"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(cefditoren pivoxil) Tablets 200 mg and 400 mg
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
SPECTRACEF® tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Chemically, cefditoren pivoxil is (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-aminothiazol-4-yl)-2-methoxy-iminoacetamido]-3- [(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula is C25H28N6O7S3 and the molecular weight is 620.73. The structural formula of cefditoren pivoxil is shown below:
The amorphous form of cefditoren pivoxil developed for clinical use is a light yellow powder. It is freely soluble in dilute hydrochloric acid and soluble at levels equal to 6.06 mg/mL in ethanol and < 0.1 mg/mL in water.
SPECTRACEF® (cefditoren pivoxil) tablets contain 200 mg or 400 mg of cefditoren as cefditoren pivoxil and the following inactive ingredients: croscarmellose sodium, mannitol, magnesium stearate, sodium caseinate (a milk protein), and sodium tripolyphosphate. The tablet coating contains carnauba wax, hypromellose, polyethylene glycol, and titanium dioxide. Tablets are printed with ink containing opacode blue S-1-10533.
What are the possible side effects of cefditoren (Spectracef)?
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;
- 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 headache with a severe blistering,...
What are the precautions when taking cefditoren pivoxil (Spectracef)?
Before taking cefditoren, 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 (such as milk protein), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain metabolic disorders (e.g., carnitine deficiency).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, decreased muscle mass, stomach/intestinal disease (e.g., colitis).
Kidney function declines as...
Last reviewed on RxList: 8/17/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Spectracef Information
Spectracef - User Reviews
Spectracef User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.