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.

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

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 your last meal or drink 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 you this injection.

Store tightly closed at room temperature, away from moisture and heat.

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).

Usual Adult Dose for Pneumonia:

Loading Dose:
-IV: 200 mg via IV infusion (over 60 minutes) on day 1 OR 100 mg via IV infusion (over 30 minutes) twice on day 1 OR
-Oral: 300 mg orally twice on day 1

Maintenance Dose:
-IV: 100 mg via IV infusion (over 30 minutes) once a day OR
-Oral: 300 mg orally once a day

Duration of Therapy: 7 to 14 days

Use: For the treatment of patients with community-acquired bacterial pneumonia due to the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, H parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae

Usual Adult Dose for Skin and Structure Infection:

Loading Dose:
-IV: 200 mg via IV infusion (over 60 minutes) on day 1 OR 100 mg via IV infusion (over 30 minutes) twice on day 1 OR
-Oral: 450 mg orally once a day on day 1 and day 2

Maintenance Dose:
-IV: 100 mg via IV infusion (over 30 minutes) once a day OR
-Oral: 300 mg orally once a day

Duration of Therapy: 7 to 14 days

Use: For the treatment of patients with acute bacterial skin and skin structure infections due to the following susceptible microorganisms: S aureus (methicillin-susceptible and -resistant isolates), S lugdunensis, S pyogenes, S anginosus group (includes S anginosus, S intermedius, and S constellatus), Enterococcus faecalis, Enterobacter cloacae, K pneumoniae

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

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.

May harm an unborn baby. Use birth control and tell your doctor if you become pregnant. Taking omadacycline during pregnancy may affect tooth and bone development in the unborn baby. Taking this medicine during the second and third trimesters of pregnancy can cause permanent tooth discoloration later in life. Tell your doctor if you are pregnant or plan to become pregnant.

Omadacycline can pass into breast milk and may harm a nursing baby. You should not breastfeed while taking this medicine and for at least 4 days after your last 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.

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

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.

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

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.

Omadacycline may cause serious side effects. Call your doctor at once if you have:

• 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 of omadacycline 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.

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.