Ambroxol + Chlorpheniramine Maleate + Guaifenesin + Phenylephrine

Usage

This combination medication is prescribed for the symptomatic relief of cough, cold, and allergy symptoms, especially when accompanied by mucus production and nasal congestion. It is indicated for conditions like the common cold, bronchitis, sinusitis, and allergic rhinitis. It also helps in managing symptoms related to acute and chronic inflammatory conditions of the upper and lower respiratory tract with excessive mucus secretion, nasal congestion, and runny nose.

• Pharmacological Classification: This is a combination drug containing:

  • Ambroxol: Mucolytic
  • Chlorpheniramine Maleate: Antihistamine
  • Guaifenesin: Expectorant
  • Phenylephrine: Decongestant

• Mechanism of Action:

  • Ambroxol reduces the viscosity of mucus by breaking down mucopolysaccharide fibers, making it easier to cough up. It has also shown some anti-inflammatory and antioxidant effects.
  • Chlorpheniramine Maleate blocks the action of histamine, reducing allergy symptoms like runny nose, sneezing, and watery eyes.
  • Guaifenesin thins and loosens mucus in the airways by increasing respiratory tract fluid, making it easier to expel.
  • Phenylephrine constricts blood vessels in the nasal passages, reducing nasal congestion and swelling.

Alternate Names

There are no widely recognized alternate names for this specific four-drug combination. It’s often referred to by its constituent drug names or simply as a cough and cold medication. Various brand names exist depending on the manufacturer and region.

• Brand Names: Brand names vary. Some examples from India include Broxyl-AP Syrup and CC Gesic Syrup. This is not an exhaustive list and many other brand names may exist.

How It Works

• Pharmacodynamics: The combined effects of the four drugs provide symptomatic relief from cough, cold, and allergy symptoms. Ambroxol’s mucolytic action reduces sputum viscosity. Chlorpheniramine Maleate’s antihistamine properties decrease allergic reactions like sneezing and runny nose. Guaifenesin facilitates mucus expulsion by increasing respiratory tract fluid volume. Phenylephrine’s decongestant effect reduces nasal congestion and swelling.

• Pharmacokinetics:

  • Ambroxol is well-absorbed orally with a bioavailability of about 79%. It’s metabolized in the liver by CYP3A4 enzyme, with a half-life of around 10 hours. It’s primarily eliminated through renal excretion.
  • Chlorpheniramine Maleate is well-absorbed orally and metabolized in the liver. It has a longer half-life, ranging from 12-43 hours. It’s also mainly excreted through the kidneys.
  • Guaifenesin is readily absorbed orally, metabolized in the liver and eliminated in the urine.
  • Phenylephrine is metabolized by monoamine oxidase in the gastrointestinal tract and liver, resulting in low oral bioavailability. It’s eliminated renally.

• Mode of Action:

  • Ambroxol stimulates the serous cells of the bronchial glands to produce a less viscous secretion.
  • Chlorpheniramine Maleate acts as a competitive antagonist at H1 histamine receptors.
  • Guaifenesin’s exact mode of action is not fully understood but believed to involve stimulation of receptors in the gastric mucosa.
  • Phenylephrine acts as an alpha-1 adrenergic receptor agonist, causing vasoconstriction.

• Elimination Pathways: Primarily renal excretion for all four components. Hepatic metabolism plays a role in the metabolism of ambroxol, chlorpheniramine, and guaifenesin.

Dosage

Due to this specific combination not being an FDA-approved product, a standardized dosage doesn’t exist. Dosages are dependent on the specific product formulation and should be determined by a healthcare professional. Always check the specific product’s information for appropriate dosage instructions.

Standard Dosage

Adults: Dosing varies widely based on product formulation and typically requires a physician’s recommendation. A typical example might include syrup formulations with dosing of 5-10ml every 4-6 hours, not to exceed four doses within a 24-hour period. For tablets, one tablet every 4-6 hours is sometimes prescribed, also limited to a maximum of four doses per day. It’s crucial to confirm this information with a healthcare professional.

Children: This combination is generally not recommended for children under 12 years of age unless specifically directed by a physician. Dosages for children above 12 may vary with specific formulation.

