Céfixime Biogaran is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Céfixime Biogaran will not work for colds, flu, or other virus infections.
Céfixime Biogaran is available only with your doctor's prescription.
Céfixime Biogaran indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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To reduce the development of drug resistant bacteria and maintain the effectiveness of Céfixime Biogaran (Céfixime Biogaran) and other antibacterial drugs, Céfixime Biogaran 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.
Céfixime Biogaran (Céfixime Biogaran) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:
Uncomplicated Urinary Tract Infections
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for Céfixime Biogaran than for the comparator.
Pharyngitis and Tonsillitis
Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Céfixime Biogaran is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Céfixime Biogaran in the subsequent prevention of rheumatic fever is not available.)
Acute Exacerbations of Chronic Bronchitis
Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea (cervical/urethral)
Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
How should I use Céfixime Biogaran?
Use Céfixime Biogaran chewable tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Céfixime Biogaran chewable tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Chew or crush Céfixime Biogaran chewable tablets before swallowing. Do not swallow Céfixime Biogaran chewable tablets whole.
To clear up your infection completely, continue using Céfixime Biogaran chewable tablets for the full course of treatment even if you feel better in a few days.
If you miss a dose of Céfixime Biogaran chewable tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Céfixime Biogaran chewable tablets.
Uses of Céfixime Biogaran in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Treatment of uncomplicated urinary tract infections (due to Escherichia coli and Proteus mirabilis), otitis media (due to Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes), pharyngitis and tonsillitis (due to Streptococcus pyogenes), acute exacerbations of chronic bronchitis (due to Streptococcus pneumoniae and Haemophilus influenzae); uncomplicated cervical/urethral gonorrhea (due to N. gonorrhoeae [penicillinase- and nonpenicillinase-producing])
Note: Due to concerns of resistance, the CDC no longer recommends use of Céfixime Biogaran as a first-line regimen in the treatment of uncomplicated gonorrhea in the US; ceftriaxone is the preferred cephalosporin in combination with azithromycin (CDC 2012; CDC [Workowski 2015]).
Off Label Uses
Gonococcal infection, expedited partner therapy
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Céfixime Biogaran in combination with azithromycin is an effective and recommended treatment of gonorrhea only in the following circumstances: Heterosexual partners with gonorrhea if health department partner-management strategies are impractical/unavailable and there is concern by the provider for the prompt evaluation and treatment of the partner; medication may be delivered to partner by patient, collaborating pharmacy, or disease investigation specialist as permitted by law; written materials to educate partners about their exposure to gonorrhea, importance of therapy, and when to seek clinical evaluation for adverse reactions/complications must also be provided with the medication.
Gonococcal, uncomplicated infection of the rectum
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Céfixime Biogaran, in combination with azithromycin, may be used as an alternative agent to ceftriaxone (in combination with azithromycin) for the treatment of uncomplicated gonococcal infections of the rectum only if ceftriaxone is unavailable.
Rhinosinusitis, acute bacterial
Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, Céfixime Biogaran (among other cephalosporins) is effective and recommended alternative agent (in combination with clindamycin) for the treatment of ABRS.
Clinical experience suggests the utility of Céfixime Biogaran (in combination with clindamycin) for the treatment of ABRS. Additional trials may be necessary to further define the role of Céfixime Biogaran for this condition.
Céfixime Biogaran description
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Céfixime Biogaran, an antibiotic, is a 3rd-generation cephalosporin like ceftriaxone and cefotaxime. Céfixime Biogaran is highly stable in the presence of β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of β-lactamases may be susceptible to Céfixime Biogaran. The antibacterial effect of Céfixime Biogaran results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Céfixime Biogaran dosage
Adults
The recommended dose of Céfixime Biogaran is 400 mg daily. This may be given as a 400 mg tablet or capsule 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 capsule and tablet may be administered without regard to food.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of Céfixime Biogaran should be administered for at least 10 days.
