Famiclav 250 mg Tab

Famiclav 250 mg Tab

Description

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including Beta-lactamase producing strains.

Cefuroxime has good stability to bacterial Beta-lactamase and consequently, is active against many Ampicillin-resistant and

Amoxicillin-resistant strains. Clavulanic Acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. The presence of Clavulanic Acid in Famiclav formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

Composition

Famiclav 250 Tablet : Each film-coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil USP and Clavulanic acid 62.50 mg as diluted Potassium Clavulanate BP.

Famiclav 500 Tablet : Each film-coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil USP and Clavulanic acid 125 mg as diluted Potassium Clavulanate BP.

Famiclav Powder for Suspension: After reconstitution, each 5 ml suspension contains Cefuroxime 125 mg as Cefuroxime Axetil USP and Clavulanic acid 31.25 mg as diluted Potassium Clavulanate BP.

Indications

• Upper respiratory tract infections: Ear, nose and throat infections such as otitis media, sinusitis, tonsillitis and pharyngitis.

• Lower respiratory tract infection : Acute bronchitis, acute exacerbations of chronic bronchitis and pneumonia.

• Skin and soft tissue infections : Furunculosis, pyoderma and impetigo.

• Genito-urinary tract infections: Pyelonephritis, urethritis and cystitis.

• Gonorrhoea: Acute uncomplicated gonococcal urethritis and cervicitis.

• Early Lyme Disease and subsequent prevention of late Lyme Disease Directions for reconstitution for oral suspension

1. Shake the bottle to loosen the powder

2. Add the total volume of water for reconstitution into the powder of the bottle

3. Replace the cap

4. Shake the bottle until all the powder is in suspension

Contraindications

Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.

Side effects

Generally Cefuroxime and Clavulanic Acid are well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic Acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Precautions

Famiclav should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.

Use in pregnancy & lactation

During pregnancy:

While all antibiotics should be avoided in the first trimester if possible. However, Famiclav can be safely used in later pregnancy to treat urinary and other infections.

During Lactation: Famiclav is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Drug interaction

Concomitant administration of probenecid with Cefuroxime increases the area under the serum concentration versus time curve by 50%.

Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

Supply

Famiclav 250 Tablet : Each box contains 1x6 tablets in Alu-Alu blister strip.

Famiclav 500 Tablet : Each box contains 1x6 tablets in Alu-Alu blister strip.

Famiclav Powder for Suspension : Each bottle contains dry powder to reconstitute 70 ml suspension.