AUROBINDO 50 mL (when reconstituted), Report Adverse Cefixime has not been studied for use during labor and delivery. Treatment involves a course of antibiotics. Call your doctor at once if you have: severe stomach pain, diarrhea that is watery or bloody; jaundice (yellowing of the skin or eyes); pale or yellowed skin, dark colored urine, confusion or weakness; low blood cell counts--sudden weakness or ill feeling, fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or. Streptococcus pyogenes, Gram-negative Bacteria Take your next dose at the regular time. (p<0.05). Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Tell your doctor if you are allergic to penicillins. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness, new signs of infection (such as sore throat that doesn't go away, fever), easy bruising/bleeding, signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as confusion). Bleeding problemsUse with caution. Geriatrics:Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. If you miss a dose, take it as soon as you remember. Note: A suggested dose has been determined for each pediatric weight range. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=068e6edd-a5fe-40d8-8dcf-ac82b78dced4, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Suggested doses for pediatric patients. Selected from data included with permission and copyrighted by First Databank, Inc. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Call your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine. Before prescribing Cefixime chewable tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including Cefixime chewable tablets. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. Uncomplicated Gonorrhea (cervical/urethral) US residents can call their local poison control center at 1-800-222-1222. If this occurs, patients should contact their physician as soon as possible. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. During pregnancy, this medication should be used only when clearly needed. For oral dosage forms (capsules, suspension, chewable tablets, or tablets): Adults and children older than 12 years of age and weighing more than 50 kilograms (kg)400 milligrams (mg) once a day or 200 mg every 12 hours. 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). Cefixime may cause live bacterial vaccines (such as typhoid vaccine) to not work well. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Escherichia coli The capsule and tablet may be administered without regard to food. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Add the remainder of water and shake well. Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain. The oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Refer to Table 1. Along with its needed effects, a medicine may cause some unwanted effects. being unable to get an erection at any time. Cefixime for oral suspension is generally effective . Otitis Media Cefixime is highly stable in the presence of beta-lactamase enzymes. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. (p<0.05), 50 mL in 1 BOTTLE; Type 0: Not a Combination Product, 100 mL in 1 BOTTLE; Type 0: Not a Combination Product, 75 mL in 1 BOTTLE; Type 0: Not a Combination Product, ANALYSIS(65862-751, 65862-752) , MANUFACTURE(65862-751, 65862-752), 8 To reconstitute: Add 7.3 mL of water to make a 10 mL suspension. [See USP Controlled Room Temperature]. Kidney diseaseUse with caution. It works by killing bacteria or preventing their growth. Navigation Menu - Opens a Simulated Dialog. Clinical Trials, Cross-over studies of tablet versus suspension have not been performed in children. The overall response rate of Streptococcus pneumoniae to Cefixime was approximately 10% lower and that of Haemophilus influenzae or Moraxella catarrhalis approximately 7% higher (12% when beta-lactamase positive isolates of H. influenzae are included) than the response rates of these organisms to the active control drugs. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Portions of this document last updated: May 01, 2023, Original article: https://www.mayoclinic.org/drugs-supplements/cefixime-oral-route/side-effects/DRG-20073374. Drug class: Third generation cephalosporins. Tell your doctor if your condition lasts or gets worse. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Each 100 mg, 150 mg and 200 mg strength contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine, respectively. Your medication may look different. 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). The following information includes only the average doses of this medicine. Rx only As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime. Keep tightly closed. 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. When these cases are included in the overall bacteriological evaluation of therapy with the control drugs, 140/185 (76%) of pathogens were considered to be eradicated. The results of some tests may be affected by this medicine. You may report side effects to Health Canada at 1-866-234-2345. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [ see Clinical Pharmacology ( 12.3) ]. Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) Drug class: third generation cephalosporins, 1 tablet of 100 mg and 1 tablet of 150 mg, 1 tablet of 150 mg and 1 tablet of 200 mg, 20 or less OR continuous peritoneal dialysis. Chemical Formula is C16H15N5O7S2.3H2O. It belongs to the class of medicines known as cephalosporin antibiotics. 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. Shake well before using. 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. Other drugs may interact with cefixime, including prescription and over-the-counter medicines, vitamins, and herbal products. This is a decision you and your doctor will make. 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. The following adverse reactions have been reported following the post-approval use of cefixime. UTI symptoms include pain, abdominal pain, mild fever, urinary urgency, and frequency. The following in vitro data are available, but their clinical significance is unknown. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Search for vitamins and natural medicines, Request for confidential communications forms, Learn more about link terms and conditions, new signs of infection (such as sore throat that doesn't go away, fever), signs of kidney problems (such as change in the amount of urine), itching/swelling (especially of the face/tongue/throat). Patients on dialysis should be monitored carefully [seeDosage and Administration (2)]. Discard unused portion after 14 days. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to Cefixime. 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. (, Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak. Proteus mirabilis. (1.6), Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting. FOR ORAL USE ONLY SHAKE WELL BEFORE USING Consult your doctor before breast-feeding. Enter your medication into the WebMD interaction checker, Treating Opioid Use Disorder With Medications, infection of the urinary tract from Proteus bacteria, urinary tract infection due to E. coli bacteria, bronchitis caused by the bacteria Streptococcus pneumoniae, infection of the middle ear by H. influenzae bacteria, infection of the middle ear caused by Streptococcus, middle ear infection caused by Moraxella catarrhalis, pneumonia due to the bacteria Haemophilus parainfluenzae, acute sinusitis caused by Streptococcus pneumoniae, acute sinusitis caused by Haemophilus influenzae, acute sinusitis caused by Moraxella catarrhalis, acute sinus infection from Haemophilus parahaemolyticus, acute sinus infection caused by Haemophilus parainfluenzae, pneumonia caused by Haemophilus parahaemolyticus, bronchitis caused by the bacteria Haemophilus influenzae. