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Doxycycline Capsules and Tablets

[18 July 2014]

Products Affected - Description

Doxycycline hyclate, Actavis (formerly Watson)8
50 mg capsules, 50 count (NDC 00591-5535-50)
100 mg capsules, 50 count (NDC 00591-5440-50)
100 mg capsules, 500 count (NDC 00591-5440-05)

Doxycycline monohydrate, Actavis (formerly Watson)8
100 mg capsules, 50 count (NDC 00591-0411-50)
50 mg capsules, 100 count (NDC 00591-0410-01)


Doxycycline hyclate, Mylan14
75 mg delayed-release tablets, 60 count (NDC 00378-4531-91)
 
Doxycycline monohydrate, Mylan14
50 mg tablets, 100 count (NDC 00378-6021-01)
 
Doxycycline hyclate, Major3
50 mg capsules, 50 count (NDC 00904-0427-51) - discontinued
100 mg tablets, 50 count (NDC 00904-0430-51) - discontinued
100 mg capsules, 50 count (NDC 00904-0428-51) - discontinued
100 mg tablets, 100 count unit-dose (NDC 00904-0430-61) - discontinued
100 mg capsules, 100 count unit-dose (NDC 00904-0428-61) - discontinued
100 mg tablets, 500 count (NDC 00904-0430-40) - discontinued
100 mg capsules, 500 count (NDC 00904-0428-40) - discontinued

Doxycycline hyclate, Teva6
20 mg tablets, 100 count (NDC 00172-4626-60) - discontinued
20 mg tablets, 500 count (NDC 00172-4626-70) - discontinued

Doxycycline hyclate, West-Ward9
100 mg capsules, 20 count (NDC 00143-3142-20) - discontinued

Reason for the Shortage

  • Actavis states the reason for the shortage is supply and demand.8
  • Teva discontinued their doxycycline presentations in May 2013.6
  • Major discontinued most doxycycline presentations in February 2013. The company could not provide a reason for the discontinuation.3

Available Products

Monodox (doxycycline monohydrate), Aqua10
75 mg capsules, 100 count (NDC 16110-0075-01)
100 mg capsules, 50 count (NDC 16110-0259-04)
100 mg capsules, 250 count (NDC 16110-0259-07)
 
Avidoxy (doxycycline monohydrate), Avidas Pharmaceuticals11
100 mg tablet, 50 count (NDC 43684-0200-20)

Doxycycline monohydrate, Global12
150 mg capsules, 60 count (NDC 00115-1327-13)
 
Doxycycline monohydrate, Heritage1
50 mg tablets, 100 count (NDC 23155-0133-01)
75 mg tablets, 100 count (NDC 23155-0134-01)
100 mg tablets, 50 count (NDC 23155-0135-25)
150 mg tablets, 30 count (NDC 23155-0136-03)


Doxycycline hyclate, Lannett2
20 mg tablets, 100 count (NDC 00527-1336-01)

Doxycycline monohydrate, Lannett2
75 mg tablets, 100 count (NDC 00527-1535-01)
100 mg tablets, 50 count (NDC 00527-1338-50)
100 mg tablets, 250 count (NDC 00527-1338-25)
150 mg tablets, 30 count (NDC 00527-1537-30)

Doxycycline hyclate, Larken13
20 mg tablets, 60 count (NDC 68047-0714-60)
20 mg tablets, 100 count (NDC 68047-0714-01)
 
Doxycycline hyclate, Caraco (formerly Mutual)4
20 mg tablets, 100 count (NDC 53489-0647-01)
50 mg capsules, 50 count (NDC 53489-0118-02)
50 mg capsules, 500 count (NDC 53489-0118-05)
100 mg tablets, 50 count (NDC 53489-0120-02)
100 mg capsules, 50 count (NDC 53489-0119-02)
100 mg tablets, 500 count (NDC 53489-0120-05)
100 mg capsules, 500 count (NDC 53489-0119-05)
 
Doxycycline hyclate, Mylan14
100 mg delayed-release tablets, 100 count (NDC 00378-4532-01)
150 mg delayed-release tablets, 100 count (NDC 00378-3030-01)

