BENIXIM CV 200 Tablet

Therapeutic Class

Cephalosporins

Indications

Cefixime-Clav should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Cefixime-Clav is indicated for the treatment of: Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis. Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta- lactamase positive) and S. pyogenes* -Pharyngitis and Tonsillitis, caused by S. pyogenes. -Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains). -Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).

Chemical Composition

Cefixime USP (As trihydrate) eq. to Anhydrous Cefixime 200 mg
Diluted Potassium Clavulanate BP eq. to Clavulanic acid 125 mg
Excipients q.s
Color: Titanium Dioxide BP

Packaging

1 x 10's / Box

Dosage & Administration

Adults and Children over 10 Years: One tablet twice daily. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Contraindications

Cefixime and Potassium Clavulanate tablet/ suspension are contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.

Warning & Precautions

Cefixime and Potassium Clavulanate tablet/ suspension should be given with caution to patients who have shown hypersensitivity to penicillin-sensitive patients, as there is some evidence of partial cross allergenicity between the penicillins and cephalosporins . If an allergic effect occurs with, the drug should be discontinued and the patient treated with appropriate agents if necessary. Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia and may result in antibiotic-associated diarrhoea . Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics; it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics.

Side Effects

The majority of adverse reactions are mild and self-limiting in nature. The most frequent side effects seen with Cefixime are diarrhoea, stool changes, nausea, abdominal pain, dyspepsia, vomiting and flatulence, headache, dizziness, allergies in the form of rash, pruritus, drug fever, arthralgia, including rare cases of urticaria or angioedema, erythema ·multiforme, Stevens-Johnson syndrome, thrombocytosis, thrombocytopenia, leucopenia, hypereosinophilia,neutropenia, agranulocytosis, transient rises in liver transaminases, alkaline phosphatase and jaundice can also occur.

Drug Interaction

Carbamazepine: Elevated carbamazepine levels have been reported when cefixime is administered concomitantly. Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly. Oral Contraceptives: Cefixime may interfere with the effectiveness of birth control pills. Glucose Test: A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets. Coombs test: A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics.