Fimoxyclav (1 gm+200 mg)/20 ml (IV Injection)
Medicine Details
Category | Details |
---|---|
Generic | Amoxicillin clavulanic acid |
Company | Synovia pharma plc |
Also available as |
Title
- Co-amoxiclav
Categories
- Antibiotics
- Medication
- Pharmaceutical
Description
- Co-amoxiclav is indicated for short-term treatment of bacterial infections at various sites such as upper respiratory tract, lower respiratory tract, genito-urinary tract, skin and soft tissue, bone and joint, and other infections. It contains Amoxicillin and Clavulanic Acid in different formulations including tablets, powder for suspension, and injections. The pharmacologic properties include broad-spectrum bactericidal activity, peak serum levels after oral administration, and low serum binding. The product is administered orally with or without meals and also available in intravenous form. Co-amoxiclav may interact with other medications, has contraindications for patients with penicillin hypersensitivity, and may cause mild and transitory side effects similar to Amoxicillin. The product's use in pregnancy and lactation is not recommended unless essential, and precautions are advised for patients with anticoagulation therapy or severe hepatic dysfunction. Dosing should be adjusted for patients with renal impairment, and overdose effects are unlikely to occur.
Dosage form
- Tablet
- Powder for Suspension
- Injection
Tablet strengths
- 375 mg
- 625 mg
- 1 gm
Suspension strengths
- 125 mg/31.25 mg per 5 ml
- 400 mg/57.5 mg per 5 ml
Injection strengths
- 0.6 gm
- 1.2 gm
Pharmacodynamic properties
The product's antibacterial combination consists of Amoxicillin and Clavulanic Acid, providing a broad spectrum of bactericidal activity. Clavulanic acid protects Amoxicillin from degradation by beta-lactamase enzymes.
Pharmacokinetic properties
Peak serum levels of both components occur about one hour after oral administration. Absorption is optimized at the start of a meal, and doubling the dosage approximately doubles the serum levels achieved.
Administration instructions
Oral dosage form may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when administered at the start of a meal. Intravenous injection is administered over 2 minutes or as a slow intravenous infusion lasting 30 minutes.
Interaction warnings
Co-amoxiclav may prolong bleeding time and prothrombin time. It may reduce the efficacy of oral contraceptives and interact with allopurinol, potentially increasing the likelihood of allergic skin reactions.
Contraindications
History of penicillin hypersensitivity or previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
Side effects
- Diarrhea
- Pseudomembranous colitis
- Indigestion
- Nausea
- Vomiting
- Candidiasis
- Hepatitis
- Cholestatic jaundice
- Urticarial and erythematous rashes
- Angioedema
- Anaphylaxis
Pregnancy and lactation
- Animal studies show no teratogenic effects. Limited use in human pregnancy with no untoward effect reported. However, use in pregnancy and lactation is not recommended unless essential.
Precautions
Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction. Dosage should be adjusted for patients with renal impairment.
Special populations dosing
Dose should be adjusted in case of patients with renal impairment, moderate or severe hepatic impairment, and during dialysis. Use with caution and monitor hepatic function at regular intervals.
Overdose effects
Problems of overdose are unlikely to occur, but if encountered, gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident.
Therapeutic class
- Broad spectrum penicillins
Reconstitution instructions
IV injection should be reconstituted with Water for Injection BP and should not be reconstituted or mixed with specified solutions. The reconstituted solution may be injected into infusion fluids containing glucose, bicarbonate, and dextran over a period of 3-4 minutes.
Storage conditions
Store below 25°C, protected from light and moisture. Once reconstituted, suspension should be kept in the refrigerator (but not frozen) and used within 7 days. Once reconstituted vial must be used within 20 minutes.
Related Brands
- Co-Clav (125 mg+31.25 mg)/5 ml (Powder for Suspension) - ad-din-pharmaceuticals-ltd
- Co-Clav 500 mg+125 mg (Tablet) - ad-din-pharmaceuticals-ltd
- Mimoxclav 500 mg+125 mg (Tablet) - albion-laboratories-limited
- Fortimox 500 mg+125 mg (Tablet) - kumudini-pharma-ltd
- Fimoxyclav ES (600 mg+42.9 mg)/5 ml (Powder for Suspension) - synovia-pharma-plc