Product Details
Amoxycillin sodium + potassium clavulanic injection
250MG+50MG / 500MG+100MG / 1GM+200MG
Product Description :
AMOXYCILLIN SODIUM + POTASSIUM CLAVULANATE INJECTION
250 mg + 50 mg / 500 mg + 100 mg / 1 g + 200 mg
Sterile Powder for Solution for Intravenous Administration
COMPOSITION
Each vial contains:
Amoxycillin Sodium equivalent to Amoxycillin ............... 250 mg
Potassium Clavulanate equivalent to Clavulanic Acid ............... 50 mg
or
Amoxycillin Sodium equivalent to Amoxycillin ............... 500 mg
Potassium Clavulanate equivalent to Clavulanic Acid ............... 100 mg
or
Amoxycillin Sodium equivalent to Amoxycillin ............... 1 g
Potassium Clavulanate equivalent to Clavulanic Acid ............... 200 mg
Excipients: As applicable.
PHARMACEUTICAL FORM
Sterile, white to off-white powder for solution for intravenous administration.
THERAPEUTIC CLASS
Aminopenicillin Antibiotic + β-Lactamase Inhibitor
INDICATIONS
Amoxycillin Sodium + Potassium Clavulanate Injection is indicated for the treatment of moderate to severe bacterial infections caused by susceptible microorganisms.
It may be used in the treatment of:
• Lower respiratory tract infections
• Complicated urinary tract infections
• Intra-abdominal infections
• Skin and soft-tissue infections
• Bone and joint infections
• Biliary tract infections
• Gynecological infections
• Septicemia and bloodstream infections
• Other serious infections caused by susceptible bacteria
Treatment should be guided by the susceptibility of the causative organism and applicable antimicrobial guidelines.
CONTRAINDICATIONS
Amoxycillin + Clavulanate is contraindicated in patients with known hypersensitivity to amoxycillin, clavulanic acid, penicillins, cephalosporins, or any component of the formulation.
It is also contraindicated in patients with a previous history of severe hepatic dysfunction associated with amoxycillin/clavulanate therapy.
DRUG INTERACTIONS
Particular consideration may be required with concomitant use of:
• Anticoagulants such as warfarin
• Methotrexate
• Probenecid
• Other β-lactam antibiotics
• Other medicines requiring renal monitoring
The treating physician should review all concomitant medications before administration.
ADMINISTRATION
Amoxycillin Sodium + Potassium Clavulanate Injection is intended for intravenous administration.
The contents of the vial should be reconstituted with a suitable compatible diluent under appropriate aseptic conditions.
The reconstituted solution should be administered by a qualified healthcare professional according to the approved product information and institutional protocol.
For Intravenous Use Only.
STORAGE
Store according to the storage conditions stated on the approved product label.
Protect from excessive heat, moisture and light.
After reconstitution, use within the period specified in the approved product information.
Do not use if the reconstituted solution shows visible particles, precipitation or unexpected discoloration.