Sarecycline (Seysara) - Uses, Dose, MOA, Brands, Side effects

Sarecycline (Seysara) is a tetracycline antibiotic that is administered orally in the management of patients with moderately to severely non-nodular acne-vulgaris.

Sarecycline Uses:

  • Acne vulgaris, non-nodular, moderate to severe:

    • It is approved to treat moderate to severe non-nodular acne vulgaris inflammatory lesions in patients 9 years of age and older.

Read: Doxycycline (Vibramycin)

Sarecycline (Seysara) Dose in Adults

Sarecycline (Seysara) Dose in the treatment of non-nodular moderate to severe Acne vulgaris:

  • Note: The dosage is based on body weight. The treatment should be reassessed if no improvement is noted after 12 weeks:
    • 33 to 54 kg: 60 mg one time everyday
    • 55 to 84 kg: 100 mg one time everyday
    • 85 to 136 kg: 150 mg one time everyday

Sarecycline (Seysara) Dose in Children

Sarecycline (Seysara) Dose in the treatment of non-nodular moderate to severe Acne vulgaris:

Note: The treatment should be reassessed if no improvement is noted after twelve weeks of therapy.

  • Children ≥9 years and Adolescents: Oral:

    • 33 to <55 kg: 60 mg one time everyday
    • 55 to <85 kg: 100 mg one time everyday
    • 85 to 136 kg: 150 mg one time everyday

Pregnancy Risk Category: N

  • Tetracyclines can build up in long tubular bones and the fetus's developing teeth.
  • Infant teeth may become permanently yellow, grey, or brownish after maternal exposure in pregnancy.
  • Pregnant women who are in their second or third trimester may experience an inhibition of bony growth. 
  • When pregnancy is confirmed, it is recommended that you immediately stop using the medication.

Use during breastfeeding:

  • If the medication is detected in breast milk is unknown. Tetracyclines shouldn't be used while nursing because they can harm the fetus's skeleton and teeth.
  • It can cause tooth discoloration, and it can also inhibit skeletal growth.
  • Breastfeeding mothers should not use it because of possible adverse drug reactions.

Dose in Kidney Disease:

  • The manufacturer's labelling does not mention dosage modifications.
  • However, no significant differences in the pharmacokinetics of the drug have been observed.

Dose in Liver disease:

  • Mild to moderate impairment (Child-Pugh class A or B):
    •  
    • However, no significant pharmacokinetic differences have been observed.
  • Severe impairment (Child-Pugh class C):
    • There are no dosage adjustments provided in the manufacturer’s labeling (it has not been studied).

Side Effects of Sarecycline (Seysara):

  • Gastrointestinal:

    • Nausea

Contraindications to Sarecycline (Seysara):

Allergy to sarecycline, Tetracyclines, and any component of the formulation

Warnings and precautions

  • CNS effects

    • It has been associated with neurological side effects, especially after treatment began. 
    • Some patients may experience dizziness, vertigo and lightheadedness. These symptoms may resolve with continued treatment or discontinuation.
    • It is important to warn patients about neurological side effects, especially when they are required to drive or operate heavy machinery.
  • Intracranial hypertension

    • Tetracyclines have been linked to benign intracranial hypertension or pseudotumor cerebri. Some patients may experience headaches, blurred vision, hypertension, and even papilledema.
    • Patients with obesity, women who use oral contraceptives and women in their twenties are particularly at risk.
    • The concomitant use of vitamin A derivatives such as isotretinoin and tetracyclines should be avoided.
    • The majority of intracranial hypertension symptoms will improve with treatment discontinuation.
    • However, visual loss can be permanent. A new onset or worsening of visual symptoms, such as impaired vision, should prompt an ophthalmologic examination.
  • Photosensitivity

    • Photosensitivity has been linked to tetracyclines. If there is any redness or other photosensitive reactions, the treatment should be stopped. 
    • Patients should be instructed to protect their skin, not use tanning equipment and to avoid prolonged exposure to the sun.
  • Superinfection

    • Long-term antibiotic use has been linked to serious fungal and bacterial superinfections. 
    • Clostridium difficile (formerly Clostridium)-associated diarrhea (CDAD) has been reported, even after only two months of antibiotic treatment.

Sarecycline: Drug Interaction

Risk Factor C (Monitor therapy)

Aminolevulinic Acid (Topical)

Aminolevulinic Acid's photosensitizing impact may be enhanced by photosensitizing agents (Topical).

BCG Vaccine (Immunization)

Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization).

Digoxin

Digoxin's serum levels may rise in response to sarecycline.

Lactobacillus and Estriol

The therapeutic effects of Lactobacillus and Estriol may be reduced by antibiotics.

Magnesium Dimecrotate

May interact via an unknown mechanism with Tetracyclines.

Mipomersen

Tetracyclines may intensify Mipomersen's hepatotoxic effects.

Neuromuscular-Blocking Agents

Tetracyclines might make neuromuscular-blocking agents more effective at blocking neuromuscular activity.

Porfimer

The photosensitizing effect of Porfimer may be strengthened by photosensitizing agents.

Verteporfin

Verteporfin's photosensitizing effect may be strengthened by photosensitizing agents.

Vitamin K Antagonists (eg, warfarin)

Tetracyclines might make Vitamin K antagonists' anticoagulant effects even more potent.