Pediatric Patients (6 months or older)
The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Céfixime Biogaran for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).
Table 1: Suggested doses for pediatric patients
PEDIATRIC DOSAGE CHART
Doses are suggested for each weight range and rounded for ease of administration
* The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges.
Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Céfixime Biogaran (Céfixime Biogaran) Chewable Tablets must be chewed or crushed before swallowing.
Otitis media should be treated with the chewable tablets or suspension. 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 or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of Céfixime Biogaran should be administered for at least 10 days.
Renal Impairment
Céfixime Biogaran 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. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.
Table 2: Doses for Adults with Renal Impairment
Renal Dysfunction
Céfixime Biogaran (Céfixime Biogaran) for
Oral Suspension
Tablet
Chewable Tablet
Creatinine Clearance (mL/min)
100 mg/5 mL
200 mg/5 mL
500 mg/5 mL
400 mg
200 mg
Dose/Day (mL)
Dose/Day (mL)
Dose/Day (mL)
Dose/Day
Dose/Day
60 or greater
Normal dose
Normal dose
Normal dose
Normal dose
Normal dose
21 to 59 * OR renal hemodialysis*
13
6.5
2.6
Not Appropriate
Not Appropriate
20 or less OR continuous peritoneal dialysis
8.6
4.4
1.8
0.5 tablet
1 tablet
* The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction
Reconstitution Directions For
Oral Suspension
Strength
Bottle Size
Reconstitution Directions
100 mg/5 mL and 200 mg/5 mL
100 mL
To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and 200 mg/5 mL
75 mL
To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and 200 mg/5 mL
50 mL
To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
200 mg/5 mL
25 mL
To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
How supplied
Dosage Forms And Strengths
Céfixime Biogaran is available for oral administration in the following dosage forms and strengths:
Film-coated tablets provide 400 mg of Céfixime Biogaran as trihydrate. These are white to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side. The tablet is debossed with “Céfixime Biogaran” across one side and “LUPIN” across the other side.
Capsules provide 400 mg of Céfixime Biogaran as trihydrate. These are size “00EL” capsules with pink opaque cap and pink opaque body with “LU” on the cap and “U43” on the body in black ink. Capsules contain white to yellowish white granular powder.
Chewable tablets provide either 100 mg or 150 mg or 200 mg of Céfixime Biogaran as trihydrate. The 100 mg tablet is pink, round tablet, debossed with “Céfixime Biogaran 100” on one side and “LUPIN” on other side. The 150 mg tablet is pink, round tablet, debossed with “Céfixime Biogaran 150” on one side and “LUPIN” on other side. The 200 mg tablet is pink, round tablet, debossed with “Céfixime Biogaran 200” on one side and “LUPIN” on other side.
Powder for oral suspension, when reconstituted, provides either 100 mg/5 mL or 200 mg/5 mL or 500 mg/5 mL of Céfixime Biogaran as trihydrate. For 100 mg/5 mL and 200 mg/5 mL, the powder has an off white to pale yellow color and is strawberry flavored. For 500 mg/5 mL, the powder has an off white to cream color and is strawberry flavored.
Storage And Handling
Céfixime Biogaran® is available for oral administration in following dosage forms, strengths and packages listed in the table below:
White to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side, debossed with “Céfixime Biogaran” across one side and “LUPIN” across other side, containing 400 mg of Céfixime Biogaran as the trihydrate.
Bottles of 10 tablets
27437-201-10
Store at 20 to 25°C (68 to 77°F).
Bottle of 50 tablets
27437-201-08
Bottle of 100 tablets
27437-201-01
Céfixime Biogaran® (Céfixime Biogaran) Capsules
400 mg
Size “00EL” capsules with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black ink, containing white to yellowish white granular powder containing 400 mg of Céfixime Biogaran as the trihydrate.
Bottle of 50 capsules
27437-208-08
Store at 20 to 25°C (68 to 77°F).