Special Cases:

• Elderly Patients: Start with a lower dose due to potential age-related decline in hepatic and renal function and monitor closely for side effects.
• Patients with Renal Impairment: Dose reduction may be necessary depending on the degree of impairment.
• Patients with Hepatic Dysfunction: Use with caution and monitor for adverse effects.
• Patients with Comorbid Conditions: Caution is advised in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, and urinary retention. Dose adjustments might be needed.

Clinical Use Cases

This drug combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. It’s intended for the outpatient management of common cold and allergy symptoms. Other medications are more appropriate for emergency situations.

Dosage Adjustments

Dose modification should be based on patient-specific factors, such as renal or hepatic impairment, other medical conditions, and concomitant medications. Always consult a physician for dosage adjustments.

Side Effects

Common Side Effects:

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

Rare but Serious Side Effects:

Allergic reactions (rash, itching, swelling, difficulty breathing), difficulty urinating, irregular heartbeat, hallucinations.

Long-Term Effects:

The potential long-term effects are not explicitly defined for this specific combination.

Adverse Drug Reactions (ADR): Any serious or unusual reaction requires immediate medical attention.

Contraindications

• Hypersensitivity to any component of the medication.
• Severe hypertension, severe coronary artery disease.
• Narrow-angle glaucoma, urinary retention.
• Monoamine oxidase inhibitor (MAOI) use within the past 14 days.

Drug Interactions

• Other cough and cold medications (e.g., dextromethorphan).
• Antidepressants (e.g., MAOIs, tricyclic antidepressants).
• Antihypertensives (e.g., beta-blockers).
• Anticholinergics (e.g., dicyclomine).
• Sedatives (e.g., benzodiazepines).
• Thyroid medications.
• Alcohol.

Pregnancy and Breastfeeding

Consult a doctor before using this medication during pregnancy or breastfeeding. The safety profile for this specific combination during these periods is not well-established.

Drug Profile Summary

• Mechanism of Action: Ambroxol (mucolytic), Chlorpheniramine (antihistamine), Guaifenesin (expectorant), Phenylephrine (decongestant).
• Side Effects: Drowsiness, dizziness, dry mouth, nausea, constipation, allergic reactions.
• Contraindications: Hypersensitivity, severe cardiovascular disease, narrow-angle glaucoma, MAOI use.
• Drug Interactions: MAOIs, other cough/cold medications, antidepressants, antihypertensives.
• Pregnancy & Breastfeeding: Consult a doctor before use.
• Dosage: Varies depending on formulation and patient specifics. Consult a doctor.
• Monitoring Parameters: Monitor for efficacy and side effects. Pay close attention to patients with comorbidities.

Popular Combinations

Information about commonly used drug combinations specifically with this combination is not readily available. Each component drug does have combinations used in other formulations, however.

Precautions

• Pre-existing medical conditions (cardiovascular disease, diabetes, renal/hepatic impairment, glaucoma, prostatic hypertrophy).
• Use with caution in elderly patients and children.
• Avoid alcohol and other CNS depressants.
• May cause drowsiness; caution with driving or operating machinery.

FAQs (Frequently Asked Questions)

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

A: A doctor should always be consulted as dosage varies based on individual patient factors and the specific formulation used. There is no standardized dosage for this specific combination.

Q2: Can this combination be used in children?

A: Generally not recommended for children under 12 years old unless specifically prescribed by a doctor.

Q3: What are the common side effects?

A: Common side effects include drowsiness, dizziness, dry mouth, nausea, and constipation.

Q4: Are there any serious side effects I should be aware of?

A: Rare but serious side effects may include allergic reactions, difficulty urinating, and irregular heartbeat. Seek immediate medical attention if these occur.

Q5: Can I take this medication with other medications?

A: This combination may interact with various medications, including antidepressants, antihypertensives, and other cough/cold medicines. Consult a doctor before using it with other medications.

Q6: Can pregnant or breastfeeding women take this medicine?

A: Consult a doctor before use during pregnancy or while breastfeeding, as the safety profile is not well-established.

Q7: What should I do if I miss a dose?

A: If you miss a dose, take it as soon as you remember. However, if it is near the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.

Q8: Can I drive or operate machinery after taking this medication?

A: This medication may cause drowsiness or dizziness, impacting your ability to drive or operate machinery safely. Exercise caution and avoid such activities if affected.

Q9: What should I do if my symptoms worsen or do not improve?

A: Consult your physician if symptoms do not improve or worsen after several days of treatment.