Cefixime 400 mg Capsule, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Cefixime is used to treat several bacterial infections: urinary tract infections (UTIs), ear infections (otitis media), strep throat and tonsillitis, acute flare-ups of chronic bro...
- What infections is cefixime used to treat?
- It depends on the form. Tablets and capsules can be taken with or without food — though food does reduce how much of the capsule your body absorbs a bit. The oral suspension can al...
- This is really important to tell your doctor before you start. Cefixime is in the cephalosporin family of antibiotics, and there's a documented cross-allergy with penicillin — it c...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cefixime — tap one for details:
Cefixime may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII NZ94SDL6WR
Low-substituted hydroxypropyl cellulose is a plant-based thickener and binder made from cellulose. It helps hold the medicine together, controls how quickly it dissolves, and improves texture in tablets and capsules.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $12.04 | $120.45 / 10 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefixime 400 mg 68180-0423-08 | Lupin | 50 capsules | $9.917 | AB | Availability likely | — |
| Cefixime 400 mgthis 59651-0647-10 | Aurobindo | 10 capsules | — | AB | FDA listed | — |
| Cefixime 400 mg 67877-0584-01 | Ascend | 100 capsules | — | AB | FDA listed | — |
| Cefixime 400 mg 70518-2749-05 | REMEDYREPACK | 2 capsules | — | AB | FDA listed | — |
| Cefixime 400 mg 70518-3221-00 | REMEDYREPACK | 2 capsules | — | AB | Discontinued | — |
| Cefixime 400 mg 83112-0400-00 | Health | 2 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59651-0647-10 You're viewing this | 1 BLISTER PACK in 1 CARTON (59651-647-10) / 10 CAPSULE in 1 BLISTER PACK | — | — | 2026-03-23 | Active |
| 59651-0647-50 | 50 CAPSULE in 1 BOTTLE (59651-647-50) | $9.92 / ea | $495.87 | 2026-03-23 | Active |
Pack size FAQ
What quantity is in NDC 59651-0647-10?
What is the difference between NDC 59651-0647-10 and NDC 59651-0647-50?
What NDC number is used to bill for this package of Cefixime 400 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
( 1.6 )
1.1Uncomplicated Urinary Tract Infections Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis .
1.3Pharyngitis and Tonsillitis Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime capsules are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.)
1.4Acute Exacerbations of Chronic Bronchitis Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.
1.5Uncomplicated Gonorrhea (cervical/urethral) Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
1.6Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults: 400 mg daily ( 2.1 ) Pediatric patients (6 months and older): 8 mg/kg/day ( 2.2 )
2.1Adults The recommended dose of cefixime capsule is 400 mg daily. This may be given as a 400 mg capsule daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule may be administered without regard to food. In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days.
2.2Pediatric Patients (weighing more than 45 kg or older than 12 years) Pediatric patients weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the Suprax tablet or cefixime capsule should not be substituted for the Suprax chewable tablets or Suprax for oral suspension in the treatment of otitis media [ see CLINICAL PHARMACOLOGY (12.3) ].
In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days.
2.3Renal Impairment Cefixime 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. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cefixime capsules are available for oral administration in the following dosage strength: Capsules provide 400 mg of cefixime USP as trihydrate. These are size “0” capsules with pink opaque cap imprinted with “CMI” and pink opaque body imprinted with “400” in black ink. Capsules contain white to yellowish white powder. Capsules: 400 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Cefixime capsules are contraindicated in patients with known allergy to cefixime or other cephalosporins. Contraindicated in patients with known allergy to cefixime or other cephalosporins. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs. ( 5.1 ) Clostridiodes difficile- Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.2 )
5.1Hypersensitivity Reactions Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to cefixime occurs, discontinue the drug.
5.2Clostridioides difficile -Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefixime, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
5.3Dose Adjustment in Renal Impairment The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration (2) ] .
