Usage
Amoxycillin + Clavulanic Acid + Lactobacillus is prescribed for the treatment of various bacterial infections, including those of the respiratory tract (e.g., pneumonia, bronchitis, sinusitis), genitourinary tract (e.g., urinary tract infections), skin and soft tissues, bones and joints, and dental infections. It can also be used to treat infectious diarrhea. This combination does not treat viral infections like the common cold or flu.
Pharmacological Classification: Antibiotic and Probiotic Combination
Mechanism of Action: Amoxycillin inhibits bacterial cell wall synthesis, leading to bacterial death. Clavulanic acid is a beta-lactamase inhibitor that protects amoxycillin from degradation by bacterial enzymes, extending its spectrum of activity. Lactobacillus, a probiotic, helps restore the balance of beneficial gut bacteria that may be disrupted by antibiotic use, reducing the risk of antibiotic-associated diarrhea.
Alternate Names
This combination is often referred to by brand names that vary by region and manufacturer. Some examples of brand names include:
- AUTOBACT LB
- Clavamoxy 625 LB
- OBENCLAV LB
- Reoclav LB 625
- SIBOCLAV-625 LB
How It Works
Pharmacodynamics: Amoxycillin exerts its bactericidal effect by binding to penicillin-binding proteins (PBPs) in the bacterial cell wall, inhibiting the final transpeptidation step of peptidoglycan synthesis. This leads to cell wall instability and bacterial lysis. Clavulanic acid, a beta-lactamase inhibitor, irreversibly binds to and inactivates beta-lactamase enzymes produced by some bacteria. These enzymes would otherwise break down amoxycillin, rendering it ineffective. Lactobacillus, a probiotic, helps restore the gut microbiome by replenishing beneficial bacteria that may be killed off by the antibiotic.
Pharmacokinetics: Amoxycillin is well-absorbed orally and distributes widely throughout the body. Clavulanic acid also has good oral bioavailability. Both drugs are primarily eliminated through renal excretion. Lactobacillus colonizes the gastrointestinal tract. Food, particularly dairy products, can interfere with amoxicillin absorption, so it’s generally recommended to take it on an empty stomach.
Elimination Pathways: Primarily renal excretion for both amoxicillin and clavulanic acid.
Dosage
Standard Dosage
Adults:
- Typical dose: 500 mg amoxycillin/125 mg clavulanic acid every 8 hours, or 875 mg amoxycillin/125 mg clavulanic acid every 12 hours. Lactobacillus is often included at 60 million spores per dose.
- Dosage and frequency can be adjusted based on the severity of infection.
Children:
- Infants < 3 months: 30 mg amoxycillin/kg/day divided every 12 hours (using the 125 mg/5 mL oral suspension only).
- Infants ≥ 3 months and Children < 40 kg: 25-45 mg amoxycillin/kg/day divided every 8-12 hours, with appropriate clavulanic acid dose based on chosen formulation.
- Children ≥ 40 kg: Adult dosing can be followed. Do not use the 250mg amoxycillin/125 mg clavulanic acid tablet in children <40 kg due to a different ratio of the two drugs. A formulation with a lower dose of clavulanic acid should be used.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary depending on renal function.
- Patients with Renal Impairment: Dose adjustments are required based on glomerular filtration rate (GFR). Consult specialized resources for specific recommendations based on GFR ranges.
- Patients with Hepatic Dysfunction: Use with caution; dose adjustment may be needed.
- Patients with Comorbid Conditions: Consider interactions and contraindications related to co-existing medical conditions.
Clinical Use Cases
Dosing in these settings would typically follow standard recommendations, potentially adjusted for severity and patient-specific factors:
- Intubation: Standard dosage or adjusted based on infection severity.
- Surgical Procedures: Prophylactic use may be indicated, but dosing will vary depending on the procedure and risk of infection.
- Mechanical Ventilation: Standard dosage or adjusted based on infection severity.
- Intensive Care Unit (ICU) Use: Standard dosage or adjusted based on infection severity and patient-specific factors.
- Emergency Situations: Standard dosage or adjusted based on the situation.
Dosage Adjustments
Always adjust dosage for renal or hepatic dysfunction. Consult resources for specific dose modifications for patients with renal impairment.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Bloating
- Gas
- Skin rash
Rare but Serious Side Effects:
- Clostridium difficile-associated diarrhea (CDAD)
- Severe allergic reactions (anaphylaxis, angioedema)
- Stevens-Johnson Syndrome
- Liver dysfunction (cholestatic jaundice)
- Seizures
Long-Term Effects:
Long-term use can lead to antibiotic resistance and disruption of the gut microbiome.
