DRUGS & SUPPLEMENTS

Cefdinir

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Cefdinir uses


INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefdinir and other antibacterial drugs, Cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefdinir capsules 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.

Adults and Adolescents

Community-Acquired Pneumonia

caused by Haemophilus influenzae, Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ).

Acute Exacerbations of Chronic Bronchitis

caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

Acute Maxillary Sinusitis

caused by Haemophilus influenzae, Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION .

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES ).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections

caused by Staphylococcus aureus and Streptococcus pyogenes.

Pediatric Patients

Acute Bacterial Otitis Media

caused by Haemophilus influenzae, Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES ).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections

caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

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CONTRAINDICATIONS

Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

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 use of nearly all antibacterial agents, including Cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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PRECAUTIONS

General

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, 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 (see DOSAGE AND ADMINISTRATION  ).

Information for Patients

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 (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefdinir or other antibacterial drugs in the future.

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.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Antacids

Concomitant administration of 300 mg Cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on Cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after Cefdinir. If antacids are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the antacid.

Probenecid

As with other β-lactam antibiotics, probenecid inhibits the renal excretion of Cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak Cefdinir plasma levels, and a 50% prolongation in the apparent elimination t1/2.

Iron Supplements and Foods Fortified With Iron

Concomitant administration of Cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the supplement.

The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on Cefdinir absorption has not been studied.

There have been reports of reddish stools in patients receiving Cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between Cefdinir or its breakdown products and iron in the gastrointestinal tract.

Drug/Laboratory Test Interactions

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. The administration of Cefdinir may result in a false-positive reaction for glucose in urine using Clinitest®, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or Tes-Tape®) be used. Cephalosporins are known to occasionally induce a positive direct Coombs’ test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Cefdinir has not been evaluated. No mutagenic effects were seen in the bacterial reverse mutation assay or point mutation assay at the hypoxanthine-guanine phosphoribosyltransferase locus (HGPRT) in V79 Chinese hamster lung cells. No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lung cells or in vivo in the micronucleus assay in mouse bone marrow. In rats, fertility and reproductive performance were not affected by Cefdinir at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/day).

Pregnancy

Teratogenic Effects

Pregnancy Category B

Cefdinir was not teratogenic in rats at oral doses up to 1000 mg/kg/day or in rabbits at oral doses up to 10 mg/kg/day (0.7 times the human dose based on mg/kg/day, 0.23 times based on mg/m2/day). Maternal toxicity (decreased body weight gain) was observed in rabbits at the maximum tolerated dose of 10 mg/kg/day without adverse effects on offspring. Decreased body weight occurred in rat fetuses at ≥ 100 mg/kg/day, and in rat offspring at ≥ 32 mg/kg/day. No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Cefdinir has not been studied for use during labor and delivery.

Nursing Mothers

Following administration of single 600 mg doses, Cefdinir was not detected in human breast milk.

Pediatric Use

Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of Cefdinir for the treatment of acute maxillary sinusitis in pediatric patients 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 Use

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 (see DOSAGE AND ADMINISTRATION ).

Adverse Reactions

Clinical Trials

Cefdinir Capsules

In clinical trials, 5093 adult and adolescent patients (3841 U.S. and 1252 non-U.S.) were treated with the recommended dose of Cefdinir capsules (600 mg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to Cefdinir. One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with Cefdinir therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to Cefdinir administration.

In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to Cefdinir capsules in multiple-dose clinical trials (N=3841 cefdinir-treated patients):

 

Incidence ≥ 1%

 

Diarrhea

 

15%

   

Vaginal moniliasis

 

4% of women

   

Nausea

 

3%

   

Headache

 

2%

   

Abdominal pain

 

1%

   

Vaginitis

 

1% of women

 

Incidence < 1%

but > 0.1%

 

Rash

 

0.9%

   

Dyspepsia

 

0.7%

   

Flatulence

 

0.7%

   

Vomiting

 

0.7%

   

Abnormal stools

 

0.3%

   

Anorexia

 

0.3%

   

Constipation

 

0.3%

   

Dizziness

 

0.3%

   

Dry mouth

 

0.3%

   

Asthenia

 

0.2%

   

Insomnia

 

0.2%

   

Leukorrhea

 

0.2% of women

   

Moniliasis

 

0.2%

   

Pruritus

 

0.2%

   

Somnolence

 