5.4Coagulation Effects Cephalosporins, including cefixime, may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic 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.
5.5Development of Drug-Resistant Bacteria Prescribing cefixime in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly seen adverse reactions in U.S. trials of the Suprax tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions.
Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.
6.2Post-marketing Experience The following adverse reactions have been reported following the post-approval use of cefixime. Incidence rates were less than 1 in 50 (less than 2%). Gastrointestinal Several cases of documented pseudomembranous colitis were identified in clinical trials.
The onset of pseudomembranous colitis symptoms may occur during or after therapy. Hypersensitivity Reactions Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.
Hepatic Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice. Renal Transient elevations in BUN or creatinine, acute renal failure. Central Nervous System Headaches, dizziness, seizures.
Hemic and Lymphatic System Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia. Abnormal Laboratory Tests Hyperbilirubinemia. Other Adverse Reactions Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.
Adverse Reactions Reported for Cephalosporin-class Drugs Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced [see Dosage and Administration (2) and Overdosage (10) ] . If seizures associated with drug therapy occur, the drug should be discontinued.
Anticonvulsant therapy can be given if clinically indicated.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. ( 7.1 ) Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. ( 7.2 )
7.1Carbamazepine Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
7.2Warfarin and Anticoagulants Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.
7.3Drug/Laboratory Test Interactions A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of cefixime may result in a false-positive reaction for glucose in the urine when using glucose tests based on the Benedict’s solution or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Efficacy and safety in pediatric patients younger than 6 months of age have not been established. ( 8.4 ) Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
( 8.5 ) Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Dose adjustment is required in patients whose creatinine clearance is less than 60 mL/min. ( 8.6 )
8.1Pregnancy Risk Summary Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Reproduction studies have been performed in mice and rats at doses equivalent to 40 and 80 times, respectively, the adult human recommended dose and have revealed no evidence of harm to the fetus due to cefixime (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified a consistent association with cephalosporin use, including cefixime, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data The results of embryo-fetal development studies in mice and rats show that cefixime, at doses up to 3200 mg/kg/day administered during the period of organogenesis did not adversely affect development. In these studies, in mice and rats, cefixime did not affect postnatal development or reproductive capacity of the F 1 generation or fetal development of the F 2 generation.
In an embryo-fetal development study in rabbits, cefixime at doses of 3.2, 10 or 32 mg/kg given daily during the period of organogenesis (gestation days 6 through 18) resulted in abortions and/or maternal deaths at doses > 10 mg/kg (typically associated with the administration of antibiotics in this species), but no malformations were reported at lower doses. A pre- and post-natal development study of cefixime at oral doses up to 3200 mg/kg/day in rats demonstrated no effect on the duration of pregnancy, process of parturition, development and viability of offspring, or reproductive capacity of the F 1 generation and development of their fetuses (F 2 ).
8.2Lactation Risk Summary There are no available data on the presence of cefixime in human milk, the effects on the breastfed infant, or the effects on milk production. Cefixime is present in animal milk (see Data). When a drug is present in animal milk, it is likely the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefixime and any potential adverse ef…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Reproduction studies have been performed in mice and rats at doses equivalent to 40 and 80 times, respectively, the adult human recommended dose and have revealed no evidence of harm to the fetus due to cefixime (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified a consistent association with cephalosporin use, including cefixime, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data The results of embryo-fetal development studies in mice and rats show that cefixime, at doses up to 3200 mg/kg/day administered during the period of organogenesis did not adversely affect development. In these studies, in mice and rats, cefixime did not affect postnatal development or reproductive capacity of the F 1 generation or fetal development of the F 2 generation.
