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Methylprednisolone Sodium Succinate Injection

[13 May 2013]

Products Affected - Description

Methylprednisolone sodium succinate injection, APP4
40 mg single dose vial (NDC 63323-0255-03)
125 mg single dose vial (NDC 63323-0258-03)
1 gram single dose vial (NDC 63323-0265-30)

Methylprednisolone sodium succinate injection, Hospira
40 mg single dose vial (NDC 00409-3217-05) - discontinued
125 mg single dose vial (NDC 00409-3218-05) - discontinued
40 mg single dose Univial (NDC 00409-5684-23) - discontinued
125 mg single dose Univial (NDC 00409-5685-23) - discontinued

Solu-Medrol injection, Pfizer
40 mg single dose Act-O-vial (NDC 00009-0039-28)
125 mg single dose Act-O-vial (NDC 00009-0047-22)

Reason for the Shortage

  • Hospira discontinued all methylprednisolone sodium succinate products in January 2013 due to raw material issues.1
  • Bedford discontinued methylprednisolone in May, 2011 to concentrate on the manufacturing of other products.2
  • Pfizer has Solu-Medrol on shortage due to increase demand.3

Available Products

Solu-Medrol injection, Pfizer3
500 mg single dose vial (NDC 00009-0758-01)
500 mg single dose Act-O-vial (NDC 00009-0003-02)
1 gram single dose Act-O-vial (NDC 00009-0018-20)
1 gram single dose vial (NDC 00009-0698-01)
2 gram single dose vial (NDC 00009-0796-01)

Estimated Resupply Dates

  • APP has methylprednisolone sodium succinate 40 mg and 125 mg vials on intermittent back order and the company is releasing supplies as they become available. Methylprednisolone sodium succinate 1 gram vials are on back order and the company estimates a release date of late May 2013.4
  • Pfizer has Solu-Medrol 40 mg and 125 mg vials on intermittent back order and the company is releasing product regularly. The company estimates the product will be on intermittent back order through June 2013.3
     

Implications for Patient Care

Methylprednisolone is labeled for a variety of conditions including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, acute exacerbations of multiple sclerosis, tuberculosis meningitis, and trichinosis with myocardial or neurologic involvement.5 Methylprednisolone may also be used to prevent adverse reactions in patients receiving monoclonal antibodies or other agents.5,6

Hydrocortisone possesses both mineralocorticoid and glucocorticoid activity and is generally considered the first-line agent for adrenocortical insufficiency. Because other corticosteroids primarily have glucocorticoid activity (see Table 1), concomitant mineralocorticoid supplementation with fludrocortisone may be required in these patients.7,8 In neonates, hydrocortisone is the preferred agent because of concerns about possible detrimental effects of dexamethasone on neurologic development and because dexamethasone injection contains benzyl alcohol.9-13
  • Oral methylprednisolone and hydrocortisone are as effective as the injectable products.14 However, the oral route may not be practical for all patients or for clinical situations requiring high-dose parenteral therapy.

Alternative Agents & Management

Table 1 compares the available glucocorticoid products, and Table 2 addresses alternatives in specific situations.

Methylprednisolone
  • Institutions should consider conserving supplies of methylprednisolone injection for critical indications, such as spinal cord injuries, exacerbations of multiple sclerosis, or optic neuritis.
  • Institutions may prepare intravenous methylprednisolone doses from larger vials to avoid wastage. Methylprednisolone solutions of 10 mg/mL in 0.9% sodium chloride injection, stored in polypropylene syringes, are stable for 21 days under refrigeration.15 Methylprednisolone solutions of 0.25, 2.5, or 5 mg/mL in 5% dextrose injection or 0.9% sodium chloride injection are stable for 7 days at room temperature; methylprednisolone combined with a variety of agents is stable in syringes for 2-72 hours at room temperature.16 Clinicians should consult specialized references for additional stability and compatibility information.
  • In situations where oral drug administration is possible, prednisone or oral methylprednisolone are the preferred alternative agents. Divide large oral doses into smaller ones to increase the patients’ ability to tolerate the medication.
  • Consider IV injections of dexamethasone for patients who are unable to take oral medications.

Benzyl Alcohol Content

Dexamethasone injection contains 10 mg/mL benzyl alcohol as a preservative.12,13 Hydrocortisone and methylprednisolone sodium succinate contain benzyl alcohol in varying amounts depending on the quantity of methylprednisolone or diluent used.5,7

  • Adverse reactions to benzyl alcohol are most common following intrathecal administration of products containing benzyl alcohol or administration of such products to low birth weight infants.17,18
  • There are limited data regarding the safe maximum dose of benzyl alcohol for adults. Adults may safely receive a rapid intravenous infusion of a product containing up to 270 mg of benzyl alcohol (27 mL of a product containing 10 mg/mL benzyl alcohol).17

Table 1. Glucocorticoid comparison6,8

Agent

Equivalent Dose (approximate mg)

Route of Administration

Relative Anti-inflammatory Potency

Relative Mineralocorticoid Potency

Biologic Half-Life (hours)

Betamethasone

0.6–0.75

IM, PO

20–30

0

36–54

Dexamethasone

0.75

IM, IV, PO

25–30

0

36–54

Hydrocortisonea

20

IM, IV, PO

1

2

8–12

Methylprednisolone

4

IM, IV, PO

5

0

18–36

Prednisolone

5

PO

4

1

18–36

Prednisone

5

PO

4

1

18–36
a Some patients may not be able to tolerate the higher mineralocorticoid activity of hydrocortisone.

