Sarecycline is used in adults and children at least 9 years old to treat certain types of acne.

Sarecycline may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take sarecycline once a day with or without food and with a full glass of water.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Taking more than your recommended dose will not make this medicine more effective, and may cause serious side effects.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Sarecycline will not treat a viral infection (flu or a common cold).

Store at room temperature away from moisture and heat.

Usual Adult Dose for Acne:

Weight 33 to 54 kg: 60 mg orally once a day
Weight 55 to 84 kg: 100 mg orally once a day
Weight 85 to 136 kg: 150 mg orally once a day

Use: For the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris

Usual Pediatric Dose for Acne:

9 years or older:
-Weight 33 to 54 kg: 60 mg orally once a day
-Weight 55 to 84 kg: 100 mg orally once a day
-Weight 85 to 136 kg: 150 mg orally once a day

Use: For the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris

You should not take sarecycline if you are allergic to sarecycline or similar medications such as demeclocycline, doxycycline, minocycline, tetracycline, or tigecycline.

Tell your doctor if you have ever had:

• diarrhea or watery stools; or

• vision problems.

Taking sarecycline during pregnancy may affect tooth and bone development in the unborn baby. Taking this medicine during the second and third trimesters of pregnancy can cause permanent tooth discoloration later in life. Tell your doctor if you are pregnant or plan to become pregnant.

Sarecycline can pass into breast milk and may harm a nursing baby. You should not breastfeed while taking this medicine.

It may be harder for you to get a woman pregnant while you are using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how sarecycline will affect you. Your reactions could be impaired.

Sarecycline could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sarecycline may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• vertigo (spinning sensation); or

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• antacids that contain calcium, magnesium, or aluminum;

• a mineral supplement containing iron;

• medication used to prevent blood clots--alteplase, apixaban, enoxaparin, warfarin, clopidogrel, dipyridamole, ticlopidine, and others;

• a penicillin antibiotic--amoxicillin, ampicillin, ticarcillin, Amoxil, Augmentin, Timentin, and others; or

• other acne medication--acitretin, isotretinoin.

This list is not complete and many other drugs may affect sarecycline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to sarecycline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.