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ZOVIRAX is a brand name for Acyclovir, supplied as a ointment. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
ZOVIRAX is contraindicated for patients who develop hypersensitivity or chemical intolerance to acyclovir, valacyclovir or any of the components of the formulation, such as propylene glycol or polyethylene glycol. WARNINGS ZOVIRAX is intended for topical use only and should not be used in the eye or on mucous membranes, such as the mouth or vagina.
PRECAUTIONS General The recommended dosage, frequency of application and duration of treatment of ZOVIRAX should not be exceeded (see DOSAGE AND ADMINISTRATION). There exist no data, at this time, which demonstrate that the use of ZOVIRAX will prevent transmission of infection to other persons.
Since most cutaneous herpes simplex virus infections result from reactivation of latent virus, it is unlikely that ZOVIRAX will prevent recurrence of infections when applied in the absence of signs and symptoms. ZOVIRAX should not be applied in an attempt to prevent recurrences; application should commence only at the earliest prodromal sign of disease onset.
Although clinically significant viral resistance associated with the use of ZOVIRAX has not been observed, this possibility exists (see VIROLOGY). Sexual Function/ Reproduction There is no information on the effect of acyclovir oral formulations on human female fertility.
In a study of 20 male patients with normal sperm count, oral acyclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology. Nursing Mothers Acyclovir, when given systemically, is known to be excreted into human milk.
No information is available on levels of acyclovir which may appear in breast milk after administration of ZOVIRAX and although evidence suggests that absorption of acyclovir through the skin is minimal, caution should be exercised when acyclovir is administered to a nursing mother.
PrZOVIRAX ® Product Monograph Page 5 of 32 Use in Pregnancy ZOVIRAX should not be used during pregnancy unless the physician feels the potential benefit justifies the risk of possible harm to the fetus. Teratology studies using acyclovir cream carried out to date in animals have been negative in general.
However, in a non-standard test in rats, there were fetal abnormalities such as head and tail anomalies, and maternal toxicity; and while since such studies are not always predictive of human response, the potential for high concentrations of acyclovir to cause chromosome breaks in vitro should be taken into consideration in making this decision.
All animal studies with the ointment carried out to date on reproduction and teratology have been negative. However, animal reproduction studies are not always predictive of human response. A post-marketing acyclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of ZOVIRAX.
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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The registry findings have not shown an increase in the number of birth defects amongst ZOVIRAX exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
Pediatrics Patients (< 18 years of age) The safe use of ZOVIRAX in pediatric patients less than 18 years of age has not been established DRUG INTERACTIONS Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with ZOVIRAX.
ADVERSE REACTIONS Because ulcerated genital lesions are characteristically tender and sensitive to any contact or manipulation, patients may experience discomfort upon application of ZOVIRAX. There have been very rare reports of immediate hypersensitivity reactions including angioedema with topical acyclovir.
Cream The table below shows the number of initial genital herpes patients who reported adverse reactions in the two controlled clinical trials: Adverse Reaction ZOVIRAX (n=54) Placebo (n=47) Burning/stinging on application 3 7 Rash 0 3 Itching 1 0 PrZOVIRAX ® Product Monograph Page 6 of 32 Observed During Clinical Practice Based on worldwide clinical practice experience in patients treated with ZOVIRAX cream, the adverse events most commonly reported include contact dermatitis, application site reaction, eczema, allergic reaction, pain, and rash.
Less common events include pruritus, skin discoloration, urticaria, vesiculobullous rash, and facial edema. 1%) of 370 patients treated with placebo; treatment was discontinued in 2 of these patients. 3%). 3%). In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions.
There have been very rare reports of immediate hypersensitivity reactions including angioedema with topical acyclovir. SYMPTOMS AND TREATMENT OF OVERDOSAGE Overdosage by topical application of ZOVIRAX is unlikely because of limited transcutaneous absorption.
For management of a suspected drug overdose, contact your regional poison control centre. DOSAGE AND ADMINISTRATION Apply ZOVIRAX liberally to the affected area 4 to 6 times daily for up to 10 days. A sufficient quantity should be applied to adequately cover all lesions.
A finger cot or rubber glove should be used while applying ZOVIRAX in order to prevent: (1) autoinoculation of other body sites or (2) transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.
Retention of urine 2 2 Meningism 0 2 Paronychia 0 1 Total No. (%) of patients 6 (11%) 15 (32%) PrZOVIRAX ® Product Monograph Page 7 of 32 PHARMACEUTICAL INFORMATION Drug Substance […]