Products Affected - Description

• • Furosemide injection, American Regent, 10 mg/mL, 10 mL vial, 25 count, NDC 00517-5710-25
  • Furosemide injection, American Regent, 10 mg/mL, 2 mL vial, 25 count, NDC 00517-5702-25
  • Furosemide injection, American Regent, 10 mg/mL, 4 mL vial, 25 count, NDC 00517-5704-25

Reason for the Shortage

• • Fresenius Kabi has furosemide injection available.[1]
  • American Regent has furosemide injection on shortage due to manufacturing delays.[2,3]
  • Hospira has furosemide injection available.[4,5]
  • Wockhardt has discontinued all furosemide injection presentations.[6]
  • Claris has furosemide injection available.[7]

Available Products

• • Furosemide injection, Claris, 10 mg/mL, 10 mL vial, 5 count, NDC 36000-0065-05
  • Furosemide injection, Claris, 10 mg/mL, 10 mL vial, 25 count, NDC 36000-0284-25
  • Furosemide injection, Claris, 10 mg/mL, 2 mL vial, 5 count, NDC 36000-0063-05
  • Furosemide injection, Claris, 10 mg/mL, 2 mL vial, 25 count, NDC 36000-0282-25
  • Furosemide injection, Claris, 10 mg/mL, 4 mL vial, 5 count, NDC 36000-0064-05
  • Furosemide injection, Claris, 10 mg/mL, 4 mL vial, 25 count, NDC 36000-0283-25
  • Furosemide injection, Fresenius Kabi, 10 mg/mL, 10 mL vial, 25 count, NDC 63323-0280-10
  • Furosemide injection, Fresenius Kabi, 10 mg/mL, 2 mL vial, 25 count, NDC 63323-0280-02
  • Furosemide injection, Fresenius Kabi, 10 mg/mL, 4 mL vial, 25 count, NDC 63323-0280-04
  • Furosemide injection, Pfizer, 10 mg/mL, 10 mL Luer Lock syringe, 10 count, NDC 00409-1639-10
  • Furosemide injection, Pfizer, 10 mg/mL, 10 mL vial, 25 count, NDC 00409-6102-10
  • Furosemide injection, Pfizer, 10 mg/mL, 2 mL vial, 25 count, NDC 00409-6102-02
  • Furosemide injection, Pfizer, 10 mg/mL, 4 mL syringe, 10 count, NDC 00409-9631-04
  • Furosemide injection, Pfizer, 10 mg/mL, 4 mL vial, 25 count, NDC 00409-6102-04

• • American Regent has furosemide 10 mg/mL 2 mL, 4 mL, and 10 mL vials on back order and the company cannot estimate a release date.[3]
  • All other marketed presentations are available.

• • Furosemide injection is indicated in the adjunctive treatment of acute pulmonary edema; edema associated with congestive heart failure and hepatic cirrhosis; edema caused by renal diseases including nephrotic syndrome, acute glomerulonephritis, and chronic renal failure; and hypertension, either as a single agent or in combination with other antihypertensives.[8,9,10] The preferred route of administration of furosemide is oral, although the injection may be administered when a rapid onset of action is required, or when patients cannot take oral medications.[8,9,10]

• • Loop diuretics can cause water and electrolyte imbalances from potent diuresis and individualized dosing and supervision is recommended.[8,9,10,11,12,13]
  • Patients who are allergic to sulfonamides are at risk for a cross-reaction with sulfonamide-type diuretics and should not receive these agents except for ethacrynic acid.[8,9,10,11,12,13]

• • During this shortage, use oral loop diuretics when possible. Furosemide is available as an oral liquid if tablets are not tolerated. Furosemide is the only loop diuretic available in an oral liquid presentation.[8,9,10,11,12,13] Several injectable loop diuretics are available when oral furosemide is not a viable option. Table 1 compares the pharmacodynamics of injectable loop diuretics and Table 2 provides information on dosages for injectable loop diuretics.

  Table 1. Pharmacodynamics of injectable loop diuretics8,9,10,11,12,13

  Drug	Onset of Diuretic Action (min)	Time to Peak of Diuretic Effect (min)	Duration of Diuretic Action (hours)
  Furosemide	< 5	30	2
  Bumetanide	Within minutes	15 to 30	0.5 to 1
  Torsemide	< 10	< 60	6 to 8
  Ethacrynic acid	< 5	15 to 30	2

  
  

