Nuzyra

Nuzyra is a prescription medication used to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by certain bacteria.

Nuzyra belongs to a group of drugs called tetracycline antibiotics. These work by preventing bacteria from growing by stopping protein production in the bacteria.  

This once-daily medication comes in tablet form and is taken with a full glass of water. It is important that you fast 4 hours before and 2 hours after taking Nuzyra tablets and dairy products, antacids, or multivitamins should not be consumed for 4 hours after taking Nuzyra tablets. This medication also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Nuzyra include nausea, vomiting, and allergic-like reaction at the site of infusion.

Nuzyra is a prescription medication used to treat adults with:

Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. 

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nuzyra. See the “Nuzyra Precautions” section.

Common side effects of Nuzyra include the following:

• Nausea/Vomiting
• Reaction at the site of infusion
• Increased liver enzymes
• Headache
• Diarrhea
• Insomnia

This is not a complete list of Nuzyra side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Blood thinning medications like warfarin (Coumadin)

• Antacids that contain aluminum, calcium, or magnesium like calcium carbonate (TUMs), aluminum hydroxide (Maalox), and aluminum hydroxide and magnesium hydroxide (Mylanta)

• bismuth subsalicylate (Pepto-Bismol)

• Iron containing products iron sulfate supplements

This is not a complete list of Nuzyra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nuzyra including the following:

• Death risk. Nuzyra had a higher death rate (2%) when compared to patients treated with another antibiotic called moxifloxacin (1%) during clinical trial. Talk to your doctor to assess your risks with Nuzyra.

• Tooth discoloration and effects on tooth enamel when used in pregnant and breastfeeding women and children less than 8 years of age. Tell your healthcare provider right away if you become pregnant during treatment.

• Decreased bone growth. Nuzyra showed decreased bone growth when used in pregnancy, breastfeeding, and children less 8 years of age

• Hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

  • Chest pain
  • Swelling of the face, eyes, lips, tongue, arms, or legs
  • Difficulty breathing or swallowing
  • Rash

• Clostridium difficile (C. difficile) associated diarrhea. Some antibiotics can kill the “good” bacteria in the colon leading to a growth of C. difficile bacteria. This “bad” bacterium can cause diarrhea and other digestive problems, and these problems may even occur 2 months after the last dose. Extra caution for this side effect is advised in the elderly population. Tell your healthcare provider if you experience any or all of the following symptoms:

  • Watery diarrhea (at least three bowel movements per day for two or more days)
  • Loss of appetite
  • Abdominal pain or tenderness
  • Nausea
  • Fever

• Drug-resistant bacteria development. Nuzyra should only be used for injections from certain types of bacteria. Talk to you doctor see if Nuzyra is right for you.

Do not take Nuzyra if you:

• are allergic to Nuzyra or to any of its ingredients

• are allergic to tetracycline antibiotics like doxycycline and minocycline

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nuzyra, dairy products have the potential to interact with the drug. Avoid taking Nuzyra together with dairy products. Talk to your doctor how to adjust your diet when taking Nuzyra.

Before taking Nuzyra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Nuzyra or to any of its ingredients

• are allergic to any tetracycline antibiotics

• are pregnant or plan to become pregnant

• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Nuzyra, like other tetracycline-class drugs, may cause permanent tooth discoloration and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Nuzyra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment with Nuzyra and for 4 days (based on half-life) after the last dose.

Take Nuzyra exactly as prescribed.

Nuzyra comes in tablet form and is taken one time every day.

Fast 4 hours before and 2 hours after taking Nuzyra tablets and do not consume dairy products, antacids, or multivitamins for 4 hours after taking Nuzyra tablets.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Nuzyra at the same time.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional and is given up to 2 times on day one and then once daily.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medications you are taking
• how you respond to this medication

Oral Tablet:

The recommended dose of Nuzyra tablet (omadacycline) for the treatment of acute bacterial skin and skin structure infection (ABSSSI) is 450 mg on days 1 and 2, then 300 mg daily for 7 to 14 days.

IV Injection:

The recommended dose of Nuzyra for injection (omadacycline) for the treatment of community acquired pneumonia is 200 mg on day 1, and then 100 mg daily for 7 to 14 days.

The recommended dose of Nuzyra for injection (omadacycline) for the treatment of severe bacterial skin infection is 200 mg on day 1, and then 100 mg daily for 7 to 14 days.

Oral tablet dose of 300 mg daily may be used after 1 day of IV injection to complete therapy instead of the 100 mg IV injection daily for either type of injection.

Oral Tablet:  

If you take too much Nuzyra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

IV Injection:

If Nuzyra is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Nuzyra tablets and injection at room temperature (20°C to 25°C (68°F to 77°F)).

Keep this and all medicines out of the reach of children.