Usage
This combination medication is primarily prescribed for the symptomatic relief of cough associated with allergies and the common cold. It helps loosen and thin mucus in the airways, suppress the urge to cough, relieve allergy symptoms (like runny nose, sneezing, and watery eyes), and soothe irritated airways.
Pharmacological Classification:
This drug is a combination product containing:
- Expectorant (Ammonium Chloride)
- Cough Suppressant (Dextromethorphan Hydrobromide)
- Antihistamine (Levocetirizine)
- Decongestant/Topical Anesthetic (Menthol)
Alternate Names
While this specific combination may not have a widely recognized international non-proprietary name (INN), it’s commonly found in various branded formulations. Regional variations in brand names are also common. Some formulations might substitute Bromhexine for Ammonium Chloride. Brand names include: Nilcold-DM Syrup, Qmol-PD Syrup, and Zykuf D Syrup.
How It Works
Pharmacodynamics:
- Ammonium Chloride: Acts as an expectorant by increasing respiratory tract fluid secretions, thus reducing mucus viscosity and making it easier to cough up.
- Dextromethorphan Hydrobromide: Suppresses the cough reflex by acting on the cough center in the medulla oblongata in the brain.
- Levocetirizine: A second-generation antihistamine that blocks histamine H1 receptors. This action mitigates the allergic response, relieving symptoms such as sneezing, runny nose, itching, and watery eyes.
- Menthol: Produces a cooling sensation in the airways. It also acts as a mild local anesthetic, providing soothing relief to irritated airways. Can also have mild decongestant properties.
Pharmacokinetics:
- Absorption: All components are absorbed orally.
- Metabolism: Dextromethorphan is primarily metabolized in the liver by CYP2D6 and CYP3A4 enzymes. Levocetirizine undergoes minimal metabolism. Ammonium chloride and menthol are minimally metabolized.
- Elimination: Levocetirizine is primarily excreted unchanged in urine. Dextromethorphan and its metabolites are excreted in urine. Ammonium Chloride is excreted in the urine. Menthol is primarily excreted in the urine and feces.
Dosage
Standard Dosage
Adults:
5-10 ml syrup every 4-6 hours or as directed. Tablet formulations, where available, may have different dosing instructions. Maximum daily dose of dextromethorphan should not exceed 120 mg.
Children:
Consult a healthcare professional for pediatric dosing as it varies based on age and weight. Generally, it’s not recommended for children under 4 years old. Use with caution in children under 12 years old.
Special Cases:
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Elderly Patients: Start with a lower dose and monitor closely for adverse effects due to potential age-related decline in organ function.
-
Patients with Renal Impairment: Levocetirizine dosage needs to be adjusted based on creatinine clearance (CrCl):
- CrCl 50-80 mL/min: 2.5 mg daily
- CrCl 30-50 mL/min: 2.5 mg every other day
- CrCl 10-30 mL/min: 2.5 mg twice a week
- CrCl <10 mL/min or hemodialysis: Contraindicated
-
Patients with Hepatic Dysfunction: Use with caution and monitor closely for adverse effects due to potential impaired metabolism. Dose adjustments may be necessary.
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Patients with Comorbid Conditions: Use with caution in patients with persistent cough, cough accompanied by excessive mucus secretion, history of peptic ulcer disease, diabetes, hypertension, glaucoma, enlarged prostate gland, urinary retention, seizure disorders, and psychiatric disorders.
Clinical Use Cases
The combination is not typically indicated for specific clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its usage is primarily for the symptomatic relief of cough and cold related to allergies and common cold.
Dosage Adjustments
Dosage adjustments may be required in special populations (elderly, renally impaired, hepatically impaired) as mentioned above. Adjustments may also be necessary based on patient-specific factors like drug interactions, concomitant medications, and other underlying medical conditions.
Side Effects
Common Side Effects:
Drowsiness, dizziness, nausea, vomiting, dry mouth.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), hallucinations, respiratory depression, cardiac arrhythmias (rarely QT prolongation with levocetirizine, especially at higher doses or with drug interactions).
