Usage
- This combination medication is prescribed for the relief of symptoms associated with the common cold, allergies, and other respiratory tract infections, particularly those characterized by a cough with mucus (productive cough) and nasal congestion. It is indicated for conditions like bronchitis, laryngitis, sinusitis, pneumonia, and URTI (Upper Respiratory Tract Infection), as well as in cases of asthma and COPD to manage mucus.
- Pharmacological Classification: This is a combination drug containing a mucolytic (Bromhexine), an expectorant (Guaifenesin), and a decongestant (Phenylephrine).
- Mechanism of Action: Bromhexine breaks down the thick mucus, making it less viscous and easier to expectorate. Guaifenesin helps increase the volume of respiratory secretions and thins the mucus further, promoting its expulsion. Phenylephrine constricts the blood vessels in the nasal passages, relieving nasal congestion.
Alternate Names
- No widely recognized alternate names exist for this specific combination. However, variations may exist regionally.
- Brand Names: This drug is marketed under various brand names like Flemnil and BIMED.
How It Works
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Pharmacodynamics: Bromhexine acts on the disulfide bonds of mucoproteins in the mucus, reducing its viscosity. Guaifenesin increases respiratory tract fluid volumes, hydrating the airways and facilitating mucus clearance. Phenylephrine, an alpha-adrenergic agonist, acts on alpha-1 receptors in the vascular smooth muscle of the nasal mucosa, causing vasoconstriction and thereby reducing nasal congestion.
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Pharmacokinetics:
- Bromhexine: Absorbed well orally. Metabolized in the liver. Excreted mainly in the urine.
- Guaifenesin: Rapidly absorbed from the GI tract. Metabolized in the liver and excreted in urine.
- Phenylephrine: Poorly absorbed orally. Undergoes first-pass metabolism in the gut and liver. Excreted in urine.
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Mode of Action: Bromhexine acts by directly depolymerizing mucopolysaccharides in the mucus. Guaifenesin is believed to stimulate receptors in the gastric mucosa, triggering reflex stimulation of bronchial glands, increasing respiratory secretions. Phenylephrine binds to alpha-1 adrenergic receptors, leading to vasoconstriction.
Dosage
Standard Dosage
Adults:
- The typical adult dose is 10 ml of syrup or one tablet, administered every 4-6 hours, not exceeding six doses per day. Dose is also available as a dissolving granule or powder. The strength is 8 mg Bromhexine, 100 mg Guaifenesin, and 60 mg pseudoephedrine per 10 ml.
Children:
- Children (2 to under 6 years): 1 mL of 50/2.5mg/1ml solution every 4 hours, maximum 6 doses per day.
- Children (6 - 11 years): 2.5 to 5 mL every 4-6 hours, not exceeding six doses/day of a 4mg/50mg/5mg/5ml solution. The maximum single dose is 5ml.
- Children 12 years and older can typically take the adult dose, as guided by their weight.
Special Cases:
- Elderly Patients: Dosage adjustments may be needed due to potential age-related decline in organ function.
- Patients with Renal Impairment: Caution advised; dose adjustment may be necessary.
- Patients with Hepatic Dysfunction: Caution advised; dose adjustment may be necessary.
- Patients with Comorbid Conditions: Dose adjustment may be needed, especially with conditions like heart disease, hypertension, diabetes, hyperthyroidism, or prostatic hypertrophy.
Clinical Use Cases
- Dosing in special clinical settings like intubation, surgery, mechanical ventilation, or ICU use should be individualized based on the patient’s condition and under the guidance of a physician.
- Emergency Situations: This combination isn’t typically used in emergency situations like status epilepticus or cardiac arrest.
Dosage Adjustments
- Dosage needs to be adjusted for patients with hepatic or renal dysfunction, metabolic disorders, and certain other conditions. Consult the prescribing information for specific recommendations.
Side Effects
Common Side Effects
- Nausea, vomiting, stomach upset, dizziness, headache, drowsiness, anxiety, restlessness, insomnia, palpitations, increased heart rate, skin rash, itching.
Rare but Serious Side Effects
- Allergic reactions, severe hypertension, arrhythmias.
Long-Term Effects
- No specific long-term adverse effects have been documented.
Adverse Drug Reactions (ADR)
- Any severe or unusual reactions should be reported immediately.
Contraindications
- Hypersensitivity to any of the active ingredients or excipients.
- Severe hypertension, coronary artery disease, hyperthyroidism.
- Concomitant use of MAO inhibitors.
- Patients with gastric ulcers.
- Children under 2 years of age.
Drug Interactions
- MAO inhibitors (e.g., phenelzine, tranylcypromine).
- Antihypertensives (e.g., amlodipine, lisinopril).
- Digoxin.
- Other sympathomimetics (e.g., pseudoephedrine, ephedrine).
- Antidepressants (e.g., duloxetine).
- Beta-blockers.
- Alcohol can potentiate side effects like drowsiness.
Pregnancy and Breastfeeding
- Safety during pregnancy and lactation has not been fully established. Use with caution and only if clearly needed under medical supervision. Phenylephrine may reduce milk production.
Drug Profile Summary
- Mechanism of Action: Mucolytic, expectorant, and decongestant.
- Side Effects: Nausea, dizziness, headache, drowsiness, rash.
- Contraindications: Hypersensitivity, severe hypertension, MAO inhibitor use.
- Drug Interactions: MAO inhibitors, antihypertensives, digoxin, sympathomimetics.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: Adults: 10 ml every 4-6 hours; Pediatric: consult dosing charts. Consult a doctor before use.
- Monitoring Parameters: Blood pressure, heart rate, respiratory status.
Popular Combinations
- Bromhexine is sometimes combined with other expectorants or cough suppressants.
Precautions
- General Precautions: Evaluate for pre-existing conditions like hypertension, heart disease, diabetes, thyroid disorders, and prostatic enlargement.
- Specific Populations: Use with caution in pregnancy, breastfeeding, children, and the elderly.
- Lifestyle Considerations: Limit alcohol. Caution when operating machinery due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine + Guaifenesin + Phenylephrine?
A: Standard adult dose is 10 ml of syrup or one tablet every 4-6 hours, not to exceed six doses in a 24-hour period. Pediatric dosages vary by age; consult appropriate guidelines. It is best to always consult with a doctor to find the dose most suitable to your needs.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, headache, dizziness, drowsiness, and skin rash.
Q3: Is it safe to use during pregnancy or while breastfeeding?
A: Safety hasn’t been fully established. Use with caution and consult a physician. Phenylephrine may decrease milk production.
Q4: Can I take it with other medications?
A: Consult your doctor or pharmacist about potential drug interactions, especially with MAO inhibitors, antihypertensives, digoxin, and other sympathomimetics.
Q5: What conditions is this medication contraindicated in?
A: Contraindicated in patients with hypersensitivity, severe hypertension, concomitant MAO inhibitor use, and gastric ulcers.
Q6: How does this medication work to relieve cough and congestion?
A: Bromhexine breaks down mucus, while Guaifenesin thins and increases secretions. Phenylephrine relieves nasal congestion by constricting blood vessels in the nasal passages.
Q7: Are there any specific precautions for patients with pre-existing medical conditions?
A: Yes. Patients with heart disease, hypertension, diabetes, or thyroid disorders should exercise caution.
Q8: Can I operate machinery or drive after taking this medication?
A: Use caution as it may cause drowsiness in some individuals.
Q9: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose.
Q10: Are there any long-term effects I should be aware of?
A: No specific long-term effects have been documented, but always discuss any concerns with your physician.
