Xerese 50 mg/g
Acyclovir and Hydrocortisone · CREAM · Bausch Health US LLC
Xerese is a cream containing acyclovir and hydrocortisone at 50 mg/g, taken topical. Manufactured by Bausch Health US LLC.
Key Facts
- Brand Name
- Xerese
- Generic Name
- Acyclovir and Hydrocortisone
- NDC Code (Product)
0187-5104- Manufacturer
- Bausch Health US LLC
- Strength
- 50 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022436
- Drug Class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Marketing Start
- 07/31/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). For each dose, topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For children 6 years of age and older, the dosage is the same as in adults. Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). (2)
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been performed with XERESE. No drug interaction studies have been performed with XERESE. (7)
Adverse Reactions
6 ADVERSE REACTIONS 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. (6.1) 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. 6.1 Adverse Reactions in Clinical Trials 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. The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1,056 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The most common adverse reactions (<1%) were local skin reactions, and occurred in the area of the application site, including: - Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation. Contact dermatitis following application has been observed whe…
Frequently Asked Questions
What is Xerese used for?
Xerese contains Acyclovir and Hydrocortisone. It is a cream taken topical. Consult your doctor for specific uses.
Is Xerese a controlled substance?
Xerese is not classified as a controlled substance by the DEA.
What is the generic name for Xerese?
The generic name for Xerese is Acyclovir and Hydrocortisone. There are no other listed brand versions of Acyclovir and Hydrocortisone.
What is the NDC code for Xerese 50 mg/g?
The NDC (National Drug Code) for Xerese 50 mg/g is 0187-5104, listed by Bausch Health US LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)