Risk Factor D (Consider therapy modification)

Antacids

Tetracyclines' absorption might be reduced. When possible, administer antacids and oral tetracycline derivatives at different times to reduce the severity of this potential interaction.

Bile Acid Sequestrants

Tetracyclines' absorption might be reduced.

Bismuth Subcitrate

Tetracyclines' serum concentration can drop. Treatment: After taking bismuth subcitrate, avoid taking oral tetracyclines for 30 minutes. This has dubious significance for at least certain H. pylori infection treatment strategies.

Bismuth Subsalicylate

Tetracyclines' serum concentration can drop. Tetracyclines may be dosed 2 hours before or 6 hours after bismuth. It's debatable if Helicobacter pylori eradication strategies require separating dosages.

Calcium Salts

Tetracyclines' serum concentration can drop. Management: If oral calcium and oral tetracyclines must be administered simultaneously, think about giving each medication several hours apart.

Iron Salts

Tetracyclines may make it harder for iron salts to be absorbed. Tetracyclines' serum levels may drop if you take iron salts. Iron Carboxymaltose, Iron Gluconate, Iron Hydroxide Polymaltose Complex, Iron Pyrophosphate Citrate, Ferumoxytol, Iron Dextran Complex, Iron Isomaltoside, and Iron Sucrose are exceptions.

Lanthanum

Tetracyclines' serum concentration can drop. Treatment: Give oral antibiotics containing tetracycline at least two hours before or after lanthanum.

Magnesium Salts

Tetracyclines' absorption might be reduced. applies only to oral forms of each drug.

Multivitamins/Minerals (with ADEK, Folate, Iron)

Tetracyclines' serum concentration can drop. Treatment: Separate the delivery of each medication by several hours if coadministration of an oral tetracycline and a multivitamin containing polyvalent cations cannot be avoided.

Multivitamins/Minerals (with AE, No Iron)

Tetracyclines' serum concentration can drop. Treatment: Separate the delivery of each medication by several hours if coadministration of an oral tetracycline and a multivitamin containing polyvalent cations cannot be avoided.

Penicillins

Tetracyclines may lessen penicillins' capacity for healing.

Quinapril

Tetracyclines' serum concentration can drop. To lessen the possibility of an interaction, quinapril and oral tetracycline derivative dosages should be separated by at least two hours. If these products are administered concurrently, keep an eye out for any tetracycline efficacy reduction.

Sodium Picosulfate

Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic.

Sucralfate

Tetracyclines' absorption might be reduced. To lessen the effects of this interaction, administer the tetracycline derivative at least two hours before sucralfate.

Sucroferric Oxyhydroxide

Tetracyclines' serum concentration can drop. Treatment: Give doxycycline orally or intravenously at least an hour before taking sucroferric oxyhydroxide. There are currently no specific dose separation recommendations for additional tetracyclines. Parenteral tetracycline treatment is not predicted to cause any interactions.

Typhoid Vaccine

Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents.

Zinc Salts

Tetracyclines' absorption might be reduced. Only a problem if both medications are taken orally. Management: Take doxycycline into account as a tetracycline derivative that does not interact. To reduce interaction, administer oral zinc salts and tetracycline derivatives at least two hours apart. ZnCl2 is an exception.

Risk Factor X (Avoid combination)

Aminolevulinic Acid (Systemic)

Aminolevulinic Acid's photosensitizing impact may be enhanced by photosensitizing agents (Systemic).

BCG (Intravesical)

Antibiotics may lessen BCG's therapeutic effects (Intravesical).

Cholera Vaccine

Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics.

Mecamylamine

Tetracyclines might strengthen Mecamylamine's ability to suppress neuromuscular activity.

Methoxyflurane

Tetracyclines might make Methoxyflurane's nephrotoxic effects worse.

Retinoic Acid Derivatives

Tetracyclines might make retinoic acid derivatives more harmful or poisonous. It is especially concerning when pseudotumor cerebri develops. Adapalene, Bexarotene (Topical), and Tretinoin are exceptions (Topical).

Strontium Ranelate

Tetracyclines' serum concentration can drop. Management: It is advised that strontium ranelate therapy be stopped during tetracycline therapy in order to reduce any potential impact of strontium ranelate on tetracycline antibiotic concentrations.

Monitoring parameters:

An ophthalmologic evaluation may be necessary if visual disturbances are reported.

How to administer Sarecycline (Seysara)?

  • It is administered orally with or without meals.
  • It is better administered with meals or plenty of water to reduce the risk of esophageal ulceration and irritation.
  • It should not be administered with antacids (containing aluminum, magnesium, and calcium), iron-containing preparations, and bismuth subsalicylates

Mechanism of action of Sarecycline (Seysara):

It is a tetracycline antibacterial that inhibits protein synthesis through binding to the 30S or 50S ribosomal ribosomal units of susceptible bacteria organisms.

Protein binding:

  • 62.5% to 74.7%

Metabolism:

  • Minimal (<15%) in vitro

Half-life elimination:

  • 21 to 22 hours

Time to peak:

  • 1.5 to 2 hours;
  • The time to peak is delayed by about half an hour if administered with a fat or a high-calorie meal including milk.

Excretion:

  • Feces (42.6%; 14.9% as unchanged drug);
  • Urine (44.1%; 24.7% as unchanged drug)

International Brand Names of Sarecycline:

  • Seysara

Sarecycline Brand Names in Pakistan:

No Brands Available in Pakistan.