Doribax

DRUG DESCRIPTION

DORIBAX®, doripenem monohydrate for injection vials contain 500 mg of doripenem on an anhydrous basis, a white to slightly-yellowish off-white sterile crystalline powder. All references to doripenem activity are expressed in terms of the active doripenem moiety. The powder is constituted for intravenous infusion. The pH of the infusion solution is between 4.5 and 5.5.

DORIBAX® is not formulated with any inactive ingredients.

DORIBAX® (doripenem monohydrate) is a synthetic broad-spectrum carbapenem antibiotic structurally related to beta-lactam antibiotics. The chemical name for doripenem monohydrate is (4R,5S,6S)-3-[((3S,5S)-5-[[(aminosulfonyl)amino]methyl]-3pyrrolidinyl)thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene2-carboxylic acid monohydrate.

Its molecular weight is 438.52, and its chemical structure is:

DORIBAX (doripenem) Structural Formula Illustration

What are the possible side effects of doripenem (Doribax)?

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;
  • trouble breathing;
  • pale skin, easy bruising or bleeding;
  • seizure (convulsions); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Doribax »

What are the precautions when taking doripenem for injection (Doribax)?

Before using doripenem, tell your doctor or pharmacist if you are allergic to it; or to carbapenems (e.g., meropenem), penicillins or cephalosporins; 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, seizures.

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known...

Read All Potential Precautions of Doribax »


Doribax Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site, nausea, headache, or diarrhea may occur. 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 right away if you have any serious side effects, including: unusual tiredness, pale skin.

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.

Get medical help right away if this rare but very serious side effect occurs: seizures.

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. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

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 doripenem, tell your doctor or pharmacist if you are allergic to it; or to carbapenems (e.g., meropenem), penicillins or cephalosporins; 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, seizures.

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Doribax Patient Information Including Side Effects

Brand Names: Doribax

Generic Name: doripenem (Pronunciation: dor i PEN em)

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

What is doripenem (Doribax)?

Doripenem is an antibiotic that fights serious infections caused by bacteria.

Doripenem is used to treat severe infections of the stomach, bladder, or kidneys.

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

What are the possible side effects of doripenem (Doribax)?

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;
  • trouble breathing;
  • pale skin, easy bruising or bleeding;
  • seizure (convulsions); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • pain, swelling, or redness where the medicine was injected;
  • mild nausea;
  • headache;
  • mild skin rash or itching;
  • white patches or sores inside your mouth; 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 doripenem (Doribax)?

You should not use this medication if you are allergic to doripenem or imipenem (Primaxin), or a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others.

Before using doripenem, tell your doctor if you are allergic to any drugs, or if you have kidney disease or a seizure disorder.

Before using doripenem, tell your doctor if you are using valproic acid (Depakene) or probenecid (Benemid).

You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to mix the medicine, give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Call your doctor at once if you have serious side effects such as diarrhea that is watery or bloody, trouble breathing, easy bruising or bleeding, seizure (convulsions), or fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

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