  Table 2. Dosage regimens of injectable loop diuretics8,9,10,11,12,13

  Drug	Usual Adult Dosage	Comments
  Abbreviations: IM = intramuscular; IV = intravenous; SC = subcutaneous
  Furosemide	Edema, initial dose: 20-40 mg/dose IV or IM every 2 hours as needed. Increase the dose by 20 mg every 2 hours until desired effects are seen. Edema, maintenance dosage: Give the effective dose once or twice daily. Up to 4 grams/day in patients with congestive heart failure and 6 grams/day in patients with chronic renal failure is being investigated. Acute pulmonary edema: 40 mg IV. After 1 hour, may increase the dose to 80 mg if diuretic response is inadequate. Continuous infusion: 20-40 mg bolus IV, followed by 10-40 mg/hour. Double the rate every 2 hours, up to a maximum 80-160 mg/hour.	Administer small doses (20-80 mg) IV over 1-2 min. Administer large doses (1 gram) IV over 30 min. Avoid use in patients with oliguria. Rates up to 4 mg/minute have been used.
  Bumetanide	Edema, initial dose: 0.5-1 mg IV or IM. Repeat in 2-3 hours if response is inadequate, up to a maximum of 10 mg/day. Edema, maintenance dose: give the effective dose (from titration) intermittently as needed.	Administer IV over 1-2 minutes. Risk of cross-reactivity in patients with furosemide allergy is low (1:40); bumetanide may be a good choice in these patients.
  Torsemide	10-20 mg IV once daily. Double the dose (maximum of 200 mg/dose) until desired therapeutic response is achieved. Hepatic cirrhosis: 5-10 mg IV once daily. Double the dose (maximum of 40 mg/dose) until desired therapeutic response is achieved.	Administer IV over 2 minutes. Extensively metabolized in the liver; dosage may need adjustment in patients with hepatic impairment.
  Ethacrynic acid	Edema, initial dose: 50 mg IV or 0.5-1 mg/kg (up to 100 mg/dose). Usually only a single dose is necessary; may repeat in 2-4 hours if additional diuresis is needed. Edema, maintenance dose: Give the effective dose every 8-12 hours.	Administer IV over several minutes. Causes pain and irritation at the injection site; do not inject IM or SC. If a second dose is needed, use a new injection site to reduce the risk of thrombophlebitis. Has higher risk than other loop diuretics of causing ototoxicity. Avoid use in patients with a creatinine clearance of< 10 mL/minute.

  
  

• 1. Fresenius Kabi (personal communications). June 9 and 30, July 12, 16, and 22, August 3 and 23, October 15, November 15, December 7 and 20, 2010; January 5, 12, and 27, March 25, May 11, June 8, July 27, August 29, September 16, October 17, November 11, December 1, 2011; January 4, February 1 and 28, March 20, April 11, May 29, June 7, July 3 and 23, August 7 and 22, October 1 and 22, November 5 and 30, December 7 and 21, 2012; January 14, February 28, March 18, April 1, 17, and 25, May 9, June 10, July 22, August 19, September 17, October 22, November 13, 2013; January 3, February 14, May 6 and 19, July 1, August 4 and 14, September 2 and 22, October 13, November 12, December 7, 2014; January 20, February 18, April 3, May 28, June 9 and 30, August 5, September 10 and 17, October 8 and 15, November 13, December 2, 2015; January 28, March 3, May 11, June 20, September 2, and November 7, 2016.
  2. American Regent (personal communications). June 9 and 30, July 12, August 2 and 24, September 8 and 20, October 12, November 16, and December 7, 21, and 30, 2010; January 24, March 23, April 21, and May 31, 2011.
  3. American Regent (website). July 27, August 31, September 20, October 17, November 14, December 1, 2011; January 4 and 31, February 28, March 20, April 11, May 30, June 11, July 3 and 25, August 8 and 21, September 28, October 24, November 5, December 4, 10, and 20, 2012; January 14, February 28, March 18, April 1, 16, and 29, May 8, June 12, July 22, August 19, September 19, October 23, November 15, 2013; January 2, February 18, May 9 and 20, July 7, August 4 and 14, September 3 and 23, October 21, November 10, December 12, 2014; January 22, February 23, April 3, May 28, June 12 and 26, August 12, September 11 and 22, October 6 and 19, November 17, December 10, 2015; February 1, March 8, May 12, June 28, September 6, and November 8, 2016.
  4. Hospira (personal communications). June 9 and 30, July 12 and 14, August 5 and 26, September 16 and 20, October 12 and 15, November 15, December 7, 20, and 28, 2010; January 4 and 25, February 3, March 23, May 10, June 16, August 29, December 1, 2011; January 4 and 31, February 28, March 20, June 12, July 3 and 24, August 6 and 22, October 1 and 24, and December 10 and 26, 2012; April 1 and 17, June 12, July 22, 2013; and December 8, 2015.
  5. Hospira (website) July 27, August 29, September 20, October 17, November 14, 2011; April 11, May 30, June 11, November 6, December 4, 2012; January 15, March 1 and 19, April 29, May 13 and 24, August 19, September 19, October 23, November 15, 2013; January 7, and February 18, May 9 and 20, July 7, August 6 and 18, September 3 and 19, October 21, November 10, December 12, 2014; January 23, February 23, April 3, May 28, June 12 and 29, August 12, September 11 and 22, October 6 and 19, November 17, December 11, 2015; February 1, March 8, May 13, June 28, September 6, and November 8, 2016.
  6. Wockhardt (personal communications). May 19, 2010.
  7. Claris Lifesciences (personal communications). May 20, July 7, August 6, November 13, December 15, 2014; February 23, April 7, May 27, June 29, September 11, October 6, November 2, 2015; February 1, March 7, May 13, June 28, July 13, September 6, and November 8, 2016.
  8. Loop Diuretics. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010:2737-2750.
  9. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2010.
  10. Anon. Drug Evaluation: Furosemide. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2010.
  11. Anon. Drug Evaluation: Bumetanide. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2010.
  12. Anon. Drug Evaluation: Torsemide. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2010.
  13. Anon. Drug Evaluation: Ethacrynic acid. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2010.