DMSCAREPHARMA Amoxicillin and Clavulanate Tablets

 C0-Amxlin tablet is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients:

• Lower respiratory tract infections
• Acute bacterial otitis media
• Sinusitis
• Skin and skin structure infections
• Urinary tract infections

Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, C0-Amxlin should not be used.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of C0-Amxlin tablet and other antibacterial drugs, C0-Amxlin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

• Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component.
• Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.
• Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended.

• Tablets: 875 mg/125 mg tablets are scored

• History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins).
• History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.

• Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction occurs.
• Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.
• Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment.
• Clostridioides difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.
• Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and clavulanate potassium use in these patients.
• Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).

• Co-administration with probenecid is not recommended.
• Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time.
• Co-administration with allopurinol increases the risk of rash.
• Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives.

• Pediatric Use: Modify dose in patients 12 weeks or younger.
• Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30mL/min).