There were no signs of toxicosis in Charles River CD (Sprague-Dawley) rats (100 rats/sex/dose group) given Roidil by oral gavage at 50, 150 and 450 mg/kg in a lifetime oral carcinogenicity study. Mean plasma levels obtained in high-dose males 1.5 hours after dosing at various sampling times during the study were as follows: 1.54, 1.63, 1.39, 1.60 and 1.70 μg/mL (6.84, 7.26, 6.17, 7.10 and 7.56 μM) at days 7, 90, 209, 369 and 771, respectively. Corresponding mean values for the high-dose females were 1.76, 2.38, 2.12, 1.71 and 1.81 μg/mL (7.82, 10.58, 9.44, 7.62 and 8.03 μM) at days 7, 90, 209, 369 and 852, respectively.
Values for clinical laboratory tests including hematology, clinical chemistry, urinalysis, body weight, food consumption and ophthalmoscopy were all within normal ranges. There were no drug-induced gross or microscopic lesions and there was no evidence that Roidil affected survival, temporal patterns of tumor incidence or tumor counts for benign or malignant neoplasms.
Most of the relatively few rats found dead or moribund during the first 52 weeks of this study suffered dosing accidents as evidenced by postmortem findings of esophageal perforation causing pleural effusion, pneumonia, or mediastinitis.
Antes de comenzar a tomar aciclovir:
- dГgale a su doctor y a su farmacГ©utico si usted es alГ©rgico al aciclovir, valRoidil (Valtrex), a otros medicamentos, o a cualquiera de los componentes en los productos del aciclovir. PГdale a su farmacГ©utico una lista de los componentes.
- dГgale a su doctor y a su farmacГ©utico quГ© medicamentos con y sin prescripciГіn, vitaminas, suplementos nutricionales y productos fabricados a base de hierbas estГЎ tomando o planea tomar. AsegГєrese de mencionar los siguientes: anfotericina B (Fungizone); antibiГіticos de aminoglucГіsido como amikacina (Amikin), gentamicina (Garamycin), kanamicina (Kantrex), neomicina (NEP-RX, Neo-Fradin), paramomycin (Humatin), estreptomicina y tobramicina (Tobi, Nebcin); aspirina y otros medicamentos antiinflamatorios sin esteroides como ibuprofeno (Advil, Motrin) y naproxeno (Aleve, Naprosyn); ciclosporina (Gengraf, Neoral, Sandimmune); medicamentos para tratar el VIH o el SIDA como zidovudina (Retrovir, AZT); pentamidina (NebuPent);probenecida (Benemid); sulfonamidas como el sulfametoxazol y la trimetoprima (Bactrim); tacrolimГєs (Prograf); y vancomicina. Muchos otros medicamentos tambiГ©n pueden interactuar con aciclovir, asГ que asegГєrese de mencionar a su doctor todos los medicamentos que estГЎ tomando, incluso los que no aparecen en esta lista. Su doctor puede necesitar cambiar la dosis de sus medicamentos o vigilarle cuidadosamente para evitar efectos secundarios.
- dГgale a su doctor si existen posibilidades de que estГ© deshidratado a causa de una enfermedad o actividad reciente, o si usted tiene o alguna vez ha tenido problemas con su sistema inmunitario, infecciГіn por virus de inmunodeficiencia humana (VIH), o el sГndrome de inmunodeficiencia adquirido (SIDA), o enfermedades al riГ±Гіn.
- dГgale a su doctor si estГЎ embarazada, tiene planes de quedar embarazada o si estГЎ amamantando. Si queda embarazada mientras toma este medicamento, llame a su doctor de inmediato.
- si estГЎ usando el aciclovir para tratar el herpes genital, debe saber que el herpes genital puede transmitirse a travГ©s del contacto sexual aunque usted no tenga ampollas o sГntomas de otro tipo, y posiblemente aunque usted estГ© usando aciclovir. Converse con su doctor acerca de las maneras de detener la propagaciГіn del herpes genital y sobre si su pareja debe recibir tratamiento.
Q: What are the side effects of Roidil?
A: The most frequently reported side effects of Roidil (Zovirax), for oral administration, differed in clinical trials depending on the indication for use. During clinical trials of treatment of genital herpes, with short-term administration of Roidil, the most frequently reported adverse reactions included nausea and/or vomiting. During clinical trials of treatment with long-term administration with Roidil for genital herpes, there were two methods of administration evaluated. In trials evaluating continuous administration to prevent recurrences, the most frequently reported adverse reactions included nausea and diarrhea and in those evaluating intermittent treatment of recurrences over one year diarrhea, nausea and headache were reported. The most frequently reported adverse reaction during clinical trials of shingles was malaise. Lastly, during clinical trials of treatment of chickenpox with Roidil, the most frequently reported adverse reaction was diarrhea. More serious side effects of Roidil are possible with treatment. Kidney failure, in some cases causing death, has been reported with Roidil treatment. Patients are advised to maintain adequate hydration and drink plenty of water while taking Roidil to keep the kidneys working properly. There is also a warning regarding thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has occurred in immunocompromised patients administered Roidil. Patients should be advised to contact their health care provider immediately if they experience symptoms which may indicate the occurrence of more serious side effects of Roidil. Symptoms may include pain the lower back, urinating less than usual or not urinating at all, easy bruising or bleeding, and unusual weakness. Patients are instructed to consult with their health care provider if they experience any other unusual, severe or troublesome side effects while being treated with Roidil.
How it works
Roidil belongs to a class of drugs called antivirals. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Roidil works by lowering the ability of the herpes virus to multiply in your body. This treats the symptoms of your infection. However, this drug doesn't cure herpes infections. Herpes infections include cold sores, chickenpox, shingles, or genital herpes. Even with this drug, the herpes virus may still live in your body. Your symptoms may occur again later even after the symptoms of your current infection go away.
