Claforan

DRUG DESCRIPTION

Sterile CLAFORAN (cefotaxime sodium) is 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-l-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). CLAFORAN contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of CLAFORAN range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.

CLAFORAN® (cefotaxime) Structural Formula Illustration

CLAFORAN is supplied as a dry powder in conventional and ADD-Vantage® System compatible vials, infusion bottles, pharmacy bulk package bottles, and as a frozen, premixed, iso-osmotic injection in a buffered diluent solution in plastic containers. CLAFORAN, equivalent to 1 gram and 2 grams cefotaxime, is supplied as frozen, premixed, iso-osmotic injections in plastic containers. Solutions range from very pale yellow to light amber. Dextrose Hydrous, USP has been added to adjust osmolaliry (approximately 1.7 g and 700 mg to the 1 g and 2 g cefotaxime dosages, respectively). The injections are buffered with sodium citrate hydrous, USP. The pH is adjusted with hydrochloric acid and may be adjusted with sodium hydroxide.

The plastic 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 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 toxiciry studies.

What are the possible side effects of cefotaxime injection (Claforan)?

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;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • uneven heartbeats;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • fever, sore throat,...

Read All Potential Side Effects and See Pictures of Claforan »

What are the precautions when taking cefotaxime (Claforan)?

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 Claforan »


Claforan 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.


Claforan Patient Information Including Side Effects

Brand Names: Claforan

Generic Name: cefotaxime (Pronunciation: SEF oh TAX eem)

  • What is cefotaxime injection (Claforan)?
  • What are the possible side effects of cefotaxime injection (Claforan)?
  • What is the most important information I should know about cefotaxime injection (Claforan)?
  • What should I discuss with my health care provider before using cefotaxime injection (Claforan)?
  • How should I use cefotaxime injection (Claforan)?
  • What happens if I miss a dose (Claforan)?
  • What happens if I overdose (Claforan)?
  • What should I avoid while using cefotaxime injection (Claforan)?
  • What other drugs will affect cefotaxime injection (Claforan)?
  • Where can I get more information?

What is cefotaxime injection (Claforan)?

Cefotaxime is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefotaxime injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms. Cefotaxime is also used to prevent infections in people having surgery.

Cefotaxime may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cefotaxime injection (Claforan)?

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;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • uneven heartbeats;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • seizure (black-out or convulsions); or
  • jaundice (yellowing of the eyes or skin).

Less serious side effects may include:

  • pain, irritation, or hardening where the injection was given;
  • stomach pain, nausea, vomiting;
  • headache; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cefotaxime injection (Claforan)?

Do not use this medication if you are allergic to cefotaxime, or to similar antibiotics, such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, diabetes, a stomach or intestinal disorder, or a heart rhythm disorder.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefotaxime will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

This medication can cause you to have unusual results with certain lab tests to check for glucose (sugar) in the urine. Tell any doctor who treats you that you are using cefotaxime.

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