CEFDINER-ELSaad (susp)
-
Chemical Name:
Cefdinir -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin (Third Generation) -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Cefdinir 125mg/5ml
CEFDINIR ELSaad
Capsules, Dry Powder for Oral Suspension
Cefdinir
1-CLINICAL PHARMACOLOGY:
Microbiology:
As with other cephalosporins, bactericidal activity of CEFDINIR results from inhibition of cell wall synthesis. CEFDINIR is stable in the presence of some, but not all, β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to CEFDINIR.
CEFDINIR has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:
Aerobic Gram-Positive Microorganisms:
Staphylococcus aureus (including β-lactamase producing strains)
Streptococcus pneumoniae (penicillin-susceptible strains only)
Streptococcus pyogenes
Staphylococcus epidermidis (methicillin-susceptible strains only)
Streptococcus agalactiae
Viridans group streptococci
Aerobic Gram-Negative Microorganisms:
Haemophilus influenzae (including β-lactamase producing strains)
Haemophilius parainfuenzae (including β-lactamase producing strains)
Moraxella catarrhalis (including β-lactamase producing strains)
The following in vitro data are available, but their clinical significance is unknown:
Citrobacter diversus, Escherichia coli, Klebsiella pneumonia, Proteus mirabilis
Pharmacokinetics:
Absorption:
Oral Bioavailability: Maximal plasma CEFDINIR concentrations occur 2 to 4 hours post dose following capsule or suspension administration. Estimated bioavailability of CEFDINIR capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of CEFDINIR suspension is 25%.
Effect of Food: CEFDINIR may be taken without regard to food.
Multiple Dosing: CEFDINIR does not accumulate in plasma following once or twice-daily administration to subjects with normal renal function.
Distribution:
The mean volume of distribution (Vd area) of CEFDINIR in adult subjects is 0.35 L/kg (±0.29); in pediatric subjects ( age 6 months - 12 years ), CEFDINIR Vd area is 0.67 L/kg (±0.38). CEFDINIR is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.
Metabolism and Excretion:
CEFDINIR is not appreciably metabolized. Activity is primarily due to parent drug. CEFDINIR is eliminated principally via renal excretion with a mean plasma elimination half-life (t½) of 1.7 (±0.6) hours. In healthy subjects with normal renal function, renal clearance is 2.0 (±1.0) mL/ min/kg.
Mean percent of dose recovered unchanged in the urine following 300 and 600 mg doses is 18.4% (±6.4) and 11.6% (±4.6), respectively. CEFDINIR clearance is reduced in patients with renal dysfunction.
Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis.
2-INDICATIONS:
CEFDINIR Capsules and CEFDINIR for Oral Suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
-Community - acquired pneumonia.
-Acute exacerbations of chronic bronchitis.
-Pharyngitis / tonsillitis caused by Streptococcus pyogenes.
-Skin and skin structure infections.
-Acute bacterial otitis media.
3-CONTRAINDICATIONS:
CEFDINIR is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
4-PRECAUTIONS:
-Inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to CEFDINIR, other cephalosporins, penicillins or other drugs.
-It is important to consider pseudomembranous colitis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
-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.
-Pregnancy: Category B.
This drug should be used during pregnancy only if clearly needed.
-Nursing Mothers: CEFDINIR was not detected in human breast milk.
5-SIDE EFFECTS:
It may rarely cause: Diarrhea, nausea, rash or headache.
6-DRUG INTERACTIONS:
-Antacids containing magnesium or aluminum interfere with the absorption of CEFDINIR. If this type of antacid is required during CEFDINIR therapy, CEFDINIR should be taken at least 2 hours before or after the antacid.
-Iron supplements, including multivitamins that contain iron, interfere with the absorption of CEFDINIR. If iron supplements are required during CEFDINIR therapy, CEFDINIR should be taken at least 2 hours before or after the supplement.
-Probenecid inhibits the renal excretion of CEFDINIR.
7-DOSAGE & ADMINISTRATION:
Capsules:
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as b.i.d. dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, CEFDINIR capsules should be administered twice daily in these infections. CEFDINIR capsules may be taken without regard to meals.
| Adults and Adolescents (Age: 13 years and older) | ||
| Type of Infection | Dosage | Duration |
| Community-Acquired Pneumonia | 300 mg q12h | 10 days |
| Bronchitis |
300 mg q12h
or
600 mg q24h
|
10 days |
| Sinusitis |
300 mg q12h
or
600 mg q24h
|
10 days |
| Pharyngitis/Tonsillitis |
300 mg q12h
or
600 mg q24h
|
5 to 10 days
10 days
|
| Skin and Skin Structure Infections | 300 mg q12h | 10 days |
Dry Powder for Oral Suspension:
The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as b.i.d. dosing. Once-daily dosing has not been studied in skin infections; therefore, CEFDINIR for oral suspension should be administered twice daily in this infections. CEFDINIR for oral suspension may be administered without regard to meals.
| Pediatric Patients (Age: 6 months to 12 years) | ||
| Type of Infection | Dosage | Duration |
| Acute Bacterial Otitis Media |
7 mg/kg q12h
or
14 mg/kg q24h
|
10 days |
| Acute Maxillary Sinusitis |
7 mg/kg q12h
or
14 mg/kg q24h
|
10 days |
| Pharyngitis/Tonsillitis |
7 mg/kg q12h
or
14 mg/kg q24h
|
5 to 10 days
10 days
|
| Uncomplicated Skin and Skin Structure Infections | 7 mg/kg q12h | 10 days |
|
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC
DOSAGE CHART
|
|
| Weight | 125 mg/5mL |
| 9 kg |
2.5 mL (½ tsp) q12h
or 5 mL (1 tsp) q24h
|
| 18 kg |
5 mL (1 tsp) q12h
or 10 mL (2 tsp) q24h
|
| 27 kg |
7.5 mL (1 ½ tsp) q12h
or 15 mL (3 tsp) q24h
|
| 36 kg |
10 mL (2 tsp) q12h
or 20 mL (4 tsp) q24h
|
| ≥ 43 kga |
12 mL (2 ½ tsp) q12h
or 24 mL (5 tsp) q24h
|
| a Pediatric patients who ≥ 43 kg should receive the maximum daily dose of 600 mg. | |
Patients with Renal Insufficiency:
For adult patients with creatinine clearance < 30mL/min, the dose of CEFDINIR should be 300 mg given once daily.
-Preparing CEFDINIR for Oral Suspension:
Tap the bottle to loosen powder, then add water in 2 portions.
Shake well after each aliquot.
After mixing, the suspension can be stored at room temperature (25 ºC). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.
8-PACKAGING & COMPOSTION:
-CEFDINIR ELSaad - Capsules: A pack of 10 or 20 capsules in blister. Each capsule contains Cefdinir 300 mg.
-CEFDINIR ELSaad - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, Each 5 mL of the suspension contains Cefdinir 125 mg.
9-STORAGE CONDITIONS:
Store CEFDINIR ELSaad – Capsules and Dry Powder for Oral Suspension at temperature between (15-30)°C.
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