Ezcef Cefixime USP Tablets

EZCEF

Cefixime Tablets USP 400 mg

 

THE DESCRIPTION OF THE DRUG

Brand Name: EZCEF

Generic Name: CEFIXIME TABLETS USP 400 MG

Dosage Form And Strenght: Solid Oral Dosage Form; Tablet 400mg

Active Ingredient: Cefixime USP
C16H15N5O7S2.3H2O 6R,7R)-7-{[2-(2-amino-1,3-thiazol-4-yl)-2 (carboxymethoxyimino)acetyl]amino}- 3-ethenyl-8-oxo-5thia azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

Net Content: 400mg

 

CLINICAL PHARMACOLOGY

Mechanism Of Action

Antimicrobial Spectrum: Cefixime is a semi-synthetic third generation oral cephalosporin with a broad spectrum of antibacterial activity against many Gram positive and Gram negative bacteria. It is highly stable in presence of betalactamases. Cefixime tablet is bactericidal to a wide range of organisms including:

Gram Positive: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae.

Gram Negative: Hemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), Escherichia coli, Proteus vulgaris, Klebsiella species, Pasteurella multocida, Providencia species, Salmonella species, Shigella species, Citrobacter species, Neisseria gonorrheae.

Cefixime is not effective against Pseudomonas spp, group D streptococci (including enterococci), Listeria monolcytogenes, most staphylococcal strains (including methicillin-resistant strains), Enterobacter spp, and most strains of bacteroides and clostridia.

 

Pharmacokinetics And Metabolism

Absorption: Absorption of cefixime is 40-50% with or without food. The time to maximal absorption is 0.8 hours when Cefixime Tablet is given with food.

Plasma Levels: Peak plasma concentrations (Cmax) are produced 2 to 5 hours (Tmax) with a single dose of Cefixime Tablet Suspension. With doses of 200 to 400 mg, average Cmax is 3 mcg/ml and 4.6 mcg/ml respectively. The Cmax and area under the curve (AUC) are 10-25% with oral suspension as compared to tablets after doses of 100-400 mg of cefixime tablet. Average AUCs are 40% higher at steady state. The plasma half-life of cefixime is 3-4 hours, and may range up to 9 hours.

The serum protein binding is concentration-independent and the bound portion constitutes 65%. It achieves extremely high concentrations in bile following cefixime tablet administration.

Elimination: Approximately 50% of cefixime tablet’s dose is excreted in urine in 24 hours; over 10% of intake is also eliminated via bile.

 

INDICATIONS AND USAGE

Cefixime tablet is indicated for the treatment of infections caused by susceptible bacteria for

• Upper respiratory tract infections e.g. Otitis media and other URTI such as pharyngitis and tonsillitis.

• Lower respiratory tract infections e.g. Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis.

• Uncomplicated urinary tract infections e.g. cystitis, cystourethritis, pyelonephritis.

 

CONTRAINDICATIONS

Cefixime contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

 

DRUG INTERACTIONS

Carbamazepine: Elevated carbamazepine levels have been reported in post marketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

 

WARNINGS

• Periodic assessment of hematopoietic function is advisable during prolonged cefixime tablet therapy.

• Cefixime Tablet is not ideally meant for pregnant lady or lactating mother; however, it could be only if strictly necessary.

• Nursing discontinuation temporarily must be considered whilst taking cefixime tablet. Safety and efficacy of cefixime in children less than 6 months old have not been established.

 

PRECAUTIONS

• Cefixime Tablet should be advocated with caution in presence of renal impairment or GI disease, particularly colitis.

• Prolonged use of cefixime tablet could result in overgrowth of non- susceptible organisms.

• If super infections occur (usually involving Aerobacter, Pseudomonas or Candida spp), cefixime tablet should be discontinued and/or appropriate therapy instituted.

 

ADVERSE REACTIONS

Hypersensitivity: Anaphylactic reaction including shock, internal swelling of the larynx with airways constriction, fever, serum sickness-like reaction, rash, urticaria, angioedema, pruritus and inflammation of mucous membranes. Toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema mutiforme have also rarely been reported.

Haematology: Pancytopenia, leucopenia, eosinophilia, haemolytic anaemia, thrombocytopenia, thrombocytosis, hypereosinophilia, neutropenia, prolongation in prothrombin time and blood coagulation disturbances.
Agranulocytosis has also been rarely reported.

Hepatic: Hepatitis, jaundice, increases in ALT, AST and alkaline phosphatase. Increase in bilirubin.

Gastrointestinal: Serious colitis (such as pseudomembranous colitis), diarrhoea, abdominal pain, vomiting, nausea, dyspepsia, anorexia and flatulence.

Renal: Transient elevation in BUN or creatinine and rare cases of renal failure and interstitial nephritis.

Others: Candidiasis, genital pruritus, vaginitis, headache, dizziness and hyperactivity.

 

DRUG ABUSE AND DEPENDENCE

Not Applicable.

 

SYMPTOMS OF OVERDOSE AND ANTIDOTE

There has been limited clinical experiences with overdose of cefixime to date.

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

Gastric lavage may be indicated in over dosage. No specific antidote exists.

Cefixime is not removed from the circulation in significant quantities by dialysis.

 

DOSAGE AND ADMINISTRATION

Adults: The recommended dose of cefixime is 400mg daily.

Children 5-10 years: 200mg daily.

 

PREPARATION FOR USE

Not applicable.

 

PRESENTATION

10 x 1 x 10 Tablet Alu Alu Pack.

 

STORAGE CONDITION

Store in a dry place at a temperature below 30°C.

 

Marketed by

DONY-TRIUMPH & CO. NIG. LTD.

19 Ozubulu Street, Fegge Onitsha, Nigeria.

 

Manufactured by

WEST- COAST Pharmaceutical Works Ltd.

FP No. 17 & 16/5, Meldi Estate, B/s. Meldi Mata Temple, Nr. Gota

Railway Crossing, At & post: Gota, Ahmedabad –382 481, Gujarat. INDIA.

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