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Acyclovir and Hydrocortisone

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Overview

What is Xerese?

XERESE contains acyclovir, a synthetic nucleoside analogue active against herpes viruses, and hydrocortisone, an anti-inflammatory corticosteroid, combined in a cream for topical administration. Each gram of XERESE contains 5% (w/w) of acyclovir, 1% (w/w) of hydrocortisone and the following inactive ingredients: cetostearyl alcohol, mineral oil, Poloxamer 188, propylene glycol, isopropyl myristate, sodium lauryl sulfate, white petrolatum, citric acid, sodium hydroxide and water. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH to approximately pH 5.

Acyclovir, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one, is a synthetic nucleoside analogue active against herpes viruses. The maximum solubility of acyclovir in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. Its empirical formula is CHNO. The structural formula is provided in Figure 1:

Figure 1: Structural Formula of Acyclovir

Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(beta))-, is an anti-inflammatory corticosteroid. Its empirical formula is CHO. The structural formula is provided in Figure 2:

Figure 2: Structural Formula of Hydrocortisone



What does Xerese look like?



What are the available doses of Xerese?

Topical cream containing 5% acyclovir and 1% hydrocortisone.

What should I talk to my health care provider before I take Xerese?

How should I use Xerese?

XERESE, a combination of acyclovir, a herpes simplex virus nucleoside 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).

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.


What interacts with Xerese?

Sorry No Records found


What are the warnings of Xerese?

Sorry No Records found


What are the precautions of Xerese?

Sorry No Records found


What are the side effects of Xerese?

Sorry No records found


What should I look out for while using Xerese?

None.


What might happen if I take too much Xerese?

Overdosage by topical application of XERESE is unlikely because of minimal systemic exposure [see ].


How should I store and handle Xerese?

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14XERESE is supplied in a plastic-laminated aluminum tube containing 5 gm of XERESE. Each gram of XERESE contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.NDC 0187-5104-01:       5 gm tubesStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.XERESE is supplied in a plastic-laminated aluminum tube containing 5 gm of XERESE. Each gram of XERESE contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.NDC 0187-5104-01:       5 gm tubesStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.XERESE is supplied in a plastic-laminated aluminum tube containing 5 gm of XERESE. Each gram of XERESE contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.NDC 0187-5104-01:       5 gm tubesStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Acyclovir is an antiviral drug and hydrocortisone an anti-inflammatory drug [see ].

Non-Clinical Toxicology
None.

The effect of surgical and/or medical androgen ablation on the imaging performance of Indium In 111 ProstaScint has not been studied. Preliminary data suggest hormone ablation may increase PSMA expression, with concurrent decrease in tumor expression of PSA. The use of ProstaScint in this patient population cannot be recommended at this time.

XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.

There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

XERESE has a potential for irritation and contact sensitization [see ].

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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