Roximax Tablet
Cefuroxime
250mg
Veritas Pharmaceuticals Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 25.07 AED |
Available as:
Indications
Roximax Tablet 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 (mild to moderate)
250 mg PO every 12 hours for 10 days
Acute Bacterial Maxillary Sinusitis (mild to moderate)
250 mg PO every 12 hours for 10 days
Acute Bacterial Exacerbations of Chronic Bronchitis (mild to moderate)
250-500 mg PO every 12 hours for 10 days
500-750 mg IV every 8 hours; switch to oral therapy as soon as clinically possible
Secondary Bacterial Infections of Acute Bronchitis
250-500 mg PO every 12 hours for 5-10 days
Uncomplicated Pneumonia
750 mg IV/IM every 8 hours
Uncomplicated Skin/Skin Structure Infections
250-500 mg PO every 12 hours for 10 days
750 mg IV/IM every 8 hours; switch to oral therapy as soon as clinically possible
Uncomplicated Urinary Tract Infections
125-250 mg PO every 12 hours for 7-10 days
750 mg IV/IM every 8 hours; 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 every 12 hours for 20 days
Severe or Complicated Infections
1.5 g IV/IM every 8 hours; may be administered every 6 hours in life-threatening situations
Oral
Susceptible infections
Adult: 250 mg bid.
Parenteral
Susceptible infections
Adult: 0.75 g 8 hourly, by deep IM or slow IV inj over 3-5 min or IV infusion, may increase up to 1.5 g 6-8 hourly in more severe infections.
Child Dose
Children
Acute Bacterial Maxillary Sinusitis
<3 months: Safety and efficacy not established
3 months-12 years: 30 mg/kg/day suspension PO divided every 12 hours for 10 days; not to exceed 1000 mg/day;
alternatively, 75-150 mg/kg/day IV/IM divided every 8 hours; not to exceed 6 g/day
>12 years: 250 mg tablet PO every 12 hours for 10 days
Acute Otitis Media
<3 months: Safety and efficacy not established
3 months-12 years: 30 mg/kg/day suspension PO divided every 12 hours for 10 days; not to exceed 1000 mg/day;
alternatively, 75-150 mg/kg/day IV/IM divided every 8 hours; not to exceed 6 g/day
Alternatively: 125-250 mg PO every 12 hours for 10 days
>12 years: 250-500 mg tablet PO every 12 hours for 10 days
Impetigo
<3 months: Safety and efficacy not established
3 months-12 years: 30 mg/kg/day suspension PO divided every 12 hours for 10 days; not to exceed 1000 mg/day or
75-100mg/kg/day IV/IM divided every 8 hours; not to exceed 6 g/day
Alternatively: 125-250 mg PO every 12 hours for 10 days
>12 years: 250-500 mg tablet PO every 12 hours for 10 days
Pharyngitis/Tonsillitis
<3 months: Safety and efficacy not established
3 months-12 years: 20 mg/kg/day PO divided every 12 hours for 10 days; not to exceed 500 mg/day or 75-150 mg/kg/day IV/IM divided every 8 hours; not to exceed 6 g/day
Alternatively: 125-250 mg PO every 12 hours for 10 days
>12 years: 250 mg PO every 12 hours for 10 days
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
Prolonged INR in nutritionally deficient patients, prolonged treatment, and hepatic and renal disease reported
Film-coated tablet and oral solution are not bioequivalent; tablets should not be crushed
Use caution in patients with history of colitis, renal impairment, or with a history of seizure disorders
Use with caution in patients with history of penicillin allergy
Clostridioides difficile-associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD
Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy
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.
Contraindicated (0)
Serious (3)
BCG vaccine live
cholera vaccine
microbiota oral
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
Roximax 250mg Tablet manufactured by Veritas Pharmaceuticals Ltd.. Its generic name is Cefuroxime. Roximax is availble in Bangladesh.
Farmaco BD drug index information on Roximax Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.