Adverse Drug Reactions (ADR):
Any serious adverse reaction such as anaphylaxis, angioedema, Stevens-Johnson Syndrome, or severe CDAD requires immediate medical attention.
Contraindications
- Hypersensitivity to penicillins, cephalosporins, or any component of the formulation
- History of cholestatic jaundice or hepatic dysfunction associated with amoxycillin/clavulanate use.
Drug Interactions
- Allopurinol: Increased risk of skin rash.
- Anticoagulants (e.g., warfarin): May enhance anticoagulant effect.
- Oral contraceptives: May reduce efficacy of oral contraceptives.
- Methotrexate: Amoxycillin may increase methotrexate levels.
- Mycophenolate mofetil: Amoxycillin may decrease mycophenolate levels.
- Probenecid: Can increase amoxicillin levels.
It is essential to separate the administration of probiotics and antibiotics by at least 2 hours. Although this combination includes lactobacillus, concurrent use of additional probiotic supplements may still be permissible.
Pregnancy and Breastfeeding
This medication is generally considered safe during pregnancy and breastfeeding, but it is crucial to consult a physician to assess the risks and benefits for individual cases. Amoxycillin and clavulanic acid are present in breastmilk.
Drug Profile Summary
- Mechanism of Action: Amoxicillin inhibits cell wall synthesis; clavulanic acid protects amoxicillin; lactobacillus restores gut flora.
- Side Effects: Nausea, vomiting, diarrhea, rash. Serious side effects: CDAD, allergic reactions, liver dysfunction, seizures.
- Contraindications: Hypersensitivity, history of cholestatic jaundice/hepatic dysfunction with this combination.
- Drug Interactions: Allopurinol, anticoagulants, oral contraceptives, methotrexate, mycophenolate mofetil, probenecid.
- Pregnancy & Breastfeeding: Generally safe, but consult a physician.
- Dosage: See detailed dosage guidelines above.
- Monitoring Parameters: Observe for signs of infection resolution, adverse reactions, and signs of liver or kidney dysfunction with prolonged use.
Popular Combinations
This medication itself is a popular combination. It’s not typically combined with other drugs for synergistic effects, though other medications may be prescribed separately to address specific symptoms or co-existing medical conditions.
Precautions
- General Precautions: Assess for allergies, renal/hepatic function, and history of gastrointestinal disease.
- Specific Populations: Consult a physician for use in pregnant or breastfeeding women, children, and the elderly.
- Lifestyle Considerations: Avoid alcohol while taking this medication. Use caution when driving or operating machinery as it can cause dizziness in some patients.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Amoxycillin + Clavulanic Acid + Lactobacillus?
A: See detailed dosage guidelines above.
Q2: Can this combination be used to treat viral infections?
A: No, it is ineffective against viral infections.
Q3: What should I do if a patient develops diarrhea while taking this medication?
A: Evaluate for C. difficile infection. Mild diarrhea may be self-limiting, but severe or persistent diarrhea should be promptly investigated.
Q4: Are there any specific dietary recommendations while taking this medicine?
A: This medicine can be taken with or without food. However, as amoxicillin absorption can be affected by dairy, consider taking it on an empty stomach.
Q5: Can a patient drink alcohol while taking this medication?
A: It’s generally advised to avoid alcohol while on antibiotics, including this combination, as it may increase the risk of side effects or reduce the medicine’s effectiveness.
Q6: What should I do if a patient misses a dose?
A: Take the missed dose as soon as possible unless it is almost time for the next dose. Do not double the next dose.
Q7: Is it safe to use this combination in patients with penicillin allergy?
A: No. It is contraindicated in patients with a penicillin allergy.
Q8: What are the signs of a serious allergic reaction to this medication?
A: Signs can include hives, difficulty breathing, swelling of the face, throat, or tongue, and a rapid heartbeat. Seek immediate medical attention if these occur.
Q9: Can this combination be used in patients with kidney disease?
A: It can be used, but with careful dose adjustments based on renal function. Consult specific guidelines and resources.
Q10: What are the long-term effects of this medication?
A: The primary long-term concern is the development of antibiotic resistance and potential alteration of the gut microbiome.
