Indication
ZINAROX® is indicated in the following infections caused by susceptible organisms :
- Infections of upper respiratory tract for example, ear, nose, throat infections, such as otitis media, sinusitis and pharyngitis.
- Infections of lower respiratory tract for example, acute and chronic bronchitis, and pneumonia.
- Infections of genito-urinary tract for example, pyelonephritis, cystitis and urethritis.
- Infections of skin and soft-tissues for example, furunculosis, pyoderma and impetigo.
Composition
Each Film coated tablet of ZINAROX® 500 contains:
- Cefuroxime 500 mg (as Cefuroxime axetil).
Each Film coated tablet of ZINAROX® 250 contains:
- Cefuroxime 250 mg (as Cefuroxime axetil).
Each Film coated tablet of ZINAROX® 125 contains:
- Cefuroxime 125 mg (as Cefuroxime axetil).
Dosage
Adults:
- For mild to moderate RTIs (e.g. Bronchitis): 250mg twice daily.
- For more severe LRTIs (pneumonia) : 500mg twice daily.
- For UTIs: 125mg twice daily is usually adequate.
- In pyelonephritis: the recommended dose is 250mg twice daily.
- Uncomplicated gonorrhea: a single dose of 1g is recommended.
children:
- The usual dose is 125mg twice daily.
Otitis Media:
- Children < 2 years :125mg twice daily.
- Children > 2 years : 250mg twice daily.
Note:
- ZINAROX® Tablets should not be crushed and are therefore unsuitable for children under 5 years of age.
- No special precautions are necessary in patients with renal impairment or on renal dialysis or in the elderly at dosages up to the normal maximum of 1g per day.
- Cefuroxime axetil is an oral prodrug of the bactericidal cephalosporin antibiotic, Cefuroxime, which is active against a wide range of Gram-positive and Gram-negative organisms.
- Cefuroxime is resistant to most beta-lactamases and consequently, is active against many Ampicillin-resistant strains and Amoxicillin-resistant strains.The bactericidal action of Cefuroxime results from inhibition of cell-wall synthesis by binding to essential target proteins.
- Cefuroxime axetil is absorbed from the gastro-intestinal tract and is rapidly hydrolysed in the intestinal mucosa and blood to Cefuroxime.The absorption of Cefuroxime axetil is enhanced in the presence of food .
- Peak plasma level of Cefuroxime in plasma occur approximately 2 to 3 hours after oral administration .The plasma half life is about 1.2 hours . Plasma levels of Cefuroxime is reduced by dialysis .
- Cefuroxime bound to plasma protein by 50% .
- Cefuroxime is widely distributed in the body. It crosses the placenta and has been detected in breast milk.
- Cefuroxime is not metabolised and is excreted unchanged in the urine. Small amounts of Cefuroxime are excreted in bile..
Each Film coated tablet of ZINAROX® 500 contains:
- Cefuroxime 500 mg (as Cefuroxime axetil).
Each Film coated tablet of ZINAROX® 250 contains:
- Cefuroxime 250 mg (as Cefuroxime axetil).
Each Film coated tablet of ZINAROX® 125 contains:
- Cefuroxime 125 mg (as Cefuroxime axetil).
ZINAROX® is indicated in the following infections caused by susceptible organisms :
- Infections of upper respiratory tract for example, ear, nose, throat infections, such as otitis media, sinusitis and pharyngitis.
- Infections of lower respiratory tract for example, acute and chronic bronchitis, and pneumonia.
- Infections of genito-urinary tract for example, pyelonephritis, cystitis and urethritis.
- Infections of skin and soft-tissues for example, furunculosis, pyoderma and impetigo.
ZINAROX® is contraindicated in patients with known hypersensitivity to the Cephalosporins antibiotics.
- Probenecid competes for renal tubular secretion with ZINAROX® resulting in higher and more prolonged plasma concentrations of cefuroxime.
- ZINAROX® should be administered with caution during the early months of pregnancy.
- Cefuroxime is excreted in breast milk, and consequently caution should be exercised when ZINAROX® is administered to a nursing mother.
Generally mild and transient in nature:
- As with other Cephalosporins, there have been rare reports of hypersensitivity reactions including (skin rashes, urticaria, pruritis, drug fever and very rarely anaphylaxis).
- Gastrointestinal disturbances, including (diarrhoea, nausea, and vomiting) .
Diarrhoea, although uncommon, is more likely to be associated with higher doses of ZINAROX®.
- Headache has been reported.
- Eosinophilia and transient increases of hepatic enzyme levels have been noted during ZINAROX® therapy
Adults:
- For mild to moderate RTIs (e.g. Bronchitis): 250mg twice daily.
- For more severe LRTIs (pneumonia) : 500mg twice daily.
- For UTIs: 125mg twice daily is usually adequate.
- In pyelonephritis: the recommended dose is 250mg twice daily.
- Uncomplicated gonorrhea: a single dose of 1g is recommended.
children:
- The usual dose is 125mg twice daily.
Otitis Media:
- Children < 2 years :125mg twice daily.
- Children > 2 years : 250mg twice daily.
Note:
- ZINAROX® Tablets should not be crushed and are therefore unsuitable for children under 5 years of age.
- No special precautions are necessary in patients with renal impairment or on renal dialysis or in the elderly at dosages up to the normal maximum of 1g per day.
- As with other antibiotics, prolonged use of ZINAROX® may result in the overgrowth of non-susceptible organisms (eg., Candida, Enterococci, Clostridum difficile), which may require interruption of treatment.
- Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use.
- Special care is indicated in patients who have experienced an anaphylactic reaction to penicillins.
- ZINAROX® should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.
- False positive reactions may occur if using methods depending on copper reduction eg. Fehling’s, Benedict’s, solutions and Clinitest. There for enzyme-based tests should be used.
ZINAROX® 500 mg ,250 mg &125 mg Tablets:
- (Blister of 5 tablets, Pack of two blisters).
- Store the drug in a dry place at a temperature below 30o C.
- ZINAROX® for Oral suspension, once reconstituted, must be stored in a refrigerator and used within one weak .