Doxycycline monohydrate, Mylan14
75 mg tablets, 100 count (NDC 00378-6022-01)
100 mg tablets, 50 count (NDC 00378-6023-89)
150 mg tablets, 30 count (NDC 00378-6124-93)
 
Doxycycline monohydrate, Par Pharmaceuticals5
50 mg capsules, 100 count (NDC 49884-0726-01)
50 mg tablets, 100 count (NDC 49884-0091-01)
75 mg tablets, 100 count (NDC 49884-0092-01)
100 mg capsules, 50 count (NDC 49884-0727-03)
100 mg tablets, 50 count (NDC 49884-0093-03)
100 mg capsules, 250 count (NDC 49884-0727-04)
100 mg tablets, 250 count (NDC 49884-0093-04)
150 mg tablets, 30 count (NDC 49884-0236-11)
150 mg capsules, 60 count (NDC 49884-0305-02)

Doxycycline monohydrate, Ranbaxy15
75 mg capsules, 100 count (NDC 63304-0615-01)
 
Doxycycline hyclate, VersaPharm7
100 mg capsules, 14 count (NDC 61748-0111-14)

 
Doxycycline hyclate, West-Ward9
50 mg capsules, 50 count (NDC 00143-3141-50)
100 mg tablets, 50 count (NDC 00143-2112-50)
100 mg capsules, 50 count (NDC 00143-3142-50)
100 mg capsules, 500 count (NDC 00143-3142-05)
100 mg capsules, 50 count (NDC 00143-9803-50)
100 mg capsules, 500 count (NDC 00143-9803-05)
100 mg tablets, 500 count (NDC 00143-2112-05)

Adoxa, Sandoz16
150 mg capsule, 60 count (NDC 10337-0815-06)
 
Vibramycin (doxycycline hyclate), Pfizer17
100 mg capsules, 50 count (NDC 00069-0950-50)  

Estimated Resupply Dates

  • Actavis has all doxycycline presentations on allocation.
  • Mylan has doxycycline hyclate 75 mg capsules on back order and the company estimates a release date in late-July 2014. Doxycycline monohydrate 50 mg tablets are on back order and the company estimates a release date in mid-August 2014.

Implications for Patient Care

  • Doxycycline is a broad-spectrum bacteriostatic antibiotic that inhibits protein synthesis in a wide variety of gram-negative and gram-positive organisms, as well as intracellular organisms (eg, Rickettsiae, Chlamydiae, Mycoplasmas), some anaerobes, spirochetes (eg, Borrelia), and protozoan parasites (eg, Plasmodium spp).18, 19, 20
  • Other oral tetracycline antibiotics include minocycline and tetracycline.19
  • All tetracycline products were on nationwide drug shortage from August 2011 until October 2013. Tetracycline capsules are currently available.21

Alternative Agents & Management

  • Minocycline has similar antimicrobial broad spectrum activity to doxycycline. The Table compares doxycycline and minocycline. Doxycycline may be preferred over minocycline in terms of adverse effect profile, and until recently doxycycline was available at a lower cost than minocycline.22-27
  • If doxycycline is unavailable, an alternative antibiotic from a different medication class may be preferred over minocycline depending on the indication.
  • When choosing an alternative to doxycycline, use clinical judgement. Do not substitute if doxycycline is the clear drug of choice for the specified indication and product is available.
  • It may not be feasible to automatically interchange minocycline and doxycycline. These two agents have only been compared in head-to-head clinical trials for acne, non-gonococcal urethritis and cervicitis, chlamydial infection, acute bacterial exacerbation of chronic bronchitis, non-complicated scrub typhus, tick-borne relapsing fever, and community onset MRSA skin and soft tissue infection.28-35  Even though doxycycline and minocycline have a similar antimicrobial spectrum, minocycline has not been used as extensively as doxycycline because of adverse effect profile.36
  • For sexually transmitted diseases including epididymitis, syphilis in non-pregnant patients with penicillin allergy, cervicitis, chlamydial infections, gonococcal infections, and pelvic inflammatory disease, doxycycline is recommended as a treatment agent, either alone or in combination with other medications, according to the CDC 2010 STD Treatment guidelines. Refer to CDC Website for treatment alternatives to doxycycline.
  • Doxycycline is one recommended therapy for malarial prophylaxis. See CDC malarial prophylaxis information for alternatives to doxycycline.

