Fexitas

White to off-white colored, biconvex, oblong shaped film-coated tablet.
Each film-coated tablet contains: Cefixime (as trihydrate), USP 200 mg.

Pharmacotherapeutic group: Third generation cephalosporin.
Pharmacology: Pharmacodynamics: Cefixime (Fexitas) is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime (Fexitas).
Pharmacokinetics: The absolute oral bioavailability of Cefixime (Fexitas) is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime (Fexitas) may therefore be given without regard to meals.
From in vitro studies, serum or urine concentrations of 1 mcg/mL or greater were considered to be adequate for most common pathogens against which Cefixime (Fexitas) is active. Typically, the peak serum levels following the recommended adult or paediatric doses are between 1.5-3 mcg/mL. Little or no accumulation of Cefixime (Fexitas) occurs following multiple dosing.
The pharmacokinetics of Cefixime (Fexitas) in healthy elderly (age >64 years) and young volunteers (11-35) compared the administration of 400 mg doses once daily for 5 days. Mean Cmax and AUC values were slightly greater in the elderly. Elderly patients may be given the same dose as the general population.
Cefixime (Fexitas) is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of Cefixime (Fexitas) have not been isolated from human serum or urine.
Serum protein binding is well characterised for human and animal sera; Cefixime (Fexitas) is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of Cefixime (Fexitas) is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.
Transfer of 14C-labelled Cefixime from lactating rats to their nursing offspring through breast milk was quantitatively small (approximately 1.5% of the mother's body content of cefixime (Fexitas) in the pup). No data are available on secretion of Cefixime (Fexitas) in human breast milk. Placental transfer of Cefixime was small in pregnant rats dosed with labelled cefixime (Fexitas).

It is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms: Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
Lower Respiratory Tract Infection: e.g. bronchitis.
Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.

The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
Adults and Children over 10 years or weighing more than 50 kg: The recommended dose is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.
Children under 10 years: Cefixime (Fexitas) Tablets 200 mg are not recommended for use in children under 10 years old. The safety and efficacy of Cefixime (Fexitas) has not been established in children less than 6 months.
Elderly: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed, and dosage should be adjusted in severe renal impairment.
Renal impairment: Cefixime (Fexitas) may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances 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 peritoneal dialysis or hemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 mL/min.
Or as prescribed by the physician.

There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including Cefixime (Fexitas), particularly in case of overdose or renal impairment.
Adverse reactions seen at dose levels up to 2 g Cefixime (Fexitas) in normal subjects did not differ from the profile seen in patients treated at the recommended doses. Cefixime (Fexitas) is not removed from the circulation in significant quantities by dialysis.
No specific antidote exists. General supportive measures are recommended.

Hypersensitivity to cephalosporin antibiotics or to any of the excipients.

Encephalopathy: Beta-lactams, including Cefixime (Fexitas), predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCARS) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS) drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in association with cefixime (Fexitas). Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of skin hypersensitivity.
Cefixime (Fexitas) should be given with caution to patients who have shown hypersensitivity to other drugs.
Hypersensitivity to penicillins: As with other cephalosporins, cefixime (Fexitas) should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.
Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime (Fexitas), the drug should be discontinued and the patient treated with appropriate agents if necessary.
Hemolytic anemia: Drug-induced hemolytic anemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of hemolytic anemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime)-associated hemolytic anemia has also been reported.
Acute renal failure: As with other cephalosporins, Cefixime (Fexitas) may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, Cefixime (Fexitas) should be discontinued and appropriate therapy and/or measures should be taken.
Renal impairment: Cefixime (Fexitas) should be administered with caution in patients with markedly impaired renal function.
Antibiotic-associated colitis: Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of Pseudomembranous colitis may occur during or after antibiotic treatment.
Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Use in Children: Safety of cefixime (Fexitas) in premature or newborn infant has not been established.

Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefixime (Fexitas). In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefixime (Fexitas) should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

The following adverse reactions will be considered listed: Blood and lymphatic system disorders: Eosinophilia, Hypereosinophilia, Agranulocytosis, Leucopenia, Neutropenia, Granulocytopenia, Hemolytic anemia, Thrombocytopenia, Thrombocytosis.
Gastrointestinal Disorders: Abdominal pain, Diarrhea*, Dyspepsia, Nausea, Vomiting, Flatulence.
Hepatobiliary Disorders: Jaundice.
Infections and Infestations: Pseudomembranous colitis, Vaginitis.
Investigations: Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bilirubin increased, Blood urea increased, Blood creatinine increased.
Nervous system disorders: Dizziness, headache, cases convulsions have been reported with cephalosporins including cefixime (frequency not known)**.
Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment (frequency not known)**.
Respiratory, thoracic and mediastinal disorders: Dyspnea.
Renal and urinary disorders: Acute renal failure with tubulointerstitial nephritis.
Immune System Disorders: Anaphylactic Reactions, Angio-edema, Serum sickness-like reaction.
Skin and subcutaneous tissue disorders: Drug rash with eosinophilia and systemic symptoms (DRESS), Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria, Rash, Pruritus, Acute generalised exanthematous pustulosis (AGEP).
General Disorders and administrative site conditions: Drug fever, Arthralgia, Pyrexia, Face edema, Genital pruritus.
*Diarrhea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhea have been reported; this has occasionally warranted cessation of therapy. Cefixime (Fexitas) should be dicontinued if marked diarrhea occurs.
**Cannot be estimated from available data.

Anticoagulants: In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.
Cefixime (Fexitas) should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.
Other forms of interaction: A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.
A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the drug.

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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