Sarecycline

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

Sarecycline may also be used for reasons that are not mentioned in this medication guide.

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.

Use only as directed. Inform your doctor if you are using other medicines, have other medical conditions, or have any allergies.

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.

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

Sarecycline may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might faint;
• severe stomach pain, diarrhea that is watery or bloody (even if it happens 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 happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Acne:

Weight 33 to 54 kg: 60 mg orally once a dayWeight 55 to 84 kg: 100 mg orally once a dayWeight 85 to 136 kg: 150 mg orally once a dayUse: 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 dayUse: For the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris

Take the medicine as soon as you remember, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

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

Avoid driving or doing anything dangerous until you know how sarecycline will affect you. Your reactions could be affected.

Sarecycline could make you more likely to get sunburned. Stay away from sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

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.

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