Usage
- Medical Conditions: This combination medication is prescribed for bacterial infections, especially those involving penicillinase-producing organisms like Staphylococcus aureus. Common infections treated include respiratory tract infections (pneumonia, bronchitis, sinusitis), skin and soft tissue infections (cellulitis, abscesses), urinary tract infections (cystitis), ear, nose, and throat infections (otitis media, tonsillitis), dental infections, and bone and joint infections (osteomyelitis).
- Pharmacological Classification: Antibiotic and anti-inflammatory.
- Mechanism of Action: Amoxycillin and Dicloxacillin are beta-lactam antibiotics that inhibit bacterial cell wall synthesis. Dicloxacillin is penicillinase-resistant. Serratiopeptidase is a proteolytic enzyme that reduces inflammation by breaking down proteins involved in the inflammatory process.
Alternate Names
- May be marketed under various brand names or with the addition of Lactobacillus (e.g., Inloxy SLB, Gaiclox-SP). There are also alternative combinations available by substituting Cloxacillin for Dicloxacillin
How It Works
- Pharmacodynamics: Amoxycillin and Dicloxacillin have bactericidal effects by disrupting bacterial cell wall synthesis, leading to bacterial cell lysis and death. Serratiopeptidase reduces inflammation, pain, and swelling by breaking down proteins involved in the inflammatory response.
- Pharmacokinetics:
- Absorption: Amoxycillin and Dicloxacillin are absorbed orally, but food may affect Dicloxacillin absorption. Serratiopeptidase has limited oral bioavailability.
- Metabolism: Amoxycillin is primarily excreted unchanged in urine. Dicloxacillin undergoes hepatic metabolism. Serratiopeptidase is metabolized in the liver.
- Elimination: Primarily renal excretion for Amoxycillin and Dicloxacillin.
- Mode of Action: Amoxycillin and Dicloxacillin bind to penicillin-binding proteins (PBPs) in bacteria, inhibiting cell wall synthesis. Serratiopeptidase cleaves peptide bonds in inflammatory proteins.
Dosage
Standard Dosage
Adults:
- 250-500 mg of Amoxycillin and 250-500 mg of Dicloxacillin, along with 10-15 mg of Serratiopeptidase, every 6-8 hours.
- Maximum daily dose: Not to exceed 4 grams of Amoxycillin and 4 grams of Dicloxacillin.
Children:
- Pediatric dosing is weight-based and varies depending on infection severity. Serratiopeptidase use in children is generally not recommended. Consult a pediatrician or pediatric infectious disease specialist.
Special Cases:
- Elderly Patients: Dosage adjustments may be needed based on renal function.
- Patients with Renal Impairment: Dose reduction is necessary based on creatinine clearance (CrCl).
- Patients with Hepatic Dysfunction: Use with caution, dosage adjustments may be necessary.
- Patients with Comorbid Conditions: Consider individual patient factors and adjust accordingly.
Clinical Use Cases
Dosage in specialized clinical settings (intubation, surgical procedures, mechanical ventilation, ICU, emergency situations) should be individualized based on infection severity, patient factors, and current clinical guidelines. Consult an infectious disease specialist.
Dosage Adjustments
Dosage modifications are based on renal/hepatic function, other medical conditions, concomitant medications, and individual patient response. Therapeutic drug monitoring might be helpful in some cases.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain/discomfort, indigestion, skin rash, heartburn, bloating, gas, mouth ulcers, red or swollen gums.
Rare but Serious Side Effects:
Allergic reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome), Clostridium difficile-associated diarrhea, liver dysfunction, blood disorders (leukopenia, thrombocytopenia), seizures (rare).
Long-Term Effects:
Antibiotic resistance, superinfections (e.g., fungal infections), vitamin K deficiency.
Adverse Drug Reactions (ADR):
Any sign of hypersensitivity, severe diarrhea, hepatotoxicity, or blood dyscrasias require immediate discontinuation and medical intervention.
Contraindications
- Hypersensitivity to penicillins, cephalosporins, or any component of the medication.
