Mega Cv
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Last updated: June 2025
For educational purposes only
Clinical Reference
# Amoxicillin/Clavulanate (Mega cv)
## Overview
- **Classification**: Beta-lactam antibiotic, Penicillin + Beta-lactamase inhibitor
- **Mechanism**: Amoxicillin inhibits bacterial cell wall synthesis. Clavulanate inactivates bacterial beta-lactamase enzymes, preventing amoxicillin degradation.
## Primary Indications
1. **Acute Bacterial Sinusitis** - Due to beta-lactamase producing strains.
2. **Otitis Media** - Often in pediatric patients, effective against resistant strains.
3. **Lower Respiratory Tract Infections** - Including community-acquired pneumonia, acute exacerbations of chronic bronchitis.
4. **Skin and Skin Structure Infections** - Such as animal/human bite wounds, cellulitis.
5. **Urinary Tract Infections** - Caused by susceptible organisms.
## Adult Dosing
### Standard Dosing (Doses are Amoxicillin/Clavulanate)
**Acute Bacterial Sinusitis, Otitis Media, Lower Respiratory Tract, Skin/Skin Structure Infections**
- **Dose**: **875 mg**/ **125 mg** or **500 mg**/ **125 mg**
- **Frequency**: **875 mg/125 mg** every **12 hours**; **500 mg/125 mg** every **8 hours**
- **Route**: Oral
- **Duration**: 7-14 days (e.g., 10-14 days for sinusitis/otitis; 7 days for skin/structure).
**Urinary Tract Infections**
- **Dose**: **500 mg**/ **125 mg**
- **Frequency**: Every **8 hours**
- **Route**: Oral
- **Duration**: 3-7 days.
### Dose Adjustments
- **Renal Impairment**: Based on amoxicillin component.
- CrCl **>30 mL/min**: No adjustment.
- CrCl **10-30 mL/min**: **250-500 mg** (amox) every **12 hours** (Max 500 mg/125 mg BID).
- CrCl **<10 mL/min**: **250-500 mg** (amox) every **24 hours** (Max 500 mg/125 mg daily).
- **Hemodialysis**: **250-500 mg** (amox) every **24 hours**, with an additional dose during/after dialysis.
- **Hepatic Impairment**: Use with caution; monitor liver function regularly.
- **Elderly Patients**: Adjust dose based on renal function and monitor for adverse effects.
## Pediatric Dosing (Doses are based on Amoxicillin component)
### Neonates (0-28 days)
- **Dose**: **Not generally recommended** due to immature renal function.
- **Special Notes**: If use is unavoidable, consult expert; consider **20 mg/kg/day** (amox) divided every **12 hours**.
### Infants (1-12 months)
- **Dose**: **25-45 mg/kg/day** (amox) divided every **12 hours**.
- Higher dose (45 mg/kg/day) for severe infections like otitis media.
- **Frequency**: Every **12 hours**.
- **Maximum**: **1000 mg/day** (amox component).
- **Special Notes**: Use pediatric suspension (e.g., 200 mg/28.5 mg or 400 mg/57 mg per 5mL).
### Children (1-12 years)
- **Dose**: **25-45 mg/kg/day** (amox) divided every **12 hours** OR **20-40 mg/kg/day** divided every **8 hours**.
- **Higher dose (45 mg/kg/day)** for otitis media, sinusitis, LRTI.
- **Lower dose (25 mg/kg/day)** for less severe infections like skin/UTI.
- **Frequency**: Every **8 or 12 hours** depending on product and dose.
- **Maximum**: Do not exceed adult doses (e.g., **875 mg**/ **125 mg** BID).
- **Special Notes**: Available in various suspension strengths (e.g., 400 mg/57 mg per 5mL for BID dosing).
### Adolescents (13-18 years)
- **Dose**: Typically follows **adult dosing** based on weight and severity of infection.
- **Maximum**: **Adult dose** (e.g., **875 mg**/ **125 mg** BID).
## Safety Information
### Contraindications
- **Absolute**: History of severe hypersensitivity to beta-lactam antibiotics (e.g., anaphylaxis).
- **Absolute**: History of amoxicillin/clavulanate-associated cholestatic jaundice or hepatic dysfunction.
- **Relative**: Infectious mononucleosis (increased risk of rash).
### Common Adverse Effects
- **Very Common (>10%)**: Diarrhea, Nausea, Vomiting.
- **Common (1-10%)**: Rash, Urticaria, Headache, Vaginitis.
- **Serious but Rare**: Clostridioides difficile-associated diarrhea (CDAD), Cholestatic jaundice, Hepatic dysfunction, Anaphylaxis, Stevens-Johnson Syndrome (SJS).
### Key Drug Interactions
- **Warfarin**: Increased INR, risk of bleeding. Monitor INR closely, adjust warfarin dose.
- **Methotrexate**: Increased methotrexate levels, increased toxicity. Avoid co-administration or monitor closely.
- **Probenecid**: Increases and prolongs amoxicillin blood levels. Avoid concurrent use if possible.
- **Oral Contraceptives**: May decrease efficacy. Advise using backup contraception.
## Monitoring & Follow-up
- **Before Treatment**: Obtain culture & susceptibility if appropriate. Assess renal/hepatic function in impaired patients.
- **During Treatment**: Monitor for therapeutic response (resolution of symptoms). Monitor for signs of adverse reactions (e.g., severe diarrhea, rash, jaundice).
- **Clinical Signs**: Watch for worsening infection, severe watery diarrhea (CDAD), yellowing of skin/eyes (jaundice), dark urine, or unusual bruising/bleeding.
## Clinical Pearls
- 💡 **Tip 1**: Administer at the start of a meal to reduce GI upset and enhance absorption.
- 💡 **Tip 2**: Suspensions must be shaken well before each use and refrigerated. Discard any unused portion after 10 days.
- 💡 **Tip 3**: Counsel patients to complete the entire prescribed course, even if symptoms improve, to prevent resistance.
- 💡 **Tip 4**: Be aware of the varying amoxicillin-to-clavulanate ratios; ensure appropriate strength is prescribed (e.g., ES-600 for specific pediatric infections).
> **⚠️ Important**: This information is for educational purposes only. Always consult current prescribing information, local guidelines, and clinical judgment before prescribing.