Omadacycline (oral/injection)

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 other reasons not mentioned in this medication guide.

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 may give you this injection or may teach you how to properly use this medicine by yourself.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don't understand how to use an injection.

Be sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture.

Store the tablet 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).

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have any allergies.

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 happen while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because this 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.

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

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

Omadacycline may lead to serious side effects. Contact your doctor immediately if you experience:

• signs of metabolic acidosis--confusion, vomiting, lack of energy, irregular heartbeats;
• signs of liver or pancreas issues--loss of appetite, upper stomach pain (which 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) at the injection site;
• 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. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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 1Maintenance Dose:-IV: 100 mg via IV infusion (over 30 minutes) once a day OR-Oral: 300 mg orally once a dayDuration of Therapy: 7 to 14 daysUse: 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 2Maintenance Dose:-IV: 100 mg via IV infusion (over 30 minutes) once a day OR-Oral: 300 mg orally once a dayDuration of Therapy: 7 to 14 daysUse: 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

Use the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not use two doses at once.

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

Omadacycline may cause you to get sunburned more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Tell your doctor about all the other medicines you are taking, especially:

• antacids that have calcium, magnesium, aluminum, or bismuth subsalicylate (Pepto-Bismol);
• multivitamins or mineral supplements that have iron or calcium; or
• blood thinners (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 mentioned here.