Omadacycline

Omadacycline is a prescription medication used for the treatment of Community-Acquired Bacterial Pneumonia, and Bacterial Skin Structure Infections. 

• Omadacycline is available under the following different brand names: Nuzyra 

Common side effects of Omadacycline include:

• Pain, irritation, redness, swelling, or a hard lump where the medicine was an injection,
• Nausea,
• Vomiting,
• Diarrhea,
• Constipation,
• Headache,
• Trouble sleeping,
• Increased blood pressure, and
• Abnormal liver function tests

Serious side effects of Omadacycline include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Little or no urination,
• Severe headaches,
• Ringing in the ears,
• Dizziness,
• Nausea,
• Vision problems, and
• Pain behind the eyes

Rare side effects of Omadacycline include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 150 mg (equivalent to 196 mg omadacycline tosylate)
• Injectable, lyophilized powder for reconstitution
• 100 mg/single-dose vial (equivalent to 131 mg omadacycline tosylate)

Community-Acquired Bacterial Pneumonia

Adult dosage

• Loading dose (Day 1)
  • 200 mg Intravenous once OR
  • 100 mg Intravenous for 2 doses OR
  • 300 mg orally for 2 doses
  • Follow up with maintenance dosing starting on Day 2
• Maintenance dose
  • 100 mg Intravenous once a day OR
  • 300 mg orally once a day
  • Treatment duration: 7-14 days

Bacterial Skin and Skin Structure Infections

Adult dosage

• Treatment duration: 7-14 days
• Loading dose
  • Intravenous (Day 1): 200 mg Intravenous once OR 100 mg Intravenous for 2 doses OR
  • orally (Days 1 and 2): 450 mg orally once a day for 2 days
• Maintenance dose
  • Intravenous: 100 mg intravenous once a day OR
  • orally: 300 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Omadacycline has severe interactions with the following drug:
  • acitretin
• Omadacycline has serious interactions with at least 23 other drugs.
• Omadacycline has moderate interactions with at least 61 other drugs.
• Omadacycline has severe interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to any tetracyclines

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Omadacycline?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Omadacycline?”

Cautions

• Mortality imbalance was observed in the CABP clinical trial, with 8 deaths (2%) occurring in patients treated with omadacycline compared with 4 deaths (1%) in patients treated with moxifloxacin; cause not established; all deaths, in both treatment arms, occurred in patients aged above 65 years and most patients had multiple comorbidities
• Clostridium difficile-associated diarrhea (CDAD) is reported with the use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures
• Bacterial resistance to tetracyclines may develop; because of this, use only as indicated
• As with other antibiotics, use may result in the overgrowth of no susceptible organisms, including fungi
• Hypersensitivity reactions reported; life-threatening hypersensitivity (anaphylactic) reactions reported with other tetracyclines (see Contraindications)
• Tetracycline class effects
  • Intracranial hypertension, pseudotumor cerebri, and antianabolic action reported in adults and adolescents associated with tetracycline use; clinical manifestations include headache, blurred vision, and papilledema
  • Photosensitivity manifested by an exaggerated sunburn reaction observed with tetracyclines; instruct patients to minimize or avoid exposure to natural or artificial sunlight
  • Increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests may occur
  • Discontinue if these adverse effects suspected
• Teratogenic effects
  • Can cause fetal harm if used during pregnancy
  • Use during tooth and bone development
  • Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow-grey-brown); enamel hypoplasia reported with tetracyclines; advise the patient of potential risk
  • May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
  • All tetracyclines form a stable calcium complex in any bone-forming tissue
  • Decreased fibula growth rate observed in premature infants given PO tetracycline in doses of 25 mg/kg every 6 hours; reversible when drug discontinued
  • Also see Pregnancy
• Drug interaction overview
  • Avoid coadministration with oral retinoids; may have additive effects on increasing intracranial pressure
  • Coadministration with antacids containing aluminum, calcium, or magnesium; bismuth subsalicylate; and iron-containing preparations decrease tetracycline absorption, which may decrease efficacy; separate doses
  • May interfere with the bactericidal action of penicillin; avoid coadministration
  • May depress plasma prothrombin activity, which may increase bleeding risk in patients who are on anticoagulant therapy

Pregnancy and Lactation

• Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy
• Pregnant women should discontinue omadacycline as soon as pregnancy is recognized
• Infertility
  • Males: Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
  • Females: Based on animal studies, omadacycline affected fertility parameters, resulting in reduced ovulation, and increased embryonic loss at intended human exposures
• Contraception
  • Advise women of reproductive potential to use a highly effective form of contraception
  • Lactation
  • Tetracyclines are excreted in human milk
  • Because of the potential for serious adverse reactions on bone and tooth development in nursing infants, omadacycline is not recommended in breastfeeding women
  • Advise women not to breastfeed during treatment and for 4 days after the last dose