INVanz (Injection)

Ertapenem is used by itself or together with other antibiotics to treat infections caused by bacteria in various parts of the body. It kills bacteria or stops their growth. This medicine will not work for colds, flu, or other viral infections. Ertapenem is also used to prevent infections after surgery on the colon and rectum.

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

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

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

In some patients, ertapenem may cause diarrhea.

• Severe diarrhea may indicate a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or prolong it.
• For mild diarrhea, you may take diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb). However, do not take other types of diarrhea medicine, as they may worsen your diarrhea or make it last longer.
• If you have any questions about this or if mild diarrhea continues or worsens, consult your health care professional.

If your symptoms do not improve within a few days or if they get worse, contact your doctor.

Do not take other medicines unless you have discussed them with your doctor.

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

In deciding to use a medicine, it's important to consider the risks of taking it compared to the benefits it may provide. This decision will be made between you and your doctor. For this medicine, please consider the following:

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 if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in children that would limit the usefulness of ertapenem in infants and children aged 3 months to 17 years. However, it is not recommended for infants younger than 3 months.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of ertapenem. However, older patients are more likely to have age-related kidney issues, which may require caution or dosage adjustments when receiving ertapenem.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together despite potential interactions. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance and are not necessarily all-inclusive.

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

• Cholera Vaccine, Live
• Valproic Acid

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Probenecid
• Tacrolimus

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Brain disease or
• Diarrhea or
• History of seizures—Use with caution. May worsen these conditions.

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

Along with its needed effects, INVanz (Injection) 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 INVanz (Injection). 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.

In the U.S.

• INVanz

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Beta-Lactam

Chemical Class: Carbapenem

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.