"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"...
(cefaclor) Pulvule, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceclor (cefaclor) and other antibacterial drugs, Ceclor (cefaclor) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Ceclor (Cefaclor, USP) is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN304S•H2O and the molecular weight is 385.82.
Each Pulvule® contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The Pulvules also contain cornstarch, F D & C Blue No. 1, F D & C Red No. 40, gelatin, magnesium stearate, silicone, titanium dioxide, and other inactive ingredients. The 500-mg Pulvule also contains iron oxide.
After mixing, each 5 mL of Ceclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain cellulose, cornstarch, F D & C Red No. 40, flavors, silicone, sodium lauryl sulfate, sucrose, and xanthan gum.
What are the precautions when taking cefaclor (Ceclor)?
Before taking cefaclor, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporins; 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: severe 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 medication passes into breast milk....
Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Ceclor Information
- Ceclor Drug Interactions Center: cefaclor oral
- Ceclor Side Effects Center
- Ceclor Overview including Precautions
- Ceclor FDA Approved Prescribing Information including Dosage
Ceclor - User Reviews
Ceclor User Reviews
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