 

Related Shortages

References

  1. Heritage (personal communications). November 27, 2012; January 23, February 13, May 1, August 29, September 3 and 30, October 7, November 4 and 26, and December 18, 2013; and January 15, March 3, and April 24, 2014.
  2. Lannett (personal communications). November 27, 2012; January 4 and 23, February 13, March 11, April 9, May 1 and 20, June 13, July 10, August 13 and 29, and November 4, 2013; and January 13, March 3, April 23, and June 16, 2014. 
  3. Major (personal communications). November 27, 2012; January 4, February 13, and May 1, 2013.
  4. Mutual (personal communications). November 27, 2012; January 4, February 13, March 11, April 9, May 1, June 13, August 29, and November 4, 2013; and January 13, March 3, April 23, and June 16, 2014.
  5. Par Pharmaceuticals (personal communications). November 27, 2012; January 4 and 23, February 13, March 11, April 9, May 1, June 13, August 29, and November 4, 2013; and January 15 and June 16, 2014.
  6. Teva (personal communications). November 27, 2012; January 4, February 13, March 11, and May 1, 2013.
  7. VersaPharm (personal communications). December 10, 2012; February 6, March 11, April 9, May 1, June 13, August 29, and November 4, 2013; and January 13, 2014.
  8. Actavis [formerly Watson] (personal communications). November 27, 2012; January 4, February 13, March 11, April 9, June 13, August 29, September 3, November 4, and December 17, 2013; and January 13, March 4, April 7 and 24, June 23, and July 17, 2014.
  9. West-Ward (personal communications). November 27, 2012; January 4, February 6, March 8, April 5, May 1 and 20, June 7, August 29, and November 4, 2013; and January 10, March 3, April 18, May 23, and June 11, 2014.
  10. Aqua Pharmaceuticals (personal communications). November 27, 2012; January 4, February 14, March 11, April 9, June 13, August 29, and November 4, 2013; and January 13, 2014.
  11. Avidas Pharmaceuticals (personal communications). December 21, 2012; January 8, February 14, and March 27, 2013.
  12. Global Pharmaceuticals (personal communications). November 27, 2012; January 4, February 13, March 11, April 9, May 1, June 13, August 29, and November 8, 2013; and January 13, 2014.
  13. Larken (personal communications). December 5, 2012; February 13, March 11, May 1, June 13, August 29, and November 4, 2013; and January 13, 2014.
  14. Mylan (personal communications). November 27, 2012; January 4, February 13, March 11, April 8, May 1, June 13, August 29, and November 4, 2013; and January 13, March 3, April 24, June 16, and July 14, 2014.
  15. Ranbaxy (personal communications). November 27, 2012; January 4, February 13, March 11, April 9, May 1, June 13, August 29, and November 8, 2013; and January 13, 2014.
  16. Sandoz (personal communications). December 1 and 10, 2012; January 9, February 13, March 11, April 9, June 13, August 29, and November 8, 2013; and January 13, March 3, and June 16, 2014.
  17. Pfizer (personal communications). May 13 and 17 June 7, August 29, and November 4, 2013; and January 10, February 28, April 18, and June 13, 2014.
  18. Aqua Pharmaceuticals. Monodox (doxycycline) oral capsules [product information]. West Chester, PA: Aqua Pharmaceuticals; 2011.
  19. Salvatore M, Meyers BR. Tetracyclines and Chloramphenicol. In: Mandell GL, Bennett JE, Dolin D, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Vol 1. 7th ed. Philadelphia, PA: Churchill Livingstone Elsevier; 2010:385-401.
  20. Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS. The Sanford Guide to Antimicrobial Therapy 2011. 41st ed. Sperryville, VA: Antimicrobial Therapy, Inc; 2011.
  21. University of Utah Drug Information Service. Tetracycline shortage. 2013 [cited 2013 April 2]; Available from: American Society of Health-System Pharmacists, Practice Resource Centers, Drug Shortages. Updated October 25, 2013
