Usage
This combination drug is prescribed for various bacterial infections, including those of the respiratory tract (pneumonia, bronchitis), skin and soft tissues (cellulitis, boils), urinary tract, ear, nose, and throat, and dental infections. It is also used to manage infections caused by Staphylococcus and Streptococcus bacteria.
Pharmacological Classification: Antibiotic (Amoxycillin and Cloxacillin), Probiotic (Lactobacillus), Anti-inflammatory enzyme (Serratiopeptidase).
Mechanism of Action: Amoxycillin and Cloxacillin inhibit bacterial cell wall synthesis. Lactobacillus helps restore the gut flora, potentially preventing antibiotic-associated diarrhea. Serratiopeptidase reduces inflammation and swelling.
Alternate Names
Various brand names exist, depending on the manufacturer (e.g., Amoclas, Miksera LB, Molox-LBS, Admoxin CS). There isn’t a universally recognized international non-proprietary name for this specific combination.
How It Works
Pharmacodynamics: Amoxycillin and cloxacillin are beta-lactam antibiotics that disrupt bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This leads to cell wall weakening, bacterial lysis, and ultimately bacterial death. Cloxacillin is penicillinase-resistant, making it effective against penicillinase-producing bacteria like Staphylococcus aureus. Lactobacillus is a probiotic that helps restore the balance of beneficial gut bacteria often disrupted by antibiotic treatment. Serratiopeptidase, a proteolytic enzyme, breaks down proteins involved in inflammation, helping reduce swelling and pain.
Pharmacokinetics: Amoxycillin and Cloxacillin are well-absorbed orally. Serratiopeptidase is often enteric-coated to protect it from stomach acid. Lactobacillus acts locally in the gut. Amoxicillin and cloxacillin are primarily eliminated renally. Information on the pharmacokinetics of serratiopeptidase and lactobacillus in this combination is limited.
Mode of Action: Amoxicillin and Cloxacillin inhibit bacterial cell wall synthesis by binding to PBPs. Lactobacillus competes with harmful bacteria for nutrients and attachment sites within the gut. Serratiopeptidase breaks down inflammatory proteins. Specific receptor interactions and neurotransmitter modulation are not relevant for these components.
Elimination Pathways: Amoxycillin and cloxacillin are primarily excreted by the kidneys. Elimination pathways for Lactobacillus (excreted in feces) and Serratiopeptidase are not explicitly detailed in available literature within the context of this combination product.
Dosage
Dosage guidelines for this specific combination are limited and vary based on individual patient factors, the severity of the infection, and the specific product used. A physician should determine the precise dosage.
Standard Dosage
Adults:
A common regimen: 250-500mg of Amoxycillin and 250-500mg of Cloxacillin, combined with Lactobacillus (e.g., 60 million spores) and Serratiopeptidase (e.g. 10mg) every 6-8 hours. The formulation and specific dosage depend on the product and infection severity.
Children:
Pediatric dosing must be determined by a physician based on the child’s weight and age. Safety and efficacy in children younger than 12 years are not consistently established across all sources. Some sources suggest use in children older than 2 years under the guidance of a healthcare professional.
Special Cases:
- Elderly Patients: Dosage adjustment based on renal function is often required.
- Patients with Renal Impairment: Dose reduction is usually needed. Consult a nephrologist for specific recommendations.
- Patients with Hepatic Dysfunction: Caution is advised, and dose adjustment might be necessary. Consult a hepatologist for guidance.
- Patients with Comorbid Conditions: Careful evaluation is required to avoid potential drug interactions and adverse events.
Clinical Use Cases
Dosage recommendations for specific clinical situations like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations aren’t clearly defined for this particular combination.
Dosage Adjustments
Dosage modifications are based on renal and hepatic function, other medications, and the patient’s overall health status. Consideration of genetic polymorphisms impacting drug metabolism is necessary.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain/cramps, skin rash, flatulence, bloating, gas.
Rare but Serious Side Effects:
- Clostridium difficile-associated diarrhea (CDAD)
- Allergic reactions (ranging from mild rash to anaphylaxis, angioedema)
- Stevens-Johnson Syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
- Serum sickness
- Cholestatic jaundice
- Hepatitis
- Convulsions
- Hypersensitivity
Long-Term Effects:
Chronic complications from prolonged use aren’t clearly defined for this combination in the provided information. However, long-term use of broad-spectrum antibiotics can contribute to antibiotic resistance.
