DRUGS & SUPPLEMENTS

Active ingredient: Ceftibuten

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Ceftibuten uses


INDICATIONS AND USAGE

Ceftibuten (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections).

Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, Ceftibuten clinical efficacy was 22% less than control.

Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.

NOTE: Although Ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, Ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.

Pharyngitis and Tonsillitis due to Streptococcus pyogenes.

NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the Ceftibuten product for the prophylaxis of subsequent rheumatic fever are not available.

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CONTRAINDICATIONS

Ceftibuten (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS

BEFORE THERAPY WITH THE Ceftibuten PRODUCT IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Ceftibuten, OTHER 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 ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO THE Ceftibuten PRODUCT OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Ceftibuten, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile.

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PRECAUTIONS

General

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency, particularly in patients with creatinine clearance less than 50 mL/min or undergoing hemodialysis. Ceftibuten is readily dialyzable. Dialysis patients should be monitored carefully, and administration of Ceftibuten should occur immediately following dialysis.

Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Information to Patients

Patients should be informed that:

  • If the patient is diabetic, he/she should be informed that Ceftibuten Oral Suspension contains 1 gram sucrose per teaspoon of suspension.
  • Ceftibuten Oral Suspension should be taken at least 2 hours before a meal or at least 1 hour after a meal (see CLINICAL PHARMACOLOGY, Food Effect on Absorption ).

Drug Interactions

Theophylline

Twelve healthy male volunteers were administered one 200-mg Ceftibuten capsule twice daily for 6 days. With the morning dose of Ceftibuten on day 6, each volunteer received a single intravenous infusion of theophylline. The pharmacokinetics of theophylline were not altered. The effect of Ceftibuten on the pharmacokinetics of theophylline administered orally has not been investigated.

Antacids or H2-receptor antagonists

The effect of increased gastric pH on the bioavailability of Ceftibuten was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg Ceftibuten capsule. A single dose of liquid antacid did not affect the Cmax or AUC of Ceftibuten; however, 150 mg of ranitidine q12h for 3 days increased the Ceftibuten Cmax by 23% and Ceftibuten AUC by 16%. The clinical relevance of these increases is not known.

Drug/Laboratory Test Interactions

There have been no chemical or laboratory test interactions with Ceftibuten noted to date. False-positive direct Coombs' tests have been reported during treatment with other cephalosporins. Therefore, it should be recognized that a positive Coombs' test could be due to the drug. The results of assays using red cells from healthy subjects to determine whether Ceftibuten would cause direct Coombs' reactions in vitro showed no positive reaction at Ceftibuten concentrations as high as 40 µg/mL.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Ceftibuten. No mutagenic effects were seen in the following studies: in vitro chromosome assay in human lymphocytes, in vivo chromosome assay in mouse bone marrow cells, Chinese Hamster Ovary cell point mutation assay at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus, and in a bacterial reversion point mutation test (Ames). No impairment of fertility occurred when rats were administered Ceftibuten orally up to 2000 mg/kg/day (approximately 43 times the human dose based on mg/m2/day).

Pregnancy

Teratogenic effects

Pregnancy Category B

Ceftibuten was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day. Ceftibuten was not teratogenic in the pregnant rabbit at oral doses up to 40 mg/kg/day (approximately 1.5 times the human dose based on mg/m2/day) and has revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Ceftibuten has not been studied for use during labor and delivery. Its use during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus.

Nursing Mothers

It is not known whether Ceftibuten is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ceftibuten is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Ceftibuten in infants less than 6 months of age has not been established.

Geriatric Patients

The usual adult dosage recommendation may be followed for patients in this age group. However, these patients should be monitored closely, particularly their renal function, as dosage adjustment may be required.

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ADVERSE EVENTS

Clinical Trials

Ceftibuten CAPSULES

In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of Ceftibuten capsules (400 mg per day). There were no deaths or permanent disabilities thought due to drug toxicity in any of the patients in these studies. Thirty-six of 1728 (2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea, vomiting, or nausea. Six of 1728 (0.3%) patients were discontinued due to rash or pruritus thought related to Ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to Ceftibuten capsules in multipledose clinical trials (n = 1092 ceftibuten-treated patients).