Related Shortages

References

  1. Hospira (personal communications). January 15, 2013.
  2. Bedford Laboratories, Customer Service (personal communication). June 2, 2011.
  3. Pfizer (personal communications). January 16 and 22, March 6, 22, and 29, April 17, and May 10, 2013.
  4. APP (personal communications). January 15, March 6, 22, and 28, April 5 and 17, and May 9, 2013.
  5. Solu-Medrol [product information]. New York, NY: Pfizer; May 2012.
  6. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. 20th ed. Hudson, OH: Lexi-Comp;2011-2012:1056-1059.
  7. Solu-Cortef [product information]. New York, NY: Pfizer; July 2012.
  8. Corticosteroids general statement. In: McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2013.
  9. Siberry GK, Iannone R, eds. The Harriet Lane Handbook. 15th Edition. St. Louis, MO: Mosby, Inc.;2000.
  10. Young TE, Mangum B, eds. Neofax 2010. Raleigh, NC: Acorn Publishing; 2010.
  11. Pagliaro AM. Administering drugs to infants, children, and adolescents. In: Pagliaro LA, Pagliaro AM, eds. Problems in Pediatric Drug Therapy. 4th ed. Washington, DC: American Pharmaceutical Association; 2002:1-86.
  12. Dexamethasone sodium phosphate injection [product information]. Shirley, NY: American Regent; December 2009.
  13. Dexamethasone sodium phosphate injection [product information]. Schaumburg, IL: APP; January 2008.
  14. Hutchison TA, Shahan DR, Anderson ML, eds. Micromedex 2.0 [internet database]. Greenwood Village, CO: Truven Health Analytics; 2013.
  15. Gupta VD. Chemical stability of methylprednisolone sodium succinate after reconstitution in 0.9% sodium chloride injection and storage in polypropylene syringes. Int J Pharm Compd. 2001;5(2):148-150.
  16. Pharmacia & Upjohn, Medical Information (written communication). April 7, 2000.
  17. Benzyl alcohol toxicity (Drug Consult). In: Hutchison TA, Shahan DR eds. Drugdex System. Greenwood Village, CO: Micromedex. (Last modified October 2010) Accessed January 16, 2013.
  18. Storey RA. Benzyl alcohol. In: Rowe RC ed. Handbook of Pharmaceutical Excipients, 6th ed. Washington, DC: American Pharmaceutical Association;2009:64-66.
  19. Bjerre JS. Effect of glucocorticoids on ICP in patients with a cerebral tumour. Acta Neurol Scand. 1997;96:167-170.
  20. Ducker TB and Zeidman SM. Spinal cord injury: role of steroid therapy. Spine. 1994;19(20):2281-2287.
  21. Zaidat OO, Ruff RL. Treatment of spinal epidural metastasis improves patient survival and functional state. Neurology. 2002;58:1360-1366.
  22. Heary RF, Vaccaro AR, Mesa JJ. Steroids and gunshot wounds to the spine. Neurosurgery. 1997;41(3):576-584.
  23. Kiwerski JE. Application of dexamethasone in the treatment of acute spinal cord injury. Injury. 1993;24(7): 457-460.
  24. Short DJ, Masry WS, Jones PW. High dose methylprednisolone in the management of acute spinal cord injury – a systematic review from a clinical perspective.
  25. Anderson P, Goodkin DE. Glucocorticosteroid therapy for multiple sclerosis: a critical review. J Neurological Sci. 1998;160(1):16-25.
  26. Tselis AC and Lisak RP. Multiple sclerosis: therapeutic update. Arch Neurol. 1999;56:277-280.
  27. Heun R, Sliwka U, Ruttinger H, Schimrigk K. Intrathecal versus systemic corticosteroids in the treatment of multiple sclerosis: results of pilot study. J Neurol. 1992;239(1):31-35.
  28. Barnes D, Hughes RAC, Morris RW et al. Randomised trial of oral and intravenous methylprednisolone in acute relapses of multiple sclerosis. Lancet. 1997;349(9056):902-06.
  29. Zenk KE, Sills JH, Koeppel RM, eds. Neonatal Medications and Nutrition A Comprehensive Guide. Santa Rosa, CA: NICU Ink Book Publishers; 1999; 145-150.
  30. Takemoto CK, Hodding JH, Kraus DM, eds. Pediatric Dosage Handbook. 16th Edition. Hudson, OH: Lexi-Comp, Inc.;2009-2010.
  31. Spoor TC, Hartel CS, Lensink DB, Wilkinson MJ. Treatment of traumatic optic neuropathy with corticosteroids. Am J Ophthalmol. 1990;110:665-669.
  32. Seiff SR. High dose corticosteroids for treatment of vision loss due to indirect injury to the optic nerve. Ophthalmic Surg. 1990;21:389-395.
  33. Baker SM, Hurwitz JJ. Sports and industrial ophthalmology. Ophthalmol Clin North Am. 1999;12:435-455.
  34. Eggenberger ER. Inflammatory optic neuropathies. Ophthalmol Clin North Am. 2001;14(1):73-82.
  35. Frohman EM. Multiple sclerosis. Med Clin North Am. 2003;87(4):867-897.
  36. Hickman SJ, Kapoor R, Jones SJ, et al. Corticosteroids do not prevent optic nerve atrophy following optic neuritis. J Neurol Neurosurg Psychiatry. 2003;74:1139-1141.

Updated

Updated May 13, 2013 by Jane Chandramouli,  PharmD Drug Information Specialist. Created April 12, 2001, by Cyndie Taylor, PharmD, Drug Information Specialist, and M. Christina Beckwith, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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