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(Generic versions may still be available.)
(cefotetan disodium) for Injection
For Intravenous or Intramuscular Use
In GALAXY® Plastic Container (PL 2040) For Intravenous Use Only
CEFOTAN (cefotetan disodium for injection) and CEFOTAN (cefotetan injection) in Galaxy®* plastic container (PL 2040) as cefotetan disodium are sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotics for parenteral administration. It is the disodium salt of [6R-(6α,7α)]-7- [[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3- dithietan-2-yl]carbonyl]amino]-7- methoxy-3-[[(1-methyl-1H-tetrazol-5-yl) thio]methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2- carboxylic acid. Its molecular formula is C17H15N7Na2O8S4 with a molecular weight of 619.57.
CEFOTAN (cefotetan disodium for injection) is supplied in vials containing 80 mg (3.5 mEq) of sodium per gram of cefotetan activity. It is a white to pale yellow powder which is very soluble in water. Reconstituted solutions of CEFOTAN (cefotetan disodium for injection) are intended for intravenous and intramuscular administration. The solution varies from colorless to yellow depending on the concentration. The pH of freshly reconstituted solutions is usually between 4.5 to 6.5.
CEFOTAN (cefotetan) in the ADD-Vantage Vial† is intended for intravenous use only after dilution with the appropriate volume of ADD-Vantage diluent solution.
CEFOTAN (cefotetan) is available in two vial strengths. Each CEFOTAN 1 g vial contains cefotetan disodium equivalent to 1 g cefotetan activity. Each CEFOTAN 2 g vial contains cefotetan disodium equivalent to 2 g cefotetan activity.
CEFOTAN (cefotetan injection) in the Galaxy® plastic container (PL 2040) is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 50 mL solution containing 1 g or 2 g cefotetan as sterile cefotetan disodium. Dextrose, USP has been added to adjust the osmolality to 300 mOsmol/kg (approximately 1.9 g and 1.1 g to the 1 g and 2 g dosages, respectively); sodium bicarbonate has been added to convert cefotetan free acid to the sodium salt. The pH has been adjusted between 4 and 6.5 with sodium bicarbonate and may have been adjusted with hydrochloric acid. CEFOTAN (cefotetan injection) in the Galaxy® plastic container (PL 2040) contains 80 mg (3.5 mEq) of sodium per gram of cefotetan activity. After thawing to room temperature, the solution is intended for intravenous use only.
This Galaxy® container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration dating period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers as well as by tissue culture toxicity.
What are the possible side effects of cefotetan (Cefotan)?
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;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- severe tingling, numbness, pain, muscle weakness;
- seizure (convulsions);
- pale skin, dark colored...
What are the precautions when taking cefotetan (Cefotan)?
Before using cefotetan, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; 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, liver disease, stomach/intestinal diseases (e.g., colitis), use/abuse of alcohol.
Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine. Drinking alcohol may result in severe stomach upset/cramps, nausea, vomiting, headache, and flushing.
Kidney function declines as you grow older. This medication...
Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Cefotan Information
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.
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