Generic Name: sarecycline
Dosage Form: Tablets
Date of Approval: October 1, 2018
Company: Almirall, S.A.
Treatment for: Acne
Medically reviewed on Oct 2, 2018
FDA Approves Seysara
The Food and Drug Administration (FDA) has approved Seysara (sarecycline), a first in class tetracycline-derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Seysara?
- Seysara is a prescription medicine used to treat moderate to severe acne vulgaris in people 9 years and older.
- Seysara should not be used for the treatment or prevention of infections.
It is not known if this medicine is safe and effective for use for longer than 12 weeks.
It is not known if this medicine is safe and effective in children under 9 years of age.
Who should not take Seysara?
Do not take Seysara:
- if you are allergic to medicines in the tetracycline-class. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Before taking Seysara
Before taking Seysara, tell your healthcare provider about all of your medical conditions, including if you:
- have diarrhea or watery stools
- have vision problems
- are pregnant or plan to become pregnant. Seysara may harm your unborn baby. Taking Seysara during the second and third trimesters of pregnancy may cause serious side effects on the growth of bone and teeth of your baby. Stop taking this medicine and call your healthcare provider right away if you become pregnant during your treatment.
- are breastfeeding or plan to breastfeed. Seysara can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Seysara. You should not breastfeed during treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Seysara and other medicines can affect each other causing serious side effects.
Especially tell your healthcare provider if you take:
- a blood thinner
- a penicillin antibiotic medicine
- antacids that contain aluminum, calcium or magnesium or iron-containing products
- an acne medication taken by mouth that contains isotretinoin or acitretin
How should I take Seysara?
- Take Seysara exactly as your healthcare provider tells you.
- Skipping doses or not taking all doses may:
- make the treatment not work as well.
- increase the chance that the bacteria will become resistant.
- Take Seysara one time a day with or without food.
- Take Seysara with enough fluid to completely swallow the tablet and to lower your risk of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
- If you take too much or overdose, stop treatment and call your healthcare provider right away or go to the nearest hospital emergency room.
What should I avoid during treatment?
- Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop treatment if you get sunburn.
- You should not drive or operate dangerous machinery until you know how Seysara affects you. Tetracyclines may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).
Seysara side effects
Seysara may cause serious side effects, including:
- Harm to an unborn baby. See Before taking Seysara.
- Permanent teeth discoloration. Seysara may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use this medicine during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth to 8 years of age.
- Slow bone growth. Seysara may slow bone growth in infants and children. This is reversible after stopping treatment.
- Diarrhea. Diarrhea can happen with most antibiotics, including Seysara. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools.
- Central nervous system effects. See What should I avoid during treatment? Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment or if treatment is stopped. Call your healthcare provider if these symptoms do not go away.
- Increased pressure around the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You may be more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop treatment and tell your healthcare provider right away if you have blurred vision, vision loss, or headaches.
- Sensitivity to sunlight (photosensitivity). See What should I avoid during treatment?
The most common side effect is nausea.
Seysara may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Allergan at 1-800-678-1605.
How should I store Seysara tablets?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the tablets away from moisture and excessive heat.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Seysara.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in Seysara?
Active ingredient: sarecycline hydrochloride
Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titanium dioxide.