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  • Manufacturer Name : AUROMEDICS
  • MFG # : 55150028220
  • NDC : 55150028220
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description Ertapenem inj, 500 MG
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 06/25/2018
FDA Therap Equiv AP
HCPCS J1335
Market Entry Date 07/20/2018
Medical Coverage COVERED WITH CARRIER DISCRETION
Termination Date -
Unit EA
Units Per Pkg 10
Active Ingredients 9555 ertapenem sodium 153832383
AHFS Class 8120708 CARBAPENEM ANTIBIOTICS
DEA Class NC
Dose Form VIAL (EA)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 49835 ertapenem sodium INJECTION VIAL 1 G
Inactive Ingredients 743 sodium bicarbonate 144558
OMP Family -
Product Category RX Pharmaceuticals
Strength 1GM
Common Brand Name COMMON BRAND NAME(S): Invanz
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: valproic acid and related drugs (such as divalproex sodium, sodium valproate).
Allocation Period -
Case Quantity 10
Drug Form Pack Size 10
Form SINGLE DOSE VIAL
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AP Injectable aqueous solutions including dry powders, concentrated solutions or ready-to-use solutions are considered pharmaceutically and therapeutically equivalent if they produce the same concentration and are labeled similarly.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit Size 10
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ertapenem and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection into a muscle or vein as directed by your doctor, usually once or twice daily. If you are using this medication to prevent an infection, it is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually 1 hour before your surgery. If this medication is given by injection into a muscle, follow the manufacturer's directions for mixing with lidocaine 1 percent solution. Do not use this solution for injection into a vein. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on age and weight. For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day. Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Notes NOTES: Lab and/or medical tests (such as complete blood count, kidney function tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (ER-ta-PEN-em)
Precautions PRECAUTIONS: Before using ertapenem, tell your doctor or pharmacist if you are allergic to it; or to other carbapenems (such as imipenem); or to penicillins or cephalosporins; or if you have any other allergies. Before getting ertapenem by injection into a muscle, also tell your doctor or pharmacist if you are allergic to any amide-type local anesthetics (such as lidocaine). 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: brain disorders (such as seizures, head injury, tumor), kidney disease, stomach/intestinal diseases (such as colitis). Ertapenem may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using ertapenem before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant before using this medication. This medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. Upset stomach, headache, nausea, vomiting, or diarrhea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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. Get medical help right away if you have any very serious side effects, such as: seizures, unusual weakness. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Ertapenem is used to prevent and treat a wide variety of bacterial infections. This medication is known as a carbapenem-type antibiotic. It works by stopping the growth of bacteria.

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