CEFUCLAV Cefuroxime Axetil / Clavulanate Potassium 500mg / 125mg Film-Coated Tablet 1's
RXDRUG-DR-XY46303-1pc
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Features
Brand
Cefuclav
Full Details
Dosage Strength
500 mg / 125 mg
Drug Ingredients
- Cefuroxime
- Clavulanate Potassium
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Cefuroxime Axetil / Clavulanate Potassium
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY46303
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the treatment of many different types of bacterial infections such as bronchitis, sinusitis, tonsillitis, pharyngitis, ear infections, skin infections, gonorrhea, and urinary tract infections.
Dosage/Direction for Use
FC tablet: Uncomplicated Urinary Tract Infection: Adult: 125 mg twice daily.
Respiratory Tract Infections: Adult: 250-500 mg twice daily.
Child: >3 month: 125 mg twice daily or 10mg/kg twice daily. Max dose: 250 mg daily.
Uncomplicated Gonorrhoea: Adult: 1 g as a single dose. 1 g oral probenecid may be given concurrently.
Otitis Media: Child: >2 yr: 250 mg twice daily or 15 mg/kg twice daily up to 500 mg daily.
Meningitis: Adult: 3 g every 8 hrs.
Child: 200-240 mg/kg/day in 3-4 divided doses, decreased to 100 mg/kg/day after 3 days or once symptoms have improved.
Neonate: 100 mg/kg/day, decreased to 50 mg/kg/day when control has been achieved.
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 twice daily. (See table.)
Oral suspension: Uncomplicated Urinary Tract Infection: Child: 10 mg/kg 2x a day.
Respiratory Tract Infections: Child >3 months: 125 mg 2x a day or 10 mg/kg 2x a day. Max dose: 250 mg daily.
Otitis Media: Child: >2 yrs: 250 mg 2x a day or 15 mg/kg 2x a day up to 500 mg daily.
Meningitis: Child: 200-240 mg/kg/day in 3-4 divided doses, decreased to 100 mg/kg/day after 3 days or once symptoms have improved.
Neonate: 100 mg/kg/day, decreased to 50 mg/kg/day when control has been achieved.
Respiratory Tract Infections: Adult: 250-500 mg twice daily.
Child: >3 month: 125 mg twice daily or 10mg/kg twice daily. Max dose: 250 mg daily.
Uncomplicated Gonorrhoea: Adult: 1 g as a single dose. 1 g oral probenecid may be given concurrently.
Otitis Media: Child: >2 yr: 250 mg twice daily or 15 mg/kg twice daily up to 500 mg daily.
Meningitis: Adult: 3 g every 8 hrs.
Child: 200-240 mg/kg/day in 3-4 divided doses, decreased to 100 mg/kg/day after 3 days or once symptoms have improved.
Neonate: 100 mg/kg/day, decreased to 50 mg/kg/day when control has been achieved.
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 twice daily. (See table.)
Oral suspension: Uncomplicated Urinary Tract Infection: Child: 10 mg/kg 2x a day.
Respiratory Tract Infections: Child >3 months: 125 mg 2x a day or 10 mg/kg 2x a day. Max dose: 250 mg daily.
Otitis Media: Child: >2 yrs: 250 mg 2x a day or 15 mg/kg 2x a day up to 500 mg daily.
Meningitis: Child: 200-240 mg/kg/day in 3-4 divided doses, decreased to 100 mg/kg/day after 3 days or once symptoms have improved.
Neonate: 100 mg/kg/day, decreased to 50 mg/kg/day when control has been achieved.
Overdosage
Overdosage of cephalosporins may cause cerebral irritancy leading to convulsions. In case of overdose, cefuroxime serum levels can be reduced by haemodialysis and peritoneal dialysis.
Contraindications
Hypersensitivity to cephalosporins.
Special Precautions
Before therapy with Cefuclav is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime.
Prescribing Cefuclav 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.
Severe renal impairment; pregnancy, lactation; hypersensitivity to penicillins.
Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime.
Prescribing Cefuclav 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.
Severe renal impairment; pregnancy, lactation; hypersensitivity to penicillins.
Adverse Reactions
Diarrhea/loose motions, nausea/vomiting, transient elevation in AST, ALT, LDH, eosinophilia. Abdominal pain/cramps, flatulence, indigestion, headache, vaginitis, vulvar itch, hives, itch, dysuria, chills, chest pain, shortness of breath, swollen tongue, sleepiness, anorexia. FC tab: Rash, mouth ulcers, thirst. Oral susp: Dehydration.
Drug Interactions
Probenecid: Concomitant administration of probenecid with cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after a 1.5-g single dose is greater when taken with 1 g of probenecid (mean = 14.8 mcg/mL) than without probenecid (mean = 12.2 mcg/mL).
