lower doses may be used, as directed by the physician.
Special Cases:
- Elderly Patients: Start with a lower dose due to potential age-related decrease in organ function. Careful monitoring is advised.
- Patients with Renal Impairment: Use with caution, especially in severe impairment where pseudoephedrine may accumulate. Dosage adjustment is often required, and the drug may even be contraindicated in severe cases.
- Patients with Hepatic Dysfunction: Use with caution. Dose adjustment may be necessary.
- Patients with Comorbid Conditions: Use with caution in patients with hypertension, diabetes, hyperthyroidism, cardiovascular disease, and prostatic hypertrophy.
Clinical Use Cases
Bromhexine + Pseudoephedrine is primarily indicated for symptomatic relief of respiratory tract infections in outpatient settings. It’s not typically used for intubation, surgical procedures, mechanical ventilation, intensive care unit (ICU) use, or acute emergency situations.
Dosage Adjustments
Dosages should be adjusted based on patient factors like renal/hepatic function and coexisting medical conditions, particularly cardiovascular disease.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Dizziness, headache
- Dry mouth, nose, or throat
- Restlessness, insomnia
- Increased heart rate, palpitations
- Sweating
Rare but Serious Side Effects:
- Allergic reactions (e.g., skin rash, itching, swelling, severe dizziness, trouble breathing)
- Hallucinations
- Seizures
- Irregular heartbeat
- Difficulty urinating
Long-Term Effects:
Long-term use of pseudoephedrine can potentially lead to tolerance, rebound congestion, and cardiovascular issues like elevated blood pressure and heart rate. Long-term bromhexine use is generally well-tolerated but gastrointestinal disturbances might continue.
Adverse Drug Reactions (ADR):
Significant ADRs requiring urgent medical attention include severe allergic reactions, cardiac arrhythmias, significant changes in blood pressure, and neuropsychiatric effects like seizures and hallucinations.
Contraindications
- Hypersensitivity to bromhexine, pseudoephedrine, or any component of the formulation.
- Severe hypertension
- Severe coronary artery disease
- History of stroke
- Severe renal impairment
- Concomitant use of or within 14 days of discontinuation of Monoamine Oxidase Inhibitors (MAOIs).
- Angle-closure glaucoma
- Pheochromocytoma
Drug Interactions
- MAOIs: Concomitant use can cause hypertensive crisis.
- Antihypertensives: Pseudoephedrine may counteract the effects of antihypertensive medications.
- Tricyclic antidepressants, beta-blockers: May interact with pseudoephedrine affecting heart rate and blood pressure.
- Decongestants, stimulants: Additive effects with pseudoephedrine might increase side effects.
- Furazolidone, procarbazine: May interact with pseudoephedrine posing a risk of hypertensive crisis.
- OTC cold/cough medications: Many contain similar ingredients which may lead to overdose if combined.
Pregnancy and Breastfeeding
Pseudoephedrine is classified as Category C during pregnancy. It is generally not recommended during the first trimester and should be used with caution in later trimesters under physician supervision. Bromhexine’s safety during pregnancy is not fully established. Its use during pregnancy should be limited to cases where the potential benefits outweigh the risks. Pseudoephedrine can pass into breast milk. It is generally recommended to avoid using this combination while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Bromhexine: Mucolytic; Pseudoephedrine: Decongestant.
- Side Effects: Nausea, dizziness, dry mouth, insomnia, increased heart rate, allergic reactions.
- Contraindications: Hypersensitivity, severe hypertension/cardiac disease, MAOI use, severe renal impairment.
- Drug Interactions: MAOIs, antihypertensives, some antidepressants.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks. Consult a physician.
- Dosage: Adults: 8 mg/60 mg every 4-6 hours (max 4 doses/24h). Pediatric use not typically recommended except for patients older than 12.
- Monitoring Parameters: Blood pressure, heart rate, respiratory status, and any signs of allergic reaction.
Popular Combinations
While Bromhexine + Pseudoephedrine is itself a combination, it can sometimes be found combined with other medications like Guaifenesin for its expectorant properties, or Dextromethorphan as a cough suppressant. However, combining medications should only be done based on a physician’s recommendation.
Precautions
- General Precautions: Screen for allergies, underlying cardiac/renal/hepatic disease, hypertension, thyroid issues, diabetes, and other contraindications.
- Pregnant Women: Use cautiously only if benefits outweigh potential risks after consultation with a physician. Generally not recommended during the first trimester.
- Breastfeeding Mothers: Avoid use due to potential transfer into breast milk and effects on the infant.
- Children & Elderly: Generally not recommended for children under 12 years. Elderly: use lower doses due to potential age-related decline in organ function.
- Lifestyle Considerations: Avoid alcohol as it might worsen side effects. Patients should avoid driving or operating machinery if they experience dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine + Pseudoephedrine?
A: The typical adult dosage is 8 mg bromhexine and 60 mg pseudoephedrine every 4-6 hours, not to exceed 4 doses within a 24-hour period. Pediatric dosages (for children older than 12) may be the same as for adults or lower, strictly as determined and monitored by a physician.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, dizziness, headache, dry mouth/nose/throat, restlessness, insomnia, and increased heart rate.
Q3: Can this combination be used in patients with hypertension?
A: It should be used with caution in patients with mild to moderate hypertension, with careful monitoring of blood pressure. It’s generally contraindicated in severe hypertension.
Q4: Is Bromhexine + Pseudoephedrine safe during pregnancy?
A: It is generally not recommended during the first trimester. In later trimesters, it should only be used if clearly necessary and after careful consideration of potential benefits and risks by a physician.
Q5: Can I take this medicine with other cold and cough remedies?
A: Avoid concomitant use of other OTC cold and cough medications, especially those containing decongestants or sympathomimetic amines, as this may lead to an overdose or increased risk of adverse effects. Always consult a doctor before combining medications.
Q6: How does Bromhexine work in this combination?
A: Bromhexine acts as a mucolytic, reducing the viscosity of mucus by breaking down mucopolysaccharides, making it easier to expectorate.
Q7: How does Pseudoephedrine work in this combination?
A: Pseudoephedrine is a decongestant. It stimulates alpha-adrenergic receptors in the nasal mucosa, causing vasoconstriction and reducing nasal congestion.
Q8: What should I do if my symptoms persist after 7 days?
A: If symptoms persist or worsen after 7 days of treatment, consult a physician. Do not self-medicate beyond the recommended duration.
Q9: What are the signs of an allergic reaction to this medication?
A: Allergic reactions can manifest as skin rash, itching, hives, swelling (especially of the face, tongue, or throat), severe dizziness, and difficulty breathing. Seek immediate medical attention if any of these occur.
Q10: Can this medication affect my sleep?
A: Yes, pseudoephedrine can cause insomnia or difficulty sleeping in some individuals. Taking the last dose several hours before bedtime might minimize this side effect.