In an embryo-fetal development study in rabbits, cefixime at doses of 3.2, 10 or 32 mg/kg given daily during the period of organogenesis (gestation days 6 through 18) resulted in abortions and/or maternal deaths at doses > 10 mg/kg (typically associated with the administration of antibiotics in this species), but no malformations were reported at lower doses. A pre- and post-natal development study of cefixime at oral doses up to 3200 mg/kg/day in rats demonstrated no effect on the duration of pregnancy, process of parturition, development and viability of offspring, or reproductive capacity of the F 1 generation and development of their fetuses (F 2 ).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of cefixime have been established in pediatric patients 6 months of age and older. Safety and effectiveness of cefixime in pediatric patients younger than 6 months of age have not been established. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the Suprax for oral suspension, was comparable to the incidence seen in adult patients receiving tablets.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see Clinical Pharmacology (12.3) ] .
These differences were small and do not indicate a need for dosage adjustment of cefixime in the elderly.
🆘 Overdosage ▾
10 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cefixime is a semisynthetic cephalosporin antibacterial drug [see Microbiology (12.4) ] .
12.3Pharmacokinetics Suprax tablets and Suprax for oral suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of Suprax produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg Suprax tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The Suprax for oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers.
Two hundred and 400 mg doses of Suprax for oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the Suprax for oral suspension than with the Suprax tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the Suprax for oral suspension is to be substituted for the Suprax tablet.
Because of the lack of bioequivalence, SUPRAX tablets should not be substituted for SUPRAX for oral suspension in the treatment of otitis media [see Dosage and Administration (2) ] . Cross-over studies of Suprax tablet versus Suprax for oral suspension have not been performed in pediatric patients. The 400 mg cefixime capsule is bioequivalent to the 400 mg Suprax tablet under fasting conditions.
However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on C max . Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg Suprax tablet or 400 mg of Suprax for oral suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of Suprax for oral suspension.
Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg cefixime capsule. Distribution Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the Suprax tablet or Suprax for oral suspension, there was little accumulation of drug in serum or urine after dosing for 14 days.
Adequate data on CSF levels of cefixime are not available. Elimination Metabolism and Excretion There is no evidence of metabolism of cefixime in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours.
In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers. Specific Populations Geriatric Patients: Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults.
Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of cefixime once daily for 5 days are summarized as follows: Table 4. Pharmacokinetic Parameters for Cefixime in Both Young and Elderly Subjects Pharmacokinetic Parameters (mean ± SD) for Cefixime in Both Young and Elderly Subjects Pharmacokinetic parameter Young Elderly C max (mg/L) 4.74 ± 1.43 5.68 ±
1.83T max (h)* 3.9 ± 0.3 4.3 ±
0.6AUC (mg.h/L)* 34.9 ± 12.2 49.5 ±
19.1T ½ (h)* 3.5 ± 0.6 4.2 ±
0.4C ave (mg/L)* 1.42 ±0.50 1.99 ± 0.75 *Difference between age groups was significant. (p<0.05) Howeve…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cefixime is a semisynthetic cephalosporin antibacterial drug [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Cefixime Capsules, 400 mg are size “0” capsules with pink opaque cap imprinted with “CMI” and pink opaque body imprinted with “400” in black ink containing white to yellowish white powder containing 400 mg of cefixime USP as the trihydrate. They are supplied as follows: Bottles of 50 NDC 59651-647-50 Cartons of 10 (1 x 10) Unit-dose Capsules NDC 59651-647-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]
📋 Description ▾
11 DESCRIPTION Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is ( 6R,7R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 7 2 -( Z )-[ O -(carboxy methyl) oxime] trihydrate. Molecular weight = 507.50 as the trihydrate.
Chemical Formula is C 16 H 15 N 5 O 7 S 2 .3H 2 O The structural formula for cefixime is: Inactive ingredients contained in cefixime 400 mg capsules are: colloidal silicon dioxide, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, and mannitol. The capsule shell contains the following inactive ingredients: gelatin, iron oxide red, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Development of Drug Resistance Bacteria Patients should be counseled that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime or other antibacterial drugs in the future. Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including cefixime, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug.
If this occurs, patients should contact their physician as soon as possible. The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2026