Usage
Amoxycillin + Potassium Clavulanate is prescribed for a variety of bacterial infections, including:
- Upper Respiratory Tract Infections: Sinusitis, tonsillitis, pharyngitis, otitis media.
- Lower Respiratory Tract Infections: Pneumonia, bronchitis, acute exacerbations of chronic bronchitis.
- Genitourinary Tract Infections: Cystitis, pyelonephritis, gonorrhea.
- Skin and Soft Tissue Infections: Cellulitis, impetigo, abscesses, animal bites.
- Bone and Joint Infections: Osteomyelitis, septic arthritis.
- Other Infections: Dental infections, intra-abdominal infections, sepsis.
Pharmacological Classification: Antibiotic (beta-lactam, penicillin combination).
Mechanism of Action: Amoxycillin is a bactericidal antibiotic that inhibits bacterial cell wall synthesis. Potassium clavulanate is a beta-lactamase inhibitor that protects amoxycillin from degradation by bacterial enzymes, extending its spectrum of activity against bacteria that produce beta-lactamases.
Alternate Names
- International Nonproprietary Name (INN): Amoxicillin/clavulanic acid (or amoxicillin/clavulanate potassium)
- Brand Names: Augmentin, Co-amoxiclav, Clavace
How It Works
Pharmacodynamics: Amoxycillin + Potassium Clavulanate exerts a synergistic bactericidal effect by disrupting bacterial cell wall synthesis. Amoxycillin binds to penicillin-binding proteins (PBPs) in the bacterial cell wall, inhibiting peptidoglycan cross-linking and leading to cell lysis. Potassium clavulanate inhibits beta-lactamase enzymes produced by certain bacteria, preventing amoxycillin degradation and extending its effectiveness.
Pharmacokinetics:
- Absorption: Both components are well-absorbed orally. Food may slightly delay absorption, but overall bioavailability remains good.
- Distribution: Widely distributed throughout the body, including tissues and fluids.
- Metabolism: Amoxycillin undergoes minimal metabolism. Clavulanate is extensively metabolized in the liver.
- Elimination: Primarily excreted renally, with a small amount eliminated in the bile.
Dosage
Standard Dosage
Adults:
- Mild to Moderate Infections: 250 mg/125 mg every 8 hours or 500 mg/125 mg every 12 hours.
- Severe Infections: 500 mg/125 mg every 8 hours or 875 mg/125 mg every 12 hours. Extended release tablets 1000 mg/62.5 mg every 12 hours.
Children:
- Children <40 kg, >3 months: Dosing is weight-based and should be determined by a physician, usually 20-60 mg/5-15 mg/kg/day divided every 8 or 12 hours.
- Neonates and Infants (<3 months): 30 mg/kg/day divided every 12 hours (based on the amoxycillin component). Use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended in this age group.
- Children ≥ 40kg: Adult dosage.
- Specific scenarios: Always follow the appropriate guidelines based on the specific condition.
Special Cases:
- Elderly Patients: Dose adjustment may be necessary in patients with renal impairment.
- Patients with Renal Impairment: Dose reduction and/or increased dosing interval may be necessary based on creatinine clearance. Consult specific guidelines for precise adjustments based on GFR levels.
- Patients with Hepatic Dysfunction: Caution is advised. Dosage adjustment may be required in severe cases.
- Patients with Comorbid Conditions: No specific dosage adjustments provided based on diabetes or cardiovascular conditions, however, consult individual conditions.
Clinical Use Cases
Dosages in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are determined on a case-by-case basis by the treating physician, factoring in the type and severity of infection, patient-specific factors, and local guidelines.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Rash
- Vaginal Itching or Discharge
- Diaper Rash (in Infants)
Rare but Serious Side Effects:
- Clostridium difficile-associated diarrhea
- Hepatotoxicity (jaundice, liver dysfunction)
- Stevens-Johnson Syndrome
- Toxic Epidermal Necrolysis
- Anaphylaxis
- Angioedema
Long-Term Effects:
Antibiotic-associated colitis can develop after prolonged use.