Unit Dose Package of 10 (1 blister of 10 capsules)
Pink, round tablet, debossed with “Céfixime Biogaran 100” on one side and “LUPIN” on other side.
Bottles of 10 tablets
27437-203-10
Store at 20 to 25°C (68 to 77°F).
Bottle of 50 tablets
27437-203-08
Unit Dose Package of 10 (1 blister of 10 tablets)
27437-203-11
150 mg
Pink, round tablet, debossed with “Céfixime Biogaran 150” on one side and “LUPIN” on other side.
Bottles of 10 tablets
27437-204-10
Bottle of 50 tablets
27437-204-08
Unit Dose Package of 10 (1 blister of 10 tablets)
27437-204-11
200 mg
Pink, round tablet, debossed with “Céfixime Biogaran 200” on one side and “LUPIN” on other side.
Bottles of 10 tablets
27437-205-10
Bottle of 50 tablets
27437-205-08
Unit Dose Package of 10 (1 blister of 10 tablets)
27437-205-11
Céfixime Biogaran® (Céfixime Biogaran) for
Oral Suspension USP
100 mg/5 mL
Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of Céfixime Biogaran as the trihydrate.
Bottle of 50 mL
68180-202-03
Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77°F). After reconstitution: Store at room temperature or under refrigeration. Keep tightly closed.
Bottle of 75 mL
68180-202-02
Bottle of 100 mL
68180-202-01
200 mg/5 mL
Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 200 mg of Céfixime Biogaran as the trihydrate.
Bottle of 25 mL
27437-206-05
Bottle of 37.5 mL
27437-206-06
Bottle of 50 mL
27437-206-03
Bottle of 75 mL
27437-206-02
Bottle of 100 mL
27437-206-01
500 mg/5 mL
Off white to cream colored powder forming off-white to pale yellow suspension with characteristic fruity odor on constitution. After reconstituted as directed, each mL of reconstituted suspension contains 100 mg of Céfixime Biogaran as the trihydrate.
Bottle of 10 mL
27437-207-02
Bottle of 20 mL
27437-207-03
Manufactured for: Lupin Pharma Baltimore, Maryland 21202 United States. Manufactured by:Lupin Limited Mandideep 462 046 India. Revised: January 2016
Carbamazepine: Elevated carbamazepine levels have been reported when administered concomitantly with Céfixime Biogaran. Drug monitoring when these drugs are given together is advised.
Chloramphenicol: In vitro and in vivo antagonism have been noted between cephalosporins and chloramphenicol against a variety of gram-positive and gram-negative bacteria; therefore, it is recommended that combined therapy with chloramphenicol and a cephalosporin be avoided, particularly when bactericidal activity is considered important.
Nifedipine: Concomitant administration of Céfixime Biogaran and nifedipine increases oral bioavailability of Céfixime Biogaran as a result of higher Cmax and AUC.
Probenecid: Concomitant administration of probenecid reportedly increases Cmax and AUC of Céfixime Biogaran 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 Céfixime Biogaran in healthy adult men may result in a 20-25% decrease in Cmax and AUC of Céfixime Biogaran but did not affect protein-binding, serum t½ or renal clearance. This effect may not be clinically important since serum concentrations of Céfixime Biogaran 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.
Warfarin and other Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when Céfixime Biogaran is given concomitantly.
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 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, eg, 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.
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 Céfixime Biogaran. It is recommended that other tests based on enzymatic glucose oxidase reactions (eg, Clinistix) be used.
Céfixime Biogaran is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.
Gastrointestinal Disturbances: The most frequent side effects seen with Céfixime Biogaran are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Céfixime Biogaran should be discontinued if marked diarrhoea occurs. Other GI side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy. Rarely, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible.
Mild transient changes in liver and renal function tests have been observed.
Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Do not take this medication if you are allergic to Céfixime Biogaran, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.
Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).
Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Céfixime Biogaran will not treat a viral infection such as the common cold or flu.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
DailyMed. "CEFIXIME: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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