Augmentin

# Augmentin ## Overview - **Classification**: Penicillin antibiotic (aminopenicillin) combined with a beta-lactamase inhibitor. - **Mechanism**: Amoxicillin inhibits bacterial cell wall synthesis. Clavulanate irreversibly inhibits beta-lactamase enzymes, protecting amoxicillin from hydrolysis. ## Primary Indications 1. **Acute Bacterial Sinusitis**: Infection of the paranasal sinuses. 2. **Acute Otitis Media (AOM)**: Middle ear infection. 3. **Lower Respiratory Tract Infections (LRTIs)**: Exacerbations of chronic bronchitis, community-acquired pneumonia. 4. **Skin and Skin Structure Infections**: Certain skin infections caused by susceptible organisms. 5. **Urinary Tract Infections (UTIs)**: Caused by susceptible organisms. ## Adult Dosing ### Standard Dosing **Acute Bacterial Sinusitis, AOM, LRTI, Skin/Soft Tissue Infections** - **Dose**: **500 mg** amoxicillin/**125 mg** clavulanate - **Frequency**: Every **8 hours (TID)** - **Route**: Oral - **Duration**: 10-14 days for sinusitis/AOM; 5-7 days for uncomplicated skin/URTI. OR - **Dose**: **875 mg** amoxicillin/**125 mg** clavulanate - **Frequency**: Every **12 hours (BID)** - **Route**: Oral - **Duration**: 10-14 days for sinusitis/AOM; 5-7 days for uncomplicated skin/URTI. **Severe/Recurrent Acute Otitis Media, Severe Sinusitis** - **Dose**: **875 mg** amoxicillin/**125 mg** clavulanate - **Frequency**: Every **12 hours (BID)** - **Route**: Oral - **Duration**: 10 days - **Special Considerations**: High dose amoxicillin (875mg) to improve penetration. ### Dose Adjustments - **Renal Impairment**: * **CrCl >30 mL/min**: No dosage adjustment required. * **CrCl 10-30 mL/min**: **500 mg/125 mg** every **12 hours**. * **CrCl <10 mL/min**: **500 mg/125 mg** every **24 hours**. * **Hemodialysis**: **500 mg/125 mg** every **24 hours**, with an additional dose during and after dialysis. - **Hepatic Impairment**: Administer with caution; monitor liver function regularly. - **Elderly Patients**: No specific dose adjustment solely for age. Adjust based on renal function. ## Pediatric Dosing (based on amoxicillin component) ### Neonates (0-28 days) - **Dose**: **Generally NOT RECOMMENDED** due to immature renal function and increased risk of adverse effects. - **Special Notes**: If use is considered essential, consult an Infectious Diseases specialist and monitor closely. ### Infants (1-12 months) **Standard Dose (e.g., AOM, sinusitis, uncomplicated skin infections)** - **Dose**: **25 mg/kg/day** (amoxicillin component) - **Frequency**: Divided every **12 hours (BID)** or **8 hours (TID)** - **Route**: Oral suspension - **Maximum**: Not to exceed **45 mg/kg/day** for standard indications. - **Special Notes**: Use Augmentin **200mg/5mL** or **400mg/5mL** for BID; **125mg/5mL** or **250mg/5mL** for TID. **High Dose (e.g., severe AOM, recurrent AOM, refractory sinusitis)** - **Dose**: **90 mg/kg/day** (amoxicillin component) - **Frequency**: Divided every **12 hours (BID)** - **Route**: Oral suspension - **Maximum**: Do not exceed **600 mg/dose** amoxicillin (using ES-600 formulation). - **Special Notes**: Use Augmentin **ES-600 (600mg/42.9mg per 5mL)** to minimize clavulanate intake. ### Children (1-12 years) **Standard Dose (e.g., AOM, sinusitis, lower respiratory tract infections, skin/soft tissue infections)** - **Dose**: **25-45 mg/kg/day** (amoxicillin component) - **Frequency**: Divided every **12 hours (BID)** or **8 hours (TID)** - **Route**: Oral suspension or chewable tablets - **Maximum**: Max **1750 mg/day** amoxicillin (standard adult dose). - **Special Notes**: Choose concentration to minimize clavulanate exposure (e.g., **200/28.5mg per 5mL** or **400/57mg per 5mL** for BID). **High Dose (e.g., severe AOM, recurrent AOM, refractory sinusitis)** - **Dose**: **90 mg/kg/day** (amoxicillin component) - **Frequency**: Divided every **12 hours (BID)** - **Route**: Oral suspension or chewable tablets - **Maximum**: Max **2000 mg/day** amoxicillin (equivalent to two 875 mg doses). - **Special Notes**: Use Augmentin **ES-600 (600mg/42.9mg per 5mL)** or **875 mg** tablets (if able to swallow) to limit clavulanate. ### Adolescents (13-18 years) - **Dose**: Typically follows **Adult Dosing** recommendations. - **Route**: Oral tablets or suspension. - **Maximum**: **875 mg** amoxicillin/**125 mg** clavulanate every **12 hours (BID)**. ## Safety Information ### Contraindications - **Absolute**: History of severe hypersensitivity reaction to any penicillin (e.g., anaphylaxis, SJS). - **Absolute**: History of cholestatic jaundice or hepatic dysfunction associated with Augmentin use. - **Absolute**: Patients with infectious mononucleosis (increased risk of maculopapular rash). ### Common Adverse Effects - **Very Common (>10%)**: Diarrhea, Nausea, Vomiting. - **Common (1-10%)**: Rash, Urticaria, Vaginitis, Headache. - **Serious but Rare**: Clostridium difficile-associated diarrhea (CDAD), Hepatitis, Cholestatic jaundice, Stevens-Johnson syndrome (SJS), Anaphylaxis, Hemolytic anemia. ### Key Drug Interactions - **Warfarin**: May prolong prothrombin time (INR). **Monitor INR closely.** - **Methotrexate**: May decrease renal excretion of methotrexate, increasing toxicity. **Monitor for methotrexate toxicity.** - **Allopurinol**: Increased incidence of rash, especially in hyperuricemic patients. - **Oral Contraceptives**: May decrease efficacy. Advise alternative contraception during therapy. ## Monitoring & Follow-up - **Before Treatment**: Assess for penicillin allergy, history of mononucleosis. - **During Treatment**: * Monitor for signs of allergic reaction (rash, hives, difficulty breathing). * Monitor for severe diarrhea (potential CDAD). * Monitor liver function tests (LFTs) in patients with hepatic impairment or prolonged therapy. * Monitor renal function in patients with pre-existing renal impairment. - **Clinical Signs**: Resolution of infection symptoms, improvement in fever, reduction in pain. ## Clinical Pearls - 💡 **Administration**: Administer **at the start of a meal** to enhance absorption and minimize gastrointestinal upset. - 💡 **Formulation**: Always confirm the specific **amoxicillin:clavulanate ratio** (e.g., 250/125 vs 500/125 vs 875/125) to avoid clavulanate overdose, especially with higher amoxicillin doses. - 💡 **Suspension Dosing**: Ensure parents/patients use the **calibrated dosing device** provided with the medication for accurate measurement. - 💡 **Storage**: Oral suspensions must be **refrigerated** and discarded after **10 days**. > **⚠️ Important**: This information is for educational purposes only. Always consult current prescribing information, local guidelines, and clinical judgment before prescribing.