Adverse Drug Reactions (ADR):
Clinically significant ADRs needing immediate intervention include anaphylaxis, angioedema, C. difficile-associated diarrhea, and severe skin reactions (SJS/TEN).
Contraindications
- Known hypersensitivity to penicillins, cephalosporins, or any component of the formulation.
- History of cholestatic jaundice or hepatic dysfunction associated with amoxycillin/cloxacillin use.
Drug Interactions
- Warfarin and other anticoagulants: Increased bleeding risk
- Methotrexate: Increased methotrexate toxicity
- Probenecid and allopurinol: Altered antibiotic excretion
- Oral contraceptives: Reduced efficacy of contraceptives
- Tetracyclines: Reduced effectiveness of penicillin antibiotics
- Other antibiotics: Synergistic or antagonistic effects possible
- Alcohol: May increase side effects
Pregnancy and Breastfeeding
Amoxycillin and cloxacillin are generally considered safe during pregnancy, though information on lactobacillus and serratiopeptidase use during pregnancy is limited. These antibiotics are excreted in breast milk. Consult a physician before using this medication during pregnancy or breastfeeding.
Drug Profile Summary
- Mechanism of Action: Amoxycillin and Cloxacillin inhibit bacterial cell wall synthesis. Lactobacillus restores gut flora. Serratiopeptidase reduces inflammation.
- Side Effects: Nausea, vomiting, diarrhea, abdominal pain, skin rash, allergic reactions, C. difficile infection, SJS/TEN.
- Contraindications: Penicillin/cephalosporin allergy, history of cholestatic jaundice/hepatic dysfunction associated with penicillin use.
- Drug Interactions: Other antibiotics, anticoagulants, oral contraceptives, methotrexate, probenecid, allopurinol.
- Pregnancy & Breastfeeding: Limited safety data for the combination; consult a physician.
- Dosage: Varies; physician-determined.
- Monitoring Parameters: Renal and hepatic function, signs of allergic reactions, superinfections.
Popular Combinations
This combination is not typically considered a standard or “popular” combination in clinical practice.
Precautions
- General Precautions: Assess for allergies to penicillins or cephalosporins, renal or hepatic dysfunction.
- Specific Populations: Consult a physician for pregnant or breastfeeding women. Pediatric and elderly patients require careful dosing.
- Lifestyle Considerations: Avoid alcohol during treatment. Caution advised while driving or operating machinery due to possible dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Amoxycillin + Cloxacillin + Lactobacillus + Serratiopeptidase?
A: There’s no standardized dosage for this combination. It’s determined by the physician considering the patient’s age, weight, renal and hepatic function, infection severity, and the specific product used.
Q2: What infections are typically treated with this combination?
A: This combination is often used for bacterial infections of the respiratory tract (like pneumonia and bronchitis), skin and soft tissues (like cellulitis and boils), urinary tract, ear, nose and throat, dental infections and those caused by Staphylococcus and Streptococcus bacteria. It also contains a probiotic to help prevent antibiotic-associated diarrhea.
Q3: Is this combination safe during pregnancy?
A: Amoxicillin and cloxacillin are generally considered safe during pregnancy. However, the safety of the combination including lactobacillus and serratiopeptidase during pregnancy has not been definitively established. Consult with a physician to evaluate the benefit-risk ratio before use during pregnancy.
Q4: Are there any major drug interactions I should be aware of?
A: Yes, this combination can interact with several medications, including anticoagulants (like warfarin), methotrexate, probenecid, allopurinol, oral contraceptives, and other antibiotics. It’s crucial to inform your doctor about all other medications you are taking.
Q5: What are the most common side effects?
A: The most common side effects include nausea, vomiting, diarrhea, abdominal pain, and skin rash. More severe side effects, though less frequent, can include allergic reactions (including anaphylaxis), Clostridium difficile infection, and Stevens-Johnson Syndrome.
Q6: Can I take this medication with alcohol?
A: It is generally recommended to avoid alcohol while taking this medication, as it can increase the risk of side effects or reduce the effectiveness of the medication.
Q7: Is this a fixed-dose combination approved by regulatory bodies?
A: While individual components are approved, the specific fixed-dose combination of amoxicillin, cloxacillin, lactobacillus, and serratiopeptidase is not universally approved by all regulatory authorities. Its availability and regulatory status can vary by region.
Q8: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Q9: How should this medication be stored?
A: Store this medication as directed on the product packaging. Typically, it should be stored at room temperature, away from moisture, heat, and direct sunlight. Keep it out of reach of children.