Acyclovir 400 Stada tablets 400 mg 35 pcs.

The active substance is acyclovir (one tablet contains 400 mg of acyclovir).

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), copolyvidone, magnesium stearate.

Hypersensitivity to acyclovir, valacyclovir or any other component of the drug.

The tablet should be taken whole with water. When using high doses of acyclovir, adequate hydration should be maintained.

Adults

For the treatment of infections caused by the herpes simplex virus, it is necessary to take acyclovir tablets at a dose of 200 mg 5 times a day with an interval of about 4 hours, except for the night period. Treatment should last 5 days, but in case of severe primary infection it can be extended. For patients with severe immunodeficiency (for example, after bone marrow transplantation) or for patients with reduced intestinal absorption, the dose can be doubled to 400 mg or an appropriate dose for intravenous administration can be used. Treatment should be started as early as possible after the onset of infection. In case of recurrent herpes, it is better to start treatment in the prodromal period or after the first signs of skin lesions appear.

Prevention of recurrence (suppressive therapy) of infections caused by the herpes simplex virus. In patients with normal immunity, to prevent recurrence of infections caused by the herpes simplex virus, 200 mg tablets should be taken 4 times a day at 6-hour intervals. For convenience, most patients can take 400 mg of acyclovir 2 times a day at 12-hour intervals. Treatment will be effective even after reducing the dose of acyclovir to 200 mg, which should be taken 3 times a day at 8-hour intervals or even 2 times a day at 12-hour intervals. In some patients, radical improvement is observed after taking a daily dose of acyclovir 800 mg. To monitor possible changes in the natural course of the disease, acyclovir therapy should be periodically interrupted at intervals of 6-12 months.

Prevention of infections caused by the herpes simplex virus. For the prevention of infections caused by the herpes simplex virus in immunocompromised patients, 200 mg tablets should be taken 4 times a day with an interval of 6 hours. For patients with significant immunocompromise (e.g. after bone marrow transplantation) or for patients with reduced intestinal absorption, the dose can be doubled to 400 mg or the appropriate dose for intravenous administration can be used. The duration of prophylaxis depends on the duration of the risk period.

For the treatment of infections caused by the varicella and herpes zoster viruses, you need to take 800 mg tablets 5 times a day with a 4-hour interval, except for the night period. Treatment should last 7 days. Patients with severe immunodeficiency (for example, after bone marrow transplantation) or patients with reduced absorption in the intestine are better off using intravenous administration. Treatment should be started as early as possible after the onset of the disease, the result will be better if treatment is started immediately after the appearance of rashes.

Children

For the treatment and prevention of infections caused by the herpes simplex virus, doses similar to those for adults can be used in immunocompromised children aged 2 years and older.

For the treatment of chickenpox in children over 6 years of age, 800 mg of acyclovir should be prescribed 4 times a day, children aged 2 to 6 years can receive 400 mg of acyclovir 4 times a day. The duration of treatment is 5 days.

A more accurate dose can be calculated based on the child’s body weight: 20 mg/kg of body weight per day (not to exceed 800 mg) of acyclovir in 4 divided doses.

This dosage form of the drug should not be used in children under 2 years of age.

Pregnant women

There has been no increase in the number of birth defects in children whose mothers used acyclovir during pregnancy compared with the general population. However, acyclovir tablets should be used only if the potential benefit of the drug to the mother outweighs the possible risk to the fetus.

When administered orally at a dose of 200 mg acyclovir 5 times a day, acyclovir penetrates into breast milk in concentrations that are 0.6-4.1% of the corresponding plasma acyclovir level. Potentially, a child fed this milk can absorb acyclovir at a dose of up to 0.3 mg/kg body weight per day. Therefore, acyclovir should be prescribed to breastfeeding women with caution, taking into account the risk/benefit ratio.

Drivers

When deciding whether to drive or operate machinery, the patient’s clinical status and the side-effect profile of the drug should be taken into account. Studies of the effect of acyclovir on the speed of reaction when driving or operating machinery have not been conducted. In addition, the pharmacology of acyclovir does not give reason to expect any negative effects.

Symptoms

Acyclovir is only partially absorbed from the gastrointestinal tract. Accidental ingestion of up to 20 g of acyclovir by patients without toxic effects has been reported. Accidental repeated oral overdose of oral acyclovir produces gastroenterological (such as nausea and vomiting) and neurological symptoms (headache and confusion) over several days. Overdose of intravenous acyclovir increases serum creatinine and blood urea nitrogen, leading to renal failure. Neurological manifestations of overdose may include confusion, hallucinations, agitation, convulsions and coma.

Treatment

The patient should be carefully examined for signs of intoxication. Since acyclovir is well removed from the blood by hemodialysis, the latter should be used in case of overdose.

Blood and lymphatic system disorders: anemia, thrombocytopenia, leukopenia.

Immune system disorders: anaphylaxis.

Mental and nervous system disorders: headache, dizziness, agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, drowsiness, encephalopathy, coma.

The above neurological reactions are generally reversible and usually occur in patients with renal insufficiency or other risk factors.

Respiratory and thoracic disorders: shortness of breath.

On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain.

From the hepatobiliary system: reversible increase in bilirubin and liver enzymes, jaundice, hepatitis.

Skin and subcutaneous tissue disorders: itching, rash (including photosensitivity), urticaria, accelerated diffuse hair loss (since hair loss can be associated with a large number of diseases and drugs, a clear relationship with acyclovir has not been identified), angioedema.

Kidney and urinary system: increased blood urea and creatinine levels, acute renal failure, kidney pain.

Kidney pain may be associated with renal failure and crystalluria.

Keep out of reach of children. Does not require any special storage conditions.

Shelf life – 5 years.