0.2%


The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with Cefdinir, were seen during clinical trials conducted in the U.S.:

 

Incidence ≥ 1%

 

↑Urine leukocytes

 

2%

   

↑Urine protein

 

2%

   

↑Gamma-glutamyltransferaseN < 3841 for these parameters

 

1%

   

↓Lymphocytes, ↑Lymphocytes

 

1%, 0.2%

   

↑Microhematuria

 

1%

 

Incidence < 1%

but > 0.1%

 

↑Glucose

 

0.9%

   

↑Urine glucose

 

0.9%

   

↑White blood cells, ↓White blood cells

 

0.9%, 0.7%

   

↑Alanine aminotransferase (ALT)

 

0.7%

   

↑Eosinophils

 

0.7%

   

↑Urine specific gravity, ↓Urine specific gravity

 

0.6%, 0.2%

   

↓Bicarbonate

 

0.6%

   

↑Phosphorus, ↓Phosphorus

 

0.6%, 0.3%

   

↑Aspartate aminotransferase (AST)

 

0.4%

   

↑Alkaline phosphatase

 

0.3%

   

↑Blood urea nitrogen (BUN)

 

0.3%

   

↓Hemoglobin

 

0.3%

   

↑Polymorphonuclear neutrophils (PMNs), ↓PMNs

 

0.3%, 0.2%

   

↑Bilirubin

 

0.2%

   

↑Lactate dehydrogenase

 

0.2%

   

↑Platelets

 

0.2%

   

↑Potassium

 

0.2%

   

↑Urine pH

 

0.2%

Postmarketing Experience

The following adverse experiences and altered laboratory tests, regardless of their relationship to Cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements, and rhabdomyolysis.

Cephalosporin Class Adverse Events

The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:

Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment (see WARNINGS ).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE ). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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OVERDOSAGE

Information on Cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes Cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

DOSAGE AND ADMINISTRATION

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.

 

Type of Infection

 

Dosage

 

Duration

 

Community-Acquired Pneumonia

 

300 mg q12h

 

10 days

 

Acute Exacerbations of Chronic Bronchitis

 

300 mg q12h

or

600 mg q24h

 

5 to 10 days

10 days

 

Acute Maxillary Sinusitis

 

300 mg q12h

or

600 mg q24h

 

10 days

10 days

 

Pharyngitis/Tonsillitis

 

300 mg q12h

or

600 mg q24h

 

5 to 10 days

10 days

 

Uncomplicated Skin and Skin Structure Infections

 

300 mg q12h

 

10 days

Patients With Renal Insufficiency

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

Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

 

Males:

 

CLcr =

 

(weight) (140 – age)

 

(72) (serum creatinine)

 

Females:

 

CLcr =

 

0.85 x above value

 

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)


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

 

CLcr = K x

 

body length or height

 

serum creatinine

 

where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year).(5)


In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of Cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

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.

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HOW SUPPLIED

Cefdinir capsules, containing 300 mg Cefdinir, are blue, opaque hard gelatin capsules imprinted with “Sandoz 663” and are supplied as follows:

NDC 67253-011-06 in bottles of 60 capsules

Store at 20°-25°C (68°-77°F).

CLINICAL STUDIES

Community-Acquired Bacterial Pneumonia

In a controlled, double-blind study in adults and adolescents conducted in the U.S., Cefdinir b.i.d. was compared with cefaclor 500 mg t.i.d.. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

   

Cefdinir b.i.d .

 

Cefaclor t.i.d .

 

Outcome

 

Clinical Cure Rates

 

150/187

 

147/186 (79%)

 

Cefdinir equivalent

to control

 

Eradication Rates

     
 

Overall

 

177/195 (91%)

 

184/200 (92%)

 

Cefdinir equivalent

to control

 

S. pneumoniae

 

31/31 (100%)

 

35/35 (100%)

 
 

H. influenzae

 

55/65 (85%)

 

60/72 (83%)

 
 

M. catarrhalis

 

10/10 (100%)

 

11/11 (100%)

 
 

H. parainfluenzae

 

81/89 (91%)

 

78/82 (95%)

 

In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, Cefdinir b.i.d. was compared with amoxicillin/clavulanate 500/125 mg t.i.d. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

   

Cefdinir b.i.d .

 

Amoxicillin/

Clavulanate t.i.d .

