Its empirical formula is CHydrocortisone, pregn-4-ene-3,20-dione, 11,17,21-trihydroxy- (11β), is an anti-inflammatory corticosteroid. working closely with the U.S. Food and Drug Administration to manage the recall and to minimize disruption to supply and inconvenience to patients. 0187-5104-01, We think that you will be very pleased, in the manner which we treat our customers.All Rights Reserved.
The affected lots, distributed from February 5, 2019 to July ñ, î ì í õ from ayer’s distribution sites in erkeley, A and Shawnee, KS, are listed below: Corticosteroids are bound to plasma proteins in varying degrees. U.S. National Library of Medicine. The safety profile of XERESE appeared similar to that observed in adults.An open-label safety trial in children with recurrent herpes labialis was conducted in 54 subjects, who averaged an episode of herpes labialis 2 months prior to trial entry. Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base. Each gram of Acyclovir Cream 5% contains 50 mg of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, purified water, sodium lauryl sulfate, and white petrolatum. A recall of 60 lots of losartan potassium tablets USP and 54 lots of losartan potassium/hydrochlorothiazide tablets USP by Torrent Pharmaceuticals Limited due to the detection of an impurity.
REPORT ADVERSE EVENTS | Recalls Acyclovir Cream is a white, odorless, smooth homogeneous cream. Do not give XERESE to other people, even if they have the same symptoms that you have. Cream: 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone. For children 6 years of age and older, the dosage is the same as in adults.Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base.XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. The following most common adverse reactions (<1%) were local skin reactions: Drying or flaking of the skin; burning or tingling, erythema; pigmentation changes; application site reactions including signs and symptoms of inflammation. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.Benefit has not been adequately assessed in immunocompromised patients. XERESE was applied using the same dosing regimen as in adolescents and adults and subjects were monitored for adverse events and select efficacy parameters.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.Table 1: Summary of Acyclovir (ACV) Resistance-associated Amino Acid Substitutions in Cell CultureTable 2: Summary of ACV Resistance-associated Amino Acid Substitutions Observed in Treated PatientsTable 3: Summary of Amino Acid Substitutions Conferring Cross-Resistance to PCV, FCV or FOSImportant information: XERESE is for use on cold sores on the lips and around the mouth only.What should I tell my healthcare provider before using XERESE?Tell your healthcare provider about all the medicines you takeKeep XERESE and all medicines out of the reach of children.General information about the safe and effective use of XERESE. The mean age was 9 years (range 6 to 11 years); 57% were female and 90% were Caucasian. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.Dermal tolerance was assessed in a 21-day cumulative irritation trial in 36 healthy subjects. The median age was 14 years (range 12 to 17 years); 50% were female and all were Caucasian. Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.Product under license from Meda Pharma S.A.R.L., Luxembourg by Bausch Health Ireland Limited, Dublin, IrelandXERESE is a trademark of Meda Pharma S.A.R.L.
Do not use XERESE for a condition for which it was not prescribed. © Delray Sales, Inc - 2020 - Designed and managed by Think IT | Technology and Business Solutions Get all the industrial and ink supplies you could ever need Topically apply XERESE 5 times per day for 5 days.
Dermal carcinogenicity studies have not been conducted.In a double-blind, clinical trial, 1,443 subjects with recurrent labial herpes were randomized to receive XERESE, 5% acyclovir in XERESE vehicle or vehicle alone. NDC 0187-5104-01: 5 g tubes Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. We respond to orders and inquiries immediately, with written acknowledgements and quotations.