Antacids: Drugs that reduce gastric acidity may result in a lower bioavailability of Cefuroxime-Clavulanate compared with that of fasting state and tend to cancel the effect of postprandial absorption.
Oral Contraceptives: In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone.
Antacids: Drugs that reduce gastric acidity may result in a lower bioavailability of Cefuroxime-Clavulanate compared with that of fasting state and tend to cancel the effect of postprandial absorption.
Oral Contraceptives: In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone.
Caution For Usage
Oral suspension: Directions for Reconstitution: Shake the bottle well to loosen the powder. To make 60 mL, slowly add water up to the mark on the bottle and shake well.
The reconstituted suspension should be used within 14 days in 2°C to 8°C or within 7 days in 25°C to 30°C.
The reconstituted suspension should be used within 14 days in 2°C to 8°C or within 7 days in 25°C to 30°C.
Storage
Store at temperatures not exceeding 30°C.
Oral suspension: Do not freeze. Shake well before use.
Oral suspension: Do not freeze. Shake well before use.
Action
Pharmacology: Cefuroxime is a β-lactam type antibiotic. More specifically, it is a second-generation cephalosporin. Cephalosporins work the same way as penicillins: they interfere with the peptidoglycan synthesis of the bacterial wall by inhibiting the final transpeptidation needed for the cross-links. This effect is bactericidal. Clavulanic acid is a mechanism-based β-lactamase inhibitor.
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 β-lactamases produced by a wide range of gram positive and gram negative microorganism.
Pharmacokinetics: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the body to release cefuroxime into the circulation. Approximately 60% of an administered dose is absorbed. Optimum absorption occurs when it is administered after a light meal. Absorption is not decreased by drugs which affect gastrointestinal motility e.g. loperamide, diphenoxylate or castor oil. However, absorption is decreased by concurrent administration of drugs such as ranitidine.
The mean peak serum level of cefuroxime following a 250 mg dose in normal healthy adults, after food, was 4.1 mg/L and occurred two to three hours after dosing. Serum levels were significantly higher in the elderly, apparently due to slower excretion. Unhydrolysed drug was not detected in the serum but 1-2% of the administered dose is excreted in the urine in a form which indicates that small amounts of the intact ester are absorbed into circulation. The mean serum half life of cefuroxime is approximately 1.2 hours. Protein binding has been variously stated as 33-50% depending on the methodology used. Cefuroxime is not metabolized to any significant extent.
Excretion occurs mainly through the kidney both by glomerular filtration and tubular secretion. Approximately 49% of an administered dose, after food, is recovered in the urine in 24 hours; urinary recovery is significantly reduced if the drug is taken on an empty stomach.
After 250 mg dose urinary concentrations at0-6 and 6-12 hours were 227 mcg/mL (range 92-515) and 35.3 mcg/mL (range 7.6-102) respectively. Concurrent administration of probenecid prolongs the terminal half life of cefuroxime. Serum levels of cefuroxime are reduced by haemodialysis.
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 β-lactamases produced by a wide range of gram positive and gram negative microorganism.
Pharmacokinetics: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the body to release cefuroxime into the circulation. Approximately 60% of an administered dose is absorbed. Optimum absorption occurs when it is administered after a light meal. Absorption is not decreased by drugs which affect gastrointestinal motility e.g. loperamide, diphenoxylate or castor oil. However, absorption is decreased by concurrent administration of drugs such as ranitidine.
The mean peak serum level of cefuroxime following a 250 mg dose in normal healthy adults, after food, was 4.1 mg/L and occurred two to three hours after dosing. Serum levels were significantly higher in the elderly, apparently due to slower excretion. Unhydrolysed drug was not detected in the serum but 1-2% of the administered dose is excreted in the urine in a form which indicates that small amounts of the intact ester are absorbed into circulation. The mean serum half life of cefuroxime is approximately 1.2 hours. Protein binding has been variously stated as 33-50% depending on the methodology used. Cefuroxime is not metabolized to any significant extent.
Excretion occurs mainly through the kidney both by glomerular filtration and tubular secretion. Approximately 49% of an administered dose, after food, is recovered in the urine in 24 hours; urinary recovery is significantly reduced if the drug is taken on an empty stomach.
After 250 mg dose urinary concentrations at0-6 and 6-12 hours were 227 mcg/mL (range 92-515) and 35.3 mcg/mL (range 7.6-102) respectively. Concurrent administration of probenecid prolongs the terminal half life of cefuroxime. Serum levels of cefuroxime are reduced by haemodialysis.
MedsGo Class
Cephalosporins
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