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Zifex plus

  • ENG
  • မြန်မာ

 

COMPOSITION

Each film coated tablet contains:

Cefixime USP as Trihydrate

Equivalent to anhydrous Cefixime….200mg.

Diluted Potassium clavulanate BP

Equivalent to Clavulanate acid …….125mg

 

Description

Cefixime is a semisynthetic, third generation cephalosporin antibiotic, effective against a wide spectrum of sensitive Gram positive, Gram negative and anaerobic bacterial pathogens including beta-lactamase producing strains. It has high affinity for penicillin binding proteins with varying site of activity. It acts by inhibition of bacterial cell-wall synthesis.

 

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. Clavulanic acid is an irreversible inhibitor of intracellular and extracellular b-lactamases, demonstrating concentration-dependent and competitive inhibition.

 

Cefixime is found to be ineffective against bacteria which produces ESBL (Extended-Spectrum Beta-Lactamases)enzyme and resistance is seen in such types of bacteria. The combination of cefixime and clavulanic acid (b-lactamases inhibitor) provides a solution for treatment of bacterial infections caused by beta lactam resistant pathogens.

 

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

Otitis Media

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis,

 

DOSAGE

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.

 

ADVERSE EVENTS

The most frequent side effects seen with Cefixime-Clav are diarrhoea and stool changes. Events like nausea/vomiting, transient elevation in liver transaminases, alkaline phosphatase and jaundice can also occur.

 

DRUG INTERACTIONS

Carbamazepine: Elevated carbomazepine 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 of Fehling’s solutions or with copper sulphate test tablets.

Coombs test: A false positive direct Coombs test have been reported during treatment with cephalosporin antibiotics.

 

 

PREGNANCY & LACTATION

There are no adequate and well-controlled studies in pregnant women. Therefore this combination not be used in pregnancy or in nursing mothers Unless considered essential by the physician

 

OVERDOSE

Adverse reactions seen at dose levels up to 2g in normal subjects did not differ from the profile seen in patients treated at the recommended doses.

Gastric lavage may be indicated in overdosage.


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