Betamethasoneside effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥1%) are pruritus and scaly rash. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to calcipotriene and betamethasone dipropionate ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Calcipotriene and betamethasone dipropionate ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most subjects received once daily application, and the median weekly dose was 24.5 g. The percentage of subjects reporting at least one adverse event was 27.1% in the calcipotriene and betamethasone dipropionate ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group. Table 1 Adverse Events Reported by ≥1% of Subjects by Preferred Term Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle N = 470 Any Adverse Event 663 1055 329 157 Preferred Term # of subjects (%) Pruritus 75 183 38 43 Headache 69 75 44 12 Nasopharyngitis 56 77 34 9 Psoriasis 30 47 14 5 Rash scaly 30 40 0 1 Influenza 23 34 14 6 Upper respiratory tract infection 20 19 12 3 Erythema 15 54 3 5 Application site pruritus 13 24 10 6 Skin irritation 11 60 8 5 Pain 7 12 3 5 Burning sensation 6 30 3 6 A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border. Table 2 Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle N = 470 Any Adverse Event 213 419 85 76 Preferred Term # of subjects (%) Pruritus 69 170 31 41 Rash scaly 29 38 0 0 Application site pruritus 12 24 10 6 Erythema 9 36 2 4 Skin irritation 9 51 8 5 Burning sensation 6 25 3 5 For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for calcipotriene and betamethasone dipropionate ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle. Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%). In a separate trial, subjects (N = 207) with at least moderate disease severity were given calcipotriene and betamethasone dipropionate ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the subjects: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of serious flare-up of psoriasis was reported.

6.2 Postmarketing

Experience The following adverse reactions associated with the use of calcipotriene and betamethasone dipropionate ointment have been identified post-approval: pustular psoriasis and rebound effect. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: striae, dryness, acneiform eruptions, perioral dermatitis, secondary infection and miliaria.