Efdinir
Cefdinir Capsule & Dry Suspension

Presentation
Efdinir 300 mg capsule: Each capsule contains Cefdinir INN 300 mg.
Efdinir 60 ml powder for suspension: After reconstitution each 5 ml suspension contains Cefdinir INN 125 mg.
Efdinir DS : After reconstitution each 5 ml suspension contains Cefdinir INN 250 mg.

Description
Cefdinir is an orally administered extended spectrum, semi-synthetic 3rd generation antibiotic of Cephalosporin class. Like other beta-lactam antibiotics it is a bactericidal drug that acts by inhibition of bacterial cell wall synthesis.

Indications and Uses
Cefdinir is indicated for the treatment of patients infected with susceptible strains of micro-organisms which include a wide range of Gram-positive & Gram-negative bacteria. The susceptible organisms include Gram-positive bacteria eg. S. aureus (including beta lactamase producing strains), S. pneumoniae (penicillin-susceptible strains only), S. pyogenes, S. agalactiae, S. epidermidis (penicillin-susceptible strains only), and Gram-negative bacteria eg. E. coli, K. pneumoniae, H. influenzae (including beta-lactamase producing strains), H. parainfluenzae (including beta-lactamase producing strains), M. catarrhalis (including beta-lactamase producing strains) , P. mirabillis, C. diversus.

Efdinir is indicated in the following diseases:-
(1) Lower respiratory tract infection: Acute community-acquired pneumonia, Acute bacterial exacerbation of chronic bronchitis; (2) Upper respiratory tract infection: Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsillitis; (3) Uncomplicated skin and skin structure infections.

Contraindications
Cefdinir is contraindicated in patients with a known allergy to it or to the Cephalosporin group of antibiotics.

Dosage And Administration
Capsule
The total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID 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.

Suspension
The total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day.

Patients With Renal Impairment: For patients with severe renal impairment (creatinine clearance <30 mL/min), the dose of Cefdinir should be 300 mg given once daily.
Patients with hepatic disease: As Cefdinir is predominantly renally eliminated and appreciably metabolized; dosage adjustment is not necessary in this population.


Precautions
Cefdinir, as with other broad-spectrum 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.

Side Effects
Although side-effects from Cefdinir are not common, they can occur. More common side effects are diarrhea, nausea, vaginal infection. Less common side-effects are abdominal pain, headache, vaginal inflammation. Rare side-effects are abnormal stools, constipation, dizziness, drowsiness, gas, insomnia, itching, loss of appetite, indigestion, vomiting, weakness, vaginal discharge.

Use in pregnancy & lactation
Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Lactation: Following administration of single 600-mg doses, Cefdinir was not detected in human breast milk.

Overdosage
Information of Cefdinir overdosage in human is not avaialble. Toxic symptoms may include nausea, vomiting, epigastric distress, diarrhea and convulsion. Hemodialysis removes Cefdinir from the body.

Commercial Pack
Efdinir 300 mg capsule: Each box contains 2 Alu-Alu blisters of 4 capsules.
Efdinir 60 ml powder for suspension: Each bottle contains dry powder for 60 ml suspension.
Efdinir DS : Each bottle contains dry powder for 30 ml DS suspension.
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