Pronunciation:

dor-i-PEN-em

Brand Names:

• Doribax

Classifications:

Pharmacologic—

Beta-Lactam

Chemical—

Carbapenem

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of doripenem injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doripenem injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving doripenem injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Cholera Vaccine, Live
• Probenecid
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to penicillins, cephalosporins, or other allergens, history of—Use may increase the risk for an allergic reaction to reoccur.

• Diarrhea—Use with caution. May make this conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

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

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

Doripenem may cause diarrhea, and in some cases it can 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 checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Side Effects of This Medicine:

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.