Vivir Cream

Vivir Cream

aciclovir

Manufacturer:

Hanmi

Distributor:

AA Medical
Full Prescribing Info
Contents
Acyclovir.
Description
Vivir Cream contains acyclovir 5% w/w in an aqueous cream base.
Indications/Uses
Herpes simplex virus infection of the skin including initial and recurrent genital herpes and herpes labialis.
Dosage/Direction for Use
Apply 5 times daily at approximately 4 hourly intervals. Treatment should be continued for 5 days. If after 5 days healing is not complete, then treatment may be continued for up to an additional 5 days.
Contraindications
Hypersensitivity to acyclovir or to any of the excipients of Vivir Cream. Lactation, infants.
Special Precautions
Patients with immunodeficiency disease including acquired immune deficiency syndrome (AIDS) and bone marrow transplantation.
Therapy with Vivir Cream should be initiated as early as possible following onset of signs and symptoms. The recommended dosage, frequency of applications and length of treatment should not be exceeded.
Vivir Cream should not be used for the prevention of recurrent infections or the prevention of transmission of infection to other persons.
Although clinically significant viral resistance associated with the use of acyclovir cream has not been observed, this possibly exists.
Vivir Cream is intended for cutaneous use only and should not be used in the eye.
Vivir Cream is not recommended for application to mucous membranes eg, in the mouth, eye or vagina, as it may be irritant.
Particular care should be taken to avoid accidental introduction into the eye.
Use in pregnancy: Systemic administration of acyclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-standard test in rats, fetal abnormalities were observed, but only following such high SC doses that maternal toxicity was produced. Experience in humans is limited, so Vivir Cream should be used by a pregnant woman or possibly pregnant woman only when the expected.
Use in children: Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
Use in pregnancy: Systemic administration of acyclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-standard test in rats, fetal abnormalities were observed, but only following such high SC doses that maternal toxicity was produced. Experience in humans is limited, so Vivir Cream should be used by a pregnant woman or possibly pregnant woman only when the expected.
Use in lactation: Contraindicated in lactation.
Side Effects
Because ulcerated genital lesions are characteristically tender and sensitive to any contact or manipulation, patients may experience discomfort upon application of Vivir cream. Mild pain including transient burning or stinging, contact dermatitis, erythematous eruption, eczema, allergic reaction, vulvitis, facial edema, rash and vesicular exanthema may occur. Mild drying or flaking of the skin may occur. Erythema and itching have been reported in a small proportion of patients.
Drug Interactions
Probenecid increases the mean half-life and area under the plasma concentration curve of systemically administered acyclovir. However, this is likely to be of little relevance to the topical application of acyclovir.
Storage
Store at room temperature (1-30°C) in a tight container.
MIMS Class
ATC Classification
D06BB03 - aciclovir ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.
Presentation/Packing
Cream 250 mg (white, aqueous cream base) x 5 g.
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