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Zovirax
Generic Name: Acyclovir
Drug Category: Synthetic Nucleoside Analogue
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 3 years.
| Approved Uses |
|
Indicated for: Herpes Zoster Infections: • For the acute treatment of herpes zoster (shingles). There is no data on treatment initiated more than 72 hours after onset of the zoster rash. Genital Herpes: • For the treatment of initial episodes and the management of recurrent episodes of genital herpes. ZOVIRAX is not a cure for genital herpes. There is no data evaluating whether ZOVIRAX will prevent transmission of infection to others. Chickenpox: • For the treatment of chickenpox (varicella). Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy. Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained. There are no adequate and well-controlled studies in pregnant women. Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of ZOVIRAX and ranged from 0.6 to 4.1 times corresponding plasma levels. |
| Off-label Uses |
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• Use in patients under the age of 2. GoToSource • Post-transplantation cytomegalovirus infection. GoToSource • Post-transplantation HSV infection. GoToSource • Ocular herpes simplex virus infection. GoToSource • Infectious mononucleosis. GoToSource • Herpes zoster ophthalmicus. GoToSource • Varicella pneumonia. GoToSource • Primary HSV gingivostomatitis, prevention of cold sores after trigeminal nerve surgery or during sun exposure, prophylaxis of recurrent herpes labialis, eczema herpeticum and prevention of recurrent erythema multiforme. GoToSource |
| Adverse Events |
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Acute kidney failure. GoToSource Confusion and ataxia (lack of muscle control or coordination). GoToSource Neurotoxicity (including agitation, hallucinations, disorientation, tremors, and mild clonus) and development of acyclovir resistance. GoToSource Psychosis with manic symptoms. GoToSource Bone marrow suppression and thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (microangiopathic disorder characterized by abnormalities (chiefly blood clots) occurring within the small blood vessels of the body). GoToSource Hypokalemia (low blood potassium level). GoToSource Allergic contact dermatitis. GoToSource Bullous eruption (skin condition causing large fluid-filled blisters). GoToSource Angioedema (swelling in deep layers of skin). GoToSource Death. GoToSource Alopecia (hair loss). GoToSource |
| Litigation |
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Claims filed for death and development of shingles and chickenpox. |
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