Usage
Ambroxol + Cefixime + Lactobacillus is prescribed for bacterial respiratory tract infections, especially those with thick mucus production like bronchitis, pneumonia, and acute bacterial exacerbations of chronic bronchitis. It is also used for other bacterial infections like otitis media, pharyngitis, tonsillitis, and urinary tract infections where Cefixime is indicated. The addition of Lactobacillus aims to prevent antibiotic-associated diarrhea.
Pharmacological Classification:
- Ambroxol: Mucolytic, expectorant
- Cefixime: Third-generation cephalosporin antibiotic
- Lactobacillus: Probiotic
Mechanism of Action:
This combination drug works through the synergistic actions of its components. Ambroxol reduces mucus viscosity by breaking down mucopolysaccharides. Cefixime inhibits bacterial cell wall synthesis, leading to bacterial cell death. Lactobacillus replenishes the gut’s normal flora, which can be disrupted by antibiotic use.
Alternate Names
This combination doesn’t have a universally recognized international non-proprietary name. It’s identified by its components. Brand names include: Bactilem AX, Ceftas AL, Cembol, Wanixim AZ, and Xceft AX.
How It Works
Pharmacodynamics: Ambroxol decreases mucus viscosity, facilitating expectoration. Cefixime is bactericidal, inhibiting bacterial cell wall synthesis by binding to penicillin-binding proteins. Lactobacillus helps restore the gut flora.
Pharmacokinetics:
- Ambroxol: Well-absorbed orally, metabolized in the liver, excreted primarily in the urine.
- Cefixime: Orally absorbed (food reduces absorption rate), excreted primarily by the kidneys.
- Lactobacillus: Not systemically absorbed, exerts its effect within the gastrointestinal tract.
Mode of Action: Cefixime inhibits bacterial cell wall synthesis, while Ambroxol acts as a mucolytic and mucokinetic agent. Lactobacillus helps restore the balance of intestinal flora.
Elimination Pathways: Ambroxol and Cefixime are primarily eliminated renally.
Dosage
Standard Dosage
Adults:
One tablet/capsule twice daily. The specific strengths of each ingredient and treatment duration depend on the infection’s severity and type, determined by the physician. The maximum Cefixime dose is generally 400 mg daily.
Children:
Dosage is weight-based. The usual pediatric dose of Cefixime is 8 mg/kg orally once daily or 4 mg/kg every 12 hours, with adjustments based on weight. For children above 45 kg, the adult dose might be appropriate. Specific recommendations for Ambroxol in children vary by age: 2 to <6 years: 7.5-15 mg 3 times daily; 6-12 years: 15-30 mg 2-3 times daily; >12 years: adult dose. Safety and efficacy in children under 6 months for Cefixime and under 2 years for Ambroxol have not been fully established.
Special Cases:
- Elderly Patients: Dosage adjustment might be necessary based on renal function.
- Patients with Renal Impairment: Cefixime dosage must be adjusted based on creatinine clearance.
- Patients with Hepatic Dysfunction: Caution is advised; dosage adjustments may be needed.
- Patients with Comorbid Conditions: Dosage adjustments may be necessary.
Clinical Use Cases
Dosage in clinical settings (intubation, surgery, mechanical ventilation, ICU, emergencies) is determined by the physician, considering patient-specific factors and potential drug interactions.
Dosage Adjustments
Dose modification is based on renal/hepatic function, metabolic disorders, drug interactions, and genetic polymorphisms.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain, indigestion, flatulence, headache, dizziness.
Rare but Serious Side Effects:
Severe allergic reactions (anaphylaxis, angioedema), Clostridium difficile infection, Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatotoxicity, seizures (Cefixime), blood dyscrasias.
Long-Term Effects:
Altered gut microbiota with prolonged antibiotic use.
Adverse Drug Reactions (ADR):
Severe allergic reactions, C. difficile infection, hepatotoxicity, blood dyscrasias.
Contraindications
Hypersensitivity to any component (including cephalosporins), severe renal impairment.
Drug Interactions
Anticoagulants (e.g., warfarin, increased bleeding risk), probenecid (increased Cefixime levels), antacids (reduced Cefixime absorption), other antibiotics (especially affecting respiratory or gastrointestinal systems), alcohol.
Pregnancy and Breastfeeding
Cefixime is generally considered safe during pregnancy. Ambroxol should be avoided, especially during the first trimester. Consult a physician. Small amounts of both drugs may be present in breast milk. Consult a physician.
Drug Profile Summary
- Mechanism of Action: Ambroxol: Mucolytic; Cefixime: Antibiotic; Lactobacillus: Probiotic.
- Side Effects: Nausea, vomiting, diarrhea, allergic reactions.
- Contraindications: Hypersensitivity, severe renal impairment.
- Drug Interactions: Anticoagulants, probenecid, antacids, antibiotics.
- Pregnancy & Breastfeeding: Generally safe, but consult a physician.
- Dosage: Determined by the physician, adjusted for age, weight, and renal function.
- Monitoring Parameters: Renal function, allergic reactions, gastrointestinal status.
Popular Combinations
This combination is itself a commonly used one.
Precautions
- General Precautions: Assess for allergies, renal/hepatic function.
- Specific Populations: Consult regarding pregnancy/breastfeeding, adjust the dose for children/elderly.
- Lifestyle Considerations: Avoid alcohol, caution while operating machinery if dizziness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Cefixime + Lactobacillus?
A: Dosage is determined by the physician, considering the infection’s severity, patient age, weight, and renal function.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, and abdominal pain are common.
Q3: Is this combination safe in pregnancy?
A: Cefixime is generally considered safe; Ambroxol should be avoided, especially in the first trimester. Consult a physician.
Q4: What are the contraindications?
A: Hypersensitivity to any component, severe renal impairment.
Q5: Are there any drug interactions?
A: Yes, with anticoagulants, probenecid, and antacids. It can also interact with other antibiotics, especially those affecting respiratory or gastrointestinal systems.
Q6: Can this combination be used in children?
A: Yes, but the dosage needs to be adjusted based on the child’s weight and age. Safety and efficacy have not been established for Cefixime in children under 6 months or for Ambroxol in children under 2 years old.
Q7: What should patients do if they miss a dose?
A: Take the missed dose as soon as remembered unless it’s close to the next dose. Do not double the dose.
Q8: What are the long-term effects of this medication?
A: Long-term antibiotic use can alter gut microbiota, potentially causing recurrent infections or other gastrointestinal problems.
Q9: What should I do if a patient experiences an allergic reaction?
A: Discontinue the medication immediately and provide appropriate medical care for the allergic reaction, which may include antihistamines, corticosteroids, or epinephrine.
