200 mg, 400 mg Capsules & 100 mg/5 ml Powder For Suspension

Fixpro (Cefixime) is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

  • Composition

    Fixpro 200 Capsule : Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.

    Fixpro 400 Capsule : Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 400 mg.

    Fixpro Powder for Suspension : After reconstitution, each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.

  • Indication

    Fixpro (Cefixime) is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis. Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes. Pharyngitis and tonsillitis caused by Streptococcus pyogenes. Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae. Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
  • Dosage & Administration

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses for 7-14 days depending on the severity of the infection. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended. Single 800 mg may be given if essential.

    Children upto 12 years: Usually 8mg/kg/day given as a single dose or in two divided doses or may be given as following :
    ½-1 year : 3.75 ml or 75 mg daily.
    1-4 years : 5 ml or 100 mg daily.
    5-10 years : 10 ml or 200 mg daily.
    11-12 years : 15 ml or 300 mg daily.
    The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

    The usual course of treatment is 7 days. This may be continued for up to 14 days as in typhoid or in any severe infection, if physicians desire. In typhoid fever, dosage should be 10mg/kg/day for 14 days.
  • Contraindication

    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
  • Precaution

    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml.min-1), in that case a dose of 200 mg once daily should not be exceeded.
  • Side Effects

    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
  • Drug Interaction

    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
  • Overdose

  • Pregnancy & Lactation

    US FDA Pregnancy Category of Cefixime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
  • Storage Condition

    Keep in a dry place away from light and heat. Keep out of the reach of children.
  • How Supplied

    Fixpro 200 Capsule :Each box contains 12 capsules in Alu-Alu blister pack.

    Fixpro 400 Capsule : Each box contains 4 capsules in Alu-Alu blister pack.

    Fixpro Powder for Suspension : Each amber glass bottle contains dry powder to reconstitute 50 ml suspension.