Roxilab Plus 500 Tablet
Generic : Cefuroxime &Clavulanic Acid
Therapeutic : Cefuroxime &Clavulanic Acid
Composition:
Roxilab Plus 250 Tablet : Each film coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil BP and Clavulanic Acid 62.5 mg as Potassium Clavulanate BP.
Roxilab Plus 500 Tablet : Each film coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil BP and Clavulanic Acid 125 mg as Potassium Clavulanate BP.
Description:
Cefuroxime is a broad spectrum second generation Cephalosporin active against a wide range of Gram-positive and Gram-negative susceptible organisms including many 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 has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. The presence of Clavulanic Acid 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.
Indications:
l Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
l Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including betalactamase producing strains), Moraxella catarrhalis (including beta-lactamase producing strains) or Streptococcus pyogenes.
l Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenza.
l Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilusinfluenzae or Haemophilusparainfluenzae.
l Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
l Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiellapneumoniae.
l Uncomplicated Gonorrhea (urethral and endocervical) caused by Neisseria gonorrhoeae and Uncomplicated Gonorrhea (rectal in females) caused by non-penicillinase producing strains of Neisseria gonorrhoeae.
l Early Lyme disease (erythema migrans) caused by Borreliaburgdorferi.
l Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilusinfluenzae (including ampicillin-resistant strains) and Klebsiella spp.
l Meningitis caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including ampicillin-resistant strains), Neisseria meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains).
l Switch therapy (injectable to oral).
Dosage and Administration:
Adults (13 years and older)
1010250 mg b.i.d.250 mg b.i.d.Acute Bacterial Maxillary SinusitisAcute Otitis MediaDuration (days)DosageInfection Pediatric Patients (who can swallow tablet whole)20-7-1010-145-10105-1010105-10500 mg b.i.d.1 gm single dose250 mg b.i.d.500 mg b.i.d.250-500 mg b.i.d.250-500 mg b.i.d.250-500 mg b.i.d.250-500 mg b.i.d.250 mg b.i.d.250 mg b.i.d.LymeDiseaseUncomplicated Gonorrhea Uncomplicated Urinary Tract InfectionsMDR Typhoid Fever Community Acquired PneumoniaUncomplicated Skin and
Skin-Structure InfectionsSecondary Bacterial Infections of
Acute BronchitisAcute Bacterial Exacerbations of
Chronic BronchitisAcute Bacterial Maxillary SinusitisPharyngitis/TonsillitisDuration (days)DosageInfection
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side Effects:
Generally Cefuroxime-Clavulanic Acid is well tolerated. Major adverse reactions 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, itch, dysuria, sleepiness, thirst, anorexia etc.
Use in Special Group :
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.
Contraindication:
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to Cephalosporins& in patients with Pseudomonas Colitis.
Precautions:
As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic Acid combination may result in overgrowth of non-susceptible microorganisms.
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.
Storage :
Keep away from light & moisture and store below 250 C temperature. Keep out of reach of children.
Commercial Pack :
Roxilab Plus 250 Tablet : Each box contains 2 X 5 tablets in blister pack.
Roxilab Plus 500 Tablet : Each box contains 2 X 5 tablets in blister pack.
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