EURIX® CV – Cefuroxime & Clavulanic Acid USP & BP

Chemical Name:

1-Acetoxyethyl (6R,7R)-3-[(carbamoyloxy)methyl]-7-{[(2Z)-2-(2-furyl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

potassium;(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo [3.2.0] heptane-2-carboxylate

Description:

Cefuroxime with Clavulanic Acid is a combination of antibiotics that include the second generation cephalosporins and salt form of Clavulanic Acid (potassium clavulanate).
Cefuroxime Axetil is a potent 2nd gen Cephalosporin antibiotic that exhibits a greater coverage of Gram-negative bacteria than its predecessor generation.
Cefuroxime Axetil contains β-lactam ring in its structure that makes it susceptible to being rendered inactive by the bacterial β-lactamase.
To counter the inactivation of the cefuroxime by bacterial β-lactamase, Clavulanic Acid (potassium clavulanate) is added to the formulation. Clavulanic Acid is a β-lactamase inhibitor and in turn also has limited antibacterial properties that works in conjuncture with Cefuroxime to produce a better chemotherapy.

— 250 mg 2×7 tablets
— 500 mg 1×7 tablets
— 70 ml PFS

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EURIX® CV – Cefuroxime & Clavulanic Acid USP & BP

COMPOSITION
Available in 2 different Dosage forms:
250 mg Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.
500 mg Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Powder for Suspension: After reconstitution, each 5 ml suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.

PHARMACOLOGY
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. It has poor intrinsic antimicrobial activity, but it is an irreversible binder of lactamases-lactamases produced by a wide range of gram-positive and gram-negative microorganisms. After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed in the body to release cefuroxime into the circulation. Approximately 60% of an administered dose is absorbed. Optimum absorption occurs when ii is administered after a light meal. The mean peak serum level of cefuroxime following a 250 mg dose in normal healthy adults; after food is 4.1 mg/Land occurred two to three hours after dosing. Serum levels are significantly higher in the elderly, apparently due to slower excretion.

INDICATION
Pharyngitis/tonsillitis, Acute bacterial otitis media, Acute bacterial maxillary sinusitis, Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis, Community-Acquired Pneumonia (CAP), Uncomplicated skin and skin-structure infections, Uncomplicated urinary tract infections, Uncomplicated gonorrhea (urethral and endocervical), Early lyme disease (erythema migrans).

DOSAGE AND ADMINISTRATION

Infections Dosage Duration {days)
Adolescents and Adults (13 years and older)
Pharyngitis/ Tonsillitis 250 mg b.i.d. 05-10
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
Community-Acquired Pneumonia (CAP) 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 1000 mg Single Dose
Early Lyme Disease 500 mg b.i.d. 20
Pediatric Patients {who can swallow tablets)
Acute Otitis Media 250 mg b.i.d. 10
Acute Bacterial Maxillary Sinusitis 250 mg b.i.d. 10

SIDE EFFECT
Generally, Cefuroxime and Clavulanic Acid are well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

PRECAUTION
Cefuroxime and Clavulanic Acid should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.

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

DRUG INTERACTION
Concomitant administration of probenecid with Cefuroxime and Clavulanic Acid 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.
Over dosage:
Over dosage can cause cerebral irritation leading to convulsions. Serum level can be decreased by hemodialysis and peritoneal dialysis.
Direction for reconstitution of suspension:
Shake the bottle well to loosen the powder. Add 70 ml (with the help of supplied measuring cup) of boiled and cooled water to the dry mixture in the bottle. Shake the bottle vigorously until all the powder dissolve properly.

USE IN PREGNANCY AND LACTATION
During pregnancy all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime and Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime and Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

STORAGE
Store tablet at 30’C and Powder for Suspension at or below 25’C. Protect from light & moisture. Keep out of the reach of children

PACKAGING
EURIX CV®: 250 mg Tablet: Each box contains 2 strips of 7 tablets in Alu-Alu blister strip pack.
EURIX CV®: 500 mg Tablet: Each box contains 1 strip of 7 tablets in Alu-Alu blister strip pack.
EURIX CV®: Powder for Suspension: Each bottle contains powder for reconstitution of 70 ml suspension.

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