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Omnicef Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefdinir
Omnicef Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefdinir
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 b-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.
Pseudomembranous colitis
has been reported with nearly all antibacterial
agents, including cefdinir, and may range in severity from mild-
to life-threatening. Therefore, it is important to consider this
diagnosis in patients
who present with diarrhea
subsequent to the administration
of antibacterial
agents.
Treatment with antibacterial
agents alters the normal
flora of the colon
and may permit overgrowth
of clostridia. Studies indicate that a toxin
produced by Clostridium
difficile is a primary
cause of "antibiotic-associated
colitis".
After the diagnosis
of pseudomembranous colitis has been established, appropriate
therapeutic measures
should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug
discontinuation alone. In
moderate to severe cases, consideration should be given to management
with fluids and electrolytes, protein
supplementation, and treatment
with an antibacterial
drug clinically effective
against Clostridium
difficile.
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.
These section should be deleted from this page. A link to the drug interactions page can be added instead, and a link to the patient information page (which has been revised as below).
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).
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 ³100
mg/kg/day, and in rat offspring
at ³32
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).
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