pharmacopeia
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/api/v1/drug/cysteamine

Mechanism of action

Sourced from openFDA

Cysteamine acts as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.

Indications

Sourced from openFDA
  • CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours. ( 2.1 ) 2.1 Dosage Information Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours. Do not touch dropper tip to the eyelids, surrounding areas, or any surface, as this may contaminate the solution. In case of concomitant therapy with other topical ocular products, an interval of 10 minutes should be allowed between successive applications. Eye ointments should be administered last. If the patient misses an instillation, the patient should be told to administer a dose as soon as feasible and then continue the treatment with the next scheduled instillation. Discard bottle 7 days after first opening. 2.2 Preparation for Administration Patients should be advised to store new unopened CYSTADROPS bottles in the refrigerator in the original carton between 36°F to 46°F (2°C to 8°C). Each week, one new bottle should be removed from the refrigerator. Patients are to write the date the bottle was opened in the space on the carton. After first opening, store opened CYSTADROPS at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate after opening. Patients are to wash their hands carefully in order to avoid microbiological contamination of the content in the bottle. Remove the green protective cap (see Figure A ). Remove the metal seal (see Figure B ). Remove the gray stopper (see Figure C ) from the bottle. Do not touch the opening of the bottle after removing the gray stopper.

Warnings & precautions

Sourced from openFDA

To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. 5.2 Benign Intracranial Hypertension There have been reports of benign intracranial hypertension (or pseudotumor cerebri) associated with oral cysteamine treatment that has resolved with the addition of diuretic therapy. There have also been reports associated with ophthalmic use of cysteamine; however, all of these patients were on concurrent oral cysteamine. 5.3 Contact Lens Use CYSTADROPS contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration [see Patient Counseling Information ( 17 )] .

Adverse reactions

Sourced from openFDA

The most common adverse reactions (≥ 10%) are eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, 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 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. The most common adverse reactions (≥ 10%) reported during clinical trials were eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks. Oral administration of cysteamine to pregnant rats throughout the period of organogenesis was teratogenic at doses 240 to 960 times the recommended human ophthalmic dose (based on body surface area) [ see Data ] . CYSTADROPS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal data Teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (240 to 960 times the recommended human ophthalmic dose based on body surface area) and have shown cysteamine bitartrate to be teratogenic. Observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits.

Pharmacokinetics

Sourced from openFDA
Metabolism
The peak plasma concentration of cysteamine following ocular administration of cysteamine ophthalmic solution in humans is unknown, because all patients concomitantly received oral cysteamine and the total daily ophthalmic dose is less than 4% of the recommended oral daily dose of cysteamine.

Approval history

Sourced from openFDA
  • Aug 15, 1994NDANDA020392Mylan
  • Oct 2, 2012NDANDA200740Leadiant Biosci Inc
  • Apr 30, 2013NDANDA203389Horizon
  • Feb 14, 2020NDANDA213491Horizon
  • Aug 19, 2020NDANDA211302Recordati Rare

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,374 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Eye Irritation17713%
  2. 2Vomiting14911%
  3. 3Nausea1168.4%
  4. 4Eye Pain846.1%
  5. 5Ocular Hyperaemia654.7%
  6. 6Diarrhoea513.7%
  7. 7Headache473.4%
  8. 8Photophobia433.1%
  9. 9Abdominal Pain Upper392.8%
  10. 10Death382.8%
  11. 11Malaise372.7%
  12. 12Product Dose Omission Issue362.6%
  13. 13Off Label Use352.5%
  14. 14Abdominal Discomfort332.4%
  15. 15Treatment Noncompliance312.3%

Literature

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Recent PubMed references pinned to Cysteamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 41 ClinicalTrials.gov registrations naming Cysteamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cysteamine work?
Cysteamine acts as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.
What is Cysteamine used for?
According to FDA labeling, Cysteamine carries indications including: CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cysteamine?
Cysteamine is classified as Amino acids and derivatives, Other ophthalmologicals, Cystine Depleting Agent, Cystine Disulfide Reduction, Unknown Cellular or Molecular Interaction, Unknown Physiological Effect.
What are the brand names for Cysteamine?
Cysteamine is marketed under brand names including Cystadrops, Cystagon, Cystaran, Procysbi.
What are the contraindications for Cysteamine?
Cysteamine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for cysteamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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