Temovate Cream or Ointment is applied topically (on the skin) to the affected areas twice daily. Treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Temovate may interact with corticosteroids taken by mouth or drugs that lower the immune system . Tell your doctor about all medications you are taking. During pregnancy, Temovate should be used only when prescribed. It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breastfeeding.
Read the Instructions for Use that comes with CLOBEX Shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
How to apply CLOBEX Shampoo to your scalp:
Your hair should be dry when you apply CLOBEX Shampoo to your scalp.
Do not get CLOBEX Shampoo on your face, in your eyes or on your lips. If CLOBEX Shampoo does get on these areas, rinse well with water.
Step 1: To apply CLOBEX Shampoo to your scalp, part your hair at the area where it is to be applied.
Step 2: Hold the bottle of CLOBEX Shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.
Step 3: Gently rub CLOBEX Shampoo into the affected area so that only the affected area is covered with a thin, even layer of CLOBEX Shampoo.
Step 4: Repeat Steps 1 through 3 to apply CLOBEX Shampoo to other affected areas on your scalp as instructed by your doctor.
Step 5: Wash your hands after applying CLOBEX Shampoo.
Step 6: Leave CLOBEX Shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while CLOBEX Shampoo is on your scalp, unless your doctor tells you to.
Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with CLOBEX Shampoo, such as your hands, face, neck and shoulders.
No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using CLOBEX Shampoo.
This Patient Information and Instructions for Use have been approved by the . Food and Drug Administration.
GALDERMA LABORATORIES, .
Fort Worth, Texas 76177 USA
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the treatment of allergic rhinitis. No previous clinical studies have compared the efficacy of FFNS with another intranasal steroid. The purpose of this study was to compare the efficacy and safety of FFNS, 110 microg/day, once daily with fluticasone propionate nasal spray (FPNS), 200 microg/day, twice daily in patients with Japanese cedar pollinosis to support the regulatory filing in Japan. In this multicenter, randomized, placebo-controlled, double-blind, parallel-group study, patients (>or=16 years old) were randomized to receive 2 weeks of treatment with FFNS (n = 151), FFNS placebo (n = 72), FPNS (n = 148), or FPNS placebo (n = 75). FFNS once daily was noninferior to FPNS twice daily in mean change from baseline in three total nasal symptom scores (3TNSS; sneezing, rhinorrhea, and nasal congestion; - +/- and - +/- , respectively). Compared with placebo, FFNS was superior in reducing 3TNSS (p < ). Both FFNS and FPNS showed similar mean changes from baseline in 4TNSS (3TNSS and nasal itching) and individual nasal symptom scores. The onset of action for FFNS was observed from the 1st day of treatment, whereas in the FPNS group it was observed on the 2nd day. There were similar improvements in rhinoscopy findings, activity of daily life interference, and patient-rated overall evaluation to therapy in the FFNS and FPNS groups. FFNS was well tolerated. Treatment with once-daily FFNS was effective and noninferior to twice-daily FPNS in reducing nasal symptoms. Faster onset of action for FFNS was observed.