Fixbact

Cefixime trihydrate.

Each Film-Coated Tablet contains: Cefixime Trihydrate USP equivalent to anhydrous Cefixime 200 mg.
Cefixime is a third generation cephalosporin which has antibacterial activity similar to penicillins, carbacephems and cephamycins. It has a vinyl group at the 3^rd position and a carboxymethoxylimino group at the 7^th position of 7-aminocephalosporanic acid.

Pharmacology: Pharmacodynamics: Cefixime exerts its bactericidal activity by interfering with the synthesis of the bacterial cell wall. It binds to specific penicillin-binding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of peptidoglycan synthesis involves completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosporins. Thus, inhibition of the transpeptidase interrupts peptidoglycan synthesis, causing formation of defective cell walls and osmotically unstable spheroplasts and lysis of the bacteria.
Pharmacokinetics: Cefixime is about 30% to 50% absorbed after oral administration; food has no effect on its absorption. Peak serum concentrations (C_max) after a single, oral 200 or 400 mg dose of cefixime as capsule, tablet or oral suspension are attained between 2 to 6 hours. Although there are differences in pharmacokinetic parameters between the formulations, results of controlled, cross-over studies in healthy adults indicate that the capsules are essentially bioequivalent to tablets. However, oral suspension is more completely absorbed than tablets, thus, tablets theoretically should not be substituted for oral suspension.

For the treatment of the following infections due to susceptible microorganisms: Acute bronchitis, acute exacerbations of chronic bronchitis, bronchiectasis with infection, secondary infections in chronic respiratory tract diseases, pneumonia; Urinary tract infections including pyelonephritis and cystitis; Gonococcal urethritis; Cholecystitis, cholangitis; Scarlet fever; Sinusitis, tonsillitis, pharyngitis, otitis media; Typhoid fever (enteric fever) including multi-drug resistant typhoid fever.

Adults: The recommended dose of Cefixime trihydrate (Fixbact) is 400 mg daily. This may be given as a 400 mg tablet daily or as 200 mg tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
Children: 8 mg/kg body weight daily as a single or 2 divided doses. Not recommended for children below 6 months of age. Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose. Otitis media should be treated with the suspension. Efficacy and safety in infants aged less than six months have not been established. In the treatment of infections due to S. pyogenes, a therapeutic dosage of Cefixime trihydrate (Fixbact) should be administered for at least 10 days or as prescribed by the physician.
Renal Impairment: Cefixime trihydrate (Fixbact) may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given of the 75% standard dosage at the standard dosing interval (ie, 300 mg daily). Patients whose clearance 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (ie, 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
DIRECTIONS FOR USE: Take each dose with a full glass of water. Take Cefixime trihydrate (Fixbact) with food or milk if it causes stomach upset. Continue taking the medication till the prescribed course is complete.

Gastric lavage may be indicated. Otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

History of allergy to any ingredient in this product or other cephalosporins.
History of hypersensitivity to penicillins.

A thorough inquiry about the patient's previous hypersensitivity history should be made. Cefixime, like other cephalosporins, penicillins and other drugs, may cause serious hypersensitivity reactions and should be used with caution in any patient who has demonstrated some allergy to any drug. Although it has not been established, allergic reactions to antibiotics may occur more frequently in atopic individuals.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous fluids and intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been observed with the use of nearly all antibacterial agents, including Cefixime, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
A false-positive Coombs test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs test may be due to the drug, e.g., Coombs testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
General: As with other broad-spectrum antibiotics, Cefixime should be given with caution in individuals with a history of colitis. The safety and efficacy of Cefixime have not been established in patients with gastrointestinal malabsorption.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with kidney or liver impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing Cefixime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Renal Insufficiency: Administer Cefixime with caution in the presence of markedly impaired renal function. Modification of usual dosage is not necessary in patients with moderate or severe renal impairment. However, because clinical experience with Cefixime under such conditions is limited, close clinical observation and appropriate laboratory studies should be made.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of Cefixime.
Use in Children: Safety and efficacy of Cefixime in children less than six (6) months old have not been established.

Pregnancy: (Pregnancy category B) There are no adequate and well-controlled studies in pregnant women. Potential benefit should justify the potential risk when Cefixime is used during pregnancy.
Labor and Delivery: The effect of Cefixime in labor and delivery is unknown.
Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with Cefixime.

Most adverse effects reported with Cefixime were similar to those reported with other oral cephalosporins and were usually mild and transient in nature.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, fever, pruritus, arthralgia, angioedema, facial edema; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness-like reactions.
Gastrointestinal Effects: Diarrhea, loose or frequent stools, abdominal pain, anorexia, flatulence, dry mouth, dyspepsia, nausea, and vomiting. Several cases of documented pseudomembranous colitis were identified during the clinical studies on Cefixime. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
Hepatic Effects: Transient elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, hepatitis, and jaundice.
Renal Effects: Transient elevations in blood urea nitrogen (BUN) or creatinine levels, and rarely, acute renal failure.
Central Nervous System Effects: Headache, dizziness, nervousness, insomnia, somnolence, malaise, fatigue, seizures.
Hematologic Effects: Transient thrombocytopenia, leukopenia, neutropenia and eosinophilia; prolongation of prothrombin time was seen rarely.
Abnormal Laboratory Test: Hyperbilirubinemia.
Other Adverse Events: Rarely, genital pruritus, vaginitis, and candidiasis.
The following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.
Abnormal Laboratory Tests: Positive Coombs test, elevated lactate dehydrogenase (LDH), pancytopenia, agranulocytosis.

Carbamazepine: Elevated carbamazepine levels have been reported when administered concomitantly with Cefixime. Drug monitoring when these drugs are given together is advised.
Warfarin and other anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when Cefixime is given concomitantly.
Probenecid: Concomitant administration of probenecid reportedly increases peak serum concentration and AUC of Cefixime and decreases renal clearance and volume of distribution of the drug.
Salicylates: Concomitant administration of 650 mg oral dose of aspirin and a 400 mg oral dose of Cefixime in healthy adult men may result in a 20 - 25% decrease in peak serum concentration of Cefixime and AUC of the drug but did not affect protein binding, serum half-life or renal clearance. This effect may not be clinically important since serum concentrations of Cefixime remained higher than the MIC values reported for most susceptible organisms. However, some clinicians state that this effect may be clinically important in certain infections.
Interference with Laboratory Tests: Nitroprusside test: A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.
Coombs test: A false-positive direct Coombs test has been reported during treatment with other cephalosporin antibiotics; therefore it should be recognized that a positive Coombs test may be due to the drug.
Clinitest, Benedict's solution, Fehling's solution: A false-positive reaction for glucose in the urine using Clinitest, Benedict's solution, or Fehling's solution may result when done during therapy with Cefixime. It is recommended that other tests based on enzymatic glucose oxidase reactions be used instead.

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.

Rx