Doripenem (Intravenous)

Doripenem injection is used to treat infections caused by bacteria. It works by killing bacteria or stopping their growth. This medicine will not work for colds, flu, or other viral infections.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor monitors you closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep receiving it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you experience itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Some patients may experience tremors or seizures while receiving this medicine. If you have a history of stroke or seizures and are taking anticonvulsants, you should continue to take them unless your doctor tells you otherwise. Inform your doctor if you are also using sodium valproate (Depacon®) or valproic acid (Depakene®).

Doripenem may cause diarrhea, which can sometimes be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first consulting your doctor. Diarrhea medicines may make the diarrhea worse or prolong it. If you have any questions about this or if mild diarrhea continues or worsens, check with your doctor.

In deciding to use a medicine, you and your doctor will consider the risks of taking it versus the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how doripenem injection affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the use of doripenem injection. However, older patients are more likely to have kidney problems due to aging, which may require careful monitoring and dose adjustments for those receiving doripenem injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when breastfeeding while using this medication. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution, even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but in some cases, it may be necessary. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Cholera Vaccine, Live
• Probenecid
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken near mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Allergy to penicillins, cephalosporins, or other allergens, history of—Using this medicine may increase the risk of an allergic reaction occurring again.

• Diarrhea—Use with caution, as it may worsen this condition.

• Kidney disease—Use with caution, as the effects may be stronger due to slower elimination of the medicine from the body.

• Seizures, history of or
• Stroke, history of—May increase the risk of experiencing seizures.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bluish color
• diarrhea
• pain, tenderness, or swelling of the foot or leg
• pale skin
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Abdominal or stomach cramps, pain, or tenderness
• bloody urine
• decreased frequency or amount of urine
• fever
• increased blood pressure
• increased thirst
• itching or pain of the vagina or genital area
• loss of appetite
• lower back or side pain
• nausea or vomiting
• sore mouth or tongue
• swelling of the face, fingers, or lower legs
• thick, white vaginal discharge with mild or no odor
• troubled breathing
• watery and severe diarrhea, which may also be bloody
• weight gain
• white patches in the mouth or on the tongue

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cough
• difficulty with swallowing or sore throat
• dizziness
• fast heartbeat
• itching
• joint or muscle pain
• loss of bladder control
• muscle spasm or jerking of extremities
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• skin rash or hives
• sores, ulcers, or white spots in the mouth or on the lips
• sudden loss of consciousness
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Doribax

Pharmacologic Class: Beta-Lactam

Chemical Class: Carbapenem

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 1 hour.

To help clear up your infection completely, doripenem must be given for the full time of treatment, even if you begin to feel better after a few days. Skipping doses or not completing the full course of treatment may decrease the usefulness of this medicine. It may also increase the likelihood that the bacteria causing your infection will develop resistance. If this happens, doripenem and other medicines used to treat infections will not work in the future. Also, this medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, it must be given on a regular schedule.