ADVERSE REACTIONS

Ceftibuten CAPSULES

US CLINICAL TRIALS IN ADULT PATIENTS

(n = 1092)

Incidence equal to or greater than 1% Nausea 4%
Headache 3%
Diarrhea 3%
Dyspepsia 2%
Dizziness 1%
Abdominal pain 1%
Vomiting 1%
Incidence less than 1% but greater than 0.1% Anorexia, Constipation, Dry mouth, Dyspnea, Dysuria, Eructation, Fatigue, Flatulence, Loose stools, Moniliasis, Nasal congestion, Paresthesia, Pruritus, Rash, Somnolence, Taste perversion, Urticaria, Vaginitis
LABORATORY VALUE CHANGESChanges in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

Ceftibuten CAPSULES

US CLINICAL TRIALS IN ADULT PATIENTS

Incidence equal to or greater than 1% ↑ BUN 4%
↑ Eosinophils 3%
↓ Hemoglobin 2%
↑ ALT (SGPT) 1%
↑ Bilirubin 1%
Incidence less than 1% but greater than 0.1% ↑ Alk phosphatase
↑ Creatinine
↑ Platelets
↓ Platelets
↓ Leukocytes
↑ AST (SGOT)

Ceftibuten ORAL SUSPENSION

In clinical trials, 1152 pediatric patients (772 US and 380 international), 97% of whom were younger than 12 years of age, were treated with the recommended dose of Ceftibuten (9 mg/kg once daily up to a maximum dose of 400 mg per day) for 10 days. There were no deaths, life-threatening adverse events, or permanent disabilities in any of the patients in these studies. Eight of 1152 (<1%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily (7 out of 8) for gastrointestinal disturbances, usually diarrhea or vomiting. One patient was discontinued due to a cutaneous rash thought possibly related to Ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to Ceftibuten oral suspension in multipledose clinical trials (n = 772 ceftibuten-treated patients).

ADVERSE REACTIONS

Ceftibuten ORAL SUSPENSION

US CLINICAL TRIALS IN PEDIATRIC PATIENTS

(n = 772)

Incidence equal to or greater than 1% DiarrheaNOTE: The incidence of diarrhea in pediatric patients ≤2 years old was 8% (23/301) compared with 2% (9/471) in pediatric patients >2 years old. 4%
Vomiting 2%
Abdominal pain 2%
Loose stools 2%
Incidence less than 1% but greater than 0.1% Agitation, Anorexia, Dehydration, Diaper dermatitis, Dizziness, Dyspepsia, Fever, Headache, Hematuria, Hyperkinesia, Insomnia, Irritability, Nausea, Pruritus, Rash, Rigors, Urticaria
LABORATORY VALUE CHANGESChanges in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

Ceftibuten ORAL SUSPENSION

US CLINICAL TRIALS IN PEDIATRIC PATIENTS

Incidence equal to or greater than 1% ↑ Eosinophils 3%
↑ BUN 2%
↓ Hemoglobin 1%
↑ Platelets 1%
Incidence less than 1% but greater than 0.1% ↑ ALT (SGPT)
↑ AST (SGOT)
↑ Alk phosphatase
↑ Bilirubin
↑ Creatinine

In Post-marketing Experience

The following adverse experiences have been reported during worldwide post-marketing surveillance: aphasia, jaundice, melena, psychosis, serum sickness-like reactions, stridor, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with Ceftibuten capsules, the following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics:

  • allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, renal dysfunction, toxic nephropathy, hepatic cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis; onset of symptoms may occur during or after antibiotic treatment (see WARNINGS ).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE ). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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OVERDOSAGE

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation by a single hemodialysis session. Information does not exist with regard to removal of Ceftibuten by peritoneal dialysis.

DOSAGE AND ADMINISTRATION

The recommended doses of Ceftibuten Oral Suspension are presented in the table below. Ceftibuten Oral Suspension must be administered at least 2 hours before or 1 hour after a meal.

Type of infection Daily Maximum Dose Dose and Frequency Duration
ADULTS (12 years of age and older): 400 mg 400 mg QD 10 days
Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

(See INDICATIONS AND USAGE - NOTE .)

Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.

(See INDICATIONS AND USAGE - NOTE .)

PEDIATRIC PATIENTS: 400 mg 9 mg/kg QD 10 days
Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), and M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.

(See INDICATIONS AND USAGE - NOTE .)

Ceftibuten ORAL SUSPENSION

PEDIATRIC DOSAGE CHART

CHILD'S WEIGHT 180 mg/5 mL
Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.
10 kg 22 lbs 1/2 tsp QD
20 kg 44 lbs 1 tsp QD
40 kg 88 lbs 2 tsp QD

Renal Impairment

Ceftibuten Capsules and Ceftibuten Oral Suspension may be administered at normal doses in the presence of impaired renal function with creatinine clearance of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency are presented in the following table.

Creatinine Clearance Recommended Dosing Schedules
(mL/min)
>50 9 mg/kg or 400 mg Q24h
(normal dosing schedule)
30-49 4.5 mg/kg or 200 mg Q24h
5-29 2.25 mg/kg or 100 mg Q24h

Hemodialysis Patients

In patients undergoing hemodialysis two or three times weekly, a single 400-mg dose of Ceftibuten capsules or a single dose of 9 mg/kg oral suspension may be administered at the end of each hemodialysis session.

