Drugs Details

Drugs Info of Omnicef, Omnicef Omni-Pac
Drugs Details
  • Drugs Type  : FDA
  • Date : 8th Jan 2015 04:46 am
  • Brand Name : Omnicef, Omnicef Omni-Pac
  • Generic Name : cefdinir (Pronunciation: SEF dih neer)
Descriptions

  Proprietary name: OMNICEF
Established name: cefdinir
Route of administration: ORAL (C38288)
Active ingredients (moiety): cefdinir (cefdinir)
# Strength Form Inactive ingredients
1 300 MILLIGRAM CAPSULE (C25158) carboxymethylcellulose calcium, NF, polyoxyl 40 stearate, NF, magnesium stearate, NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, NF, gelatin, NF, silicon dioxide, NF, sodium lauryl sulfate, NF
2 125 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF
3 250 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF

OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

 

OMNICEF®
  (cefdinir) capsules  Structural Formula Illustration

OMNICEF Capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, NF; polyoxyl 40 stearate, NF; and magnesium stearate, NF. The capsule shells contain FD&C Blue #1; FD&C Red #40; D&C Red #28; titanium dioxide, NF; gelatin, NF; silicon dioxide, NF; and sodium lauryl sulfate, NF.

OMNICEF (cefdinir) for Oral Suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, NF; citric acid, USP; sodium citrate, USP; sodium benzoate, NF; xanthan gum, NF; guar gum, NF; artificial strawberry and cream flavors; silicon dioxide, NF; and magnesium stearate, NF.

What are the possible side effects of cefdinir (Omnicef, Omnicef Omni-Pac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • chest pain;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and...

Read All Potential Side Effects and See Pictures of Omnicef »

What are the precautions when taking cefdinir (Omnicef)?

Before taking cefdinir, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (e.g., cephalexin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug does not...

Read All Potential Precautions of Omnicef »

This monograph has been modified to include the generic and brand name in many instances.

Indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF (cefdinir) and other antibacterial drugs, OMNICEF (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.

OMNICEF (cefdinir) capsules and OMNICEF (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.

Adults and Adolescents

Community-Acquired Pneumonia

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) (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 (including β-lactamase producing strains), 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 (including β-lactamase producing strains) and Streptococcus pyogenes.

Pediatric Patients

Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), 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.

Dosage Administration

(see INDICATIONS for Indicated Pathogens)

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 BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, OMNICEF (cefdinir) Capsules should be administered twice daily in these infections. OMNICEF (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
Acute Exacerbations of Chronic Bronchitis 300 mg q12h or 5 to 10 days
600 mg q24h 10 days
Acute Maxillary Sinusitis 300 mg q12h or 10 days
600 mg q24h 10 days
Pharyngitis/Tonsillitis 300 mg q12h or 5 to 10 days
600 mg q24h 10 days
Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days

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 BID dosing. Once-daily dosing has not been studied in skin infections; therefore, OMNICEF (cefdinir) for Oral Suspension should be administered twice daily in this infection. OMNICEF (cefdinir) for Oral Suspension may be administered without regard to meals.

Pediatric Patients (Age 6 Months Through 12 Years)

Type of Infection Dosage Duration
Acute Bacterial Otitis Media 7 mg/kg q12h 5 to 10 days
or 14 mg/kg q24h 10 days
Acute Maxillary Sinusitis 7 mg/kg q12h 10 days
or 14 mg/kg q24h 10 days
Pharyngitis/Tonsillitis 7 mg/kg q12h 5 to 10 days
or 14 mg/kg q24h 10 days
Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days

OMNICEF (cefdinir) FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART

Weight 125 mg/5 mL 250 mg/5 mL
9 kg/20 lbs 2.5 mL q12h or 5 mL q24h Use 125 mg/5 mL product
18 kg/40 lbs 5 mL q12h or 10 mL q24h 2.5 mL q12h or 5 mL q24h
27 kg/60 lbs 7.5 mL q12h or 15 mL q24h 3.75 mL q12h or 7.5 mL q24h
36 kg/80 lbs 10 mL q12h or 20 mL q24h 5 mL q12h or 10 mL q24h
≥ 43 kga/95 lbs 12 mL q12h or 24 mL q24h 6 mL q12h or 12 mL q24h
a Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg.

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 × 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 × 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.

