Omnicef Information
Omnicef (Cefdinir)
Omnicef (Cefdinir) 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 CHNOS and the molecular
weight is 395.42. Cefdinir has the structural formula shown below:
Omnicef (Cefdinir) 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.
Omnicef (Cefdinir) Clinical Pharmacology
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 and in clinical
infections as described in .
Omnicef (Cefdinir) Indications And Usage
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) (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.
Omnicef (Cefdinir) Contraindications
Omnicef (Cefdinir) is contraindicated
in patients with known allergy to the cephalosporin class of antibiotics.
Omnicef (Cefdinir) Warnings
If CDAD is suspected
or confirmed, ongoing antibiotic use not directed against may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Omnicef (Cefdinir) Precautions
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 ).
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.
Omnicef (Cefdinir) Adverse Events
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):
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:
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):
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:
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 ).
Several cephalosporins have been implicated in triggering seizures,
particularly in patients with renal impairment when the dosage was
not reduced (see and ). If seizures associated with drug therapy
occur, the drug should be discontinued. Anticonvulsant therapy can
be given if clinically indicated.
Omnicef (Cefdinir) 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.
Omnicef (Cefdinir) Dosage And Administration
(see for Indicated Pathogens)
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.
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.
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
(CL) in adult patients. For estimates to be valid, serum
creatinine levels should reflect steady-state levels of renal function.
where creatinine
clearance is in mL/min, age is in years, weight is in kilograms, and
serum creatinine is in mg/dL.
The following formula
may be used to estimate creatinine clearance in pediatric patients:
where K = 0.55
for pediatric patients older than 1 year and 0.45 for
infants (up to 1 year).
In the above equation,
creatinine clearance is in mL/min/1.73 m, 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 m,
the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.
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.
Omnicef (Cefdinir) How Supplied
Omnicef (Cefdinir) Capsules, containing
300 mg cefdinir, as lavender and turquoise capsules imprinted with
the product name, are available as follows:
60 Capsules/Bottle 0074-3769-60
OMNI-PAC carton of
3 unit-of-use, 5-day,
10-capsule blister cards 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 0074-3771-60
100-mL bottles 0074-3771-13
250 mg/5 mL
60-mL
bottles 0074-6151-60
100-mL bottles 0074-6151-13
Omnicef (Cefdinir) Clinical Studies
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:
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:
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:
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:
Omnicef (Cefdinir)
