Usage
This combination medication is prescribed for the symptomatic relief of cough and cold associated with allergies and respiratory tract infections. It targets both productive (wet) and dry coughs and helps alleviate symptoms like sneezing, runny nose, watery eyes, itching, swelling, nasal congestion, and chest congestion.
Pharmacological Classification:
This combination includes drugs from several classifications:
- Ambroxol: Mucolytic, expectorant
- Cetirizine: Antihistamine (second generation)
- Dextromethorphan Hydrobromide: Cough suppressant (antitussive)
- Guaifenesin: Expectorant
- Phenylephrine: Decongestant
Mechanism of Action:
This combination works through the synergistic action of its components:
- Ambroxol: Reduces the viscosity of mucus by breaking down mucopolysaccharides, facilitating expectoration.
- Cetirizine: Antagonizes H1 receptors, reducing histamine-mediated allergic symptoms.
- Dextromethorphan Hydrobromide: Suppresses the cough reflex by acting on the cough center in the medulla oblongata.
- Guaifenesin: Thins and loosens bronchial secretions, making it easier to cough up phlegm.
- Phenylephrine: Acts as an alpha-1 adrenergic agonist, constricting blood vessels in the nasal mucosa, reducing congestion.
Alternate Names
There is no single international non-proprietary name (INN) for this specific combination drug. It is referred to by the names of its constituent drugs. Brand names include Tussin-DMR, Broncolite-AZ, Active Junior and others. The brand names may vary depending on the manufacturer and region.
How It Works
Pharmacodynamics: The combined effects of the individual components provide relief from cough, cold, and allergy symptoms.
Pharmacokinetics:
- Absorption: Each component is absorbed orally.
- Metabolism: Primarily hepatic metabolism for dextromethorphan, phenylephrine, ambroxol, and guaifenesin. Cetirizine is mostly excreted unchanged. CYP450 enzyme interactions are possible.
- Elimination: Primarily renal excretion for cetirizine, ambroxol, and guaifenesin metabolites. Dextromethorphan and phenylephrine metabolites are also renally excreted.
Dosage
The dosage information below is general and may not reflect the specific product being used. Always refer to the manufacturer’s instructions and patient-specific factors.
Standard Dosage
Adults: Consult the specific product labeling for adult dosing, as it varies among manufacturers. Dosage is dependent on the amount of each ingredient. Liquid dosages vary significantly.
Special Cases:
- Elderly Patients: Dose adjustment may be required due to age-related decline in organ function.
- Patients with Renal Impairment: Dose reduction may be necessary.
- Patients with Hepatic Dysfunction: Dose adjustment is usually required due to potential for altered metabolism.
- Patients with Comorbid Conditions: Exercise caution in patients with cardiovascular disease, diabetes, hypertension, hyperthyroidism, glaucoma, and other conditions.
Clinical Use Cases
This combination is typically not used in specific clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. Its use is generally limited to outpatient symptomatic relief. It’s not appropriate for emergency situations such as cardiac arrest or status epilepticus.
Dosage Adjustments
Dosage adjustments are based on individual patient factors such as renal and hepatic function, comorbidities, and potential drug interactions. Always consider individual patient characteristics when prescribing this combination.
Side Effects
Common Side Effects:
Drowsiness, dizziness, dry mouth, nausea, vomiting, headache, fatigue, stomach upset, loss of appetite, insomnia.
Rare but Serious Side Effects:
Allergic reactions (rash, hives, itching, swelling), difficulty breathing, irregular heartbeat, seizures.
Long-Term Effects:
Potential long-term effects are generally not associated with short-term use for cough and cold symptoms. Prolonged use should be avoided unless specifically directed by a physician.
Adverse Drug Reactions (ADR):
Severe allergic reactions, cardiac arrhythmias, and neurological events are potential ADRs requiring immediate medical attention.
Contraindications
- Hypersensitivity to any of the components.
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.
- Severe hepatic or renal impairment.
- Certain cardiovascular conditions.
Drug Interactions
- MAOIs, antidepressants (especially tricyclic antidepressants and SSRIs), sedatives, antihypertensives, alcohol, other antihistamines, decongestants, opioid pain medications, and some antibiotics may interact with this combination.
- CYP450 interactions are possible, especially with drugs metabolized by CYP2D6 and CYP3A4.
Pregnancy and Breastfeeding
Consult a physician before use during pregnancy or breastfeeding. The safety profile of this combination in these populations is not fully established. Some components, like phenylephrine, may pose risks during pregnancy. Cetirizine is generally considered safe during pregnancy, but individual components, like phenylephrine, may pose risks.
Drug Profile Summary
- Mechanism of Action: See “How It Works” section.
- Side Effects: Drowsiness, dizziness, dry mouth, nausea, headache (common); allergic reactions, irregular heartbeat, seizures (serious).
- Contraindications: Hypersensitivity, concurrent MAOI use, severe hepatic or renal disease, certain cardiovascular conditions.
- Drug Interactions: MAOIs, antidepressants, sedatives, antihypertensives, other antihistamines, decongestants.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: Varies by age and condition. See “Dosage” section and consult product labeling.
- Monitoring Parameters: Monitor vital signs, especially blood pressure and heart rate. Monitor for allergic reactions and CNS effects.
Popular Combinations
This combination itself is commonly used. Its individual components are also found in various other cold and cough medications, often combined with analgesics like paracetamol or ibuprofen.
Precautions
- General Precautions: Assess for allergies, pre-existing medical conditions (especially hepatic, renal, cardiovascular, and thyroid disorders), and concurrent medications.
- Pregnant Women: Consult a physician. Potential risks exist, especially with phenylephrine.
- Breastfeeding Mothers: Consult a physician. Limited information available about infant exposure through breastmilk.
- Children & Elderly: Age-appropriate formulations and dosing adjustments required.
- Lifestyle Considerations: Avoid alcohol and activities requiring mental alertness due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Cetirizine + Dextromethorphan Hydrobromide + Guaifenesin + Phenylephrine?
A: The dosage varies by product and patient-specific factors. Consult the specific product labeling for detailed instructions.
Q2: Can this combination be used in children?
A: Pediatric formulations and dosing guidelines exist, but consult a healthcare professional for appropriate use in children.
Q3: Is it safe to take this combination during pregnancy or breastfeeding?
A: Consult a physician before use during pregnancy or breastfeeding. The safety profile hasn’t been fully established.
Q4: What are the potential drug interactions?
A: Many drug interactions are possible. Inform your physician about all other medications you are taking, including OTC drugs and supplements.
Q5: What are the most common side effects?
A: Drowsiness, dizziness, dry mouth, nausea, and headache are common side effects.
Q6: Can I operate machinery or drive after taking this medication?
A: Use caution when operating machinery or driving as this combination can cause drowsiness and impair alertness.
Q7: 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.
Q8: Are there any dietary restrictions while taking this medicine?
A: No specific dietary restrictions are typically associated with this medication. However, adequate fluid intake is recommended.
Q9: What should I do if I experience severe side effects?
A: Immediately discontinue use and seek medical attention if severe side effects or allergic reactions occur.
Q10: How should this medication be stored?
A: Store as directed on the product labeling, typically in a cool, dry place away from direct sunlight and out of reach of children.
