General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Seysara
SARECYCLINE HYDROCHLORIDE
1 INDICATIONS AND USAGE SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of ot...
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Brand names:Seysara
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- SARECYCLINE HYDROCHLORIDE
- Medicine class
- General Medicine
- Brand names
- Seysara
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of sarecycline is 21 to 22 hours
- FDA approved
- Yes
What Is Seysara?
1 INDICATIONS AND USAGE SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of ot...
Seysara (SARECYCLINE HYDROCHLORIDE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Seysara. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Seysara with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Seysara is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established.
SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )] .
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )] .
SEYSARA ® is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
( 1 ) Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established.
SEYSARA has not been evaluated in the treatment of infections.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )].
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of SEYSARA is based on body weight described in Table 1 . If there is no improvement after 12 weeks, reassess treatment with SEYSARA. Table 1: Dosing Table for SEYSARA 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 Take SEYSARA once daily, with or without food. To reduce the risk of esophageal irritation and ulceration, administer SEYSARA with adequate amounts of fluid. The recommended dosage of SEYSARA is once daily with or without food ( 2 ): 60 mg for patients who weigh 33-54 kg, 100 mg for patients who weigh 55-84 kg, 150 mg for patients who weigh 85-136 kg.
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥ 1%) is nausea.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- A total of 1064 subjects and 1069 subjects with moderate to severe acne vulgaris were treated with SEYSARA and placebo, respectively, for 12 weeks in 3 controlled clinical trials.
- The only adverse drug reaction that was reported in at least 1% of subjects was nausea, SEYSARA (3.1%) versus placebo (2.0%).
- The following additional adverse drug reactions occurred in less than 1% of female SEYSARA subjects: vulvovaginal mycotic infection (0.8%) and vulvovaginal candidiasis (0.6%).
Serious
- 5 WARNINGS AND PRECAUTIONS The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
- ( 5.1 ) If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA.
- ( 5.2 ) Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use.
- Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery.
- These symptoms may disappear during therapy and may disappear when the drug is discontinued.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. ( 5.2 ) Central nervous system side effects, including
How Seysara Works
12.1 Mechanism of Action Sarecycline is an aminomethylcycline within the tetracycline class of drugs. [see CLINICAL PHARMACOLOGY ( 12.4 )] . The mechanism of action of SEYSARA in treating the inflammatory lesions of non-nodular acne vulgaris is not known.
Pharmacokinetics
Absorption
Absorption The median time to peak plasma concentration (T max ) of sarecycline is 1
Half-Life
half-life of sarecycline is 21 to 22 hours
Metabolism
Metabolism Metabolism of sarecycline by enzymes in human liver microsomes is minimal (< 15%) in vitro
Excretion
Excretion After a single 100 mg oral dose of radiolabeled sarecycline, 42
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Seysarawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Storage Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Handling Protect from moisture and excessive heat.
Frequently Asked Questions
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Seysara side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Seysara
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.