Usage
Ambroxol + Cetirizine is prescribed for the symptomatic relief of cough associated with respiratory tract infections, allergies, and other respiratory disorders like acute and chronic bronchitis, and bronchial asthma. It is also used to manage allergic conditions such as hay fever, allergic conjunctivitis, eczema, hives, and insect bite reactions.
It’s pharmacological classifications are:
- Mucolytic: Ambroxol
- Antihistamine: Cetirizine
Ambroxol works by breaking down thick mucus in the airways, making it easier to cough up. Cetirizine works by blocking histamine, a chemical that triggers allergy symptoms.
Alternate Names
There are no officially recognized alternate names for the combination. However, it is sometimes referred to as “Ambroxol-Cetirizine.” Several brand names exist depending on the manufacturer and region. Some popular brand names may include Relent, Zistam-A (with Levocetirizine).
How It Works
Pharmacodynamics:
- Ambroxol: Stimulates the serous cells of the bronchial glands to enhance the production of serous mucus in the respiratory tract. Ambroxol appears to modify the structure of the glycoproteins in bronchial mucus, decreasing its viscosity. It also increases the activity of surfactant in the lungs, promoting better air exchange and mucus clearance.
- Cetirizine: A second-generation antihistamine that selectively antagonizes peripheral H1 receptors. It reduces the effects of histamine, thus relieving allergy symptoms. Because of its minimal penetration into the central nervous system, it is less likely to cause drowsiness compared to first-generation antihistamines.
Pharmacokinetics:
- Ambroxol: Well-absorbed orally. Metabolized in the liver and excreted primarily in the urine.
- Cetirizine: Rapidly absorbed after oral administration. Minimal hepatic metabolism; primarily excreted unchanged in the urine.
Mode of Action:
- Ambroxol: Modifies the structure and reduces the viscosity of mucus.
- Cetirizine: Competes with histamine for binding at H1 receptor sites.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Ambroxol: No significant receptor binding, enzyme inhibition, or neurotransmitter modulation is associated with its therapeutic effect.
- Cetirizine: Selectively binds to and blocks peripheral H1 receptors.
Elimination Pathways:
- Ambroxol: Primarily renal excretion after hepatic metabolism.
- Cetirizine: Primarily renal excretion of unchanged drug.
Dosage
Standard Dosage
Adults:
One tablet or 10ml syrup of Ambroxol 30mg + Cetirizine 5mg twice or thrice daily. Maximum dose should not exceed Ambroxol 120mg and Cetirizine 10mg per day.
Children:
- 2-6 years: 2.5 ml syrup twice or thrice daily
- 6-12 years: 5 ml syrup twice or thrice daily.
- Above 12 years: Adult dose.
Pediatric doses are approximations, and the physician should determine the optimal dose.
Special Cases:
- Elderly Patients: Start with a lower dose and adjust as needed based on renal and hepatic function.
- Patients with Renal Impairment: Dose adjustment is necessary. Creatinine clearance should be assessed, and the dose/dosing interval should be adjusted accordingly.
- Patients with Hepatic Dysfunction: No dose adjustment is typically required for solely hepatic impairment. However, caution is advisable. In patients with both renal and hepatic dysfunction, adjust the dose as per renal impairment.
- Patients with Comorbid Conditions: Exercise caution in patients with epilepsy, diabetes, cardiovascular disease, or other relevant conditions. Monitor closely and adjust treatment as needed.
Clinical Use Cases Dosage for clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be individualized according to the patient’s specific needs and condition. No specific dosage recommendation can be given without the proper clinical evaluation.
Dosage Adjustments
Dose modifications are necessary for patients with renal or hepatic impairment. Monitor renal and liver function, and adjust the dose based on creatinine clearance and liver function tests.
