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XERESE is a brand name for Acyclovir, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General XERESE (acyclovir 5% and hydrocortisone 1%) Topical Cream should only be used cutaneously for recurrent herpes labialis of the lips and around the mouth. XERESE should not be used in or near the eyes, inside the mouth or nose, on the genitals, or rectal area.
It is not recommended for application to mucous membrane. There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. If clinical improvement is not noted within 2 weeks, patients should be encouraged to seek medical advice during this period.
The possibility of clinically significant acyclovir viral resistance exists with the use of XERESE Prolonged treatment should be avoided in children because of the possibility of adrenocortical suppression and growth retardation. Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids.
Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation. Visual disturbance may be reported associated with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) XERESE is for external use only.
Do not apply to mucosal surfaces. Avoid contact with eyes. Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may suppress adrenocortical function. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilatation, particularly on the face.
Cardiovascular Standard precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases associated with impaired circulation. Endocrine and Metabolism Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary- adrenal (HPA) axis suppression, leading to glucocorticoid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical corticosteroids including XERESE.
If either of the above are observed, discontinue treatment slowly. Recovery of HPA axis is PrXERESE® Product Monograph Page 5 of 26 generally prompt upon discontinuation of drug. Infrequently, signs and symptoms of glucocorticoid insufficiency may require supplemental systemic corticosteroids.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acyclovir in Canada.
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g. contact dermatitis) have been reported with XERESE; if such reactions occur, the drug should be discontinued, and appropriate therapy initiated (see ADVERSE REACTIONS). Skin Topical corticosteroids including XERESE may increase the risk of infections including aggravation of cutaneous infection, masked infection, and secondary infections.
If concomitant skin infections develop, XERESE should be discontinued and appropriate therapy administered. Special Populations Pregnant Women XERESE should be prescribed to woman of childbearing years only after contraceptive counseling.
XERESE should not be given to pregnant woman unless the benefits to the mother clearly outweigh the possible risks to the fetus. XERESE has not been studied in pregnant women. It is not known whether active ingredients of XERESE can cause fetal harm when used by a pregnant woman or can affect reproductive capacity.
In an epidemiologic registry post pregnancy, follow up of 759 women exposed to systemic acyclovir during the first trimester of pregnancy has not shown an increase in the number or uniqueness of birth defects in their children compared with the general population.
Teratogenicity has been reported in laboratory animals following to topical and systemic exposure of corticosteroids (see TOXICOLOGY). Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dose levels.
Epidemiological studies in human have not revealed any risk of malformation related to the use of oral corticosteroids, particularly hydrocortisone, during the first trimester. Adrenal insufficiency in the mother must be treated during pregnancy by adjusting the hydrocortisone dose to the clinical picture, if necessary.
In chronic diseases requiring treatment throughout pregnancy, a slight delay in intrauterine growth has been reported with other corticosteroids. Neonatal adrenal insufficiency has been observed in exceptional cases following corticosteroid therapy at high doses.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. Nursing Women It is not known whether acyclovir from XERESE is secreted in breast milk.
Acyclovir, when given systemically, is known to be secreted in human milk. Systemically administered corticosteroids PrXERESE® Product Monograph Page 6 of 26 appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
Because hydrocortisone is excreted into human milk, breast feeding is not recommended. Immunocompromised Subjects XERESE should not be used in severely immunocompromised patients (such as AIDS, transplant and cancer patients) since an increased risk for development of resistance to acyclovir cannot be excluded.
ADVERSE REACTIONS Adverse Drug Reaction Overview The safety of XERESE (acyclovir 5% and hydrocortisone 1%) Topical Cream was assessed in Phase II and Phase III clinical studies reflecting exposure to XERESE in 1002 patients with recurrent herpes labialis, treated 5 times daily for 5 days.
The majority of investigator determined adverse reactions in combined phase III studies were […]