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Human

KefuClav®

Tablet

250 mg + 62.5 mg

GENERIC NAMECefuroxime + Clavulanic Acid

MANUFACTURED BYEskayef Pharmaceuticals Ltd.

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Available Pack Sizes:3 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 252.00/ 7 x 2

(Unit: ৳ 35.00 / 1 Tablet)

16263

Composition

KefuClav® 250 Tablet: Each film-coated tablet contains Amorphous Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg & Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.

KefuClav® 500 Tablet: Each film-coated tablet contains Amorphous Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg & Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.

KefuClav® Powder for Suspension: After reconstitution, each 5 ml suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg & Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.

Description

KefuClav is a combined preparation of Cefuroxime & Clavulanic Acid. Cefuroxime has bactericidal activity against a wide range of common pathogens, including beta-lactamase producing strains. The bactericidal action of Cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins. Cefuroxime has good stability to bacterial beta-lactamases. Clavulanic Acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. Clavulanic Acid binds to and inactivates them thus preventing the destruction of Cefuroxime that is a substrate for this enzyme. It has poor intrinsic antimicrobial activity, but it is an irreversible binder of &-lactamases produced by a wide range of gram positive and gram negative microorganism.

Indications

Pharyngitis/Tonsillitis: caused by Streptococcus pyogenes.

Acute Bacterial Otitis Media: caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.

Acute Bacterial Maxillary Sinusitis: caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only).

Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).

Uncomplicated Skin and Skin-Structure Infections: caused by Staphylococcus aureus (including betalactamase-producing strains) or Streptococcus pyogenes.

Uncomplicated Urinary Tract Infections: caused by Escherichia coli or Klebsiella pneumoniae.

Uncomplicated Gonorrhea (urethral and endocervical): caused by penicillinase-producing & non-penicillinase producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.

Early Lyme disease (erythema migrans): caused by Borrelia burgdorferi.

Impetigo: caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.

Dosage & Administration

Tablet:

Oral: Adolescents & Adults ( 13 years & older).

Pharyngitis/tonsillitis: 250 mg b.i.d. - 10

Acute bacterial maxillary sinusitis: 250 mg b.i.d. - 10

Acute bacterial exacerbations of chronic bronchitis: 250 or 500 mg b.i.d. - 10

Secondary bacterial infections of acute bronchitis: 250 or 500 mg b.i.d. - 05-10

Uncomplicated skin and skin-structure infections: 250 or 500 mg b.i.d. - 10

Uncomplicated urinary tract infections: 250 mg b.i.d. - 07.10

Uncomplicated gonorrhea: 1,000 mg once - single dose

Early Lyme disease: 500 mg b.i.d. - 20

Oral: Paediatric patients (who can swallow tablet):

Acute otitis media: 250 mg b.i.d. - 10

Acute bacterial maxillary sinusitis: 250 mg b.i.d. - 10

Suspension:

Oral: Paediatric Patients (3 months to 12 years):

Pharyngitis/tonsillitis: 20 mg/kg/day divided b.i.d. - 500 mg - 10

Acute otitis media: 30 mg/kg/day divided b.i.d. - 1,000 mg - 10

Acute bacterial maxillary sinusitis: 30 mg/kg/day divided b.i.d. - 1,000 mg - 10

Impetigo: 30 mg/kg/day divided b.i.d. - 1,000 mg - 10

Contraindications

It is contraindicated in patients with a known hypersensitivity to Cephalosporin group of antibiotics and Clavulanic Acid.

Side Effects

Major adverse reactions which may occur are diarrhea/loose motions, nausea/vomiting, transient elevation in AST, ALT, LDH, Eosinophilia.

Pregnancy & Lactation

No adequate and well-controlled studies in pregnant women have been reported, so KefuClav®should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician. Because Cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with Cefuroxime.

Precautions & Warnings

Before therapy with KefuClav®is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to Cephalosporins, Penicillins or other drugs. * Prescribing KefuClav®in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. * Cephalosporins, including Cefuroxime, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function. * Cefuroxime, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis.

Storage Conditions

Tablet:

: Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children.

Powder for Suspension: Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children. Reconstituted suspension should be kept tightly closed and stored in a refrigerator (2- 8°C temperature). Unused portion should be discarded after 7 days.

KefuClav® • 7 x 2

৳ 252.00