Usage
- Ambroxol + Levofloxacin is primarily prescribed for the treatment of respiratory tract infections, especially those characterized by thick or excessive mucus production, such as acute and chronic bronchitis, pneumonia, and acute bacterial exacerbations of chronic bronchitis. It is also used in some cases for other bacterial infections like urinary tract infections, skin and soft tissue infections, and certain sexually transmitted diseases.
- Pharmacological Classification: Mucolytic/Expectorant (Ambroxol) and Fluoroquinolone Antibiotic (Levofloxacin) combination.
Alternate Names
- Levofloxacin and Ambroxol
- Levofloxacin/Ambroxol
- Brand Names: L-Cin A, Levofloxacin AX, Livbest AM, Mucosyn, Voxquin AM, Zilee AX, Lebact Am
How It Works
- Pharmacodynamics: Ambroxol works by breaking down mucin, a key component of mucus, thus reducing its viscosity and making it easier to expectorate. Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and repair, thus preventing bacterial growth and spread. The combination enhances the antibacterial effect of Levofloxacin.
- Pharmacokinetics: Both drugs are absorbed orally. Ambroxol is metabolized in the liver and excreted in urine. Levofloxacin is primarily excreted renally.
- Mode of Action: Levofloxacin’s mechanism involves the inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV, which are essential for bacterial DNA replication and repair. This prevents bacterial cell division and leads to cell death. Ambroxol works by reducing the viscosity of secretions by breaking down certain elements of mucus, making the mucus more liquid, and thus facilitating the ability to cough up mucus.
Dosage
Standard Dosage
Adults:
- Levofloxacin 250mg/500mg + Ambroxol 75mg once or twice daily. The dose and duration of therapy depend on the severity and type of infection.
Children:
- This combination is generally not recommended for children. Use in adolescents should be carefully considered and dosage adjusted based on weight.
Special Cases:
- Elderly Patients: Dose adjustment may be needed based on renal function.
- Patients with Renal Impairment: Dose reduction is necessary based on creatinine clearance.
- Patients with Hepatic Dysfunction: Caution advised, dose adjustment may be required on a case by case basis.
- Patients with Comorbid Conditions: Patients with epilepsy, myasthenia gravis, or a history of QT prolongation require careful monitoring. Gastric ulcer patients should also be monitored closely. Caution advised in patients with muscle disorders.
Clinical Use Cases
Dosage for specific clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined by the treating physician based on individual patient needs and should consider the standard dosing guidelines and adjustments for special populations. This medication is not typically used in emergency situations like status epilepticus or cardiac arrest.
Dosage Adjustments
- Dose adjustments are based on creatinine clearance for renal impairment. For hepatic dysfunction, dose adjustments should be made cautiously.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea, headache, dizziness, insomnia, allergic reactions.
Rare but Serious Side Effects:
- Acute renal failure, arrhythmia, tendonitis, tendon rupture (especially Achilles tendon), peripheral neuropathy, seizures, QT interval prolongation, Clostridium difficile-associated diarrhea, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Long-Term Effects:
- Peripheral neuropathy and tendon damage can persist even after stopping the medication.
Adverse Drug Reactions (ADR):
- Anaphylaxis, angioedema, hepatotoxicity, hematological disorders (thrombocytopenia, leukopenia), psychiatric disturbances.
Contraindications
- Hypersensitivity to Levofloxacin, Ambroxol, or other quinolones.
- History of tendon disorders related to quinolone use.
- Myasthenia gravis.
- Epilepsy.
- Pregnancy and breastfeeding.
Drug Interactions
- Antacids, multivitamins containing cations (calcium, magnesium, aluminum, iron, zinc).
- Warfarin and other anticoagulants.
- Theophylline.
- Nonsteroidal anti-inflammatory drugs (NSAIDs).
- Drugs that prolong QT interval (e.g., amiodarone, sotalol).
- Insulin or other antidiabetic medications.
- Dairy products.
- Other antibiotics such as tetracyclines, mucolytics like carbocisteine.
Pregnancy and Breastfeeding
This combination is generally contraindicated during pregnancy and breastfeeding due to potential risks to the fetus or infant. Ambroxol is present in breast milk.
Drug Profile Summary
- Mechanism of Action: Ambroxol reduces mucus viscosity; Levofloxacin inhibits bacterial DNA synthesis.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness; rarely: tendon rupture, peripheral neuropathy, seizures.
- Contraindications: Hypersensitivity, tendon disorders with quinolones, myasthenia gravis, epilepsy, pregnancy, breastfeeding.
- Drug Interactions: Antacids, anticoagulants, theophylline, NSAIDs, QT prolonging drugs.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adult: Levofloxacin 250mg/500mg + Ambroxol 75mg once/twice daily; adjust for renal impairment.
- Monitoring Parameters: Renal function, liver function tests, ECG (for QT interval), signs of tendonitis.
Popular Combinations
This combination itself is a popular combination for respiratory tract infections with thick mucus.
Precautions
- General Precautions: Pre-screening for allergies, metabolic disorders, organ dysfunction, and concurrent medications.
- Specific Populations: Evaluate risks and benefits in pregnant women (contraindicated), breastfeeding mothers (contraindicated), children (generally avoided), elderly patients (dose adjustments based on renal function).
- Lifestyle Considerations: Avoid alcohol as it can cause excessive drowsiness. Driving restrictions may be needed due to potential dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Levofloxacin?
A: The standard adult dosage is Levofloxacin 250mg/500mg + Ambroxol 75mg once or twice daily. Dose adjustments may be necessary for patients with renal or hepatic impairment. This combination is typically not recommended for children.
Q2: What is the primary use of Ambroxol + Levofloxacin?
A: This drug combination is primarily used to treat respiratory tract infections, particularly those associated with thick mucus production.
Q3: How does Ambroxol contribute to the efficacy of this combination?
A: Ambroxol acts as a mucolytic, thinning and loosening the mucus, making it easier to cough up and clear the airways, and enhancing the penetration of Levofloxacin.
Q4: What are the most common side effects patients might experience?
A: Common side effects include nausea, vomiting, diarrhea, headache, dizziness, and insomnia.
Q5: Are there any serious side effects I should be aware of?
A: While rare, serious side effects such as tendon rupture, peripheral neuropathy, seizures, and QT interval prolongation can occur. Patients should be monitored for these.
Q6: What are the contraindications for using this medication?
A: This medication is contraindicated in patients with hypersensitivity to either component, a history of tendon disorders related to quinolone use, myasthenia gravis, epilepsy, and during pregnancy and breastfeeding.
Q7: What are the key drug interactions to consider?
A: Important drug interactions include those with antacids, anticoagulants, theophylline, NSAIDs, and drugs that prolong the QT interval. Concurrent use of dairy products should also be avoided.
Q8: What precautions should be taken in elderly patients?
A: Dosage adjustments may be needed in elderly patients based on their renal function.
Q9: Can this combination be used in patients with liver disease?
A: Caution is advised in patients with hepatic dysfunction, and dose adjustments may be required on a case-by-case basis.
Q10: How should this medication be taken?
A: The tablets should be swallowed whole with a glass of water, with or without food, preferably at a fixed time each day. Do not chew, crush, or break the tablets.
