Cefdinir......................................300 mg
Excipients q.s.......................... 1 capsule
(Aerosil, microcrystalline cellulose M112, talc, magnesium stearate).
DOSAGE FORM: Hard capsule.
PRESENTATION: Box of 2 blisters x 10 capsules.
Cefdinir is classified as a third generation cephalosporin. Bactericidal activity of cefdinir results from inhibition of bacterial cell wall synthesis. Cefdinir has an expended spectrum of activity against gram-negative bacteria e.g. Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis and gram-positive bacteria e.g. Staphylococcus aureus, Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes. Cefdinir is not affected by the beta-lactamase enzymes. Particularly, cefdinir has been shown to be active against gram-positive bacteria including Staphylococcus sp., Streptococcus sp., resistant to other previously oral cephalosporins. Methicillin-resistant staphylococci are resistant to cefdinir.
PHARMACOKINETICS: Following oral administration of cefdinir, peak plasma concentrations are attained 2-4 hours. Estimated absolute bioavailability is 25% following administration of the oral suspension. 
In pediatric patients 6 months to 12 years of age who received a single 7-mg/kg oral dose of cefdinir as the suspension, peak plasma concentrations were attained 2.2 hours after the dose. Single 14-mg/kg oral doses in these patients resulted in peak plasma concentrations averaging at 1.8 hours after the dose.
Concomitant administration of cefdinir oral suspension with a high-fat meal decreases peak plasma concentrations and AUC of the drug by 44% and 33%. There is no evidence that cefdinir accumulates in plasma following multiple doses in patients with normal renal function receiving the drug twice daily.
Following oral administration, cefdinir is distributed into middle ear fluid, tonsils, sinus tissue, and bronchial mucosa, etc. at different plasma concentrations. In pediatric patients with acute bacterial otitis media who received single 7- or 14-mg/kg oral doses of cefdinir, median concentrations of the drug in middle ear fluid are 3 hours.
Cefdinir is 60-70% bound to plasma proteins; binding is independent of drug concentration.
Cefdinir is not appreciably metabolized. The drug is eliminated principally by renal excretion. In adults with normal renal function, the mean plasma elimination half-life of cefdinir is 1.7-1.8 hours. Clearance of cefdinir is decreased in patients with impaired renal function. In patients with creatinine clearances of 30 - 60 ml/minute, peak plasma concentrations and plasma elimination half-life of the drug are increased approximately twofold and the AUC is increased approximately threefold. In patients with creatinine clearances less than 30 ml/minute, peak plasma concentrations are increased approximately twofold but plasma elimination half-life and AUC are increased approximately fivefold and sixfold, respectively.
Cefdinir is removed by hemodialysis. A 4-hour period of dialysis removes approximately 63% of the drug and decreases the apparent elimination half-life of cefdinir in patients with substantial renal impairment from 16 to 3.2 hours.
INDICATIONS: Community acquired pneumonia, acute course of chronic bronchitis, acute sinusitis, pharyngitis, tonsillitis.
Folliculitis, paronychia, impetigo, hypodermic abscesses, vasculitis or lymphadenitis.
Pyelonephritis, cystitis.
CONTRAINDICATIONS: Known allergy to the cephalosporin class of antibiotics or any ingredients of the drug.
PRECAUTIONS: Personal or family history of allergy e.g. urticaria, skin rash, bronchial asthma.
Severe renal impairment
A history of colitis.
Children aged younger than 6 months.
No adequate studies in pregnant women has been reported.
Following administration of single 600-mg doses, cefdinir was not detected in human breast milk.
Cefdinir should be used with caution in pregnant women and nursing mothers.
Cefdinir should be used with cautions in drivers and machine users.
INTERACTIONS : Cefdinir should be taken at least 2 hours before or after the antacid or iron supplements by reduction of bioavailability.
Probenecid inhibits the renal excretion of cefdinir.  
Rarely: Nausea, vomiting, colic, anorexia, constipation, headache, dizziness, stomatitis, fungal infection, deficiency of vitamin K and B vitamins, leukopenia, increase in hepatic enzyme levels, increase in blood urea nitrogen (BUN).
Inform your physician about any adverse effects occur during the treatment.
Symptoms following overdosage with cefdinir have included nausea, vomitting, epigastric pain.
Symptomatic treatment is mainly applied and the drug should be removed from the body. Hemodialysis removes cefdinir from the body.
Oral route. Therapy duration should be from 5 to 10 days.
Adults and children aged more than 12 years: 300 mg twice daily. For patients with renal impairment (CrCl < 30 ml/min): 300 mg once daily. 
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
Shelf-life: 24 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.


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