 

Outcome

 

Clinical Cure Rates

 

83/104 (80%)

 

86/97 (89%)

 

Cefdinir not equivalent

to control

 

Eradication Rates

     
 

Overall

 

85/96 (89%)

 

84/90 (93%)

 

Cefdinir equivalent

to control

 

S. pneumonia

 

42/44 (95%)

 

43/44 (98%)

 
 

H. influenzae

 

26/35 (74%)

 

21/26 (81%)

 
 

M. catarrhalis

 

6/6 (100%)

 

8/8 (100%)

 
 

H. parainfluenzae

 

11/11 (100%)

 

12/12 (100%)

 

Streptococcal Pharyngitis/Tonsillitis

In four controlled studies conducted in the United States, Cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of Cefdinir q.d. or b.i.d. to penicillin 250 mg or 10 mg/kg q.i.d. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

 

Study

 

Efficacy

Parameter

 

Cefdinir

q.d .

 

Cefdinir

b.i.d .

 

Penicillin

q.i.d .

 

Outcome

 

Adults/

Adolescents

 

Eradication of S. pyogenes Clinical Cure Rates

 

192/210

(91%)

 

199/217

(92%)

 

181/217

(83%)

 

Cefdinir superior to control

 

199/210

(95%)

 

209/217

(96%)

 

193/217

(89%)

 

Cefdinir superior to control

 

Pediatric Patients

 

Eradication of S. pyogenes Clinical Cure Rates

 

215/228

(94%)

 

214/227

(94%)

 

159/227

(70%)

 

Cefdinir superior to control

 

222/228

(97%)

 

218/227

(96%)

 

196/227

(86%)

 

Cefdinir superior to control


Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of Cefdinir b.i.d. to 10 days of penicillin 250 mg or 10 mg/kg q.i.d.. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

 

Study

 

Efficacy

Parameter

 

Cefdinir

b.i.d .

 

Penicillin

q.i.d .

 

Outcome

 

Adults/

Adolescents

 

Eradication of S. pyogenes Clinical Cure Rates

 

193/218 (89%)

 

176/214 (82%)

 

Cefdinir equivalent to control

 

194/218 (89%)

 

181/214 (85%)

 

Cefdinir equivalent to control

 

Pediatric Patients

 

Eradication of S. pyogenes Clinical Cure Rates

 

176/196 (90%)

 

135/193 (70%)

 

Cefdinir superior to control

 

179/196 (91%)

 

173/193 (90%)

 

Cefdinir equivalent to control

REFERENCES

  • 1.National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 4th ed. Approved Standard, NCCLS Document M7-A4,Vol 17(2). NCCLS,Villanova, PA, Jan 1997.
  • 2.National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests, 6th ed. Approved Standard, NCCLS Document M2-A6, Vol 17(1). NCCLS, Villanova, PA, Jan 1997.
  • 3.Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
  • 4.Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.
  • 5.Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.

Maalox® is a registered trademark of Rhone-Poulenc Rorer.

Clinistix® and Clinitest® are a registered trademarks of Miles Diagnostics.

Tes-Tape® is a registered trademark of Lilly.

Iss. 02-14M

46129583

Manufactured For:

DAVA Pharmaceuticals, Inc.

Fort Lee, NJ 07024, USA

By Sandoz GmbH in Austria

NDC 67253-011-06

Cefdinir

CAPSULES

300 mg

60 capsules (Blue) Rx only

DAVA®

Cefdinir pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Cefdinir available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.

Price
Capsules; Oral; Cefdinir 300 mg
Cefdinir 125 mg/5ml Suspension 60ml Bottle53.05 USD
Cefdinir 300 mg capsule5.22 USD
Omnicef 125 mg/5ml Suspension 100ml Bottle101.59 USD
Omnicef 300 mg capsule6.31 USD
Omnicef 300 mg omni-pac capsule5.72 USD
Powder for Suspension; Oral; Cefdinir 125 mg / 5 ml
Powder for Suspension; Oral; Cefdinir 250 mg / 5 ml

Cefdinir destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Cefdinir Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Cefdinir pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CEFDINIR CAPSULE [PAR PHARMACEUTICAL]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CEFDINIR: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "cefdinir". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Cefdinir?

Depending on the reaction of the Cefdinir after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cefdinir not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Cefdinir addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Cefdinir, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cefdinir consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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