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OMNICEF®
(cefdinir) capsules
OMNICEF®
(cefdinir) for oral suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF and other antibacterial drugs, OMNICEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
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 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 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.
CLINICAL PHARMACOLOGY
Pharmacokinetics and Drug Metabolism
Absorption
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.
Special Populations
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 AND USAGE.
Susceptibility Tests
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF and other antibacterial drugs, OMNICEF 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 uled below.
Adults and Adolescents
Pediatric Patients
CONTRAINDICATIONS
OMNICEF (cefdinir) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
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, 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 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 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 OMNICEF should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When OMNICEF 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 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 therapy, OMNICEF 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 therapy, OMNICEF 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 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.
Drug Interactions
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 (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
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).
Adverse Events
Clinical Trials - OMNICEF 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 | ||
a 1733 males, 2108 females | ||
| 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 US:
| LABORATORY
VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES US TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) | ||
a N < 3841 for these parameters | ||
| 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% | |
Clinical Trials - OMNICEF 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 | ||
a 977 males, 806 females b Laboratory changes were occasionally reported as adverse events. | ||
| 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% | |
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) | ||
a N=1387 for these parameters | ||
| 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% | |
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.
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
(see INDICATIONS AND USAGE 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 Capsules should be administered twice daily in these infections. OMNICEF 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 |
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 for Oral Suspension should be administered twice daily in this infection. OMNICEF for Oral Suspension may be administered without regard to meals.
| Type of Infection | Dosage | Duration |
| Acute Bacterial Otitis Media | 7 mg/kg q12h or 14 mg/kg q24h | 5 to 10 days 10 days |
| Acute Maxillary Sinusitis | 7 mg/kg q12h or 14 mg/kg q24h | 10 days 10 days |
| Pharyngitis/Tonsillitis | 7 mg/kg q12h or 14 mg/kg q24h | 5 to 10 days 10 days |
| Uncomplicated Skin and Skin Structure Infections | 7 mg/kg q12h | 10 days |
| Weight | 125 mg/5 mL | 250 mg/5 mL |
a Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg. | ||
| 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 |
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.
| Final Concentration | Final Volume(mL) | Amount of Water | Directions |
| 125 mg/5 mL | 60 100 | 38 mL 63 mL | Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. |
| 250 mg/5 mL | 60 100 | 38 mL 63 mL | Tap bottle to loosen powder, then add water in 2 portions. 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
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-PACTM carton of 3 unit-of-use, 5-day,
10-capsule buler cards NDC 0074-3769-30
OMNICEF 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.
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:
| 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 H. influenzae M. catarrhalis H. parainfluenzae | 31/31 (100%) 55/65 (85%) 10/10 (100%) 81/89 (91%) | 35/35 (100%) 60/72 (83%) 11/11 (100%) 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:
| 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 H. influenzae M. catarrhalis H. parainfluenzae | 42/44 (95%) 26/35 (74%) 6/6 (100%) 11/11 (100%) | 43/44 (98%) 21/26 (81%) 8/8 (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:
| 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 control |
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:
| 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
- 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.
- 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.
- Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
- 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.
- 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.
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