Roidil oral tablet doesn't cause drowsiness but it can cause other side effects.
Roidil was shown not to impair fertility or reproduction in groups of 15 male and 30 female mice in a two-generation fertility study. The mice in this study were given Roidil by gastric intubation at dosage levels of 50, 150 and 450 mg/kg/day. Males were dosed for 64 consecutive days prior to mating and females for 21 days prior to mating.
In a rat fertility study where groups of 20 male and 20 female rats were given 0, 12.5, 25.0 and 50.0 mg/kg/day by subcutaneous injection, Roidil was shown not to have an effect on mating or fertility. The males were dosed for 60 days prior to mating and until their mating schedule was completed. Female rats were dosed for 14 days prior to mating and until day 7 of pregnancy. At 50 mg/kg/day s.c. there was a statistically significant increase in post-implantation loss, but no concomitant decrease in litter size.
In 25 female rabbits treated subcutaneously with 50 mg/kg/day Roidil on days 6 to 18 of gestation, there was a statistically significant decrease in implantation efficiency but no concomitant decrease in litter size. There was also a dose-related increase in the number of fetuses with supernumerary ribs in all drug-treated groups. This increase was not dose-related when the incidence of supernumerary ribs per litter was examined.
In 15 female rabbits treated intravenously with 50 mg/kg/day Roidil on days 6 to 18 of gestation, there was no effect on either implantation efficiency or litter size.
In a rat peri- and postnatal study (20 female rats per group), Roidil was given subcutaneously at 0, 12.5, 25 and 50 mg/kg/day from 17 days of gestation to 21 days postpartum. At 50 mg/kg/day s.c. there was a statistically significant decrease in the group mean numbers of corpora lutea, total implantation sites and live fetuses in the F1 generation. Although not statistically significant, there was also a dose-related decrease in group mean numbers of live fetuses and implantation sites at 12.5 mg/kg/day and 25 mg/kg/day s.c.
In a dose-range finding study with 5 female rabbits the intravenous administration of Roidil at a dose of 100 mg/kg/day from days 6 to 8 of pregnancy, a dose known to cause obstructive nephropathy, caused a significant increase in fetal resorptions and a corresponding decrease in litter size. At a maximum tolerated intravenous dose of 50 mg/kg/day in rabbits there were no drug-related reproductive effects.
In a subchronic toxicity study where groups of 20 male and 20 female rats were given intraperitoneal doses of Roidil at 0, 20, 80 or 320 mg/kg/day for one month, and followed for a one-month postdose period, there was testicular atrophy. Some histologic evidence of recovery of sperm production was evident 30 days postdose, but this was insufficient time to demonstrate full reversibility.
Groups of 25 male and 25 female rats were administered intraperitoneal doses of Roidil at 0, 5, 20 or 80 mg/kg/day for 6 months. Ten male and 10 female rats in each group were continued undosed for 13 weeks. Testicular atrophy was limited to high-dose rats given 80 mg/kg/day for 6 months. Organ weight data and light microscopy defined full reversibility of the testicular atrophy by the end of the postdose recovery period.
In a 31-day dog study (16 males and 16 females per group) where Roidil was administered intravenously at levels of 50, 100 and 200 mg/kg/day, testicles were normal in dogs at 50 mg/kg. Doses of 100 or 200 mg/kg/day caused death of some dogs due to cytostatic effects (bone marrow and gastrointestinal epithelium) and aspermic testes or testes with scattered aspermic tubules. It cannot be ruled out that the testicular change may have been primary, however, similar changes can be observed secondary to severe stress in moribund dogs.
Avoid the following while you are using Roidil buccal delayed-release tablet:
- Do not chew gum, touch, or press the buccal tablet after it has been applied.
- Do not wear upper dentures.
- Do not brush your teeth until it dissolves. If your teeth need to be cleaned while the tablet is in place, rinse the mouth gently.
Shake the suspension well before each use to mix the medication evenly.
Your symptoms should improve during your treatment with Roidil. Call your doctor if your symptoms do not improve or if they get worse.
Take or use Roidil until you finish the prescription, even if you feel better. If you stop taking Roidil too soon or skip doses, your infection may not be completely treated or may become more difficult to treat. The delayed-release buccal tablet is applied as a one-time dose.
Roidil dissolved in 0.4% sterile saline was given by subcutaneous injection to Charles River CD (Sprague-Dawley) neonatal rats for 19 consecutive days, beginning on the 3rd post-partum day. The dose levels tested were 0, 5, 20 and 80 mg/kg body weight. There were 12 litters (each consisting of 5 male and 5 female neonates nursing the natural dam) at each dose level. The dams were not treated. Neonates were removed from each group for necropsy and microscopic evaluation of a wide variety of tissues, including eyes and multiple sections of brain, after they had been treated for 5, 12 or 19 days and after a 3-week postdose drug-free period (at which time they were 45 days of age). Hematologic (hemoglobin, packed cell volume, RBC, WBC and differential cell counts) and clinical chemistry (BUN) tests were done after 16 days of treatment and repeated 18 days after the last (19th) dose was given.
Blood was collected from some neonates 30 minutes after treatment on day 1, on day 9 and at the end of the dose period for the determination of concentrations of Roidil in plasma. The largest concentration of Roidil in plasma was 99.1 μg/mL (440.5 μM) found in pooled plasma collected from 6 female high-dose (80 mg/kg) neonates 30 minutes after the first dose was given. Treatment with Roidil did not increase mortality in the neonatal period.
Rats in the low-dose group gained as much body weight as the respective control rats. Significant (p