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Sarecycline: Drug information

Sarecycline: Drug information
(For additional information see "Sarecycline: Patient drug information" and see "Sarecycline: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Seysara
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult
Acne vulgaris, inflammatory, moderate to severe

Acne vulgaris, inflammatory, moderate to severe:

Note: Use in combination with topical acne therapy. Treatment should ideally be limited to 3 to 4 months to minimize the risk of resistance (Ref).

Oral: Dosage based on body weight (Ref):

33 to 54 kg: 60 mg once daily.

55 to 84 kg: 100 mg once daily.

85 to 136 kg: 150 mg once daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in the pharmacokinetics of sarecycline were observed.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment (Child-Pugh class A or B): There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in the pharmacokinetics of sarecycline were observed.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sarecycline: Pediatric drug information")

Acne vulgaris, moderate to severe

Acne vulgaris (non-nodular), moderate to severe: Note: If no improvement after 12 weeks, reassess treatment. Children ≥9 years and Adolescents: Oral:

33 to <55 kg: 60 mg once daily

55 to <85 kg: 100 mg once daily

85 to 136 kg: 150 mg once daily

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. No clinical differences in the pharmacokinetics of sarecycline were noted in renal impairment; the effect of end-stage renal disease has not been studied.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. No clinical differences in the pharmacokinetics of sarecycline were noted in mild to moderate hepatic impairment; the effect of severe hepatic impairment has not been studied.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%: Gastrointestinal: Nausea (3%)

<1%, postmarketing, and/or case reports: Vulvovaginal candidiasis, vulvovaginal infection

Contraindications

Hypersensitivity to sarecycline, tetracyclines, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: Lightheadedness, dizziness, and vertigo may occur; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Symptoms usually disappear with continued therapy and when the drug is discontinued.

• Intracranial hypertension: Intracranial hypertension has been associated with use of tetracyclines; headache, blurred vision, and/or papilledema may occur. Women of childbearing age who are overweight are at greater risk. Concomitant use of isotretinoin (known to cause intracranial hypertension) and sarecycline should be avoided. Intracranial hypertension typically resolves after discontinuation of treatment; however, permanent visual loss is possible. If visual symptoms develop during treatment, prompt ophthalmologic evaluation is warranted.

• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Special populations:

• Pediatric: May cause tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth discoloration (more common with long-term use, but observed with repeated, short courses) when used during tooth development (last half of pregnancy, infancy, and childhood ≤8 years of age).

Warnings: Additional Pediatric Considerations

Do not administer to children <8 years of age due to permanent discoloration of teeth and retardation of skeletal development and bone growth; more common with long-term use, but may be observed with repeated, short courses. Pseudotumor cerebri has been reported rarely in infants and adolescents; use with isotretinoin has been associated with cases of pseudotumor cerebri; avoid concomitant treatment with isotretinoin.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Seysara: 60 mg, 100 mg, 150 mg [contains quinoline (d&c yellow #10) aluminum lake]

Generic Equivalent Available: US

No

Pricing: US

Tablets (Seysara Oral)

60 mg (per each): $42.16

100 mg (per each): $42.16

150 mg (per each): $42.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: May be administered with or without food. Administer with adequate fluid to decrease the risk of esophageal irritation and ulceration. Separate administration of antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.

Administration: Pediatric

Oral: Administer with or without food; administer with plenty of fluid to reduce the risk of esophageal irritation and ulceration.

Use: Labeled Indications

Acne vulgaris, inflammatory, moderate to severe: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Antacids: May decrease the absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Monitor for decreased therapeutic effects of tetracyclines. Risk D: Consider therapy modification

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Tetracyclines. Risk C: Monitor therapy

Bismuth Subcitrate: May decrease the serum concentration of Tetracyclines. Management: Avoid administration of oral tetracyclines within 30 minutes of bismuth subcitrate administration. This is of questionable significance for at least some regimens intended to treat H. pylori infections. Risk D: Consider therapy modification

Bismuth Subsalicylate: May decrease the serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider therapy modification

Calcium Salts: May decrease the serum concentration of Tetracyclines. Management: If coadministration of oral calcium with oral tetracyclines cannot be avoided, consider separating administration of each agent by several hours. Risk D: Consider therapy modification

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. Risk X: Avoid combination

Digoxin: Sarecycline may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Iron Preparations: Tetracyclines may decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Lanthanum: May decrease the serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider therapy modification

Lithium: Tetracyclines may increase the serum concentration of Lithium. Risk C: Monitor therapy

Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracyclines. Risk C: Monitor therapy

Magnesium Salts: May decrease the absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider therapy modification

Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination

Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. If coadministration cannot be avoided, administer the polyvalent cation-containing multivitamin at least 2 hours before or 4 hours after the tetracycline derivative. Monitor for decreased tetracycline effects. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Tetracyclines. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines cannot be avoided, administer the polyvalent cation-containing multivitamin either 2 hours before or 4 hours after the tetracycline product. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy

Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Tetracyclines. Management: Give oral tetracyclines at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Quinapril: May decrease the serum concentration of Tetracyclines. Risk C: Monitor therapy

Retinoic Acid Derivatives: Tetracyclines may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid combination

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. Risk D: Consider therapy modification

Strontium Ranelate: May decrease the serum concentration of Tetracyclines. Management: In order to minimize any potential impact of strontium ranelate on tetracycline antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during tetracycline therapy. Risk X: Avoid combination

Sucralfate: May decrease the absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to sucralfate. Risk D: Consider therapy modification

Sucroferric Oxyhydroxide: May decrease the serum concentration of Tetracyclines. Management: Administer oral/enteral doxycycline at least 1 hour before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Risk D: Consider therapy modification

Sulfonylureas: Tetracyclines may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Zinc Salts: May decrease the absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider therapy modification

Pregnancy Considerations

Tetracycline-class antibiotics may cause fetal harm following maternal use in pregnancy. Tetracyclines accumulate in developing teeth and long tubular bones. Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure. Reversible inhibition of bone growth may occur following maternal use of tetracyclines in the second and third trimesters. Sarecycline should be discontinued immediately if pregnancy occurs during treatment.

Breastfeeding Considerations

It is not known if sarecycline is present in breast milk.

As a class, tetracyclines have generally been avoided in breastfeeding females due to concerns that they may cause adverse events in the breastfeeding infant, including tooth discoloration and inhibition of bone growth. Due to the potential for adverse events, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Ophthalmologic evaluation if visual disturbances occur

Mechanism of Action

Sarecycline is an aminomethylcycline within the tetracycline class that binds to the 30S ribosomal subunit and interacts with 16S ribosomal RNA; it also protrudes its C7 moiety into the mRNA binding channel to interact with mRNA, thereby preventing Propionibacterium acnes protein synthesis and inhibiting bacterial growth.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 91.4 to 97 L

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; delayed by ~0.53 hour when administered with high-fat, high-calorie meal that included milk

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Seysara
  1. Graber E. Acne vulgaris: overview of management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 3, 2022.
  2. Moore A, Green LJ, Bruce S, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol. 2018;17(9):987-996. [PubMed 30235387]
  3. Seysara (sarecycline) [prescribing information]. Malvern, PA: Almirall LLC; March 2023.
  4. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33. http://www.jaad.org/article/S0190-9622(15)02614-6/pdf. Accessed March 3, 2022. [PubMed 26897386]
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