"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
(cefdinir) for Oral Suspension
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 bacteria.
|Proprietary name: OMNICEF
Established name: cefdinir
Route of administration: ORAL (C38288)
Active ingredients (moiety): cefdinir (cefdinir)
|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 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...
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...
Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Omnicef Information
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