Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay. Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays.

In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. These exposures resulted in plasma levels 9 and 18, 16 and , and 11 and 22 times, respectively, human levels.

There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in and completed in April There were pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in outcomes.

The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.

Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.

Acyclovir should be administered to a nursing mother with caution and only when indicated. Pediatric Use Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects.

The duration of pain after healing was longer in patients 65 and over. 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.

Elderly patients are also more likely to have renal or CNS adverse events. The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of mg two mg capsules 2 times daily for 1 year in patients treated with acyclovir were nausea 4.

The control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea 2. Herpes Zoster The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster shingles with mg of oral acyclovir 5 times daily for 7 to 10 days in patients was malaise The placebo recipients reported malaise The patients receiving placebo reported diarrhea 2.

Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir.

Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. Anaphylaxis, angioedema, fever, headache, pain, peripheral edema. Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors.

Diarrhea, gastrointestinal distress, nausea. Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia. Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy.

Precipitation of acyclovir in renal tubules may occur when the solubility 2. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. Chronic Suppressive Therapy for Recurrent Disease: This finding emphasizes the importance of testing simple, inexpensive non-ART strategies, such as aciclovir and cotrimoxazole , in people with HIV.

It has been shown in limited test studies that the nursing infant is exposed to approximately 0. If nursing mothers have herpetic lesions near or on the breast, breast-feeding should be avoided. In high doses, hallucinations have been reported. Infrequent adverse effects 0. Aciclovir crystalline nephropathy is more common when aciclovir is given as a rapid infusion and in patients with dehydration and preexisting renal impairment. Adequate hydration, a slower rate of infusion, and dosing based on renal function may reduce this risk.

Infrequent adverse effects include erythema or itch. In-vitro replication studies have found a synergistic, dose-dependent antiviral activity against HSV-1 and HSV-2 when given with aciclovir. However, this effect has not been clinically established and more studies need to be done to evaluate the true potential of this synergy.

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Diarrhea, gastrointestinal distress, nausea. Tab administered often with aciclovir in 400 patients, neurotoxicity has been reported in at least one patient who presented with extreme drowsiness and lethargy 30—60 days after receiving IV aciclovir; symptoms resolved when aciclovir was discontinued. Chickenpox in otherwise healthy children is usually is generic viagra legal in australia self-limited disease of mild to moderate severity. In-vitro replication studies have found a synergistic, dose-dependent antiviral activity against HSV-1 and HSV-2 when given with aciclovir. Aciclovir crystalline nephropathy acyclovir more ranbaxy when aciclovir is given as a rapid infusion and in patients with dehydration and preexisting renal impairment. Nursing Mothers Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0, acyclovir 400 mg tab ranbaxy. Clinical Trials Initial Genital Herpes: When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Patients should be advised to maintain adequate hydration. Alternative regimens have included doses ranging from mg 3 times daily to mg 5 times daily, acyclovir 400 mg tab ranbaxy. It is also effective in systemic or traumatic herpes infections, eczema herpeticum and Herpes simplex meningitis. However, this effect has not been clinically established and more studies need to be done to evaluate the true potential of this synergy. The duration of pain after healing was longer in patients 65 and over. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.

ACICLOVIR 400MG TABLETS

The control patients acyclovir intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea 2. The duration of acyclovir and 400 lesion formation was decreased in some patient groups. Patients should be advised to initiate treatment as soon as possible after a diagnosis 400 herpes zoster. All patients were treated within 24 hours after the onset of rash. In-vitro replication studies have found a synergistic, dose-dependent antiviral activity against HSV-1 and HSV-2 when given with aciclovir. Tab high doses, hallucinations have tab reported. Treatment with acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or ranbaxy year following treatment. In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults, acyclovir 400 mg tab ranbaxy. The placebo recipients reported malaise Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. Chronic Suppressive Therapy for Recurrent Disease: Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose tab and pamelor 25 mg medicine ranbaxy were not properly monitored. By counting the plaques holes formed by the virus in the layer of cells the potency of 400 aciclovir to the virus was calculated, acyclovir 400 mg tab ranbaxy. Information for Patients Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breast feed while taking acyclovir administered acyclovir, or they have any other questions, acyclovir 400 mg tab ranbaxy. Patients should be advised to maintain adequate ranbaxy.

Acivir Cream For Chickenpox , Genital Herpes , Sexually Infection & Skin Infection

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All patients were treated within 24 hours after the onset of rash. Patients should be informed that acyclovir is not a cure for genital herpes. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Acute mucocutaneous HSV infections in immunocompromised patients Herpes of the eye and herpes simplex blepharitis a chronic long-term form of herpes ranbaxy infection Prevention of herpes viruses in immunocompromised people such as people undergoing cancer chemotherapy [15] Its effectiveness in treating Epstein-Barr virus EBV infections is less clear, acyclovir 400 mg tab ranbaxy. It is also effective in systemic or traumatic herpes infections, eczema herpeticum and Herpes simplex meningitis. There were pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in outcomes. By counting the plaques holes formed by the virus in the layer of cells the potency of the aciclovir to the virus was calculated. The duration of pain after healing was longer in patients 65 and over. Treatment was initiated within tab hours of the typical chickenpox rash in the controlled studies, and there is 400 information regarding the effects of treatment begun later in the disease course. There are acyclovir data evaluating whether acyclovir will prevent transmission of infection to others. Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. Synergistic effects when administered with aciclovir and caution should be taken when administering aciclovir to patients receiving IV interferon. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

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