Composition
Adrox CV Powder for Suspension: Each 5 ml reconstituted suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
Pharmacology
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. It is indicated for the treatment of infections caused by sensitive bacteria.
Clavulanic Acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes.
The presence of Clavulanic Acid in Adrox CV formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.
Indication
Pharyngitis/Tonsillitis, acute bacterial otitis media, acute bacterial maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis, uncomplicated skin and skin-structure infections, uncomplicated urinary tract infections, uncomplicated gonorrhea, early lyme disease, impetigo.
Dosage & Administration
Paediatric Patients (3 months to 12 years):
Who can swallow tablets whole
|
Infection |
Dosage |
Duration (Days) |
| Acute bacterial otitis media | 250 mg twice daily |
10 |
| Acute bacterial maxillary sinusitis | 250 mg twice daily |
10 |
Adrox CV Suspension
|
Infection |
Recommended Daily Dose | Maximum Daily Dose |
Duration (Days) |
| Pharyngitis/ Tonsillitis | 20 mg/kg/day, twice daily |
500 mg |
10 |
| Acute bacterial otitis media | 30 mg/kg/day, twice daily |
1000 mg |
10 |
| Acute bacterial maxillary sinusitis (mild to moderate) | 30 mg/kg/day, twice daily |
1000 mg |
10 |
| Impetigo | 30 mg/kg/day, twice daily |
1000 mg |
10 |
or, as directed by the registered physician. Adrox CV may be administered without regard to meals.
Directions for reconstitution for oral suspension:
- Shake the bottle to loosen the powder
- Add the total volume of water for reconstitution into the powder of the bottle
- Replace the cap
- Shake the bottle until all the powder is in suspension
Volume of water required for reconstitution for labeled volume of suspension:
|
Suspension |
Labeled volume after reconstitution |
Volume of water required for reconstitution |
| 125 mg + 31.25 mg / 5 ml |
70 ml |
35 ml |
Water used for reconstitution should be boiled and cooled. The reconstituted suspension must be stored at 2°-8°C temperature & should be used within 7 days after reconstitution.
Contraindication
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporins & in patients with pseudomembranous colitis.
Precaution
As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic Acid combination may result in overgrowth of non-susceptible microorganisms.
Side Effects
Generally Cefuroxime-Clavulanic Acid is well tolerated. Major adverse reaction which may occur are diarrhea, nausea, vomiting, transient elevation in AST, ALT, LDH and eosinophilia. Other adverse events that may occur are abdominal pain, abdominal cramps, flatulence, indigestion, headache, vaginitis, rash, itching, dysuria, thirst, anorexia etc.
Use in Pregnancy & Lactation
All antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary tract and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities and consequently caution should be exercised when it is administered to a nursing mother.
Drug Interaction
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Overdose
Over-dose can cause cerebral irritation leading to convulsions. In this case, serum levels can be reduced by hemodialysis and peritoneal dialysis.
Storage
Store below 30ºC, protect from light & moisture. Keep out of the reach of children.
Packaging
Adrox CV Powder for Suspension: Each box contains an amber glass bottle containing dry powder to reconstitute 70 ml Suspension with a measuring cup and a dropper.
