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DRUGS & SUPPLEMENTS
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Cedax
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Cedax uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse events
- Overdosage
- Dosage and administration
- How supplied
- Clinical studies
- References
INDICATIONS AND USAGE
Cedax (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, Cedax 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 Cedax 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, Cedax 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. Cedax is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the Cedax product for the prophylaxis of subsequent rheumatic fever are not available.
CONTRAINDICATIONS
Cedax (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
WARNINGS
BEFORE THERAPY WITH THE Cedax PRODUCT IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cedax, 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 Cedax 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 Cedax, 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.
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 Cedax 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. Cedax is readily dialyzable. Dialysis patients should be monitored carefully, and administration of Cedax should occur immediately following dialysis.
Cedax 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 Cedax Oral Suspension contains 1 gram sucrose per teaspoon of suspension.
- Cedax 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 Cedax capsule twice daily for 6 days. With the morning dose of Cedax on day 6, each volunteer received a single intravenous infusion of theophylline. The pharmacokinetics of theophylline were not altered. The effect of Cedax 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 Cedax was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg Cedax capsule. A single dose of liquid antacid did not affect the Cmax or AUC of Cedax; however, 150 mg of ranitidine q12h for 3 days increased the Cedax Cmax by 23% and Cedax 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 Cedax 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 Cedax would cause direct Coombs' reactions in vitro showed no positive reaction at Cedax 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 Cedax. 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 Cedax orally up to 2000 mg/kg/day (approximately 43 times the human dose based on mg/m2/day).
Pregnancy
Teratogenic effects
Pregnancy Category B
Cedax was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day. Cedax 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
Cedax 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 Cedax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cedax is administered to a nursing woman.
Pediatric Use
The safety and efficacy of Cedax 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.
ADVERSE EVENTS
Clinical Trials
Cedax CAPSULES
In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of Cedax 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 Cedax administration.
In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to Cedax capsules in multipledose clinical trials (n = 1092 ceftibuten-treated patients).
| ADVERSE REACTIONS Cedax 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 CHANGES Cedax 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) | ||
Cedax 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 Cedax (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 Cedax administration.
In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to Cedax oral suspension in multipledose clinical trials (n = 772 ceftibuten-treated patients).
| ADVERSE REACTIONS Cedax ORAL SUSPENSION US CLINICAL TRIALS IN PEDIATRIC PATIENTS (n = 772) | ||
|---|---|---|
| Incidence equal to or greater than 1% | Diarrhea | 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 CHANGES Cedax 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 Cedax 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.
OVERDOSAGE
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Cedax 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 Cedax by peritoneal dialysis.
DOSAGE AND ADMINISTRATION
The recommended doses of Cedax Oral Suspension are presented in the table below. Cedax 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 .) |
| Cedax 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
Cedax Capsules and Cedax 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 Cedax capsules or a single dose of 9 mg/kg oral suspension may be administered at the end of each hemodialysis session.
Directions for Mixing Cedax 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
Cedax Capsules, containing 400 mg of Cedax (as Cedax 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.
Cedax Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains Cedax 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 Cedax 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.
| Cedax 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 Cedax 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.
| Cedax 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
Cedax ®
(ceftibuten
capsules)
For Oral Administration
Rx only
20 Capsules
PERNIX
THERAPEUTICS
Cedax pharmaceutical active ingredients containing related brand and generic drugs:
Cedax available forms, composition, doses:
Cedax destination | category:
Cedax Anatomical Therapeutic Chemical codes:
Cedax pharmaceutical companies:
References
- Dailymed."CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [PERNIX THERAPEUTICS, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "ceftibuten". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "ceftibuten". http://www.drugbank.ca/drugs/DB0141... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Cedax?Depending on the reaction of the Cedax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cedax 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 Cedax 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.
Review
sdrugs.com conducted a study on Cedax, 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 Cedax 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.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology