Information

  • AROFIX -DT 100/ 200 /400 / DS ( 50 mg in 5 ml & 100 mg in 5 ml)
  • Dosage Form: Tablets & Dry syrup
  • Pack Type: ALU-ALU & PVC bottle
  • Pack Size: 1X10 Tablets & 60 ml bottle
  • Division: Unimax

AROFIX -DT 100/ 200 /400 / DS

Cefixime

AROFIX - 400: Each film-coated tablet contains Cefixime Trihydrate USP equivalent to Cefixime anhydrous 400 mg 

AROFIX - 200: Each film-coated tablet contains Cefixime Trihydrate USP equivalent to Cefixime anhydrous 200 mg 

AROFIX DT - 100: Each uncoated dispersible tablet contains Cefixime Trihydrate USP equivalent to Cefixime anhydrous 100 mg

AROFIX DS : Each 5ml of reconstituted powder solution contains Cefixime Trihydrate equivalent to  Cefixime anhydrous 50 mg

AROFIX DS-100 : Each 5ml of reconstituted powder solution contains Cefixime Trihydrate equivalent to  Cefixime anhydrous 100 mg

Clinical Pharmacology:

Pharmacodynamic properties:

Cefixime, an antibiotic, is a third-generation cephalosporin. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

 

Pharmacokinetic properties:

Absorption: The absolute bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may, therefore, be given without regard to meals. 

 

Distribution: Serum protein binding is well characterized for human and animal sera; cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of cefixime is only concentration-dependent in human serum at very high concentrations which are not seen following clinical dosing. 

From in vitro studies, serum or urine concentrations of 1 mg/L or greater were considered to be adequate for most common pathogens against which cefixime is active. Typically, the peak serum levels following the recommended adult or pediatric doses are between 1.5 and 3 mg/L. Little or no accumulation of cefixime occurs following multiple dosing. 

 

Metabolism and elimination: Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of cefixime have not been isolated from human serum or urine. 

No data are available on the secretion of cefixime in human breast milk. Placental transfer of cefixime was small in pregnant rats dosed with labeled cefixime. 

 

 

It is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:

  • Upper Respiratory Tract: Pharyngitis and tonsillitis caused by S. pyogenes.
  • Middle Ear: Otitis media caused by S. pneumoniae, H. influenzae and S. pyogenes
  • Paranasal sinuses: Sinusitis caused by S. pneumoniae, H. influenza and M. catarrhalis.
  • Lower Respiratory Tract: Acute bronchitis caused by S. pneumoniae, M. catarrhalis and H. influenza.
  • Urinary Tract: Acute uncomplicated cystitis and urethritis caused by E. coli, P. mirabilis, and Klebsiella species.
  • Uncomplicated Gonorrhea: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae, including penicillinase and non-penicillinase producing strains.

 

 

Adults and children over 10 years of age (body weight is greater than 50 kg): The recommended dose is 200-400 mg daily according to the severity of the infection, given either as a single dose or in two divided doses.

Elderly patients: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe impairment.

Children weighing more than 50 kg or older than 10 years should be treated with the recommended adult dose (200 -400 mg daily), depending on the severity of the infection.

Children younger than 6 months of age: The safety and efficacy of cefixime has not been established in children less than 6 months.

Renal impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearance of 20 ml/ min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory dialysis or hemodialysis should follow the same recommendation as that for patients with creatinine clearance of less than 20 ml/min.

Method of administration:

Cefixime Tablets are for oral administration only. The absorption of cefixime is not significantly affected by the presence of food. Hence it can be administered with or without food.

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Cefixime can affect the way some other medicines work. Also, some medicines can affect the way Cefixime works.

In particular, tell your doctor if you are taking the following:

  • Medicines to thin the blood such as warfarin

  • Stomach upset
  • Diarrhea
  • Nausea
  • Gas
  • Headache
  • Dizziness

 

CONTRAINDICATIONS:

  • Patients with known hypersensitivity to cefixime, other cephalosporin antibiotics.
  • Cefixime is also contraindicated in patients with previous, immediate and/or severe hypersensitivity to penicillin or any beta-lactam antibiotics and preterm and term newborn infants.

 

PRECAUTIONS FOR USE:

  • Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalsporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between penicillin and cephalsporins.
  • Patients have had severe reactions (including anaphylaxis) to both classes of drugs. Special care is indicated in patients who have experienced any allergic reaction to penicillins or any beta-lactam antibiotics as cross-reactions may occur.
  • If severe hypersensitivity reactions or anaphylactic reactions occur after administration of Cefixime, the medicine should be discontinued immediately and appropriate emergency measures should be initiated.
  • Prolonged use of cefixime may result in the overgrowth of non-susceptible organisms.
  • In patients who develop severe diarrhea during or after the use of cefixime, the risk of life-threatening pseudo-membranous colitis should be taken into account. The use of cefixime should be discontinued and appropriate treatment measures should be established.
  • Cefixime should be administered with caution in adult patients with creatinine clearance <20ml/min.
  • There are insufficient data regarding the use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency, the use of cefixime in these patient-groups is not recommended.

 

Pregnancy: For cefixime, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition, or postnatal development. Cefixime should not be used in pregnant mothers unless considered essential by the physician.

Breast-feeding: It is unknown whether cefixime is excreted in human milk and non-clinical studies have shown excretion of cefixime in animal milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with cefixime should be made taking into account the benefit of breast-feeding to the child and the benefit of cefixime therapy to the woman. However, until the further clinical experience is available, cefixime should not be prescribed to breast-feeding mothers.

Fertility: Animal studies do not indicate any harmful effects with respect to fertility; however, no clinical data are available. 

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Cefixime has no known influence on the ability to drive and use machines. However, side effects may occur which may influence the ability to drive and use machines.

Overdose: There is no experience of overdose with Cefixime.