Claforan

(Cefotaxime Sodium)

The active ingredient in Claforan is cefotaxime. It is a third-generation cephalosporin antibiotic that works by blocking bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) in the bacterial cell wall, preventing the cross-linking of peptidoglycan that gives the wall its strength. This weakens the wall, leads to cell rupture (lysis), and ultimately kills the bacteria, making Claforan a bactericidal antibiotic against susceptible microorganisms.

Cefotaxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Claforan. However, the following is a synopsis of the general guidelines for the use of Claforan:

• Claforan is prepared and given by a healthcare professional.
• It may be given into a muscle or a vein, depending on the infection and urgency.
• The dose and daily dose depend on age, kidney function, and the severity of infection.
• The powder must be reconstituted with the appropriate diluent before injection.
• Treatment may last several days to several weeks, depending on the condition.
• Even if symptoms improve early, completing the full course helps prevent recurrence.

Some mild or common side effects of Claforan seen in clinical trials as compared to placebo include:

• Injection site pain, redness, tenderness, and rash or itching (pruritus).
• Diarrhea.
• Nausea or vomiting.
• Headache.
• Mild and temporary lab changes, such as increased liver enzymes, eosinophils, or slight decreases in blood counts.

Some individuals may experience serious side effects while using Claforan. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reactions such as hives, swelling, wheezing, eosinophilia, or trouble breathing.
• Severe diarrhea or symptoms of colitis, including abdominal cramping or blood in the stools.
• Sudden bruising, bleeding, or signs of thrombocytopenia.
• Yellowing of the skin or eyes, dark urine, or other signs of liver problems.
• Seizures, especially in individuals with kidney impairment receiving high doses.
• New fever or signs of infection, which may indicate neutropenia.

These are not all of the possible side effects of Claforan. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Claforan, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of allergies to penicillin, cephalosporins, or other beta-lactam antibiotics.
• Respiratory tract infections.
• Kidney impairment, especially if you are elderly or severely ill.
• A history of colitis or frequent diarrhea from antibiotics.
• Severe infections require high doses or prolonged therapy.
• Any bleeding disorders or abnormal blood counts.
• Gynecologic infections – e.g., pelvic inflammatory disease, endometritis, and pelvic cellulitis.
• Do not administer the cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days before vaccination.
• Intra-abdominal infections – e.g., peritonitis.

Your healthcare provider may monitor your kidney function, liver tests, and blood counts during treatment, especially if you receive Claforan for long periods.

Claforan should not be used in individuals who have:

A known hypersensitivity to cefotaxime or any component of the formulation.

A history of adverse reactions or life-threatening reactions to other cephalosporins or penicillin antibiotics.

Claforan begins working soon after the first dose, although clinical improvement depends on the infection being treated. Fever and symptoms often start to improve within a few days, but full recovery may take longer. Completing the entire course prescribed is essential.

When Claforan is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Aminoglycosides, because combining these drugs may increase the risk of kidney toxicity.
• Diuretics such as furosemide may also increase the risk of kidney-related side effects.
• Other antibiotics that affect the gut may raise the likelihood of colitis.
• Cefotaxime may potentiate the nephrotoxic effects of nephrotoxic drugs, including aminoglycosides, NSAIDs, and furosemide.

Your healthcare provider will determine if dose adjustments or monitoring are needed.

Claforan is supplied as cefotaxime sodium powder for injection in multiple vial sizes. After reconstitution, it may be given intravenously or intramuscularly.

The dose depends on age, weight, and type of infection.

Your healthcare provider or pharmacy will store Claforan before it is administered. Once reconstituted, it must be used within the recommended time frame according to the product labeling.

Claforan is manufactured by Sanofi.

Yes. Generic cefotaxime sodium for injection is available from several manufacturers.

Claforan is administered by a healthcare provider. If you develop side effects or feel unwell, notify your healthcare provider immediately. Do not discontinue therapy on your own, as stopping early may worsen the infection or lead to complications.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Cefotaxime has been used in pregnancy when the expected benefits outweigh potential risks.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Small amounts of cefotaxime may pass into breast milk, but your healthcare provider will determine whether it is appropriate during lactation. A small percentage is excreted in breast milk. In patients with normal renal function, the elimination half-lives of cefotaxime and desacetylcefotaxime are 1 to 1.5 hours and 1.5 to 2 hours, respectively.