Directions for Mixing Omnicef (cefdinir) for Oral Suspension

Final Concentration Final Volume (mL) Amount of Water Directions
125 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions.
100 63 mL Shake well after each aliquot.
250 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions.
100 63 mL Shake well after each aliquot.

After mixing, the suspension can be stored at room temperature (25°C/77°F). 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.

How Supplied

View Enlarged Table

OMNICEF Capsules, containing 300 mg cefdinir, as lavender and turquoise capsules imprinted with the product name, are available as follows:

60 Capsules/Bottle NDC 0074-3769-60

OMNI-PAC™ carton of 3 unit-of-use, 5-day,

10-capsule blister cards NDC 0074-3769-30

OMNICEF (cefdinir) for Oral Suspension is a cream-colored powder formulation that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspensions have a cream color and strawberry flavor. The powder is available as follows:

125 mg/5 mL

60-mL bottles NDC 0074-3771-60
100-mL bottles NDC 0074-3771-13

250 mg/5 mL

60-mL bottles NDC 0074-6151-60
100-mL bottles NDC 0074-6151-13

Store the capsules and unsuspended powder at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

REFERENCES

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.

Manufactured by: CEPH International Corporation, Carolina, Puerto Rico 00986. Manufactured For: Abbott Laboratories, North Chicago, IL 60064. FDA Rev date: 12/15/2009

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials - OMNICEF (cefdinir) Capsules (Adult and Adolescent Patients)

In clinical trials, 5093 adult and adolescent patients (3841 US and 1252 non-US) 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 US, 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):

ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES US TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)a

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%
a 1733 males, 2108 females

The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the US:

LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES US TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)

Incidence ≥ 1% ↑Urine leukocytes 2%
↑Urine protein 2%
↑Gamma-glutamyltransferasea 1%
↓Lymphocytes, ↑Lymphocytes 1%, 0.2%
↑Microhematuria 1%
Incidence < 1% but > 0.1% ↑Glucosea 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 gravitya 0.6%, 0.2%
↓Bicarbonatea 0.6%
↑Phosphorus, ↓Phosphorusa 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 dehydrogenasea 0.2%
↑Platelets 0.2%
↑Potassiuma 0.2%
↑Urine pHa 0.2%
a N < 3841 for these parameters

Clinical Trials - OMNICEF (cefdinir) for Oral Suspension (Pediatric Patients)

In clinical trials, 2289 pediatric patients (1783 US and 506 non-US) were treated with the recommended dose of cefdinir suspension (14 mg/kg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with cefdinir therapy. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 2289 (0.2%) patients were discontinued due to rash thought related to cefdinir administration.

In the US, the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir suspension in multiple-dose clinical trials (N = 1783 cefdinir-treated patients):

ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION US TRIALS IN PEDIATRIC PATIENTS (N = 1783)a

Incidence ≥ 1% Diarrhea 8%
Rash 3%
Vomiting 1%
Incidence < 1% but > 0.1% Cutaneous moniliasis 0.9%
Abdominal pain 0.8%
Leukopeniab 0.3%
Vaginal moniliasis 0.3% of girls
Vaginitis 0.3% of girls
Abnormal stools 0.2%
Dyspepsia 0.2%
Hyperkinesia 0.2%
Increased ASTb 0.2%
Maculopapular rash 0.2%
  Nausea 0.2%
a 977 males, 806 females
b Laboratory changes were occasionally reported as adverse events.

NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The incidence of diarrhea in cefdinir-treated patients ≤ 2 years of age was 17% (95/557) compared with 4% (51/1226) in those > 2 years old. The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients ≤ 2 years of age compared with 1% (8/1226) in those > 2 years old.

The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the US:

LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION US TRIALS IN PEDIATRIC PATIENTS
(N = 1783)

Incidence ≥ 1% ↑Lymphocytes, ↓ Lymphocytes 2%, 0.8%
↑Alkaline phosphatase 1%
↓Bicarbonatea 1%
↑Eosinophils 1%
↑Lactate dehydrogenase 1%
↑Platelets 1%
↑ PMNs, ↓PMNs 1%, 1%
↑Urine protein 1%
Incidence < 1% but > 0.1% ↑Phosphorus, ↓Phosphorus 0.9%, 0.4%
↑Urine pH 0.8%
↓White blood cells, ↑White blood cells 0.7%, 0.3%
↓Calciuma 0.5%
↓Hemoglobin 0.5%
↑Urine leukocytes 0.5%
↑Monocytes 0.4%
↑AST 0.3%
↑Potassiuma 0.3%
↑Urine specific gravity, ↓Urine specific gravity 0.3%, 0.1%
↓Hematocrita 0.2%
a N=1387 for these parameters

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.

