Cefotan

Cefotetan injection is used to treat bacterial infections in many different parts of the body. This medicine is also given before certain types of surgery to prevent infections.

Cefotetan injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Powder for Solution

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
2. Pediatric Population:Appropriate studies have not been performed on the relationship of age to the effects of cefotetan injection in the pediatric population. Safety and efficacy have not been established.
3. Geriatric Population:Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefotetan injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefotetan injection.
4. Pregnancy:All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
5. Breastfeeding:There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
6. Drug Interactions:Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
7. Other Interactions:
   Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
   • Ethanol
8. Other Medical Problems:The presence of other medical problems may affect the use of this medicine.Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or
• Diarrhea, severe, history of or
• Hemolytic anemia or
• Seizures—Use with caution. May make these conditions worse.
• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles, or through a needle placed in one of your veins.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Hemolytic anemia may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin.

Cefotetan injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Do not drink alcohol while you are receiving cefotetan injection and for 3 days (72 hours) after your last dose. Drinking alcohol during this period may cause flushing; headache; sweating; and fast, pounding, or irregular heartbeat.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Abdominal or stomach cramps or tenderness
• Back, leg, or stomach pains
• Black, tarry stools
• Bleeding gums
• Bloating
• Chest pain
• Chills
• Cough
• Dark urine
• Diarrhea
• Diarrhea, watery and severe, which may also be bloody
• Difficulty with breathing
• Fever
• General body swelling
• Headache
• Increased thirst
• Loss of appetite
• Nausea or vomiting
• Nosebleeds
• Pain
• Painful or difficult urination
• Pale skin
• Shortness of breath
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight loss
• Yellowing of the eyes or skin

Rare

• Blood in the urine
• Bluish color
• Change in frequency of urination or amount of urine
• Changes in skin color
• Drowsiness
• Increased thirst
• Swelling of the feet or lower legs
• Tenderness
• Weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• Cough or hoarseness
• Coughing up blood
• Difficulty with swallowing
• Dizziness
• Fast heartbeat
• Fever with or without chills
• General feeling of tiredness or weakness
• High fever
• Increased menstrual flow or vaginal bleeding
• Itching
• Itching of the vagina or genital area
• Joint or muscle pain
• Lower back or side pain
• Nosebleeds
• Pain during sexual intercourse
• Paralysis
• Pinpoint red spots on the skin
• Prolonged bleeding from cuts
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rash
• Red or black, tarry stools
• Red or dark brown urine
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Seizures
• Skin rash
• Sudden decrease in the amount of urine
• Swollen or painful glands
• Thick, white vaginal discharge with no odor or with a mild odor
• Tightness in the chest
• Unpleasant breath odor
• Vomiting of blood
• Wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.