Lotrisone Side Effects

Generic Name: betamethasone / clotrimazole topical

Note: This page contains information about the side effects of betamethasone / clotrimazole topical. Some of the dosage forms included on this document may not apply to the brand name Lotrisone.

Not all side effects for Lotrisone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

In addition to its needed effects, some unwanted effects may be caused by betamethasone / clotrimazole topical. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking betamethasone / clotrimazole topical:

Less common
  • Blistering, burning, itching, peeling, dryness, redness, or other signs of skin irritation not present before use of this medicine
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • hives
Rare
  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • rash
  • stinging
  • swelling
Incidence not known
  • Abdominal or stomach pain
  • dry mouth
  • full or round face, neck, or trunk
  • irritability
  • nausea
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • redness and scaling around the mouth
  • softening of the skin
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

Local

Skin atrophy may become evident within one to two months of use and is due to the inhibitory effect of corticosteroids on collagen formation. Skin on the face, axilla, and groin appears to be most susceptible to the adverse long-term effects of topical betamethasone. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Topical corticosteroid use may impair local immune response rendering the skin more susceptible to infections. Folliculitis is occasionally reported.

Perioral dermatitis or rosacea-like dermatitis has occurred patients treated with potent topical corticosteroids who are of seborrheic skin type. This condition may flare temporarily upon discontinuation of topical steroids, prompting patients to continue their use. If topical corticosteroids are discontinued, this flare and the initial dermatitis generally resolves over a few weeks.

Worsening of psoriasis has occurred in a few patients.[Ref]

Local side effects have commonly included burning, itching, dryness, or irritation, especially if applied to denuded skin. Allergic contact dermatitis has occasionally been reported. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding.[Ref]

Endocrine

Endocrinologic side effects have included suppression of the hypothalamic-pituitary-adrenal axis and has resulted in Cushing's Syndrome and symptoms of adrenal suppression following withdrawal of the drug. This has been more common when higher potency topical corticosteroids were used over extensive areas and when occlusive dressing were used.[Ref]

Adrenal suppression has been reported in patients with psoriasis using betamethasone dipropionate. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug, and in some cases returned to normal during continued therapy.

If betamethasone dipropionate is to be used for an extended period to time, adrenal function should be evaluated periodically. Supplemental systemic steroids may be necessary during times of stress.[Ref]

Ocular

Ocular side effects have included rare reports of glaucoma in patients who used betamethasone on the face for long periods of time. Intraocular pressure did not always return to normal following discontinuation of the drug.[Ref]

Steroid-induced cataracts and glaucoma have been reported, most often in patients receiving betamethasone eyedrops (not available in the US). In one patient, permanent eye damage resulted from long-term application of betamethasone cream to the eyelids.[Ref]

Musculoskeletal

Musculoskeletal side effect have included rare reports of osteoporosis in long-term betamethasone use. Vertebral fractures and avascular necrosis of the hips has been documented.[Ref]

Dermatologic

Betamethasone-clotrimazole topical is not recommended for the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated for diaper dermatitis.[Ref]

Dermatologic side effects have included rash, edema, dry skin, burning and stinging.[Ref]

References

1. "Product Information. Lotrisone (betamethasone-clotrimazole)." Schering Laboratories, Kenilworth, NJ.

2. Sawyer PR, Brogden RN, Pinder RM, Speight TM, Avery "Clotrimazole: a review of its antifungal activity and therapeutic efficacy." Drugs 9 (1975): 424-47

3. Kalb RE, Grossman ME "Contact dermatitis to clotrimazole." Cutis 36 (1985): 240-2

4. Grice K "Tinea of the hand and forearm. Betamethasone valerate atrophy." Proc R Soc Med 59 (1966): 254-5

5. Smith EB, Breneman DL, Griffith RF, Hebert AA, Hickman JG, Maloney JM, Millikan LE, Sulica VI, Dromgoole SH, Sefton J, et al "Double-blind comparison of naftifine cream and clotrimazole/betamethasone dipropionate cream in the treatment of tinea pedis." J Am Acad Dermatol 26 (1992): 125-7

6. Hellgren L "Induction of generalized pustular psoriasis by topical use of betamethasone-dipropionate ointment in psoriasis." Ann Clin Res 8 (1976): 317-9

7. Sneddon I "Perioral dermatitis." Br J Dermatol 87 (1972): 430-4

8. Ellis CN, Katz HI, Rex IH Jr, Shavin JS, Van Scott EJ, VanderPloeg D "A controlled clinical trial of a new formulation of betamethasone dipropionate cream in once-daily treatment of psoriasis." Clin Ther 11 (1989): 768-74

9. Balato N, Lembo G, Nappa P, Ayala F "Contact dermatitis from clotrimazole." Contact Dermatitis 12 (1985): 110

10. "Gyne-lotrimin for vaginal infections." Med Lett Drugs Ther 18 (1976): 66-7

11. Macdonald A "Topical corticosteroid preparations. Hazards and side-effects." Br J Clin Pract 25 (1971): 421-5

12. Roller JA "Contact allergy to clotrimazole." Br Med J 2 (1978): 737

13. Barkey WF "Striae and persistent tinea corporis related to prolonged use of betamethasone dipropionate 0.05% cream/clotrimazole 1% cream (Lotrisone cream)." J Am Acad Dermatol 17 (1987): 518-9

14. Flynn MD, Beasley P, Tooke JE "Adrenal suppression with intranasal betamethasone drops." J Laryngol Otol 106 (1992): 827-8

15. Reymann F, Kehlet H "Hypothalamic-pituitary-adrenocortical function. Association with topical application of betamethasone dipropionate." Arch Dermatol 115 (1979): 362-3

16. Cunliffe WJ, Burton JL, Holti G, Wright V "Hazards of steroid therapy in hepatic failure." Br J Dermatol 93 (1975): 183-5

17. Ruiz-Maldonado R, Zapata G, Lourdes T, Robles C "Cushing's syndrome after topical application of corticosteroids." Am J Dis Child 136 (1982): 274-5

18. Stoppoloni G, Prisco F, Santinelli R, Sicuranza G, Giordano C "Potential hazards of topical steroid therapy." Am J Dis Child 137 (1983): 1130-1

19. Stevens DJ "Cushing's syndrome due to the abuse of betamethasone nasal drops." J Laryngol Otol 102 (1988): 219-21

20. Walsh P, Aeling JL, Huff L, Weston WL "Hypothalamus-pituitary-adrenal axis suppression by superpotent topical steroids." J Am Acad Dermatol 29 (1993): 501-3

21. Salde L, Lassus A "Systemic side-effects of three topical steroids in diseased skin." Curr Med Res Opin 8 (1983): 475-80

22. Kitazawa Y "Increased intraocular pressure induced by corticosteroids." Am J Ophthalmol 82 (1976): 492-5

23. Butcher JM, Austin M, McGalliard J, Bourke RD "Bilateral cataracts and glaucoma induced by long term use of steroid eye drops." BMJ 309 (1994): 43

24. Eisenlohr JE "Glaucoma following the prolonged use of topical steroid medication to the eyelids." J Am Acad Dermatol 8 (1983): 878-81

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