Sarecycline

Sarecycline is a  prescription medication used for the treatment of Acne vulgaris.

• Sarecycline is available under the following different brand names: Seysara

Common side effects of Sarecycline include:

• nausea and
• vaginal yeast infections

Serious side effects of Sarecycline include:

• hives,
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• a light-headed feeling,
• a spinning sensation, or
• increased pressure inside the skull--severe headaches, ringing in the ears, vision problems, pain behind your eyes.

Rare side effects of Sarecycline include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

 Adult and pediatric dosage

 Tablet

• 60mg
• 100mg
• 150mg

Acne Vulgaris

Adult dosage

• Weight less than 54 kg: 60 mg orally every day
• Weight between 55-84 kg: 100 mg orally every day
• Weight between 85-136 kg: 150 mg orally every day
• If improvement after 12 weeks is not observed, reassess treatment
• Pediatric dosage
• Aged below 9 years: Safety and efficacy not established
• Aged above 9 years
  • 33-54 kg: 60 mg orally every day
  • 55-84 kg: 100 mg orally every day
  • 85-136 kg: 150 mg orally every day
  • If improvement after 12 weeks is not observed, reassess treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sarecycline has severe interactions with the following drug:
  • acitretin
• Sarecycline has serious interactions with at least 23 other drugs.
• Sarecycline has moderate interactions with at least 158 other drugs.
• Sarecycline has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to any tetracyclines

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sarecycline?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sarecycline?”

Cautions

• Clostridium difficile-associated diarrhea (CDAD) is reported with the use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures
• Central nervous system side effects including light-headedness, dizziness, or vertigo reported with tetracycline use; patients who experience symptoms should be cautioned about driving vehicles or using hazardous machinery; symptoms may disappear during therapy and may disappear when the drug is discontinued
• Photosensitivity manifested by an exaggerated sunburn reaction observed with tetracyclines; instruct patients to minimize or avoid exposure to natural or artificial sunlight; if patients need to be outdoors while on therapy, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician
• Bacterial resistance to tetracyclines may develop; because of this, use only as indicated
• As with other antibiotics, use may result in overgrowth of nonsusceptible organisms, including fungi; if superinfection occurs, discontinue therapy and institute appropriate therapy

Intracranial hypertension

• Intracranial hypertension in adults and adolescents is associated with tetracycline use; clinical manifestations include headache, blurred vision, and papilledema; if a visual disturbance occurs during treatment, patients should be checked for papilledema
• Women of childbearing age who are overweight have a greater risk of developing intracranial hypertension
• Patients should be questioned for visual disturbances before initiation of treatment with tetracyclines
• Concomitant use of isotretinoin should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension

Teratogenic effects

• Can cause fetal harm if used during pregnancy
• Use during tooth and bone development
  • Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow-grey-brown); enamel hypoplasia reported with tetracyclines; advise the patient of potential risk
  • May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
  • All tetracyclines form a stable calcium complex in any bone-forming tissue
  • Decreased fibula growth rate observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours; reversible when drug discontinued
  • Also, see Pregnancy

Drug interaction overview

• Avoid coadministration with oral retinoids; may have additive effects on increasing intracranial pressure
• Coadministration with antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations decrease tetracycline absorption, which may decrease efficacy; separate doses
• May interfere with the bactericidal action of penicillin; avoid coadministration
• May depress plasma prothrombin activity, which may increase bleeding risk in patients who are on anticoagulant therapy
• May increase serum concentration of P-gp substrates; monitor for toxicities if P-gp substrates coadministered

Pregnancy & Lactation

• Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy
• Pregnant women should discontinue sarecycline as soon as pregnancy is recognized

Infertility

• Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
• Avoid use in males who are attempting to conceive a child

Lactation

• Tetracyclines are excreted in human milk
• Because of the potential for serious adverse reactions to bone and tooth development in nursing infants, sarecycline is not recommended in breastfeeding women