Ambroxol + Ammonium Chloride + Chlorpheniramine Maleate + Guaifenesin + Phenylephrine

Usage

This combination medication is prescribed for the symptomatic relief of cough and cold symptoms, including nasal congestion, runny nose, sneezing, itchy throat, watery eyes, and chest congestion. It is indicated for productive and dry coughs. It is a fixed dose combination (FDC) classified as:

• Mucolytic (Ambroxol): Reduces the viscosity of mucus, making it easier to expectorate.
• Expectorant (Guaifenesin and Ammonium Chloride): Thins and loosens mucus in the airways, facilitating its removal.
• Antihistamine (Chlorpheniramine Maleate): Relieves allergy symptoms such as sneezing, runny nose, and itchy eyes.
• Decongestant (Phenylephrine): Constricts blood vessels in the nasal passages, reducing swelling and congestion.

Alternate Names

While there isn’t a universally recognized international non-proprietary name (INN) for this specific five-drug combination, each individual component has its own INN, as listed above. Some regional or descriptive names may exist, but they are not standardized. Brand names vary depending on the manufacturer and region. Coscopin BR and Amterex are examples of brand names, though several others exist.

How It Works

Pharmacodynamics: The components work synergistically to address various aspects of cough and cold symptoms. Chlorpheniramine maleate antagonizes histamine H1 receptors, mitigating allergic responses. Phenylephrine acts as an α1-adrenergic receptor agonist, causing vasoconstriction in the nasal mucosa and reducing congestion. Ambroxol, guaifenesin, and ammonium chloride work together to modify mucus properties, increase its volume, and decrease its viscosity, thus improving airway clearance through expectoration.

Pharmacokinetics:

• Ambroxol: Well-absorbed orally, metabolized in the liver, and excreted primarily in urine.
• Chlorpheniramine Maleate: Readily absorbed and extensively metabolized in the liver.
• Guaifenesin: Absorbed from the GI tract and excreted primarily by the kidneys.
• Phenylephrine: Metabolized by monoamine oxidase in the intestine and liver.
• Ammonium Chloride: Absorbed rapidly and mostly excreted unchanged in the urine.

Mode of Action: Ambroxol stimulates the synthesis and secretion of surfactant in the lungs, promoting serous and fluid mucus production. Guaifenesin and ammonium chloride are believed to increase respiratory tract fluid volumes through vagal gastric stimulation. Chlorpheniramine competes with histamine for H1-receptor sites, and phenylephrine stimulates alpha-adrenergic receptors.

Elimination Pathways: Primarily renal excretion for guaifenesin and ammonium chloride. Hepatic metabolism and subsequent renal excretion are major pathways for ambroxol and chlorpheniramine maleate. Phenylephrine is subject to both intestinal and hepatic metabolism by monoamine oxidase.

Dosage

Standard Dosage

Adults: The standard dosage is not FDA-approved and varies across manufacturers and specific product formulations. It is crucial to consult the specific product labeling and consider patient-specific factors. A typical adult dose might involve a syrup formulation containing specific concentrations of each drug, taken every 4-6 hours as needed. The maximum daily dose should be carefully considered and adjusted for patient factors.

Children: This combination is generally not recommended for children under 12 years old. Alternative treatments are available for younger children and should be prioritized. A doctor must be consulted for pediatric use.

Special Cases:

• Elderly Patients: Start with the lowest effective dose and titrate cautiously. Monitor closely for adverse effects.
• Patients with Renal Impairment: Dosage adjustments may be needed.
• Patients with Hepatic Dysfunction: Use with caution. Dosage modifications may be necessary.
• Patients with Comorbid Conditions: Caution is warranted in patients with hypertension, diabetes, glaucoma, prostatic hyperplasia, thyroid disorders, and cardiovascular disease. Adjust dosage as needed.

Clinical Use Cases

Specific dosage guidelines for these settings are not typically found in drug information resources. The use of this combination in intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be guided by the clinical judgment of the attending physician.

