Sarecycline

What is Sarecycline?

Sarecycline is an antibiotic that belongs to the tetracycline antibiotics family of drugs. It treats acne by destroying bacteria that infect pores and reducing a natural greasy substance that causes acne. Adults and children aged 9 and up are prescribed sarecycline to treat specific forms of acne.

SEYSARA® (sarecycline) tablet, is used for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

How to use this medicine?

• Drink a full glass of water with every dose of Sarecycline
• Take sarecycline at around the same time every day
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand
• Take sarecycline exactly as directed
• Do not take more or less or take it more often than prescribed by your doctor.
• If you stop taking sarecycline too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics

Sarecycline

How does this medicine work?

The exact mechanism by which SEYSARA works is not known.

Who Should Not Use this medicine?

• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sarecycline, call your doctor immediately; Sarecycline can harm the fetus
• If the drugs of the tetracycline class is used during the tooth development phase (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years), it may cause permanent discoloration of the teeth, (yellow-grey-brown)
• This reaction is more common during long-term use of these drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported

Is this medicine FDA approved?

Sarecycyline is approved by the FDA in October 2018.

What are the dosage forms and brand names of this medicine?

Body Weight (kg)	Tablet Strength
33 to 54 kg	60 mg tablet
55 to 84 kg	100 mg tablet
85 to 136 kg	150 mg tablet

• The recommended dosage of SEYSARA is based on body weight
• Sarecycline comes as a tablet to take by mouth. It is usually taken with or without food once a day

What side effects can sarecylcine cause?

Tell your doctor if any of these symptoms are severe or do not go away:

• Nausea
• Vaginal itching or discharge

Some side effects can be serious. If you experience any of these symptoms, stop taking sarecycline and call your doctor immediately:

• severe headache
• blurred vision
• seeing double, or loss of vision
• watery or bloody stools
• stomach cramps
• fever during treatment or for up to two or more months after stopping treatment
• return of fever
• sore throat
• chills
• or other signs of infection

What special precautions should I follow?

• Pregnancy
• Lactation

Tell your doctor and pharmacist if you are allergic to,

• sarecycline
• doxycycline
• minocycline
• omadacycline
• tetracycline
• demeclocycline
• any other medications, or any of the ingredients in sarecycline tablets.

What to do in case of emergency/overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222.

Information is also available online at https://www.poisonhelp.org/help.

If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Can this medicine be used in pregnancy?

SEYSARA® (sarecycline) should not be used during pregnancy.

Can this medicine be used in children?

Sarecycline can be used on children 9 years old and up.

What should I know about storage and disposal of this medication?

• 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)
• Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them (Do not flush down toilet)
• 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

• Dailymed label info on Sarecycline
• FDA Sarecycline

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