Meropenem and vaborbactam

Meropenem and vaborbactam are antibiotics that combat bacteria.

Meropenem and vaborbactam is a combination medicine used to treat severe urinary tract infections in adults.

Meropenem and vaborbactam may also be used for reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label. Do not use meropenem and vaborbactam in larger or smaller amounts or for longer than recommended.

Meropenem and vaborbactam is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Meropenem and vaborbactam is usually given every 8 to 12 hours for up to 14 days. This medicine must be given slowly, and the infusion can take about 3 hours to complete.

Meropenem and vaborbactam is a powder medicine that must be mixed with a liquid (diluent), and then further diluted before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

The diluted mixture must be used within 4 hours if you keep it at room temperature. If you store the IV bag in a refrigerator, use it within 22 hours. Do not freeze.

Each single-use vial (bottle) of meropenem and vaborbactam powder is for one use only. Throw it away after one use, even if there is still medicine left inside.

Do not mix other injectable medications in the same IV bag or tubing used to give your meropenem and vaborbactam injection.

Throw away any unused medicine left in the IV bag after your infusion. Do not save it for later use.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Meropenem and vaborbactam will not treat a viral infection such as the common cold or flu.

Your kidney function may need to be checked while you are using this medicine.

Store unmixed powder at room temperature away from moisture and heat.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Before you receive meropenem and vaborbactam, tell your doctor if you have ever had allergies to any antibiotic medications.

You may not be able to use this medicine if you have ever had an allergic reaction to any antibiotics, including:

• meropenem or vaborbactam;
• amoxicillin, ampicillin, Augmentin, Timentin, Unasyn, Zosyn;
• dicloxacillin, nafcillin, oxacillin, ticarcillin; or
• any penicillin antibiotic.

To make sure meropenem and vaborbactam is safe for you, tell your doctor if you have ever had:

• an allergy to a cephalosporin antibiotic (cephalexin, cefdinir, Keflex, Omnicef, and others);
• a head injury or brain tumor;
• epilepsy or other seizure disorder; or
• kidney disease (or if you are on dialysis).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

Meropenem and vaborbactam can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Meropenem and vaborbactam may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• a seizure (convulsions);
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• severe tingling or numbness; or
• unusual bleeding or bruising.

Common side effects of meropenem and vaborbactam may include:

• headache;
• diarrhea; or
• swelling or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Pyelonephritis:

4 g IV every 8 hoursDuration of therapy: Up to 14 daysUse: For the treatment of patients with complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex

Usual Adult Dose for Urinary Tract Infection:

4 g IV every 8 hoursDuration of therapy: Up to 14 daysUse: For the treatment of patients with complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex

Use the missed dose as soon as you remember. Skip the missed dose if it is nearly time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

meropenem and vaborbactam can cause confusion, headaches, or other side effects that may affect your thinking or reactions. Be cautious if you drive or do anything that needs you to be alert.

Antibiotic medicines can cause diarrhea, which may signal a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Tell your doctor about all the medicines you are currently taking and any that you start or stop, especially:

• divalproex sodium;
• probenecid; or
• valproic acid.

This list is not complete. Other drugs may interact with meropenem and vaborbactam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.