Read the Omnicef (cefdinir) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Antacids (aluminum- or magnesium-containing)

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 OMNICEF (cefdinir) therapy, OMNICEF (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 t½.

Iron Supplements and Foods Fortified With Iron

Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during OMNICEF (cefdinir) therapy, OMNICEF (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.

Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on cefdinir pharmacokinetics. Therefore, OMNICEF (cefdinir) for Oral Suspension can be administered with iron-fortified infant formula.

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.

Read the Omnicef Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

BEFORE THERAPY WITH OMNICEF (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 OMNICEF (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.

Precautions

General

Prescribing OMNICEF (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 (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 OMNICEF (cefdinir) should be reduced because high and prolonged plasma concentrations of cefdinir can result following recommended doses (see DOSAGE AND ADMINISTRATION).

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 (Ames) 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 (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/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 (age 6 months through 12 years) 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).

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

ContrainDications

OMNICEF (cefdinir) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Pharmacokinetics and Drug Metabolism

Absorption

Oral Bioavailability

Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. 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%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.

Effect of Food

The Cmax and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal. In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the Cmax and AUC of cefdinir are reduced by 44% and 33%, respectively. The magnitude of these reductions is not likely to be clinically significant because the safety and efficacy studies of oral suspension in pediatric patients were conducted without regard to food intake. Therefore, cefdinir may be taken without regard to food.

Cefdinir Capsules

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300- and 600-mg oral doses of cefdinir to adult subjects are presented in the following table:

Mean (± SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Capsules to Adult Subjects

Dose Cmax
(µg/mL)
tmax
(hr)
AUC
(µg•hr/mL)
300 mg 1.60
(0.55)
2.9
(0.89)
7.05
(2.17)
600 mg 2.87
(1.01)
3.0
(0.66)
11.1
(3.87)

Cefdinir Suspension

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7- and 14-mg/kg oral doses of cefdinir to pediatric subjects (age 6 months-12 years) are presented in the following table:

Mean (± SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects

Dose Cmax
(µg/mL)
tmax
(hr)
AUC
(µg•hr/mL)
7 mg/kg 2.30
(0.65)
2.2
(0.6)
8.31
(2.50)
14 mg/kg 3.86
(0.62)
1.8
(0.4)
13.4
(2.64)

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 (Vdarea) of cefdinir in adult subjects is 0.35 L/kg (± 0.29); in pediatric subjects (age 6 months-12 years), cefdinir Vdarea 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.

Skin Blister

In adult subjects, median (range) maximal blister fluid cefdinir concentrations of 0.65 (0.33-1.1) and 1.1 (0.49-1.9) µg/mL were observed 4 to 5 hours following administration of 300- and 600-mg doses, respectively. Mean (± SD) blister Cmax and AUC (0-∞) values were 48% (± 13) and 91% (± 18) of corresponding plasma values.

Tonsil Tissue

In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were 0.25 (0.22-0.46) and 0.36 (0.22-0.80) µg/g. Mean tonsil tissue concentrations were 24% (± 8) of corresponding plasma concentrations.

Sinus Tissue

In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were < 0.12 ( < 0.12-0.46) and 0.21 ( < 0.12-2.0) µg/g. Mean sinus tissue concentrations were 16% (± 20) of corresponding plasma concentrations.

Lung Tissue

In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were 0.78 ( < 0.06-1.33) and 1.14 ( < 0.06-1.92) µg/mL, and were 31% (± 18) of corresponding plasma concentrations. Respective median epithelial lining fluid concentrations were 0.29 ( < 0.3-4.73) and 0.49 ( < 0.3-0.59) µg/mL, and were 35% (± 83) of corresponding plasma concentrations.

Middle Ear Fluid

In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations 3 hours after administration of single 7- and 14-mg/kg doses were 0.21 ( < 0.09-0.94) and 0.72 (0.14-1.42) µg/mL. Mean middle ear fluid concentrations were 15% (± 15) of corresponding plasma concentrations.

CSF

Data on cefdinir penetration into human cerebrospinal fluid are not available.

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, and apparent oral clearance is 11.6 (± 6.0) and 15.5 (± 5.4) mL/min/kg following doses of 300- and 600-mg, respectively. 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 (see Special Populations - Patients with Renal Insufficiency).

