Cefotaxime

DRUG DESCRIPTION

Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is a sterile, nonpyrogenic, single use, packaged combination of Cefotaxime Sodium and Dextrose Injection (diluent) in the DUPLEX sterile container. The DUPLEX Container is a flexible dual chamber container.

The drug chamber is filled with sterile Cefotaxime (cefotaxime for injection) Sodium USP, a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). The CAS Registry Number is 64485-93-4.

Cefotaxime (cefotaxime for injection) Sodium has the following structural formula:

Cefotaxime Sodium structural formula illustration

The empirical formula of Cefotaxime (cefotaxime for injection) Sodium is C16H16N5NaO7S2, representing a molecular weight of 477.45.

Cefotaxime (cefotaxime for injection) Sodium contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity.

The diluent chamber contains Dextrose Injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

Hydrous Dextrose USP has the following structural (molecular) formula:

Hydrous Dextrose structural formula illustration

The molecular weight of Hydrous Dextrose USP is 198.17.

Cefotaxime (cefotaxime for injection) Sodium is supplied as a dry powder form equivalent to either 1 g or 2 g of cefotaxime.

Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 1.95 g and 1.2 g to 1 g and 2 g dosages, respectively).

After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality for the reconstituted solution for Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is 290 mOsmol/kg.

The DUPLEX dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.

What are the precautions when taking cefotaxime for injection (Cefotaxime)?

Before using cefotaxime, 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).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk and...

Read All Potential Precautions of Cefotaxime


Cefotaxime Consumer (continued)

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness, yellowing eyes/skin, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cefotaxime, 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).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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