cefixime
Pharmaranks rates Cefixime 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cefixime is a cephalosporin antibacterial used to treat Bronchitis, Escherichia Coli Infections, Gonorrhea, Haemophilus Infections.
Cephalosporin Antibacterial · by Fdc Ltd
Generic of Suprax
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cefixime
- Drug class
- Cephalosporin Antibacterial
- Form
- Capsule, Powder, Tablet
- Strength
- Cefixime 400MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- bronchitis, escherichia coli infections, gonorrhea
- Manufacturer
- Fdc Ltd
- What the pharmacy pays
- ~$10.03 per ml — not your price
- FDA application
- ANDA206358
What is Cefixime?
From the FDA label: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: Cefixime is available for oral administration as 400 mg film coated tablets. Inactive ingredients contained in the cefixime tablets, USP 400 mg are: dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. Cefixime Structure
How to use
Cefixime is sold in more than one form (Capsule, Powder and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA206358 — follow the label that came with the product you were actually prescribed.
Adults: 400 mg daily ( 2.1 ) Children: weighing more than 45 kg or older than 12 years should be treated with recommended adults dose ( 2.2 ) 2.1 Adults The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The tablet 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. 2.2 Pediatric Patients (weighing more than 45 kg or older than 12 years) Children 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 tablet should not be substituted for the chewable tablets or 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. 2.3 Renal Impairment Cefixime may be administered in the…
Side effects
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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 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%. 6.2 Post-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…
Warnings
Important safety information
Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs. ( 5.1 ) Clostridium difficile associated diarrhea: Evaluate if diarrhea occurs. ( 5.2 ) 5.1 Hypersensitivity 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. 5.2 Clostridium difficile -Associated Diarrhea Clostridium 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. 5.3 Dose 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 ) ]. 5.4 Coagulation 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. 5.5 Development 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.
Who should not take Cefixime
Contraindicated in patients with known allergy to cefixime or other cephalosporins. ( 4 ) Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 ) 7.1 Carbamazepine 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. 7.2 Warfarin and Anticoagulants Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly. 7.3 Drug/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 using Clinitest ® **, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ® ** or TesTape ® **) 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. **Clinitest ® and Clinistix ® are registered trademarks of Ames Division, Miles Laboratories, Inc. Tes-Tape ® is a registered trademark of Eli Lilly and Company.
Storing Cefixime, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard unused portion after 14 days.”
Drug class
How this class works, per Cephalosporins - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- bronchitis
- escherichia coli infections
- gonorrhea
- haemophilus infections
- klebsiella infections
- otitis media
See how Cefixime ranks — best-rated cephalosporin antibacterial for:
Dosage forms
Capsule, Powder and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cefixime treat?
- Cefixime (Cefixime) may be used to treat bronchitis, escherichia coli infections, gonorrhea, haemophilus infections, klebsiella infections, otitis media, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cefixime work?
- Cefixime is a cephalosporin antibacterial. Cephalosporins kill bacteria by blocking the proteins they use to build their cell walls. Without an intact wall, the bacterium cannot hold its shape and dies, which clears the infection.
- How is Cefixime rated?
- pharmaranks gives Cefixime a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Cefixime cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $10.03 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Cefixime?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cefixime. To pay less, Cefixime is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cefixime?
- Cefixime is marketed by Fdc Ltd. You can see Fdc Ltd's full profile, rating, and other products on pharmaranks.
- Is Cefixime a brand-name or generic drug?
- Cefixime is a generic medication; its active ingredient is Cefixime. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Cefixime available over the counter?
- No. Cefixime is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cefixime come in?
- Cefixime is currently marketed as capsule, powder and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Cefixime?
- Cefixime is classified as cephalosporin antibacterial, per the FDA's Established Pharmacologic Class.
- Is Cefixime FDA-registered?
- Cefixime is on record with the U.S. FDA under application number ANDA206358. You can verify this on its official FDA label.
- Has Cefixime been recalled by the FDA?
- Cefixime has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cefixime safe?
- There's no single safe-or-not verdict. pharmaranks gives Cefixime a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cefixime?
- Cefixime's side effects are taken directly from its FDA label. From the label: 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 Rising Pharma Holdings, Inc.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cefixime
72/100