503A

Melatonin Capsules

503A

Melatonin Capsules

10 mg

Melatonin Capsules

$100.00

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Product Overview

This product is available solely through our 503A Compounding Pharmacy, ensuring personalized care and precision in every order. Please note that a valid prescription is required for purchase. If you do not have an account, please contact us.

Melatonin Capsule (Each) †

10 mg

† commercial product

Melatonin capsules are a dietary supplement commonly used to aid sleep and manage circadian rhythm disorders, such as insomnia, jet lag, or shift work sleep disorder.

Mechanisms of Action:
Melatonin regulates the body’s sleep–wake cycle by acting on melatonin receptors (MT1 and MT2) in the brain, particularly in the suprachiasmatic nucleus (SCN) of the hypothalamus. Supplementing with melatonin mimics the body’s natural rise in melatonin levels at night, promoting drowsiness and helping to reset the body’s internal clock.

Contraindications & Precautions:
Melatonin should be used with caution in individuals with autoimmune disorders, seizure disorders, depression, or hormone-related conditions, as it may influence immune and neuroendocrine function. It may also interact with medications such as anticoagulants, immunosuppressants, anticonvulsants, and certain antidepressants.

Adverse Reactions / Side Effects:
Melatonin is generally well-tolerated, especially when used short-term. Common side effects may include drowsiness, headache, dizziness, and nausea. Less common effects can include vivid dreams, irritability, or mood changes. High doses or long-term use may affect hormonal balance, particularly in adolescents.

Pregnancy & Breastfeeding:
The safety of melatonin supplementation during pregnancy and breastfeeding has not been well established. Although melatonin naturally occurs in the body, taking it as a supplement may influence reproductive hormones. Therefore, its use should be avoided unless specifically advised by a healthcare provider. Breastfeeding mothers should also consult a physician before using melatonin due to the lack of safety data.

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

  1. Health Canada Drugs and Health Products and Natural Health Products Ingredients Database. Melatonin Monograph. First published 2012. Modified May 13, 2013. Web. Accessed August 4, 2015. Available at: webprod.hc-sc.gc.ca/nhpid-bdipsn.
  2. Circadin (oral melatonin) European Medicines Agency official product label. Dublin 2, Republic of Ireland; Flynn Pharma Ltd: 2015 July.
  3. Williamson BL, Tomlinson AJ, Mishra PK, et al: Structural characterization of contaminants found in commercial preparations of melatonin:similarities to case-related compounds from L-tryptophan associated with eosinophilia-myalgia syndrome. Chem
  4. Naylor S, Gleich GJ. Over-the-counter melatonin products and contamination. Am Fam Physician. 1999;59:284, 287-8.
  5. Norton SA. Raw animal tissues and dietary supplements. N Engl J Med 2000;343:304–305.
  6. Rozerem (ramelteon) package insert. Lincolnshire, IL: Takeda Pharmaceuticals; 2010 Nov.
  7. Waldron DL, Bramble D, Gringras P: Melatonin: Prescribing practices and adverse events. Arch Dis Child 2005;90(11):1206-1207.
  8. Davis FC. Melatonin: role in development. J Biol Rhythms 1997;12:498-508.
  9. Illnerova H, Buresova M, Presl J. Melatonin rhythm in human milk. J Clin Endocrinol Metab 1993;77:838—41.
  10. Chase JE, Gidal BE. Melatonin: therapeutic use in sleep disorders. Ann Pharmacother 1997;31:1218-26.
  11. McArthur AJ, Budden SS. Sleep dysfunction in Rett Syndrome: a trial of exogenous melatonin treatment. Dev Med Child Neurol 1998;40:186-92.
  12. Holliman BJ, Chyka PA. Problems in assessment of acute melatonin overdose. South Med J 1997;90:451-3.
  13. Force RW, Hansen L, Bedell M. Psychotic episode after melatonin. Ann Pharmacother 1997;31:1408.
  14. Hong YG, Riegler JL. Is melatonin associated with the development of autoimmune hepatitis? J Clin Gastroenterol 1997;25:376-8.
  15. Fourman LT, Robert Meyer B. Autoimmune hepatitis in association with ramelteon. J Clin Gastroenterol. 2013 Apr 29. [Epub ahead of print]

Related medications

503A vs 503B

  • 503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider.
  • 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices.

Frequently asked questions

Our team of experts has the answers you're looking for.

A clinical pharmacist cannot recommend a specific doctor. Because we are licensed in Arizona, California, New Mexico, Texas, we can accept prescriptions from many licensed prescribers if the prescription is written within their scope of practice and with a valid patient-practitioner relationship.

*Licensing is subject to change.

Each injectable IV product will have the osmolarity listed on the label located on the vial.

Given the vastness and uniqueness of individualized compounded formulations, it is impossible to list every potential compound we offer. To inquire if we currently carry or can compound your prescription, please fill out the form located on our Contact page or call us at (806) 744-8477.

We source all our medications and active pharmaceutical ingredients from FDA-registered suppliers and manufacturers.

We're licensed to ship Arizona, California, New Mexico and Texas.

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