Pronunciation:

sar-e-SYE-kleen

Brand Names:

• Seysara

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiacne Antibacterial

Chemical—

Tetracycline (class)

Uses of This Medicine:

Sarecycline is used to treat moderate to severe acne vulgaris. It belongs to the class of medicines known as tetracycline antibiotics. However, this medicine is not used to prevent or treat infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Sarecycline may cause permanent discoloration of the teeth and slow down bone growth. This medicine should not be given to children 8 years of age and younger, unless directed by the child's doctor.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sarecycline in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Amoxicillin
• Ampicillin
• Apixaban
• Ardeparin
• Argatroban
• Bacampicillin
• Betrixaban
• Bexarotene
• Bivalirudin
• Certoparin
• Cloxacillin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dicloxacillin
• Edoxaban
• Enoxaparin
• Etretinate
• Fondaparinux
• Heparin
• Isotretinoin
• Lepirudin
• Magnesium Sulfate
• Methicillin
• Methotrexate
• Nafcillin
• Oxacillin
• Palovarotene
• Parnaparin
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin V
• Phenindione
• Phenprocoumon
• Piperacillin
• Pivampicillin
• Protein C
• Reviparin
• Rivaroxaban
• Sultamicillin
• Temocillin
• Tinzaparin
• Tretinoin
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Eye or vision problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with or without food.

Drink plenty of fluids to avoid throat irritation and ulceration.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your acne may not clear up.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  • For acne:
    • Adults and children 9 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing 85 kilograms (kg) to 136 kg—150 milligrams (mg) once a day for 12 weeks.
      • Weighing 55 kg to 84 kg—100 mg once a day for 12 weeks.
      • Weighing 33 kg to 54 kg—60 mg once a day for 12 weeks.
    • Children 9 years of age and older weighing less than 33 kilograms (kg)—Use and dose must be determined by your doctor.
    • Children 8 years of age and younger—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Sarecycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause dizziness, lightheadedness, or spinning feeling. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause intracranial hypertension (increased pressure in the head). This is more likely to occur in women of childbearing age who are overweight. Tell your doctor right away if you have a headache, blurred vision, or other change in vision.

Sarecycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for short periods of time, may cause skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a sun protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor right away.

You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron, such as vitamin or mineral supplements.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Itching of the vagina or genitals

thick, white vaginal discharge with mild or no odor

Incidence not known

Blurred vision

change in the ability to see colors, especially blue or yellow

fever

headache

increased sensitivity of the skin to sunlight

itching, skin rash

nausea

pain

redness or other discoloration of the skin

severe sunburn

stomach cramps

tenderness

vomiting

watery or bloody diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Dizziness

feeling of constant movement of self or surroundings

lightheadedness

sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.