omadacycline (oral/injection)

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is omadacycline?

Omadacycline is a tetracycline antibiotic that is used in adults 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?

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I use omadacycline?

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

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 you this injection.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Omadacycline will not treat a viral infection (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?

What should I avoid while using omadacycline?

What are the possible side effects of omadacycline?

Some side effects may occur during the injection. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

• signs of metabolic acidosis --confusion, vomiting, lack of energy, irregular heartbeats;
• signs of liver or pancreas problems --loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes); 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, hard lump (induration) where the injection was given;
• nausea, vomiting, diarrhea, constipation;
• headache;
• trouble sleeping;
• high 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 that contain calcium, magnesium, aluminum, or bismuth subsalicylate (Pepto-Bismol);
• multivitamin or mineral supplement that contains iron or calcium; 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 doctor or pharmacist can provide more information about omadacycline.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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