Long-Term Effects:
Chronic use of dextromethorphan at high doses can lead to psychological dependence.
Contraindications
- Hypersensitivity to any of the ingredients.
- Severe respiratory conditions like emphysema or chronic bronchitis.
- Narrow-angle glaucoma.
- Urinary retention.
- Severe liver or kidney impairment.
Drug Interactions
- Monoamine oxidase inhibitors (MAOIs)
- Certain antidepressants (e.g., tricyclic antidepressants, SSRIs)
- Alcohol
- Sedatives or tranquilizers
- Other antihistamines
- Opioids
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been fully established. Consult a healthcare professional for guidance. Alternative options might be considered. It is generally recommended to avoid using this combination during pregnancy unless the benefits outweigh the risks. Its use during breastfeeding should be carefully considered, and alternative safer options might be explored.
Drug Profile Summary
- Mechanism of Action: Expectorant, cough suppressant, antihistamine, decongestant.
- Side Effects: Drowsiness, dizziness, nausea, vomiting, dry mouth. Rarely: Allergic reactions, hallucinations, respiratory depression, cardiac arrhythmias.
- Contraindications: Hypersensitivity, severe respiratory disease, glaucoma, urinary retention, severe liver/kidney impairment.
- Drug Interactions: MAOIs, certain antidepressants, alcohol, sedatives, other antihistamines, opioids.
- Pregnancy & Breastfeeding: Consult a physician.
- Dosage: Adults: 5-10 ml syrup every 4-6 hours or as directed. Pediatric dosing: consult a healthcare professional.
- Monitoring Parameters: Respiratory rate, heart rate, mental status, allergic symptoms.
Popular Combinations
This specific combination itself is a commonly used formulation. It’s not typically combined with other drugs, though individual components might be used in other combination products.
Precautions
- General Precautions: Assess for allergies, pre-existing medical conditions, and concomitant medications.
- Pregnant Women: Consult guidelines. Generally avoid unless benefits outweigh risks.
- Breastfeeding Mothers: Consult guidelines. Risk of neonatal exposure. Consider safer alternatives.
- Children & Elderly: Use with caution. Age-specific dosage adjustments may be needed.
- Lifestyle Considerations: Avoid alcohol and driving or operating machinery if drowsiness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ammonium Chloride + Dextromethorphan Hydrobromide + Levocetirizine + Menthol?
A: The standard adult dosage is 5-10 ml syrup every 4-6 hours, not exceeding 120mg of Dextromethorphan daily. Consult a doctor for pediatric dosing and adjustments for renal or hepatic impairment.
Q2: Can this combination be used during pregnancy?
A: The safety during pregnancy isn’t fully established. Consult a doctor before use, as the benefits must outweigh the potential risks. Alternatives may be considered.
Q3: What are the common side effects?
A: Common side effects include drowsiness, dizziness, nausea, vomiting, and dry mouth.
Q4: Are there any serious side effects I should be aware of?
A: Rarely, allergic reactions, hallucinations, respiratory depression, or cardiac arrhythmias may occur. Seek immediate medical attention if these occur.
Q5: What are the contraindications for this medication?
A: Contraindications include hypersensitivity to any ingredient, severe respiratory disease, glaucoma, urinary retention, and severe liver/kidney impairment.
Q6: Can I take this medicine with alcohol?
A: Alcohol should be avoided while taking this medication, as it can exacerbate drowsiness and other side effects.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it’s close to the next dose, skip the missed dose and continue your regular schedule. Do not double the dose.
Q8: How does this medication interact with other drugs?
A: This medication can interact with MAOIs, antidepressants, sedatives, other antihistamines, and opioids. Inform your doctor about all medications you are taking to avoid potential interactions.
Q9: Can I drive or operate machinery while taking this medication?
A: This medication may cause drowsiness. Avoid driving or operating heavy machinery if drowsiness occurs.