Nuzyra (Oral)

Omadacycline is used to treat community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Omadacycline belongs to a group of medicines called tetracycline antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

If your symptoms do not improve within a few days, or if they get worse, contact your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions that can be life-threatening and need immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Omadacycline may cause diarrhea, which can be severe in some cases. This can happen 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may worsen the diarrhea or make it last longer. If you have any questions about this, or if mild diarrhea continues or gets worse, contact your doctor.

This medicine may cause intracranial hypertension (increased pressure in the head). Tell your doctor right away if you have a headache, blurred vision, or any other change in vision.

Omadacycline may make your skin more sensitive to sunlight than usual. Even brief sunlight exposure may cause skin rash, itching, redness or other discoloration of the skin, or severe sunburn. When you start taking this medicine:

• Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Use a sunblock product with a sun protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF, especially if they have a fair complexion. If you have any questions about this, contact your doctor.
• Use a sunblock lipstick with an SPF of at least 15 to protect your lips.
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction to the sun, contact your doctor right away.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Omadacycline may cause permanent discoloration of teeth and slow down bone growth. This medicine should not be given to children younger than 8 years old, unless directed by the child's doctor.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the effectiveness of omadacycline.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, there are cases where two different medicines may be used together even if an interaction might happen. In these cases, your doctor may change the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not be a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or adjust some of the other medicines you take.

• Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Acenocoumarol
• Apixaban
• Ardeparin
• Argatroban
• Betrixaban
• Bexarotene
• Bivalirudin
• Certoparin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Edoxaban
• Enoxaparin
• Etretinate
• Fondaparinux
• Heparin
• Isotretinoin
• Lepirudin
• Magnesium Sulfate
• Methotrexate
• Palovarotene
• Parnaparin
• Phenindione
• Phenprocoumon
• Porfimer
• Protein C
• Reviparin
• Rivaroxaban
• Tinzaparin
• Tretinoin
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Bismuth Subsalicylate
• Calcium
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Iron
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Diarrhea or
• Eye or vision problems—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irritation
• itching of the vagina or genitals
• joint pain, stiffness, or swelling
• nervousness
• pale skin
• pounding in the ears
• redness of the skin
• sore mouth or tongue
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• thick, white vaginal discharge with mild or no odor
• tightness in the chest
• troubled breathing or swallowing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• white patches in the mouth or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Nausea
• vomiting

Less common

• Belching
• change or loss in taste
• constipation
• diarrhea
• feeling of constant movement of self or surroundings
• heartburn
• increased sweating
• indigestion
• mouth or throat pain
• sensation of spinning
• stomach discomfort or upset
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Nuzyra

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibacterial

Chemical Class: Tetracycline (class)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Do not eat or drink (except water) 4 hours before and 2 hours after using this medicine.

Do not eat dairy products or take antacids or multivitamins (containing aluminum, calcium, magnesium, bismuth subsalicylate, or iron) for 4 hours after using this medicine.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not clear up.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For acute bacterial skin and skin structure infections: Adults and children 8 years of age and older—450 milligrams (mg) once a day on Day 1 and 2, then 300 mg once a day for 7 to 14 days. Children younger than 8 years of age—Use is not recommended. For community-acquired bacterial pneumonia: Adults and children 8 years of age and older—300 milligrams (mg) once a day for 7 to 14 days. Children younger than 8 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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