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. 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. A urinary tract infection (UTI) is an infection of the bladder, kidneys, ureters, or urethra. Resistance to Cefixime in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). By the 2 to 4 week follow-up, a total of 30%-31% of patients had evidence of either treatment failure or recurrent disease. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Incidence rates were less than 1 in 50 (less than 2%). In these studies, in mice and rats, cefixime did not affect postnatal development or reproductive capacity of the F1 generation or fetal development of the F2 generation. Cefixime is used to treat a wide variety of bacterial infections. tablet, chewable 100mg 200mg oral suspension 100mg/5mL 200mg/5mL 500mg/5mL Acute Exacerbations of Chronic Bronchitis Indicated in the treatment of acute exacerbations of chronic bronchitis caused. Klebsiella pneumoniae Products that may interact with this drug include: This medication may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Transfer to the Fetus and Nursing Pup. 50 mL Bottles NDC 65862-752-5075 mL Bottles NDC 65862-752-75 DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Do not use it later for another infection unless your doctor tells you to. Cefixime stops bacteria from forming a cell wall, which bacteria need to survive. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, USP should be used . Follow all directions on your cefixime label. Patients on dialysis should be monitored carefully [ see Dosage and Administration ( 2.3) ]. In these studies, patients were randomized and treated with either Cefixime at dose regimens of 4 mg/kg twice a day or 8 mg/kg once a day, or with a comparator. Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis. This condition may occur during treatment or weeks to months after treatment has stopped. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C.difficile may need to be discontinued. Klebsiella oxytoca Discard unused portion after 14 days. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60mL/min. Keep the container tightly closed. Medically reviewed by Carmen Pope, BPharm. Prior to Reconstitution: Store drug powder at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Do not take other medicines unless they have been discussed with your doctor. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. This medication may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). Cross-over studies of tablet versus suspension have not been performed in children. When evaluated at the completion of therapy, 17% of patients receiving cefixime and 14% of patients receiving effective comparative drugs (18% including those patients who had Haemophilus influenzae resistant to the control drug and who received the control antibacterial drug) were considered to be treatment failures. Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia. Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Uses Warnings Before taking Side effects Interactions Dosage FAQ What is cefixime? 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. If this occurs, patients should contact their physician as soon as possible. Cefixime may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Gastric lavage may be indicated; otherwise, no specific antidote exists. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Shigella species. Files, All Mapping In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days. Anticonvulsant therapy can be given if clinically indicated. 65862-751-01, This medication is known as a cephalosporin antibiotic. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. Not all photos of the drug may be displayed. A very serious allergic reaction to this drug is rare. Anticonvulsant therapy can be given if clinically indicated. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Is there a gonorrhea treatment available over the counter? "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. Many people using this medication do not have serious side effects. However, the efficacy of cefixime in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. Cefixime is an effective and safe oral medication during pregnancy for the treatment of acute obstetric diseases and STDs such as gonorrhea. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours. Do not share this medication with others. Powder for oral suspension, when reconstituted, provides either 100 mg/5 mL or 200 mg/5 mL of cefixime as trihydrate. Safety and effectiveness of Cefixime in children aged less than six months old have not been established. 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. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Anaphylaxis can be life-threatening and requires immediate medical attention. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. This medicine is available only with your doctor's prescription. In children, this medication may also be taken twice a day (every 12 hours). Tell your doctor right away if you have any serious side effects, including: This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. Haemophilus parainfluenzae This product may contain inactive ingredients, which can cause allergic reactions or other problems. Your symptoms may improve before the infection is completely cleared. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. Moraxella catarrhalis Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule. Serum protein binding is concentration independent with a bound fraction of approximately 65%. After Reconstitution: Store at room temperature or under refrigeration. Two hundred and 400 mg doses of 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. Biochemical Data Summary. Symptoms of overdose may include: severe vomiting, seizures. The cefixime suspension (liquid) contains sucrose. being able to get an erection, but not having it last long enough for sex. Suggested doses for pediatric patients, Table 2. Register, The photos shown are samples only Cefixime for oral suspension is 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. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Although not all of these side effects may occur, if they do occur they may need medical attention. These differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. All rights reserved. Dosage forms: oral capsule, oral powder for reconstitution, oral tablet, oral chewable tablet Drug class: Third generation cephalosporins Medically reviewed by Carmen Pope, BPharm. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. This medicine kills bacteria and prevents the spread of infections. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Version: 6.01. Several cases of documented pseudomembranous colitis were identified in clinical trials. Cefixime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indicationsand Usage (1)]. The dose is usually 8 milligrams (mg) per kilogram (kg) of body weight per . 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