Directions for Mixing Ceftibuten Oral Suspension

Final Concentration Bottle Size Amount of Water Directions
After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator.

Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.

180 mg per 5 mL 30 mL Suspend in 28 mL of water First tap the bottle to loosen powder. Then add water in two portions, shaking well after each aliquot.
60 mL Suspend in 53 mL of water

HOW SUPPLIED

Ceftibuten Capsules, containing 400 mg of Ceftibuten (as Ceftibuten dihydrate) are white, opaque capsules imprinted with the product name and strength, are available as follows:

  • 20 Capsules/Bottle (NDC 65224-800-22)

Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening.

Ceftibuten Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains Ceftibuten equivalent to 180 mg/5 mL, supplied as follows:

180 mg/5 mL

  • 36 mg/mL 30-mL Bottle (NDC 65224-804-30)
  • 36 mg/mL 60-mL Bottle (NDC 65224-804-02)

Prior to reconstitution, the powder must be stored between 2° and 25°C (36° and 77°F). Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2° and 8°C (36° and 46°F).

CLINICAL STUDIES

Acute Bacterial Exacerbations of Chronic Bronchitis

Three clinical trials have been conducted testing Ceftibuten in the treatment of acute exacerbations of chronic bronchitis (AECB). Overall, the clinical outcome among patients who had signs and symptoms of AECB, who had a gram stain showing a predominance of PMNs and few epithelial cells, and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. The bacterial eradication rates of specific pathogens are presented below.

Ceftibuten 400 mg QD Control
Bacteriological Eradication Rates
  Haemophilus influenzae 45/62 (73%) 26/36 (72%)
  H. parainfluenzae 10/10 4/6
  Moraxella catarrhalis 33/46 (72%) 32/34 (94%)
  Streptococcus pneumoniae 23/35 (66%) 14/20 (70%)

Acute Bacterial Otitis Media

Four clinical trials (three domestic, the fourth abroad) have been conducted testing Ceftibuten in the treatment of acute bacterial otitis media. Overall, the clinical outcome among patients who had signs and symptoms of acute bacterial otitis media and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. Tympanocentesis was performed on patients in three of the above-mentioned studies; the bacterial eradication rates of specific pathogens are presented below.

Ceftibuten 9 mg/kg QD Control
Bacteriological Eradication Rates
  Haemophilus influenzae 56/67 (81%) 29/38 (76%)
  Moraxella catarrhalis 20/26 (77%) 13/17 (77%)
  Streptococcus pneumoniae 68/105 (65%) 35/40 (88%)
  Streptococcus pyogenes 13/15 (87%) 5/5

REFERENCES

  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA. December, 1993.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA. December, 1993.

For inquires call 1-800-793-2145

Manufactured by:

Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA

Distributed by Pernix Therapeutics, LLC

Morristown, NJ 07960, USA

Rev. 03/15

34459029

NDC 65224-800-22

Ceftibuten ®

(ceftibuten

capsules)

For Oral Administration

Rx only

20 Capsules

PERNIX

THERAPEUTICS

Ceftibuten available forms, composition, doses:

Price
Cedax 400 mg capsule16.13 USD

Indications and Usages:

ATC codes:


ICD-10 codes:


Ceftibuten destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

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  4. "ceftibuten: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/servl... (accessed August 28, 2018).
  5. "ceftibuten: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Ceftibuten (accessed August 28, 2018).
  6. "Ceftibuten (By mouth) (Cedax): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhealth... (accessed August 28, 2018).
  7. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/680009... (accessed August 28, 2018).
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  9. "ceftibuten: Literature references related to scientific contents from Springer Nature journals and books. ". https://pubchem.ncbi.nlm.nih.gov/substan... (accessed August 28, 2018).
  10. "Ceftibuten: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB00154... (accessed August 28, 2018).
  11. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/DataStan... (accessed August 28, 2018).
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  16. "ChEBI Ontology: The ChEBI Ontology is a structured classification of the entities contained within ChEBI.". http://www.ebi.ac.uk/chebi/userManualFor... (accessed August 28, 2018).
  17. "International Patent Classification: The World Intellectual Property Organization (WIPO) International Patent Classification (IPC), established by the Strasbourg Agreement 1971, provides for a hierarchical system of language independent symbols for the classification of patents and utility models according to the different areas of technology to which they pertain.". http://www.wipo.int/classifications/ipc/ (accessed August 28, 2018).
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Frequently asked Questions

Can i drive or operate heavy machine after consuming Ceftibuten?

Depending on the reaction of the Ceftibuten after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ceftibuten not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Ceftibuten addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Ceftibuten, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ceftibuten consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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