Omadacycline (Oral)

Generic name: Omadacycline
Drug class: Tetracyclines

Usage of Omadacycline (Oral)

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

Omadacycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Omadacycline (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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. Also, your health care professional may 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.

Before taking Omadacycline (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omadacycline in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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 cause an increased 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 change the dose or how often you use one or both of the 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 eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Omadacycline (Oral)

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.

Warnings

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

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, which can be life-threatening and require 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, and in some cases it can be severe. It may occur 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 make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with 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 other change in vision.

Omadacycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for short periods of time, may cause skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sunblock product that has a sun protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Apply a sunblock lipstick that has 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 from the sun, check with your doctor right away.

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

Disclaimer

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