Pronunciation:

er-ta-PEN-em

Brand Names:

• INVanz

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

Beta-Lactam

Chemical—

Carbapenem

Uses of This Medicine:

Ertapenem is used alone or in combination with other antibiotics to treat infections caused by bacteria in many different parts of the body. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. Ertapenem is also used to prevent infections after having surgery of the colon and rectum .

This medicine is available only with your doctor's prescription.

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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ertapenem in infants and children 3 months to 17 years of age. Use in infants younger than 3 months of age is not recommended .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ertapenem in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution or adjustment of dosage in patients receiving ertapenem .

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 taking 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
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Probenecid
• Tacrolimus

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:

• Brain disease or
• Diarrhea or
• Seizures, history of—Use with caution. May make these conditions worse .

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

Proper Use of This Medicine:

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Skipping doses or not completing the full course of therapy 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, ertapenem 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.

This medicine is given as an injection into a muscle, or through a needle placed into a vein. Ertapenem may sometimes be given to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

Ertapenem should not be mixed with other medicines or with diluents containing dextrose .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For bacterial infections:
    • Adults and teenagers—1 gram (g) injected into a vein or injected into a muscle once a day. Your doctor will determine your injection site and the length of time that you will take it.
    • Children and infants (3 months to 12 years of age)—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 milligram (mg) per kilogram (kg) (or 6.8 mg per pound [lb]) of body weight injected into a vein or injected into a muscle twice a day. Your doctor will determine your injection site and the length of time you will take it.
    • Infants younger than 3 months of age—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze .

Store the medicine that has been mixed at room temperature and use it within 6 hours. You may also store this mixture for 24 hours in the refrigerator and use it within 4 hours after removing from the refrigerator. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects .

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

In some patients, ertapenem may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.
• For mild diarrhea, diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your 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 health care professional.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .

This medicine is usually mixed with lidocaine (Xylocaine®). Do not inject this medicine into your muscle if you have had an allergic reaction to lidocaine .

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 immediately if any of the following side effects occur:

More common

Bleeding

blistering

burning

coldness

diarrhea

discoloration of skin

feeling of pressure

hives

infection

inflammation

itching skin

lumps

numbness

pain

redness of skin

scarring

skin rash

soreness

stinging

swelling

tenderness

tingling

ulceration

unusually warm skin

Less common

Bluish color changes in skin color

dry, red, hot, or irritated skin

fast, pounding, or irregular heartbeat or pulse

pain, tenderness, or swelling of foot or leg

Rare

Abdominal or stomach cramps

abdominal tenderness

bloating

convulsions

diarrhea, watery and severe, which may also be bloody

fainting or loss of consciousness

fast or irregular breathing

fever

increased thirst

loss of bladder control

muscle spasm or jerking of all extremities

nausea

sudden loss of consciousness

swelling of eyes or eyelids

tightness in chest

trouble in breathing

unusual tiredness or weakness

unusual weight loss

vomiting

wheezing

Incidence not known

Cough

difficulty swallowing

itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue

seeing, hearing, or feeling things that are not there

shortness of breath

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

Agitation

chest pain

confusion about identity, place, and time

drowsiness

headache

mental depression

Less common

Acid or sour stomach

belching

blurred vision

body aches or pain

congestion

difficult or labored breathing

difficulty having a bowel movement (stool)

dizziness

dryness or soreness of throat

faintness or lightheadedness when getting up from a lying or sitting position

fear

flushing

heartburn

hoarseness

indigestion

itching of the vagina or genital area

lack or loss of strength

leg pain

nervousness

pain during sexual intercourse

pounding in the ears

runny nose

sleeplessness

slow heartbeat

sore mouth or tongue

stomach discomfort, upset, or pain

sudden sweating

tender, swollen glands in neck

thick, white vaginal discharge with no odor or with a mild odor

tightness in chest

trouble sleeping

unable to sleep

voice changes

white patches in mouth and/or on tongue

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.