Geviran pills p/o 800mg №10×3

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Geviran tabl p/o 800mg in a blister pack. No. 10×3
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Coated tablets, round, biconvex. The main active ingredient Acyclovir Release form Tablets Dosage 800 mg Pharmacological action Acyclovir is a synthetic analogue of the purine nucleoside, which in vitro and in vivo inhibits the replication of viruses of the Herpes group pathogenic for humans, such as: Herpes simplex virus (HSV) type 1 and 2, also the Varicella-Zoster virus (VZV) . The inhibitory effect of acyclovir on the replication of these viruses is very selective. In uninfected cells, endogenous thymidine kinase (TK) does not use acyclovir as a substrate, hence the toxic effect on mammalian cells is small. However, TK of viral origin, encoded by HSV and VZV viruses, phosphorylates acyclovir to a monophosphate derivative (nucleoside analog), which is then phosphorylated by cellular enzymes, successively into acyclovir di- and triphosphate. Acyclovir triphosphate is a substrate for viral DNA polymerase and is incorporated by it into viral DNA, which, as a result, leads to the completion of viral DNA chain synthesis and inhibits its replication. Long-term treatment with acyclovir or repeated courses of treatment in patients with severe immunodeficiency may lead to the selection of strains of the virus resistant to acyclovir. Most isolated strains with reduced susceptibility show relative TK deficiency, but strains with altered viral TK or DNA polymerase have also been described. In vitro studies have also revealed the ability to form HSV strains with reduced sensitivity. There is no known relationship between in vitro susceptibility of HSV to acyclovir and clinical response to treatment. Indications for use in the treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent genital herpes (excluding neonatal herpes and severe herpes infections and immunocompromised children) for suppressive therapy (prevention of recurrence) of herpes simplex ( Herpes simplex virus) in patients with intact immunity for the prevention of herpes simplex (Herpes simplex virus) in patients with immunodeficiency. Route of administration and dosesGeviran medicinal product should be taken in accordance with the doctor’s recommendations. If in doubt, contact your doctor again. Doses of the drug may be different for different patients. Treatment should begin immediately, immediately after diagnosis. During treatment, the patient should take plenty of fluids to avoid the risk of kidney damage and reduce the risk of side effects. Tablets should be swallowed whole with water. Dosage in adults Treatment of infections caused by the herpes simplex virus (Herpes simplex virus) The drug should be taken at a dose of 200 mg five times a day, every 4 hours, with a break at night for 5 days. In severe cases, treatment is extended. In patients with reduced immunity (for example, after bone marrow transplantation) or with malabsorption from the gastrointestinal tract, the dose can be increased to 400 mg (intravenous administration of the drug may be considered as an option). Treatment should begin as soon as possible, immediately after diagnosis. In recurrent infections, it is especially important to start treatment in the prodromal period or immediately after the appearance of the first changes on the skin. Suppressive therapy of herpes simplex virus (Herpes simplex virus) in patients with intact immunity The drug is prescribed 200 mg four times a day, every 6 hours. In most patients, it can be effective and convenient to take the drug twice a day, every 12 hours, at 400 mg. Gradually reducing the dose to 200 mg three times a day, every 8 hours, or even 2 times a day, every 12 hours may also be effective. In some patients, the reaction to taking the drug occurs after the appointment of a total daily dose of the drug product, which is 800 mg. Therapy with the drug may be interrupted every 6 to 12 months in order to monitor possible changes in the course of the disease. Prevention of herpes simplex virus (Herpes simplex virus) in patients with immunodeficiency The drug is prescribed 200 mg four times a day, every 6 hours. In patients with reduced immunity (for example, after bone marrow transplantation) or with malabsorption from the gastrointestinal tract, the dose can be increased to 400 mg (intravenous administration of the drug may be considered as an option). The duration of prophylactic treatment is determined by the duration of the risk period. Treatment of infections caused by the varicella-zoster virus and herpes zoster (Varicella-Zoster virus) The drug is prescribed 800 mg five times a day (every 4 hours), with a night break. Treatment is continued for 7 days. Patients with reduced immunity (for example, after bone marrow transplantation) or with a disorder of absorption from the gastrointestinal tract should consider the possibility