TERGECEF OD Cefixime 400mg Capsule 1's
RXDRUG-DR-XY35403-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
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.
Dosage/Direction for Use
Cefixime (Tergecef) 100 mg and 200 mg capsule: See Table 3.
Oral Cefixime Dose for Specific Infections in Adults: See Table 4.
Overdosage
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.
Administration
May be taken with or without food.
Contraindications
History of allergy to any ingredient in this product or other cephalosporins.
History of hypersensitivity to penicillins.
History of hypersensitivity to penicillins.
Special Precautions
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of cefixime.
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 condition is limited, close clinical observation and appropriate laboratory studies should be made.
Use in Children: Safety and efficacy of cefixime in children less than six (6) months old have not been established.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of cefixime.
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 condition is limited, close clinical observation and appropriate laboratory studies should be made.
Use in Children: Safety and efficacy of cefixime in children less than six (6) months old have not been established.
Use In Pregnancy & Lactation
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.
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.
Adverse Reactions
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.
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.
Drug Interactions
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.
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.
Storage
Store at temperatures not exceeding 30°C.
Action
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 (Cmax) 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.
Peak serum concentrations of cefixime are approximately 15-50% higher when the drug is administered as an oral suspension rather than as tablets. When 200 and 400 mg doses of cefixime are administered as an oral suspension, peak serum concentrations average 3-3.4 mcg/mL and 4.6 mcg/mL, respectively. Areas under the concentration-time curves (AUCs) of 100-400 mg cefixime oral suspension are approximately 10-25% higher than cefixime tablets. This lack of bioequivalence between dosage forms should be considered if the oral suspension is to be substituted for tablets.
Cefixime is not extensively bound to protein; the free drug is about 31% and is concentration-dependent. The absolute bioavailability based on comparisons of the concentration-time curve values after 200 mg intravenous, 200 mg oral solution, and 200 and 400 mg capsule doses ranged from 40-52%, showing a comparable bioavailability for cefixime at single 200 and 400 mg oral doses. In a four-way cross-over study, the serum concentration time curve values of cefixime was 52.3%, 47.9%, and 40.2% after the 200 mg oral solution, 200 mg capsule and 400 mg capsule doses, respectively. Respective ratios based on 24-hour urinary recovery data were 44.7%, 41.7%, and 40.5% for the 200 mg oral solution, 200 mg capsule and 400 mg capsule doses.
The serum elimination half-life of cefixime in adults with normal renal function ranges from 2.4-4 hours. Cefixime is eliminated by renal and nonrenal mechanisms. Urinary concentrations of cefixime generally range from 2.2-103 mcg/mL during the first 2 hours and from 15.07-305 mcg/mL 6-8 hours after a single 200 or 400 mg oral dose of the drug. Fecal concentrations of cefixime in healthy adults may range from 0.237-1.55 g/kg following usual oral doses of the drug as capsules or tablets.
Studies in children using cefixime doses of 4 to 8 mg/kg body weight indicate that serum concentrations of cefixime are not directly dose proportional. In a dose proportionality study in healthy adults using an oral dose range of 200 to 2000 mg cefixime, Cmax and AUC increased linearly but were not also directly proportional with dose. Upon multiple dosing for 2 weeks with a 400 mg capsule daily or 200 mg twice daily regimen, serum concentrations and urinary recovery of unchanged drug were similar for each group showing that there was no drug accumulation.
Microbiology: Antimicrobial Spectrum of Activity: Cefixime is active against the following organisms, both in vitro and in clinical infections: See Table 2.
Pharmacokinetics: Cefixime is about 30% to 50% absorbed after oral administration; food has no effect on its absorption. Peak serum concentrations (Cmax) 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.
Peak serum concentrations of cefixime are approximately 15-50% higher when the drug is administered as an oral suspension rather than as tablets. When 200 and 400 mg doses of cefixime are administered as an oral suspension, peak serum concentrations average 3-3.4 mcg/mL and 4.6 mcg/mL, respectively. Areas under the concentration-time curves (AUCs) of 100-400 mg cefixime oral suspension are approximately 10-25% higher than cefixime tablets. This lack of bioequivalence between dosage forms should be considered if the oral suspension is to be substituted for tablets.
Cefixime is not extensively bound to protein; the free drug is about 31% and is concentration-dependent. The absolute bioavailability based on comparisons of the concentration-time curve values after 200 mg intravenous, 200 mg oral solution, and 200 and 400 mg capsule doses ranged from 40-52%, showing a comparable bioavailability for cefixime at single 200 and 400 mg oral doses. In a four-way cross-over study, the serum concentration time curve values of cefixime was 52.3%, 47.9%, and 40.2% after the 200 mg oral solution, 200 mg capsule and 400 mg capsule doses, respectively. Respective ratios based on 24-hour urinary recovery data were 44.7%, 41.7%, and 40.5% for the 200 mg oral solution, 200 mg capsule and 400 mg capsule doses.
The serum elimination half-life of cefixime in adults with normal renal function ranges from 2.4-4 hours. Cefixime is eliminated by renal and nonrenal mechanisms. Urinary concentrations of cefixime generally range from 2.2-103 mcg/mL during the first 2 hours and from 15.07-305 mcg/mL 6-8 hours after a single 200 or 400 mg oral dose of the drug. Fecal concentrations of cefixime in healthy adults may range from 0.237-1.55 g/kg following usual oral doses of the drug as capsules or tablets.
Studies in children using cefixime doses of 4 to 8 mg/kg body weight indicate that serum concentrations of cefixime are not directly dose proportional. In a dose proportionality study in healthy adults using an oral dose range of 200 to 2000 mg cefixime, Cmax and AUC increased linearly but were not also directly proportional with dose. Upon multiple dosing for 2 weeks with a 400 mg capsule daily or 200 mg twice daily regimen, serum concentrations and urinary recovery of unchanged drug were similar for each group showing that there was no drug accumulation.
Microbiology: Antimicrobial Spectrum of Activity: Cefixime is active against the following organisms, both in vitro and in clinical infections: See Table 2.
Cefixime has been shown to be active in vitro against most strains of Gram-positive organisms such as Streptococcus agalactiae and most strains of Gram-negative organisms such as Haemophilus parainfluenzae (β-lactamase positive and negative strains), Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Citrobacter amalonaticus, Citrobacter diversus, and Serratia marcescens; however, clinical efficacy has not been established.
MedsGo Class
Cephalosporins
Features
Brand
Tergecef OD
Full Details
Dosage Strength
400mg
Drug Ingredients
- Cefixime
Drug Packaging
Capsule 1's
Generic Name
Cefixime
Dosage Form
Capsule
Registration Number
DR-XY35403
Drug Classification
Prescription Drug (RX)
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