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 (see DOSAGE AND ADMINISTRATION).

Special Populations

Patients with Renal Insufficiency

Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function. Decreases in cefdinir elimination rate, apparent oral clearance (CL/F), and renal clearance were approximately proportional to the reduction in creatinine clearance (CLcr). As a result, plasma cefdinir concentrations were higher and persisted longer in subjects with renal impairment than in those without renal impairment. In subjects with CLcr between 30 and 60 mL/min, Cmax and t½ increased by approximately 2-fold and AUC by approximately 3-fold. In subjects with CLcr < 30 mL/min, Cmax increased by approximately 2-fold, t½ by approximately 5-fold, and AUC by approximately 6-fold. Dosage adjustment is recommended in patients with markedly compromised renal function (creatinine clearance < 30 mL/min; see DOSAGE AND ADMINISTRATION).

Hemodialysis

Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis. Dialysis (4 hours duration) removed 63% of cefdinir from the body and reduced apparent elimination t½ from 16 (± 3.5) to 3.2 (± 1.2) hours. Dosage adjustment is recommended in this patient population (see DOSAGE AND ADMINISTRATION).

Hepatic Disease

Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. It is not expected that dosage adjustment will be required in this population.

Geriatric Patients

The effect of age on cefdinir pharmacokinetics after a single 300-mg dose was evaluated in 32 subjects 19 to 91 years of age. Systemic exposure to cefdinir was substantially increased in older subjects (N = 16), Cmax by 44% and AUC by 86%. This increase was due to a reduction in cefdinir clearance. The apparent volume of distribution was also reduced, thus no appreciable alterations in apparent elimination t½ were observed (elderly: 2.2 ± 0.6 hours vs young: 1.8 ± 0.4 hours). Since cefdinir clearance has been shown to be primarily related to changes in renal function rather than age, elderly patients do not require dosage adjustment unless they have markedly compromised renal function (creatinine clearance < 30 mL/min, see Patients with Renal Insufficiency, above).

Gender and Race

The results of a meta-analysis of clinical pharmacokinetics (N = 217) indicated no significant impact of either gender or race on cefdinir pharmacokinetics.

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 as described in INDICATIONS.

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus (including β-lactamase producing strains)

NOTE: Cefdinir is inactive against methicillin-resistant staphylococci.

Streptococcus pneumoniae (penicillin-susceptible strains only)
Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (including β-lactamase producing strains)
Haemophilus parainfluenzae
(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.

Cefdinir exhibits in vitro minimum inhibitory concentrations (MICs) of 1 µg/mL or less against ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of cefdinir in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Aerobic Gram-Positive Microorganisms

Staphylococcus epidermidis (methicillin-susceptible strains only)
Streptococcus agalactiae

Viridans group streptococci
NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.

Aerobic Gram-Negative Microorganisms

Citrobacter diversus
Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method(1) (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cefdinir powder. The MIC values should be interpreted according to the following criteria:

For organisms other than Haemophilus spp. and Streptococcus spp:

MIC (µg/mL) Interpretation
≤ 1 Susceptible (S)
2 Intermediate (I)
≥ 4 Resistant (R)

For Haemophilus spp:a

MIC (µg/mL) Interpretation b
≤ 1 Susceptible (S)
a These interpretive standards are applicable only to broth microdilution susceptibility tests with Haemophilus spp. using Haemophilus Test Medium (HTM).(1)
b The current absence of data on resistant strains precludes defining any results other than "Susceptible." Strains yielding MIC results suggestive of a "nonsusceptible" category should be submitted to a reference laboratory for further testing.

For Streptococcus spp:

Streptococcus pneumoniae that are susceptible to penicillin (MIC ≤ 0.06 µg/mL), or streptococci other than S. pneumoniae that are susceptible to penicillin (MIC ≤ 0.12 µg/mL), can be considered susceptible to cefdinir. Testing of cefdinir against penicillin-intermediate or penicillin-resistant isolates is not recommended. Reliable interpretive criteria for cefdinir are not available.