of intravenous administration of the drug. Treatment should begin as soon as possible, immediately after the onset of symptoms of infection. As in the case of chickenpox and herpes zoster, the best results of treatment were observed after taking the drug within the first 24 hours from the onset of the rash. Dosage in children Treatment of Herpes simplex virus infections in immunocompromised patients Children 2 years of age and older should receive the same dose as adults. Children under two years of age are given half the adult dose. The dose can be set more precisely, at the rate of 20 mg / kg body weight (up to a maximum dose of 800 mg) four times a day. Treatment should be continued for 5 days. There are no data on the features of suppressive therapy of infections caused by the herpes simplex virus or chicken pox in children with intact immunity. Dosage in elderly patients In elderly patients, the risk of impaired renal function should be considered and the dose of the drug should be adjusted accordingly (see Use in Patients with Impaired Renal Function). Fluid replacement should be monitored in these patients. Use in patients with impaired renal function Caution is advised when using acyclovir in patients with impaired renal function. Fluid replacement should be monitored in these patients. During the treatment of infections caused by the herpes simplex virus or the prevention of viral infection in patients with moderate to severe renal insufficiency, the use of the recommended oral doses does not lead to the accumulation of acyclovir in the body at concentrations higher than those accepted as safe during intravenous administration of the drug. However, in patients with severe renal insufficiency (creatinine clearance less than 10 ml / min), it is recommended to reduce the dose to 200 mg twice a day, every 12 hours. During the treatment of infections caused by the varicella-zoster virus and herpes zoster in patients with moderate renal insufficiency (creatinine clearance 10-25 ml / min), it is recommended to reduce the dose to 800 mg three times a day, every 8 hours, and in patients with severe renal insufficiency (creatinine clearance less than 10 ml / min), it is recommended to reduce the dose to 800 mg twice a day, every 12 hours. In case of taking a larger dose of the drug than recommended. In case of an overdose, you should immediately consult a doctor who will prescribe the appropriate treatment. If you miss a dose of a drug If you forget to take a dose of a drug, you should take it as soon as possible. However, if it is nearing time to take your next dose of the drug, you should not take the missed dose. Do not take a double dose to make up for a missed dose. Discontinuation of the drug Treatment should not be interrupted, even if the patient does not feel very well. Only a doctor can make such a decision. If you have any further doubts related to the use of the medicinal product, you should consult your doctor or pharmacist. Use during pregnancy and lactation In post-marketing trials of medicinal products containing acyclovir, there have been cases of the use of acyclovir by pregnant women. The results of these trials did not reveal an increase in the incidence of malformations in newborns whose mothers took acyclovir compared with the general population. There was no causal relationship between the use of acyclovir by pregnant women and the appearance of congenital malformations. The appointment of acyclovir to pregnant women is possible only if the expected benefit to the mother outweighs the potential threat to the fetus. After oral administration of acyclovir at a dose of 200 mg five times a day, its concentration in breast milk was 60% to 410% of the concentration of the drug, determined in blood plasma. Such a concentration of acyclovir in breast milk could lead to the intake of the drug to the fetus in a daily dose of up to 0.3 mg/kg of body weight. Therefore, special care should be taken when using the drug in nursing mothers. The ability to influence the reaction rate when driving vehicles or operating other mechanisms No studies have been conducted on the effect of acyclovir on the ability to drive vehicles and operate mechanisms. Geviran may cause unwanted effects (eg headaches or dizziness) which may affect driving and operating machinery. Precautions: Patients taking acyclovir by mouth should receive adequate fluids. The risk of renal failure increases with simultaneous use with other nephrotoxic drugs. Aciclovir is excreted from the body by the kidneys, so the dose of the drug in people with renal insufficiency should be reduced (see “Method of administration and dosage”). In elderly patients, the risk of impaired renal function should be considered, and in this group of patients, dose reduction should be considered. The elderly and patients with renal insufficiency are at increased risk of adverse effects from the nervous system, and therefore patients in these