Cefdinir................................................300 mg
Excipients q.s...................................... 1 capsule
Hard capsule
Box of 2 blisters x 10 hard capsules.
Cefdinir is classified as a third-generation cephalosporin. The bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir has an expanded 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, it is active against gram-positive bacteria e.g., Staphylococcus sp., Streptococcus sp. and resistant to other pre-existing oral cephalosporins. Enterococci (Enterococcus faecalis) and methicillin-resistant Staphylococci are resistant to cefdinir.
Following oral administration of cefdinir, peak plasma concentrations are attained 2 - 4 hours. Estimated absolute bioavailability is 21% following a 300-mg dose and 16% following a 600-mg dose. Cefdinir is distributed into tonsils, sinus tissue, bronchial tissue, lung mucosa … at different plasma concentrations. The mean volume of distribution of cefdinir in adult subjects is 0.35 L/kg (± 0.29); in pediatric subjects (age 6 months - 12 years), cefdinir is 0.67 L/kg (± 0.38). Cefdinir is 60% to 70% bound to plasma; binding is independent of concentration. There is no evidence that cefdinir accumulates in plasma following multiple doses in patients with normal renal function receiving the drug twice daily.
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.
Cefdinir should be used cautiously by drivers and machine users.
Personal or family history of allergy e.g. urticaria, skin rash, bronchial asthma.
Severe renal impairment
A history of colitis.
Children aged less than 6 months.
No adequate studies in pregnant women have been reported.
Following administration of single 600-mg doses, cefdinir was not detected in human breast milk. Cefdinir should be used with caution in nursing mothers.
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 effect occur during the treatment.
Symptoms following overdosage with cefdinir have included nausea, vomiting, epigastric pain.
Treatment: Symptomatic treatment is mainly applied and the drug should be removed from the body. Hemodialysis removes cefdinir from the body.
Store in dry places, not exceeding 300C, protect from light.
24 months from the manufacturing date.
Community acquired pneumonia, acute course of chronic bronchitis, acute sinusitis, pharyngitis, tonsillitis.
Folliculitis, paronychia, impetigo, hypodermic abscesses, vasculitis or lymphadenitis.
Pyelonephritis, cystitis.
Known allergy to the cephalosporin class of antibiotics or any ingredients of the drug.
Oral route. Therapy duration should be from 5 to 10 days.
Adults and adolescents aged over 12 years: 300 mg twice daily.
For patients with renal impairment (CrCl < 30 ml/ min): 300 mg once daily.
Or as directed by a physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
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