A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. Standard cefdinir powder should provide the following MIC values:

Microorganism MIC Range (µg/mL)
Escherichia coli ATCC 25922 0.12-0.5
Haemophilus influenzae ATCC 49766c 0.12-0.5
Staphylococcus aureus ATCC 29213 0.12-0.5
c This quality control range is applicable only to H. influenzae ATCC 49766 tested by a broth microdilution procedure using HTM.
Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure(2) requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5-µg cefdinir to test the susceptibility of microorganisms to cefdinir.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5-µg cefdinir disk should be interpreted according to the following criteria:

For organisms other than Haemophilus spp. and Streptococcus spp:d

Zone Diameter (mm) Interpretation
≥ 20 Susceptible (S)
17-19 Intermediate (I)
≤ 16 Resistant (R)
d Because certain strains of Citrobacter, Providencia, and Enterobacter spp. have been reported to give false susceptible results with the cefdinir disk, strains of these genera should not be tested and reported with this disk.

For Haemophilus spp:e

Zone Diameter (mm) Interpretationf
≥ 20 Susceptible (S)
e These zone diameter standards are applicable only to tests with Haemophilus spp. using HTM.(2)
f The current absence of data on resistant strains precludes defining any results other than "Susceptible." Strains yielding MIC results suggestive of a "nonsusceptible" category should be submitted to a reference laboratory for further testing.

For Streptococcus spp:

Isolates of Streptococcus pneumoniae should be tested against a 1-µg oxacillin disk.

Isolates with oxacillin zone sizes ≥ 20 mm are susceptible to penicillin and can be considered susceptible to cefdinir. Streptococci other than S. pneumoniae should be tested with a 10-unit penicillin disk. Isolates with penicillin zone sizes ≥ 28 mm are susceptible to penicillin and can be considered susceptible to cefdinir.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. For the diffusion technique, the 5-µg cefdinir disk should provide the following zone diameters in these laboratory quality control strains:

Organism Zone Diameter (mm)
Escherichia coli ATCC 25922 24-28
Haemophilus influenzae ATCC 49766g 24-31
Staphylococcus aureus ATCC 25923 25-32
g This quality control range is applicable only to testing of H. influenzae ATCC 49766 using HTM.

Clinical Studies

Community-Acquired Bacterial Pneumonia

In a controlled, double-blind study in adults and adolescents conducted in the US, cefdinir BID was compared with cefaclor 500 mg TID. 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:

US Community-Acquired Pneumonia Study Cefdinir vs Cefaclor

  Cefdinir BID Cefaclor TID Outcome
Clinical Cure Rates 150/187 (80%) 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 BID was compared with amoxicillin/clavulanate 500/125 mg TID. 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:

European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate

  Cefdinir BID Amoxicillin/ Clavulanate TID 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. pneumoniae 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 QD or BID to penicillin 250 mg or 10 mg/kg QID. 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:

Pharyngitis/Tonsillitis Studies Cefdinir (10 days) vs Penicillin (10 days)

Study Efficacy Parameter Cefdinir QD Cefdinir BID Penicillin QID Outcome
Adults/ Adolescents Eradication of S. pyogenes 192/210 (91%) 199/217 (92%) 181/217 (83%) Cefdinir superior to control
Clinical Cure Rates 199/210 (95%) 209/217 (96%) 193/217 (89%) Cefdinir superior to control
Pediatric Patients Eradication of S. pyogenes 215/228 (94%) 214/227 (94%) 159/227 (70%) Cefdinir superior to control
Clinical Cure Rates 222/228 (97%) 218/227 (96%) 196/227 (86%) Cefdinir superior to

Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir BID to 10 days of penicillin 250 mg or 10 mg/kg QID. 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:

Pharyngitis/Tonsillitis Studies Cefdinir (5 days) vs Penicillin (10 days)

Study Efficacy Parameter Cefdinir BID Penicillin QID Outcome
Adults/ Adolescents Eradication of S. pyogenes 193/218 (89%) 176/214 (82%) Cefdinir equivalent to control
Clinical Cure Rates 194/218 (89%) 181/214 (85%) Cefdinir equivalent to control
Pediatric Patients Eradication of S. pyogenes 176/196 (90%) 135/193 (70%) Cefdinir superior to control
Clinical Cure Rates 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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be counseled that antibacterial drugs including OMNICEF (cefdinir) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When OMNICEF (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 OMNICEF (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 OMNICEF (cefdinir) therapy, OMNICEF (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 OMNICEF (cefdinir) therapy, OMNICEF (cefdinir) should be taken at least 2 hours before or after the supplement.