Dosage Adjustments

Adjustments should be made on a patient-specific basis. Renal and hepatic impairment, metabolic disorders, and genetic polymorphisms all affect drug metabolism. Consider drug interactions when modifying doses.

Side Effects

Common Side Effects:

Drowsiness, headache, dizziness, loss of appetite, diarrhea, nausea, vomiting, stomach upset, dry mouth/throat, blurred vision, and constipation.

Rare but Serious Side Effects:

Allergic reactions (rash, itching, hives, swelling), difficulty breathing, irregular heartbeat, hallucinations, seizures, and cardiac arrhythmias.

Long-Term Effects:

Rebound congestion with prolonged phenylephrine use.

Adverse Drug Reactions (ADR):

Severe allergic reactions, cardiac arrhythmias, and neurological effects require immediate medical attention.

Contraindications

• Hypersensitivity to any components.
• Severe hypertension.
• Severe coronary artery disease.
• Narrow-angle glaucoma.
• Urinary retention.
• MAOI use within 14 days.

Drug Interactions

• Other cough and cold medications (e.g., dextromethorphan).
• Antidepressants (e.g., fluoxetine, tricyclic antidepressants).
• Antihypertensives (e.g., metoprolol).
• Anticholinergics (e.g., dicyclomine).
• Sedatives (e.g., diazepam).
• Thyroid medications (e.g., levothyroxine).
• Alcohol.

Pregnancy and Breastfeeding

Consult a physician before use during pregnancy or breastfeeding. Use is generally discouraged, especially during the first trimester.

Drug Profile Summary

• Mechanism of Action: See above.
• Side Effects: See above.
• Contraindications: See above.
• Drug Interactions: See above.
• Pregnancy & Breastfeeding: Consult a doctor. Use is generally discouraged.
• Dosage: See above.
• Monitoring Parameters: Blood pressure, heart rate, respiratory rate, symptoms of adverse effects.

Popular Combinations

The combination presented contains the commonly used components. Some formulations also include menthol for added cooling and soothing effects.

Precautions

• General Precautions: Screening for allergies, metabolic disorders, organ dysfunction is essential.
• Specific Populations: See above.
• Lifestyle Considerations: Avoid alcohol; caution with driving or operating machinery.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Ambroxol + Ammonium Chloride + Chlorpheniramine Maleate + Guaifenesin + Phenylephrine?

A: Dosage varies according to individual patient factors and the specific product formulation. Consult a physician or refer to the product’s packaging for dosage information. Always start with the lowest effective dose.

Q2: Can this combination be used in children?

A: Generally not recommended for children under 12 years old. Consult a physician for alternative treatments in younger children.

Q3: What are the common side effects?

A: Drowsiness, dizziness, headache, dry mouth/throat, nausea, vomiting, stomach upset, blurred vision, and constipation.

Q4: What are the serious side effects that warrant immediate medical attention?

A: Severe allergic reactions (difficulty breathing, swelling), irregular heartbeat, hallucinations, and seizures.

Q5: Can this medication be taken during pregnancy or while breastfeeding?

A: Consult with a doctor before use. Generally not recommended, especially during the first trimester, or while breastfeeding.

Q6: Does this combination interact with other medications?

A: Yes, it can interact with various medications, including antidepressants, antihypertensives, anticholinergics, sedatives, and thyroid medications. Consult a physician about potential drug interactions.

Q7: Are there any precautions for patients with pre-existing medical conditions?

A: Use with caution in patients with hypertension, heart disease, diabetes, glaucoma, thyroid disorders, kidney or liver disease, stomach ulcers, and prostatic hyperplasia. Dosage adjustments might be necessary.

Q8: What should patients do if they miss a dose?

A: Take the missed dose as soon as remembered, unless it is almost time for the next dose. Do not double the dose.

Q9: Can patients consume alcohol while taking this medication?

A: Alcohol should be avoided as it can worsen side effects like dizziness and drowsiness. It can also interact with certain components of the medication.

Q10: Can patients drive or operate machinery while on this medication?

A: Exercise caution. Drowsiness or dizziness are potential side effects, and thus driving or operating machinery may be unsafe.