Omadacycline (oh-mad-a-SYE-kleen)

Treats community-acquired pneumonia and acute bacterial skin and skin structure infections (ABSSSI). This medicine is a tetracycline antibiotic.

Brand Name(s):

Nuzyra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. The medicine must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how omadacycline works. Tell your doctor if you are using a blood thinner (including warfarin).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine and for 4 days after the last dose.
• Tell your doctor if you have diarrhea or eye or vision problems.
• This medicine may cause the following problems:
  • Slow bone growth or permanent change in tooth color (in children 8 years of age and younger)
  • Increased pressure inside the head
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other change in vision
• Changes in the amount or frequency of urination, bloody or cloudy urine, lower back or side pain
• Increased sensitivity of the skin to sunlight, severe sunburn or skin rash
• Severe diarrhea that is watery or bloody
• Severe headache, dizziness

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088