- History of cholestatic jaundice or hepatic dysfunction associated with penicillin use.
Drug Interactions
- Other antibiotics (tetracyclines, macrolides, aminoglycosides): Potential synergistic or antagonistic effects.
- Anticoagulants (warfarin): Increased bleeding risk.
- Methotrexate: Increased methotrexate levels.
- Probenecid: Increased penicillin levels.
- Oral contraceptives: Reduced efficacy.
- Live vaccines: Reduced vaccine effectiveness, some vaccines contraindicated.
- Uricosuric agents (probenecid, allopurinol): Potential interactions.
- Cytotoxic agents (methotrexate, leflunomide): Potential interactions.
Pregnancy and Breastfeeding
Safety not fully established. Use only if clearly needed and under close medical supervision. Amoxycillin is generally considered safe during pregnancy, but Dicloxacillin and Serratiopeptidase should be used cautiously. Consult an obstetrician and pediatrician.
Drug Profile Summary
- Mechanism of Action: Beta-lactam antibiotics inhibit bacterial cell wall synthesis; Serratiopeptidase reduces inflammation.
- Side Effects: Nausea, vomiting, diarrhea, allergic reactions.
- Contraindications: Hypersensitivity to penicillins or cephalosporins.
- Drug Interactions: Anticoagulants, methotrexate, probenecid, oral contraceptives, other antibiotics.
- Pregnancy & Breastfeeding: Use with caution if clearly needed.
- Dosage: See detailed dosage section.
- Monitoring Parameters: Renal function, liver function, complete blood count (CBC) in prolonged therapy, signs of superinfection.
Popular Combinations
Amoxycillin and Dicloxacillin are often combined for broader spectrum activity. Serratiopeptidase is added for anti-inflammatory effects. Probiotics (Lactobacillus) may be added to mitigate antibiotic-associated diarrhea.
Precautions
- General Precautions: Assess allergies, renal/hepatic function, and drug interactions before initiating therapy. Culture and sensitivity testing is recommended.
- Specific Populations: Use with caution in pregnancy, breastfeeding, patients with renal/hepatic impairment, and elderly patients. Monitor closely.
- Lifestyle Considerations: Alcohol may exacerbate side effects. Driving or operating machinery should be avoided if dizziness or drowsiness occur.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Amoxycillin + Dicloxacillin + Serratiopeptidase?
A: See detailed dosage guidelines above. Dosage should be individualized based on the patient’s age, weight, renal function, and the severity of the infection.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, abdominal discomfort, and skin rash.
Q3: Are there any serious side effects?
A: Yes, although rare, serious side effects can include allergic reactions (anaphylaxis, angioedema), Clostridium difficile infection, and liver dysfunction.
Q4: Can this combination be used in pregnant or breastfeeding women?
A: The safety during pregnancy and breastfeeding isn’t fully established. Use only if clearly needed and under close medical supervision after consulting with an obstetrician and pediatrician.
Q5: What are the contraindications to this medication?
A: Contraindications include hypersensitivity to penicillins, cephalosporins, or any component of the medication, and a history of cholestatic jaundice or hepatic dysfunction related to penicillin use.
Q6: Does this combination interact with other medications?
A: Yes, it can interact with other antibiotics, anticoagulants (warfarin), methotrexate, probenecid, oral contraceptives, and live vaccines. Always check for potential drug interactions before prescribing.
Q7: What should be monitored during therapy?
A: Renal function, liver function, and complete blood count (CBC) should be monitored, especially during prolonged therapy. Watch for signs of superinfection.
Q8: What is the role of Serratiopeptidase in this combination?
A: Serratiopeptidase reduces inflammation, pain, and swelling associated with infection.
Q9: Why are Amoxycillin and Dicloxacillin combined?
A: Combining these two antibiotics broadens the spectrum of activity, especially against penicillinase-producing bacteria like Staphylococcus aureus.
Q10: Can this medication be taken with food?
A: Amoxycillin can be taken with or without food. While Dicloxacillin can also be taken with or without food, its absorption might be affected by food. It is better to take it at a fixed time for optimal effectiveness.