Contraindications
- History of severe hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) to amoxycillin, clavulanate, or other beta-lactam antibiotics.
- Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxycillin/clavulanate.
- Severe Renal Dysfunction.
Drug Interactions
- Probenecid: Increases amoxycillin levels.
- Allopurinol: May increase risk of skin rash.
- Oral Anticoagulants (e.g., warfarin): May enhance anticoagulant effect.
- Methotrexate: Increases methotrexate levels and risk of toxicity.
- Oral Contraceptives: Efficacy of oral contraceptives may be reduced.
Pregnancy and Breastfeeding
- Pregnancy: Pregnancy Category B. Amoxycillin/clavulanate crosses the placenta. Use only if clearly needed and after careful risk-benefit assessment.
- Breastfeeding: Amoxycillin and clavulanate are excreted in breast milk in small amounts. Generally considered safe for breastfeeding, but monitor infant for diarrhea, rash, or candidiasis.
Drug Profile Summary
- Mechanism of Action: Inhibits bacterial cell wall synthesis, extended spectrum by beta-lactamase inhibition.
- Side Effects: Nausea, vomiting, diarrhea, rash; rarely C. difficile colitis, liver dysfunction, severe hypersensitivity reactions.
- Contraindications: Hypersensitivity to beta-lactams, prior cholestatic jaundice with this drug, severe renal dysfunction
- Drug Interactions: Probenecid, allopurinol, anticoagulants, methotrexate, oral contraceptives.
- Pregnancy & Breastfeeding: Category B, use with caution; generally safe during breastfeeding, monitor infant.
- Dosage: See detailed section above.
- Monitoring Parameters: Renal function, liver function (especially with prolonged use), complete blood count (in prolonged/high-dose therapy).
Popular Combinations: Often used alone.
Precautions
- Assess for penicillin allergy.
- Monitor renal and hepatic function, especially with prolonged use.
- Advise patients to report any signs of hypersensitivity or gastrointestinal issues.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Amoxycillin + Potassium Clavulanate?
A: See detailed dosage section above. It varies with age, weight, the severity of the infection, and renal function.
Q2: What are the most common side effects?
A: The most common side effects are gastrointestinal, including nausea, vomiting, and diarrhea. Skin rashes can also occur.
Q3: Are there any serious side effects I should be aware of?
A: Although rare, serious side effects include Clostridium difficile-associated diarrhea, hepatotoxicity, and severe allergic reactions like anaphylaxis and Stevens-Johnson syndrome.
Q4: Can this drug be used in pregnant or breastfeeding women?
A: It’s a Pregnancy Category B drug, meaning it should be used during pregnancy only if clearly needed. It’s generally considered safe during breastfeeding, but infants should be monitored for potential side effects.
Q5: What are the key drug interactions I should consider?
A: Important interactions occur with probenecid, allopurinol, anticoagulants, methotrexate, and potentially oral contraceptives.
Q6: Are there any contraindications to using this medication?
A: Yes, contraindications include a history of hypersensitivity to beta-lactams, prior cholestatic jaundice with this medication, and severe renal dysfunction.
Q7: What should I monitor in patients taking this drug long-term?
A: For prolonged or high-dose therapy, monitor renal and hepatic function and complete blood counts.
Q8: What patient education points should I cover?
A: Advise patients to take the medication as prescribed, even if they feel better. They should also be instructed to report any signs of an allergic reaction or severe diarrhea. Discuss the possibility of reduced effectiveness of oral contraceptives.
Q9: How should I adjust the dose in patients with renal impairment?
A: Dosage adjustments are based on the degree of impairment (creatinine clearance or GFR). Refer to renal dosing guidelines for specific recommendations.
A: No, different formulations have different amoxicillin-to-clavulanate ratios and are not interchangeable. Use the specific form and strength prescribed by the physician.
