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omadacycline (oral/injection)

omadacycline (oral/injection)

Pronunciation: oh MA da SYE kleen

Brand: Nuzyra

What is the most important information I should know about omadacycline?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is omadacycline?

Omadacycline is a tetracycline antibiotic that is used to treat pneumonia or skin infections caused by bacteria.

Omadacycline may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using omadacycline?

You should not use this medicine if you are allergic to omadacycline or similar antibiotics such as demeclocycline, doxycycline, minocycline, sarecycline, tetracycline, or tigecycline.

Using omadacycline during pregnancy may affect tooth and bone development in the unborn baby. Using this medicine during the last half of pregnancy can cause permanent tooth discoloration later in the baby's life. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Omadacycline can pass into breast milk and may affect bone and tooth development in a nursing infant. Do not breastfeed while you are using omadacycline and for at least 4 days after your last dose.

Omadacycline is not approved for use by anyone younger than 18 years old. This medicine can cause permanent yellowing or graying of the teeth in children.

How is omadacycline given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Omadacycline oral is taken by mouth. Take the tablets with water on an empty stomach, at least 4 hours after you last ate or drank anything other than water.

For at least 2 hours after taking the tablets: do not eat or drink anything except water.

For at least 4 hours after taking the tablets:

  • Do not eat or drink any dairy product such as milk, cheese, or yogurt.
  • Do not take a vitamin or mineral supplement that contains iron.
  • Do not take an antacid (including Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Tums, Pepto-Bismol, and others).

Omadacycline injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Omadacycline injection must be mixed with a liquid (diluent) in an IV bag before using it. The injection must be given slowly, and the infusion can take 30 to 60 minutes to complete. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Store the tablets at room temperature away from moisture and heat. You may store the IV bag at room temperature for up to 24 hours.

You may also store the IV bag in a refrigerator for up to 48 hours. Take the bag out of the refrigerator and let it reach room temperature for 60 minutes before injecting your dose. Keep the bag in an upright position.

Do not freeze this medicine.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Use omadacycline for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Omadacycline will not treat a viral infection such as the flu or a common cold.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

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

What should I avoid while using omadacycline?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Omadacycline could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of omadacycline?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • little or no urination; or
  • increased pressure inside the skull --severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • pain, irritation, redness, swelling, or a hard lump where the medicine was injected;
  • nausea, vomiting, diarrhea, constipation;
  • headache;
  • trouble sleeping;
  • increased blood pressure; or
  • abnormal liver function tests.

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.

What other drugs will affect omadacycline?

Tell your doctor about all your other medicines, especially:

  • antacids;
  • vitamin or mineral supplements; or
  • a blood thinner --warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect omadacycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about omadacycline.

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