Side Effects
Common Side Effects
- Drowsiness
- Fatigue
- Headache
- Dry mouth
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Constipation
Rare but Serious Side Effects
- Allergic reactions (e.g., skin rash, itching, swelling, difficulty breathing)
- Severe drowsiness
- Irregular heartbeat
Long-Term Effects
No specific long-term adverse effects have been reported with Ambroxol + Cetirizine use. However, long-term use should be monitored, particularly in patients with pre-existing conditions.
Adverse Drug Reactions (ADR)
Clinically significant ADRs include severe allergic reactions, such as anaphylaxis, and severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis. These require immediate medical attention.
Contraindications
- Hypersensitivity to ambroxol, cetirizine, or any component of the formulation.
- Severe liver impairment
- Severe renal impairment (creatinine clearance <10 ml/min)
- Hypersensitivity to piperazine derivatives
- Patients with known allergy to piperazine derivatives, hereditary galactose intolerance, hereditary Lapp lactase deficiency, inherited glucose-galactose malabsorption disorder and severe renal dysfunction
Drug Interactions
- CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids)
- Antihistamines
- Aprepitant
- Midodrine
- Ritonavir
- Some antibiotics like amoxicillin
- Blood thinners (Warfarin)
- Tricyclic antidepressants
- Herbal/Ayurvedic supplements
The combination should be used cautiously with medications metabolized by CYP450 enzymes.
Pregnancy and Breastfeeding
Consult with a doctor before using during pregnancy. It is generally not recommended during breastfeeding as cetirizine can be excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Ambroxol: Mucolytic; Cetirizine: Antihistamine (H1 receptor antagonist).
- Side Effects: Drowsiness, fatigue, dry mouth, dizziness, nausea, vomiting, diarrhea, constipation.
- Contraindications: Hypersensitivity, severe liver/kidney disease.
- Drug Interactions: CNS depressants, antihistamines.
- Pregnancy & Breastfeeding: Consult a physician.
- Dosage: Adults: Ambroxol 30mg + Cetirizine 5 mg twice or thrice daily. Children: Dose adjusted by age.
- Monitoring Parameters: Respiratory function, liver and kidney function tests in patients with underlying disease.
Popular Combinations
Ambroxol and Cetirizine are sometimes combined with other drugs, such as Dextromethorphan and Guaifenesin. However, these combinations should be used cautiously.
Precautions
- Pre-existing medical conditions (asthma, liver or kidney disease, epilepsy)
- Pregnancy: Consult with physician.
- Breastfeeding: Not recommended.
- Children and Elderly: Adjust dose accordingly.
- Driving restrictions due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Cetirizine?
A: Adults: One tablet or 10ml syrup of Ambroxol 30mg + Cetirizine 5mg twice or thrice daily. Pediatric dosages vary by age and should be determined by a physician.
Q2: Can this medication be taken during pregnancy?
A: Consult your doctor before taking this medication during pregnancy. It is generally not recommended.
Q3: Can I breastfeed while taking this medication?
A: It is not advisable to breastfeed while taking this medication as Cetirizine is excreted in breast milk.
Q4: Can I drink alcohol while taking this medication?
A: No, avoid alcohol as it can increase drowsiness and other side effects.
Q5: Can I drive while on this medication?
A: This medication may cause drowsiness or dizziness. Avoid driving or operating heavy machinery until you know how it affects you.
Q6: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Don’t double the dose.
Q7: What are the serious side effects to watch out for?
A: Serious side effects include severe allergic reactions, difficulty breathing, swelling, severe drowsiness, and irregular heartbeat. Seek immediate medical attention if these occur.
Q8: Does Ambroxol + Cetirizine interact with other medications?
A: Yes, it can interact with CNS depressants, antihistamines, and certain antibiotics. Inform your doctor about all other medications you are taking.
Q9: Can children take this medication?
A: Yes, but the dosage needs to be adjusted according to the child’s age and weight. Consult a pediatrician.
Q10: How long should I take this medication?
A: Take this medication as prescribed by your doctor. Do not exceed the recommended duration of treatment.
