CEFUZIME Tablets / Film-coated

Cefuroxime
500mg
Julphar (Gulf Pharmaceutical Industries)
Pack size 10's (5's Blister x 2)
Dispensing mode POM
Source UAE
AgentJULPHAR
Retail Price 73.00 AED

Indications

CEFUZIME Tablets / Film-coated is used for: Pharyngitis, Acute otitis media, Lyme disease, Susceptible infections, Sinusitis, Otitis media, Skin and skin structure infections,Tonsillitis, Respiratory tract infections, Acute Maxillary Sinusitis, Urinary tract infections, Acute bacterial exacerbation of chronic bronchitis, Surgical Prophylaxis

Adult Dose

Pharyngitis/Tonsillitis 250 mg PO q12hr for 10 days Acute Bacterial Maxillary Sinusitis 250 mg PO q12hr for 10 days Acute Bacterial Exacerbations of Chronic Bronchitis 250-500 mg PO q12hr for 10 days 500-750 mg IV q8hr; switch to oral therapy as soon as clinically possible Secondary Bacterial Infections of Acute Bronchitis 250-500 mg PO q12hr for 5-10 days Uncomplicated Pneumonia 750 mg IV/IM q8hr Uncomplicated Skin/Skin Structure Infections 250-500 mg PO q12hr for 10 days 750 mg IV/IM q8hr; switch to oral therapy as soon as clinically possible Uncomplicated Urinary Tract Infections 125-250 mg PO q12hr for 7-10 days 750 mg IV/IM q8hr; switch to oral therapy as soon as clinically possible Gonorrhea Uncomplicated: 1 g PO once or 1.5 g IM once at 2 different sites with 1 g probenecid PO Disseminated: 750 mg IV/IM q8hr Early Lyme Disease 500 mg PO q12hr for 20 days Severe or Complicated Infections 1.5 g IV/IM q8hr; may be administered q6hr in life-threatening situations Oral Susceptible infections Adult: 250 mg bid. Parenteral Susceptible infections Adult: 0.75 g 8 hrly, by deep IM or slow IV inj over 3-5 min or IV infusion, may increase up to 1.5 g 6-8 hrly in more severe infections.

Child Dose

Children: PO 20–30 mg/kg/day q12h For bone and joint infections, up to 100 mg/kg/day IV, IM 100–150 mg/kg/day q8h

Renal Dose

Renal impairment: Patients undergoing haemodialysis should receive an additional 750-mg dose after each dialysis; those undergoing continuous peritoneal dialysis may be given 750 mg bid. CrCl (ml/min) 10-20 750 mg bid. <10 750 mg once daily.

Administration

Tab: May be taken with or without food. Oral susp: Should be taken with food. IV Preparation Direct injection: reconstitute in 8 mL (for 750-mg vial) or 16 mL (for 1.5-g vial) to obtain ~90 mg/mL solution Infusion: Reconstitute in 100 mL SWI, D5W or NS to obtain 7.5 mg/mL (750-mg vial) or 15 mg/mL (1.5-g vial) solution 7.5 g bulk package not to be used for direct injection IM Preparation Reconstitute 750 mg in 3 mL SWI to obtain ~220 mg/mL solution IV Administration Direct injection: Inject directly into vein over 3-5 minutes or slowly into tubing of free-flowing compatible IV solution Infusion: Infuse intermittently over 15-60 minutes

Contra Indications

Hypersensitivity to cephalosporins.

Precautions

Severe renal impairment; pregnancy, lactation; hypersensitivity to penicillins. Lactation: Drug excreted in breast milk; use with caution

Pregnancy-Lactation

Pregnancy Available data from published epidemiologic studies, case series, and case reports over several decades in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes Lactation Based on several published case reports describing multiple lactating women receiving therapy via intravenous, intramuscular, and oral routes, drug is present in human milk; the highest maternal milk concentration described occurred in lactating women 8 hours after an intramuscular administration of 750 mg; allowing for an infant milk consumption of 150 mL/kg/day, the estimated breastfed infant dose would be less than 1% of adult dose No data are available on effects of drug on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Interactions

May enhance the nephrotoxic effect of strong-acting diuretics (e.g. furosemide) and aminoglycosides. May enhance the effect of oral anticoagulants. May reduce the efficacy of OCs. Probenecid prolongs the excretion of cefuroxime and elevated peak serum level.

Adverse Effects

Side effects of Cefuroxime : >10% Diarrhea (4-11%; depends on duration) 1-10% Decreased hemoglobin or hematocrit (10%), Eosinophilia (7%), Nausea or vomiting (3-7%), Vaginitis (<5%), Transient rise in hepatic transaminases (2-4%), Diaper rash (3%), Increase in alkaline phosphatase (2%), Thrombophlebitis (2%), Increase in lactate dehydrogenase (1%) <1% Anemia, Cholestasis, Colitis, Dyspnea, Epidermal necrolysis, Increase in blood urea nitrogen (BUN) and creatinine, Jaundice, Nephritis, Prolonged prothrombin time (PT)/international normalized ratio (INR), Rash, Stevens-Johnson syndrome, Stomach cramps, Transient neutropenia and leukopenia, Urticaria Potentially Fatal: Anaphylaxis, nephrotoxicity, pseudomembranous colitis.

Mechanism of Action

Cefuroxime binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

Note

CEFUZIME 500mg Tablets / Film-coated manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Cefuroxime. CEFUZIME is availble in United Arab Emirates. Farmaco UAE drug index information on CEFUZIME Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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