Maxipime

DRUG DESCRIPTION

MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:

MAXIPIME® (cefepime hydrochloride for injection)  
  (Cefepime Hydrochloride) Structural Formula Illustration

Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water.

MAXIPIME (cefepime hydrochloride for injection) for Injection is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. (See DOSAGE AND ADMINISTRATION.) MAXIPIME (cefepime hydrochloride for injection) is a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4.0–6.0. Freshly constituted solutions of MAXIPIME (cefepime hydrochloride for injection) will range in color from colorless to amber.

What are the possible side effects of cefepime (Maxipime)?

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:

  • confusion, hallucinations, or convulsiones o se desmaya. seizure (black-out or convulsions);
  • diarrhea that is watery or bloody;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, chills, body aches, flu symptoms;
  • easy bruising...

Read All Potential Side Effects and See Pictures of Maxipime »

What are the precautions when taking cefepime hydrochloride for injection (Maxipime)?

Before using cefepime, 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, 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...

Read All Potential Precautions of Maxipime »


Maxipime 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, mental/mood changes (such as confusion, hallucinations), seizures, unusual weakness, yellowing eyes/skin.

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


Maxipime Patient Information Including Side Effects

Brand Names: Maxipime

Generic Name: cefepime (Pronunciation: SEF e peem)

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

What is cefepime (Maxipime)?

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

Cefepime injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms.

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

What are the possible side effects of cefepime (Maxipime)?

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:

  • confusion, hallucinations, or convulsiones o se desmaya. seizure (black-out or convulsions);
  • diarrhea that is watery or bloody;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness; or
  • sore throat and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • pain, swelling, or skin rash where the injection was given;
  • stomach pain, nausea, vomiting;
  • headache;
  • skin rash or itching;
  • white patches or sores inside your mouth or on your lips; 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 cefepime (Maxipime)?

Do not use cefepime if you have ever had an allergic reaction to another cephalosporin or to a penicillin without first talking to your doctor.

Before using cefepime, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have kidney disease, liver disease, or a stomach or intestinal disorder such as colitis.

Tell your doctor if you are also using any other injected antibiotics, or a diuretic (water pill).

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefepime 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.

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