Isocef

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Isocef uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse events
• Overdosage
• Dosage and administration
• How supplied
• Clinical studies
• References
• Isocef reviews

INDICATIONS AND USAGE

Isocef (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, Isocef 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 Isocef 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, Isocef 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. Isocef is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the Isocef product for the prophylaxis of subsequent rheumatic fever are not available.

CONTRAINDICATIONS

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

WARNINGS

BEFORE THERAPY WITH THE Isocef PRODUCT IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Isocef, 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 Isocef 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 Isocef, 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 Isocef 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. Isocef is readily dialyzable. Dialysis patients should be monitored carefully, and administration of Isocef should occur immediately following dialysis.

Isocef 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 Isocef Oral Suspension contains 1 gram sucrose per teaspoon of suspension.
• Isocef 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 Isocef capsule twice daily for 6 days. With the morning dose of Isocef on day 6, each volunteer received a single intravenous infusion of theophylline. The pharmacokinetics of theophylline were not altered. The effect of Isocef 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 Isocef was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg Isocef capsule. A single dose of liquid antacid did not affect the C_max or AUC of Isocef; however, 150 mg of ranitidine q12h for 3 days increased the Isocef C_max by 23% and Isocef 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 Isocef 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 Isocef would cause direct Coombs' reactions in vitro showed no positive reaction at Isocef 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 Isocef. 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 Isocef orally up to 2000 mg/kg/day (approximately 43 times the human dose based on mg/m²/day).

Pregnancy

Teratogenic effects

Pregnancy Category B

Isocef was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day. Isocef 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

Isocef 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 Isocef is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isocef is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Isocef 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

Isocef CAPSULES

In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of Isocef 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 Isocef administration.

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

Isocef 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 Isocef (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 Isocef administration.

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

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 Isocef 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. Isocef 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 Isocef by peritoneal dialysis.

DOSAGE AND ADMINISTRATION

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

Renal Impairment

Isocef Capsules and Isocef 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.

Hemodialysis Patients

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

Directions for Mixing Isocef Oral Suspension

HOW SUPPLIED

Isocef Capsules, containing 400 mg of Isocef (as Isocef 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.

Isocef Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains Isocef 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 Isocef 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.

Acute Bacterial Otitis Media

Four clinical trials (three domestic, the fourth abroad) have been conducted testing Isocef 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.

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

Isocef ^®

(ceftibuten

capsules)

For Oral Administration

Rx only

20 Capsules

PERNIX

THERAPEUTICS

Isocef pharmaceutical active ingredients containing related brand and generic drugs:

• Ceftibuten

Isocef available forms, composition, doses:

• N/A

Isocef destination | category:

• Human:
• Cephalosporins third-generation

Isocef Anatomical Therapeutic Chemical codes:

• J01DD14 - Ceftibuten

Isocef pharmaceutical companies:

• Recordati

References

1. "ceftibuten". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
2. "ceftibuten". http://www.drugbank.ca/drugs/DB0141... (accessed August 28, 2018).
3. "IW71N46B4Y: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Isocef after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Isocef 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.

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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The information was verified by Dr. Rachana Salvi, MD Pharmacology