  22. Anon, editor. Red Book Online. via Micromedex 2.0 [internet database]. Greenwood Village, CO: Truven Health Analytics; 2013.
  23. Kircik LH. Doxycycline and minocycline for the management of acne: a review of efficacy and safety with emphasis on clinical implications. J Drugs Dermatol. 2010 Nov;9(11):1407-11.
  24. Cunha BA, Comer JB, Jonas M. The tetracyclines. Med Clin North Am. 1982 Jan;66(1):293-302.
  25. Klein NC, Cunha BA. Tetracyclines. Med Clin North Am. 1995 Jul;79(4):789-801.
  26. Lebrun-Vignes B, Kreft-Jais C, Castot A, Chosidow O. Comparative analysis of adverse drug reactions to tetracyclines: results of a French national survey and review of the literature. Br J Dermatology. 2012 Jun;166(6):1333-41.
  27. Smith K, Leyden JJ. Safety of doxycycline and minocycline: a systematic review. Clin Ther. 2005 Sep;27(9):1329-42.
  28. Kovacs GT, Westcott M, Rusden J, et al. A prospective single-blind trial of minocycline and doxycycline in the treatment of genital Chlamydia trachomatis infection in women. Medical J Australia. 1989 May 1;150(9):483-5.
  29. Maesen FP, Davies BI, van den Bergh JJ. Doxycycline and minocycline in the treatment of respiratory infections: a double-blind comparative clinical, microbiological and pharmacokinetic study. J Antimicrobial Chemother. 1989 Jan;23(1):123-9.
  30. Romanowski B, Talbot H, Stadnyk M, Kowalchuk P, Bowie WR. Minocycline compared with doxycycline in the treatment of nongonococcal urethritis and mucopurulent cervicitis. Ann Internal Med. 1993 Jul 1;119(1):16-22.
  31. Harrison PV. A comparison of doxycycline and minocycline in the treatment of acne vulgaris. Clin Exp Derm. 1988 Jul;13(4):242-4.
  32. de Pierpont E, Goubau P, Verhaegen J, Vandepitte J. Single dose minocycline and doxycycline treatment of tick-borne relapsing fever. A double-blind clinical trial in Rwanda. Ann Soc Belg Med Trop. 1983 Dec;63(4):357-61.
  33. Tsai CC, Lay CJ, Ho YH, Wang LS, Chen LK. Intravenous minocycline versus oral doxycycline for the treatment of noncomplicated scrub typhus. J Microbiol Immunol Infect. 2011 Jan 12;44(1):33-8.
  34. Ruhe JJ, Menon A. Tetracyclines as an oral treatment option for patients with community onset skin and soft tissue infections caused by methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2007 Sep;51(9):3298-303.
  35. Smit F. Minocycline versus doxycycline in the treatment of acne vulgaris. A double-blind study. Dermatologica. 1978;157(3):186-90.
  36. Cunha BA. New uses for older antibiotics: nitrofurantoin, amikacin, colistin, polymyxin B, doxycycline, and minocycline revisited. Med Clin North Am. 2006 Nov;90(6):1089-107.
  37. Pfizer. Vibramycin (doxycycline hyclate) oral capsules [product information]. New York, NY: Pfizer; 2011.
  38. Warner Chilcott. Doryx (doxycycline hyclate) delayed-release capsules [product information]. Rockaway, NJ; Warner Chilcott; 2007.
  39. Galderma Laboratories. Oracea (doxycycline) capsules [product information]. Fort Worth, TX: Galderma Laboratories; 2012.
  40. Par Pharmaceutical. Minocycline tablets [product information]. Spring Valley, NY: Par Pharmaceutical; 2011.
  41. Medicis Pharmaceutical. Solodyn (minocycline) extended release tablets [product information]. Scottsdale, AZ: Medicis; 2012.
  42. 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; 2011.
  43. 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.
  44. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.
  45. Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2013.

Updated

Updated July 18, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist; May 1, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created April 9, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist, and Erin R Fox, Director, Drug Information Service. Copyright 2014, 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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