Iron-fortified infant formula does not significantly interfere with the absorption of cefdinir. Therefore, OMNICEF (cefdinir) for Oral Suspension can be administered with iron-fortified infant formula.

Diabetic patients and caregivers should be aware that the oral suspension contains 2.86 g of sucrose per teaspoon.

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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CEFDINIR - ORAL

 

(SEFF-dih-neer)

 

COMMON BRAND NAME(S): Omnicef

 

USES: Cefdinir is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

 

HOW TO USE: Take this medication by mouth, with or without food, usually once a day, or twice a day every 12 hours, or as directed by your doctor.

The dosage is based on your medical condition and response to therapy. Do not take more than the maximum recommended amount of 600 milligrams per day.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Some medications can bind with cefdinir preventing its full absorption. If you take antacids containing magnesium or aluminum, iron supplements, or vitamin/mineral products, take them at least 2 hours apart from cefdinir.

Inform your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Diarrhea or nausea may occur. If either of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause your stools to turn a reddish color, especially if you also take iron products. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Omnicef (cefdinir) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking cefdinir, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (e.g., cephalexin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug does not pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: live bacterial vaccines, probenecid.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). This drug may also affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe vomiting, seizures.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Omnicef, Omnicef Omni-Pac

Generic Name: cefdinir (Pronunciation: SEF dih neer)

  • What is cefdinir (Omnicef)?
  • What are the possible side effects of cefdinir (Omnicef)?
  • What is the most important information I should know about cefdinir (Omnicef)?
  • What should I discuss with my healthcare provider before taking cefdinir (Omnicef)?
  • How should I take cefdinir (Omnicef)?
  • What happens if I miss a dose (Omnicef)?
  • What happens if I overdose (Omnicef)?
  • What should I avoid while taking cefdinir (Omnicef)?
  • What other drugs will affect cefdinir (Omnicef)?
  • Where can I get more information?

What is cefdinir (Omnicef)?

Cefdinir is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefdinir is used to treat many different types of infections caused by bacteria.

Cefdinir may also be used for purposes not listed in this medication guide.

Cefdinir 300 mg-TEV

capsule, green/purple, imprinted with 93 3160

What are the possible side effects of cefdinir (Omnicef)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • chest pain;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, stomach pain, indigestion, vomiting, mild diarrhea;
  • headache, dizziness;
  • diaper rash in an infant taking liquid cefdinir;
  • mild itching or skin rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Omnicef (cefdinir) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about cefdinir (Omnicef)?

Do not take this medication if you are allergic to cefdinir, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Cefdinir will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking cefdinir and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Side Effects Centers
  • Omnicef

Patient Detailed How Take

What should I discuss with my healthcare provider before taking cefdinir (Omnicef)?

Do not take this medication if you are allergic to cefdinir or to other cephalosporin antibiotics, such as:

  • cefaclor (Raniclor);
  • cefadroxil (Duricef);
  • cefazolin (Ancef);
  • cefditoren (Spectracef);
  • cefpodoxime (Vantin);
  • cefprozil (Cefzil);
  • ceftibuten (Cedax);
  • cefuroxime (Ceftin);
  • cephalexin (Keflex); or
  • cephradine (Velosef); and others.

To make sure you can safely take cefdinir, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);
  • a history of intestinal problems, such as colitis; or
  • if you are allergic to any drugs (especially penicillins).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cefdinir passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The cefdinir suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefdinir if you have diabetes.

How should I take cefdinir (Omnicef)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefdinir.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Cefdinir will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat. Throw away any unused cefdinir liquid that is older than 10 days.

Side Effects Centers
  • Omnicef

Patient Detailed Avoid Taking

What happens if I miss a dose (Omnicef)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Omnicef)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

What should I avoid while taking cefdinir (Omnicef)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking cefdinir and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid using antacids or mineral supplements that contain iron within 2 hours before or after taking cefdinir. Antacids or iron can make it harder for your body to absorb cefdinir. This does not include baby formula fortified with iron.

Taking cefdinir with products that contain iron may cause your stools (bowel movements) to appear red in color. If this discoloration looks like blood in your stools, call your doctor.

What other drugs will affect cefdinir (Omnicef)?

Tell your doctor about all other medications you use, especially:

  • probenecid (Benemid); or
  • vitamin or mineral supplements that contain iron.

This list is not complete and other drugs may interact with cefdinir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about cefdinir.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.01. Revision date: 3/31/2011.

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Side Effects Centers
  • Omnicef

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