Bostocef 300

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Adults and Adolescents (Age 13 Years and Older)

The total daily dose for all infections is 600 mg. Oral dose can be divided into 1-2 times/day, for 10 days (effectiveness is similar). However, Once-daily dosing has not been studied in pneumonia or skin infections, therefore, the dose for these indications is divided into two divided doses.

Dosage recommendations for all indications for adults and children 13 years of age and older are shown in the following table:

Table 1. Dose for adults and Adolescents (Age 13 Years and Older)

Patients with Renal Insufficiency

For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.

For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

The following formula may be used to estimate creatinine clearance in pediatric patients:

ClCr (males)= (140-age)×weight/(72 ×SCr) (mL/mins)

ClCr (Females)= (140-age)×weight/(72 ×SCr) ×0,85 (mL/phút)

ClCr (Pediatric)= K× body length or (height)/SCr (mL/phút/1,73 m2)

In there:

+ Weight is in kilograms

+ Age is in years

+ Body length (height) is in cm

+ SCr: Creatinine clearance (mg/dL)

+ K: 0.55 for pediatric patients older than 1 year; K = 0.45 for infants up to 1 year

Patients on Hemodialysis

Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

* Dose of 7 mg/kg body weight: Use powder dosage form for the suspension to use the appropriate dose.

Children from 6 months to 12 years old:
Use the dosage form of granules oral suspension to ensure the right dosage.

Children under 6 months old

Safety and efficacy of infants less than 6 months of age have not been established

Method of administration

BOSTOCEF 300 for oral use, it may be given with or without food.

CONTRAINDICATIONS

Hypersensitivity to cefdinir or to any ingredient in the drug product.

Patients with a known allergy to the cephalosporin group of antibiotics

WARNINGS AND PRECAUTIONS

Warnings

-  Before therapy with cefdinir is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, or other drugs. if cefdinir is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among β-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 cefdinir occurs, the drug should be discontinued. 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. 

- Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alter the normal flora of the colon leading to overgrowth of C. difficile.

- C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents

- If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

- Prescribing cefdinir in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

- 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 alternative therapy should be administered. Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis. In patients with transient or persistent renal insufficiency (creatinine clearance < 30 mL/min), the total daily dose of cefdinir should be reduced because high and prolonged plasma concentrations of cefdinir can result following recommended doses.

- Patients should be counseled that antibacterial drugs including cefdinir should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefdinir 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. Skipping doses or not completing the full course of
therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by cefdinir or other antibacterial drugs in the future.

Pediatric Use 

Safety and efficacy in neonates and infants less than 6 months of age have not been established. The use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.

Geriatric
Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised.

Precautions with excipients

Products containing azorubine, FD&C Red 40: may cause an allergic reaction

Shelf-life

36 months from the manufacturing date.

Al/Al blisters. Box of 2 blisters x 10 tablets