Usage
- This combination medication is prescribed for the symptomatic relief of cough and cold associated with allergies, flu, or other respiratory tract infections. It helps to relieve symptoms such as nasal congestion, runny nose, sneezing, cough, and watery eyes.
- Pharmacological Classification: This is a combination drug containing a mucolytic (Ambroxol), an antihistamine (Chlorpheniramine Maleate), and a decongestant (Pseudoephedrine).
- Mechanism of Action: Ambroxol thins and loosens mucus, facilitating its expulsion. Chlorpheniramine Maleate blocks histamine, reducing allergic symptoms. Pseudoephedrine constricts blood vessels in the nasal passages, relieving nasal congestion.
Alternate Names
- No widely recognized alternate names exist for this specific combination. The individual components are sometimes referred to by other names (e.g., ambroxol hydrochloride for ambroxol).
- Brand Names: Ambrodil Plus RF Syrup. Several other brand names may exist regionally.
How It Works
- Pharmacodynamics: Ambroxol stimulates the serous glands in the respiratory tract, increasing the production of thin, watery mucus. It also promotes ciliary activity, enhancing mucus clearance. Chlorpheniramine Maleate antagonizes the H1 histamine receptor, reducing allergic symptoms. Pseudoephedrine acts as an alpha-adrenergic agonist, causing vasoconstriction in the nasal mucosa and reducing congestion.
- Pharmacokinetics: Ambroxol is well absorbed orally and metabolized in the liver. Chlorpheniramine Maleate is also absorbed orally, metabolized in the liver, and eliminated renally. Pseudoephedrine is absorbed orally and excreted both unchanged and as metabolites in the urine.
- Mode of Action/Receptor Binding: Ambroxol: stimulates serous glands, increases surfactant production. Chlorpheniramine Maleate: H1 receptor antagonist. Pseudoephedrine: alpha-adrenergic receptor agonist.
- Elimination Pathways: Ambroxol and Chlorpheniramine Maleate are primarily eliminated via hepatic metabolism and renal excretion. Pseudoephedrine is excreted renally, both unchanged and as metabolites.
Dosage
Standard Dosage
Adults:
- The typical adult dose is one tablet or 10ml of syrup every 4 to 6 hours, not exceeding 4 doses (tablets) or 60 ml (syrup) in a 24-hour period.
Children:
- This medication should not be used for children under 6 years old unless otherwise advised by a doctor. Dosing above age 6 should be in accordance with body weight or age with particular pediatric formulations (syrup). The standard dose is 2-5 mL, depending on weight and age, every 4 to 6 hours.
Special Cases:
- Elderly Patients: Start with a lower dose and monitor for side effects. Dose adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Dose reduction is advised.
- Patients with Hepatic Dysfunction: Dose reduction is recommended.
- Patients with Comorbid Conditions: Caution is advised in patients with hypertension, heart disease, diabetes, glaucoma, hyperthyroidism, and prostatic hypertrophy.
Clinical Use Cases
- This drug combination isn’t typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or ICU care. Its use is mainly limited to outpatient symptomatic relief of cold and cough symptoms. In emergency situations requiring airway management or hemodynamic support, more targeted therapies are employed.
Dosage Adjustments
- Dose adjustments should be made based on patient-specific factors, such as renal or hepatic impairment, age, and other medical conditions.
Side Effects
Common Side Effects
- Drowsiness, dizziness, dry mouth, nausea, constipation, headache, blurred vision, restlessness, and difficulty sleeping.
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling), hallucinations, irregular heartbeat, seizures, difficulty urinating.
Long-Term Effects
- Chronic use of pseudoephedrine can lead to tolerance and rebound congestion.
Adverse Drug Reactions (ADR)
- Severe allergic reactions (anaphylaxis), cardiac arrhythmias, and central nervous system effects (confusion, hallucinations).
Contraindications
- Hypersensitivity to any of the components.
- Severe hypertension, coronary artery disease, narrow-angle glaucoma, urinary retention.
- Monoamine oxidase inhibitor (MAOI) use within the past 14 days.
- Pregnancy (especially first trimester) and breastfeeding.
Drug Interactions
- MAOIs, beta-blockers, antihypertensives, tricyclic antidepressants, digoxin, diuretics, anticholinergics, other decongestants or antihistamines, alcohol.
- CYP450 interactions are not significant for this combination.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Contraindicated. Not recommended, especially during the first trimester. Potential risks include fetal harm.
- Breastfeeding: Contraindicated. The drug can pass into breast milk and potentially harm the infant.
Drug Profile Summary
- Mechanism of Action: Mucolytic, antihistamine, and decongestant.
- Side Effects: Drowsiness, dizziness, dry mouth, nausea, constipation.
- Contraindications: Hypersensitivity, severe cardiovascular disease, glaucoma, MAOI use.
- Drug Interactions: MAOIs, other sympathomimetics.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: 1 tablet/10ml syrup every 4-6 hours (max 4 tablets/60ml in 24 hours). Children (6 years and above): 2-5ml syrup every 4-6 hours.
- Monitoring Parameters: Blood pressure, heart rate, respiratory rate.
Popular Combinations
- While this specific combination is itself commonly prescribed, additional medications may be included in some formulations, such as guaifenesin (expectorant) or menthol (soothing agent), for broader symptomatic relief.
Precautions
- Pre-existing conditions: Assess for hypertension, heart disease, diabetes, glaucoma, hyperthyroidism, prostatic hypertrophy.
- Pregnant/Breastfeeding women: Contraindicated.
- Children/Elderly: Use with caution, dose adjustments may be necessary.
- Lifestyle: Avoid alcohol and driving or operating machinery due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Chlorpheniramine Maleate + Pseudoephedrine?
A: Adults: 1 tablet or 10 ml syrup every 4-6 hours, not exceeding 4 tablets/60 ml in 24 hours. Children (6 years and above): 2-5ml syrup every 4-6 hours.
Q2: Can this combination be used during pregnancy or breastfeeding?
A: No, it is contraindicated in both pregnancy and breastfeeding.
Q3: What are the common side effects?
A: Drowsiness, dizziness, dry mouth, nausea, constipation, and headache are common side effects.
A: Allergic reactions, irregular heartbeat, seizures, difficulty urinating, and hallucinations are serious side effects.
Q5: What are the contraindications for this medicine?
A: Hypersensitivity, severe cardiovascular disease, narrow-angle glaucoma, urinary retention, MAOI use, pregnancy, and breastfeeding.
Q6: Can this combination be used with alcohol?
A: No, alcohol should be avoided as it may potentiate the sedative effects of chlorpheniramine.
Q7: Can this combination be used with other cold and cough medications?
A: No, it is essential to avoid using this combination with other medications containing similar ingredients, as it can lead to an overdose.
Q8: What should patients do if they experience side effects?
A: Patients should discontinue the medication and consult a doctor if they experience any bothersome side effects.
Q9: How does this combination interact with MAOIs?
A: Co-administration with MAOIs can cause a dangerous drug interaction and should be avoided.
Q10: Does this medicine cause any long term side effects?
A: Long-term use of the pseudoephedrine component can potentially lead to tolerance and rebound congestion.
