Roxilab 750 IM/IV Injection

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Generic : Cefuroxime
Therapeutic : Cefuroxime

Description :

Cefuroxime is one of the bactericidal second generation cephalosporin antibiotics which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains.


Indications :

Roxilab (Cefuroxime) is indicated in the treatment of:

1. Upper respiratory tract infections: for example, ear, nose and throat infections such as otitis media, sinusitis, tonsillitis and pharyngitis.

2. Lower respiratory tract infections: for example, acute bronchitis, acute exacerbations of chronic bronchitis and pneumonia.

3. Skin and soft tissue infections: such as furunculosis, pyoderma, and impetigo.

4. Genito-urinary tract infections: such as pyelonephritis, urethritis, and cystitis.

5. Gonorrhoea: acute uncomplicated gonococcal urethritis, and cervicitis.

6. Early Lyme disease & subsequent prevention of late Lyme disease.


Dosage and Administration :

For Tablet

Adults : Most infections will respond to 250 mg b.i.d. in mild to moderate lower respiratory tract infections e.g. bronchitis 250 mg b.i.d. should be given. For more severe lower respiratory tract infections, or if pneumonia is suspected then 500 mg b.i.d. should be given. For urinary tract infections a dose of 125 b.i.d. is usually adequate; in pyelonephritis the recommended dose is 250 mg b.i.d. A single dose of one gram is recommended for the treatment of uncomplicated gonorrhoea. Lyme disease in adults and children over the age of 12 years: the recommended dose is 500 mg b.i.d. for 20 days.


For Suspension

Children: The usual dose is 125 mg b.i.d. or 10 mg/kg b.i.d. to a maximum of 250 mg daily. For otitis media, in children less than 2 years of age the usual dosage is 125 mg b.i.d. or 10 mg/kg b.i.d. to a maximum of 250 mg daily and in children over 2 years of age, 250 mg b.i.d. or 15 mg/kg b.i.d to a maximum of 500 mg daily. There is no experience in children under three months of age. The usual course of therapy is seven days. Cefuroxime should be taken after food for optimum absorption.


For Injection

Adults : 750 mg to 1.5 gm IV every 8 hourly, usually 5 to 10 days.

Preoperative prophylaxis : For clean contaminated or potentially contaminated surgical procedures, administer 1.5 gm IV prior to surgery (30 min. to 1 hour before). Thereafter, given 750 mg IV or IM every 8 hours when the procedure is prolonged.


Infants and children (>3 months) : 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours.

Bone & joint infections : 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

Bacterial meningitis : Initially 200 to 240 mg/kg/day IV in divided doses every 6 to 8 hours.


Direction for Reconstitution :

For Suspension : Shake the bottle well before adding water. Then add 50 ml of boiled and cooled water to the bottle. Then continue shaking the bottle until the powder is dissolved properly.

For 750 Intravenous Injection : Add at least 6 ml water for injection BP and shake gently to produce a clear solution.

For 750 Intramuscular Injection : Add 3 ml water for injection BP and shake gently to produce an opaque suspension.


Side effects :

Cefuroxime has been associated with nausea, vomiting, headache, rashes, dizziness in a small number of patients.


Use in special group :

Pregnancy: There is no experimental evidence of embryopathic or teratogenic effect attributable to Cefuroxime but as with all medicines, it should be administered with caution during the early months of pregnancy.

Nursing mother: Cefuroxime is excreted in human milk and consequently, caution should be exercised when Cefuroxime is administered to a nursing mother.

Pediatric use: The safety and effectiveness of Cefuroxime have been established for pediatric patient aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults.


Contraindications :

Cefuroxime is contraindicated in patients with known allergy to cephalosporins.


Precautions :

Prolonged use of Cefuroxime may result in the over growth of non-susceptible organisms (e.g. Candida, Enterococci, Clostridium difficile), which may result interruption of treatment.


Drug Interaction :

No potentially hazardous interaction has been reported. In common with other antibiotics, Cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives.


Storage :

For Tablet & PFS: Keep away from light, moisture & store below 30O C.

For Injection: Keep away from light, moisture & store below 25O C.



Commercial Pack :

Roxilab 250 Tablet: Each box contains 2 x 7 tablets in Alu-Alu blister pack.

Roxilab 500 Tablet: Each box contains 1 x 7 tablets in Alu-Alu blister pack.

Roxilab Powder for Suspension: Each bottle contains Cefuroxime powder for preparation of 70 ml suspension.

Roxilab 750 IM/IV Injection: Each combipack contains 1 vial of Cefuroxime 750 mg as Cefuroxime Sodium USP with one ampoule of 10 ml water for injection BP, sterile disposable syringe (10 ml) and butterfly needle.

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