groups should be carefully monitored. Until now, known symptoms usually disappeared after discontinuation of the drug (see “Side Effects”). Long-term treatment with acyclovir or repeated courses of treatment in patients with severe immunodeficiency may lead to the selection of strains of the virus resistant to acyclovir. Interaction with other drugs With the simultaneous use of acyclovir with drugs excreted by active tubular secretion, it is possible to increase the concentration of active substances or their metabolites in plasma (care must be taken when prescribing such combinations). Probenecid and cimetidine increase the AUC of acyclovir and decrease its renal clearance. Co-administration of acyclovir and mycophenolate mophenyl, an immunosuppressant drug used in organ transplantation, results in an increase in the AUC of acyclovir and the inactive metabolite of mycophenolate mophenyl. However, correction of the dosing regimen of acyclovir is not required. With the appointment of acyclovir 1 hour after taking 1 g of probenecid, the half-life and AUC increased by 18 and 40%, respectively. In patients treated with antiretroviral drugs, the additional intake of acyclovir did not cause a significant increase in toxic effects. A study in five male patients showed that the concomitant use of acyclovir with theophylline increased the total theophylline AUC by approximately 50%. It is recommended to evaluate the level of theophylline in blood plasma during concomitant use with acyclovir. Contraindications Hypersensitivity to acyclovir or valaciclovir or to other ingredients of the drug. Composition One tablet contains: active substance: 400 mg of acyclovir excipients: tablet core: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate; tablet shell: hypromellose, macrogol 6000, titanium dioxide (E171), triethyl citrate, talc. Overdose Symptoms: acyclovir is only partially absorbed from the gastrointestinal tract. A single patient dose of up to 20 g of acyclovir usually does not cause toxic symptoms. Sporadic, repeated cases of overdose of oral acyclovir within 7 days have been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion). With an overdose of the intravenous form of the drug, an increase in the level of urea nitrogen and creatinine in the blood and a breakdown in renal function were observed. Neurological symptoms, including confusion, hallucinations, agitation, seizures and coma, have also been described in overdose of the drug in injectable form. Treatment: The patient should be observed for the development of toxic symptoms. Hemodialysis accelerates the elimination of aciclovir from the blood and may be a treatment option in cases of overdose symptoms. Side effect Undesirable effects are classified according to the frequency of their occurrence as follows: very often (? 1/10); often (? 1/100 to < 1/10); not very common (? 1/1,000 to < 1/100); rarely (? 1/10,000 to < 1/1,000); very rare (<1/10,000). Hematopoietic and lymphatic system disorders Very rare: anemia, decreased white blood cell count, thrombocytopenia. Immune system disorders Rare: anaphylactic reactions. Psychiatric and nervous system disorders Common: headache, dizziness. Very rare: agitation, disorientation, tremor, ataxia, slurred speech, hallucinations, psychotic reactions, convulsions, drowsiness, encephalopathy, coma. These symptoms are usually transient and occur mainly in patients with impaired renal function or other predisposing factors (see Precautions for use). Respiratory, thoracic and mediastinal disorders Rare: dyspnoea. Gastrointestinal disorders Common: Nausea, vomiting, diarrhea, abdominal pain. Liver and biliary tract disorders Rare: transient increase in bilirubin levels and increased liver transaminase activity in the blood. Very rare: hepatitis, jaundice. Skin and subcutaneous tissue disorders Common: itching, rash (also increased sensitivity to light). Infrequently: urticaria, accelerated, generalized alopecia. Since accelerated, generalized alopecia can be caused by most diseases and the use of many drugs, its relationship with the action of acyclovir is not obvious. Rare: Quincke's edema. Renal and urinary disorders Rare: increased serum creatinine and urea levels. Very rare: acute renal failure, kidney pain. Pain in the kidneys may be associated with insufficiency of the kidney(s) and crystalluria. The patient's hydration status should be monitored. Renal impairment usually resolves quickly after the patient is rehydrated and/or the dose is reduced or the drug is discontinued. In exceptional cases, acute renal failure may occur. General disorders and disorders at the injection site Common: fatigue, fever. In case of adverse reactions, including those not listed in this leaflet, you should immediately consult a doctor. Storage conditions Store in the original packaging to protect from light and moisture, at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Geviran tablets p/o 800mg No. 10x3