Seysara (sarecycline) belongs to a class of medications called tetracycline antibiotics. Sarecycline works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne.

Seysara is a prescription medicine used to treat severe acne vulgaris in adults and children who are at least 9 years old.

Antibiotics such as Seysara will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Antacids containing magnesium, aluminum, or calcium; laxatives containing magnesium; and iron products interfere with sarecycline, making it less effective. Take Seysara 2 hours before or 6 hours after taking antacids, calcium supplements, and laxatives containing magnesium. Take Seysara 2 hours before or 4 hours after iron preparations and vitamin products that contain iron.

Tell your doctor if you have or have ever had intracranial hypertension (pseudotumor cerebri; high pressure in the skull that may cause headaches, blurry or double vision, vision loss, and other symptoms).

Before taking this medicine

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

To make sure Seysara is safe for you, tell your doctor if you have ever had:

• diarrhea or watery stools; or

• vision problems.

Taking Seysara 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 Seysara exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Seysara 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. Seysara 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 Seysara if you are allergic to sarecycline or similar medications such as demeclocycline, doxycycline, minocycline, tetracycline, or tigecycline.

To make sure Seysara is safe for you, tell your doctor if you have ever had:

• diarrhea or watery stools; or

• vision problems.

Taking Seysara 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.

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

Seysara 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 to Seysara: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seysara 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 Seysara 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 clot = 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 interact with sarecycline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.