Amoxicillin + Clavulanic Acid (Clavulanate)

Amoxicillin + Clavulanic Acid (Clavulanate) is a penicillin-type antibiotic that helps your body fight infections caused by bacteria. It is used to treat infections of the lungs (e.g., pneumonia), ear, nasal sinus, urinary tract, skin and soft tissue. It will not work for viral infections such as the common cold.

This medicine is best taken with a meal to reduce the chance of stomach upset. Take it regularly at evenly spaced intervals as per the schedule prescribed by your doctor. Complete the full course of this antibiotic as prescribed - do not stop even when you feel better.

Amoxicillin prevents bacterial cell wall formation and Clavulanic Acid blocks beta-lactamase enzymes to enhance Amoxicillin's effectiveness. Common side effects include vomiting, nausea, and diarrhea.

• Respiratory tract infections (pneumonia, bronchitis)
• Ear, nose and sinus infections (otitis media, sinusitis)
• Urinary tract infections
• Skin and soft tissue infections
• Dental infections
• Abdominal infections
• Septicemia
• Bone and joint infections

Amoxicillin is a broad-spectrum penicillin antibiotic that binds to penicillin-binding proteins and inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, resulting in bacterial lysis.

Clavulanic Acid is a beta-lactamase inhibitor that binds to and inactivates beta-lactamase enzymes produced by certain bacteria. These enzymes typically inactivate amoxicillin by hydrolyzing its beta-lactam ring. Clavulanic Acid prevents this resistance mechanism, extending amoxicillin's antibacterial spectrum to include many bacteria normally resistant to amoxicillin and other penicillins.

Amoxicillin kills bacteria by inhibiting the synthesis of the bacterial cell wall peptidoglycan layer. However, some bacteria produce beta-lactamase enzymes that inactivate amoxicillin. Clavulanic Acid inhibits these beta-lactamase enzymes, protecting amoxicillin and allowing it to maintain its antibacterial activity. This combination is effective against amoxicillin-resistant bacteria.

Adult Oral Dosage:

• Mild-moderate infections: 375 mg (250/125) every 8 hours OR 625 mg (500/125) every 12 hours
• Severe infections: 625 mg (500/125) every 8 hours OR 1000 mg (875/125) every 12 hours
• Maximum dose: up to 6000 mg amoxicillin/600 mg clavulanic acid daily

Adult IV Dosage:

• 1.2 g (1000/200 mg) every 6-8 hours
• Severe infections: 1.2 g every 4-6 hours
• Maximum dose: up to 7.2 g daily

Pediatric Oral Dosage:

• Suspension (125/31.25 or 250/62.5 mg/5 mL): 20-40 mg/kg/day (amoxicillin) every 8 hours, max 1500 mg/day
• Suspension (200/28.5 or 400/57 mg/5 mL): 25-45 mg/kg/day (amoxicillin) every 12 hours, max 1750 mg/day

Pediatric IV Dosage:

• Children (3 months-12 years): 30 mg/kg every 6-8 hours
• Children (0-3 months): 30 mg/kg every 8 hours (every 12 hours in perinatal period and premature infants)

Renal Dose: Dose adjustment needed in severe renal impairment.

Take this medicine in the dose and duration as advised by your doctor. Take with food to reduce stomach upset. Swallow tablets whole - do not chew, crush or break. Take suspension at start of meal to enhance absorption. IV Injection: Dissolve 500/100 mg in 10 mL solvent and 1000/200 mg in 20 mL solvent.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

• Vomiting
• Nausea
• Diarrhea
• Abdominal pain
• Loss of appetite
• Skin rash
• Allergic reactions

Important Precautions:

• Inform your doctor if allergic to penicillin or cephalosporin antibiotics - serious anaphylactic reactions may occur
• Complete the full course - do not stop even if you feel better
• Stop and inform your doctor immediately if you develop allergic reactions (rash, swelling of face/throat/tongue, breathing difficulties)
• Inform your doctor if you notice bloody stools or develop abdominal cramps
• Caution in infectious mononucleosis
• Caution in kidney and liver disease
• Do not use leftover medicine for any future infection
• Take with food and plenty of fluids

• Penicillin or cephalosporin allergy
• Infectious mononucleosis
• Severe renal impairment (in certain cases)

• Allopurinol: Increases risk of skin rash
• Probenecid: Reduces amoxicillin excretion, increasing serum levels
• Oral contraceptives: May reduce contraceptive efficacy
• Methotrexate: May increase methotrexate levels
• Warfarin: May increase INR
• Anticoagulants: Effect may be increased

[SAFE] Consuming alcohol with Amoxicillin + Clavulanic Acid does not cause any harmful side effects. However, alcohol may reduce immune function and worsen stomach upset.

[SAFE IF PRESCRIBED] Amoxicillin + Clavulanic Acid is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects on the developing baby; however, there are limited human studies. Use under doctor's supervision.

[SAFE IF PRESCRIBED] Amoxicillin + Clavulanic Acid is safe to use during breastfeeding. Amoxicillin is excreted in breast milk in small amounts. Clavulanic Acid is also found in milk in small amounts. Not harmful to the baby.

Dosage for children should be determined based on weight and age. For children under 3 months, give every 12 hours.

Elderly patients may have decreased renal function, so dose adjustment may be needed.

[CAUTION] Use with caution in kidney disease. Not recommended in severe renal impairment (CrCl <30 mL/min). Dose adjustment needed.

[CAUTION] Use with caution in liver disease. Regular monitoring of liver function tests is recommended.

Amoxicillin: Overdose may cause nausea, vomiting, diarrhea, and electrolyte imbalance. Can be removed by hemodialysis.

Clavulanic Acid: Overdose may cause gastrointestinal problems.

Store below 30°C, away from light and moisture. Keep out of reach of children. Prepared suspension should be used within 7 days and stored in the refrigerator.