Viramun

"Viramune" (Viramune) is the trade name of a medicinal product whose main active substance is nevirapine (Nevirapine). Nevirapine belongs to the class of antiretroviral drugs and is used in the treatment of HIV infection.

Viramune is often used in combination with other antiretroviral drugs to manage HIV infection in adults, children and newborns. It can be used as part of antiretroviral therapy to control viral load and maintain immune function in patients with HIV.

It is important to note that the use of Viramune requires strict supervision and prescription by a physician, as it may have side effects and may interact with other medications. Improper use or discontinuation of Viramune without consulting a physician may result in decreased effectiveness of therapy and development of HIV resistance to the drug.

Indications Viramuna

Viramune (nefevirapine) is commonly used in the treatment of HIV infection in adults, children, and newborns. Its indications for use include:

1. Treatment of HIV infection in adults: Viramune is used in combination with other antiretrovirals to reduce viral load, maintain immune function, and improve quality of life in adult patients with HIV infection.
2. Prevention of vertical transmission of HIV: Viramune can be administered to pregnant women with HIV to reduce the risk of transmission to the fetus. The use of antiretroviral therapy during pregnancy can significantly reduce the likelihood of mother-to-child transmission of HIV.
3. Treatment of HIV infection in children and newborns: Viramune may be used in combination with other antiretroviral drugs to treat HIV infection in children and newborns as part of therapy.
4. Prophylaxis after possible HIV exposure: Viramune may also be used as prophylaxis after possible HIV exposure, such as exposure to infected material, to reduce the risk of infection.

When prescribing Viramun, the doctor takes into account the individual characteristics of the patient, the stage of HIV infection, the presence of comorbidities and other factors.

Release form

The drug is available in several forms of release, including:

1. Tablets: Viramune is supplied as oral tablets. The tablets can have different dosages, depending on the doctor's advice and the patient's needs. The tablets are usually taken once or twice a day in combination with other antiretroviral medicines.
2. Syrup: For children or people who have difficulty swallowing tablets, Viramune may be available in syrup form. This is a more convenient form to take for certain patients.
3. Solution for Injection: Viramune may also be used as an injectable solution for intravenous administration. However, this form is rarely used and is usually used in specific clinical situations.

It is important to note that the specific release form of Viramune may vary depending on the country and manufacturer. Dosage and recommendations for use may also vary depending on the individual characteristics of the patient and the stage of HIV infection.

Pharmacodynamics

Viramune is a drug whose active ingredient, nevirapine, is used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to a class of antiviral drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).

Viramune's mechanism of action is based on its ability to inhibit viral reverse transcriptase, an enzyme that the HIV virus needs to turn its RNA into DNA. This occurs during the process of infection of the body's cells. Nevirapine, by acting as a reverse transcriptase inhibitor, blocks this key step in viral replication.

It should be noted that nevirapine, like many antiretroviral drugs, does not cure HIV, but it can significantly slow the spread of the virus in the body and maintain a low viral load, which can improve immune function and slow disease progression. It is usually used in combination with other antiretroviral drugs as part of therapy for HIV infection.

Pharmacokinetics

Viramune (or viravudine, as the active ingredient is often called) pharmacokinetics information includes how the drug is absorbed, metabolized, and eliminated from the body. Here are the main aspects of Viramune pharmacokinetics:

1. Absorption: Viravudine has good and almost complete bioavailability after oral administration. Its absorption occurs in the gastrointestinal tract and is mainly completed in the small intestine.
2. Distribution: After absorption, viravudine is rapidly distributed in body tissues, including organs and fluids. It also penetrates the blood-brain barrier and can reach high concentrations in the central nervous system.
3. Metabolism: Viravudine is metabolized in the liver, where it is biotransformed to form active and inactive metabolites. The main metabolic pathway includes glucuronidation and cytochrome P450-dependent oxidative processes.
4. Excretion: Final excretion of viravudine metabolites from the body occurs mainly through the kidneys. Part of the drug is also excreted with bile.
5. Half-life: The half-life of viravudine from the blood is approximately 25-30 hours, which means that during this time half of the initial concentration of the drug is reduced.
6. Dosekinetics: Dose kinetics of viravudine may be linear or non-linear depending on the dosage and dosing regimen. A change in dose may or may not proportionally change the blood concentration of the drug.

Dosing and administration

Here are the general recommendations for the method of administration and dosage of Viramune:

1. Method of Application:

   • Viramune is usually taken orally, that is, by mouth, in tablet form.
   • The tablets should be swallowed whole with sufficient water. Do not dissolve, chew or crush the tablets.

2. Dosage:

   • Viramune dosage may vary depending on the stage of HIV infection, its severity, the presence of comorbidities, and other factors.
   • It is usually recommended to start treatment with a low dose and gradually increase it over the first few weeks under a doctor's supervision.
   • The generally accepted starting dosage for adults is 300 mg of viravudine per day (usually one 300 mg tablet).
   • The dosage for children depends on their weight and health status, and should be determined by a doctor.

3. Admission Schedule:

   • Viramune is usually taken once a day, preferably at the same time each day to ensure a constant level of the drug in the blood.
   • The tablets can be taken independently of meals.

4. Duration of treatment:

   • The duration of treatment with Viramune may vary depending on the characteristics of each individual case and the doctor's recommendations.
   • Viramune treatment is usually long term and can last for years, sometimes even for life.

Use Viramuna during pregnancy

The use of Viramune during pregnancy may be considered in the following cases:

1. Prevention of vertical transmission of HIV: In pregnant women with HIV, antiretroviral therapy, including Viramune, may be prescribed to reduce the risk of transmission to the baby during pregnancy, the birth canal, and during breastfeeding. Reducing the mother's viral load reduces the likelihood of infection in the fetus.
2. Treatment of HIV infection in pregnant women: If a woman is already infected with HIV and needs antiretroviral therapy, the doctor may decide to prescribe Viramune in combination with other drugs to control the viral load and preserve the health of the mother and fetus.

However, it is important to note that there may be risks associated with the use of Viramune during pregnancy. Viramune may cause side effects in both mother and fetus, including allergic reactions, hepatic dysfunction.

The decision to use Viramune during pregnancy should be made by a doctor based on an individual assessment of the risks and benefits to the mother and fetus. It is important to carefully discuss all treatment options with your doctor and follow all recommendations and prescriptions of the specialist.

Contraindications

1. Known allergic reaction: People with a known allergy to nefaviropine or other ingredients of the drug should avoid using it.
2. Severe liver damage: The drug may cause toxic hepatitis, especially in women with high levels of CD4 cells in the blood (>250 in women and >400 in men). Viramune may be contraindicated in patients with existing severe liver disease.
3. Severe skin damage: The use of Viramune may cause severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. In case of previous skin reactions to nefaviropine, its use should be discussed with a physician.
4. Pregnancy and lactation: The safety of Viramune use during pregnancy and lactation has not been established, therefore the use of the drug in these cases should be evaluated by a physician and considered in the context of benefit to the mother and potential risk to the fetus or child.
5. Pediatric age: The safety and efficacy of Viramune in children younger than 3 months of age have not been established. Therefore, use in this age group may be contraindicated.
6. Concomitant treatment with terfenadine, astemizole or cisapride: Viramune may increase the concentration of these drugs in the blood, which may lead to serious cardiac complications. Therefore, their concomitant use may be contraindicated.

Side effects Viramuna

Viramune can cause a number of side effects in patients using it to treat HIV infection. Some of the most common side effects include:

1. Rash or skin rash: This is one of the most common side effects of nevirapine. The rash may be mild or severe and may cause itching or discomfort.
2. Headache: Some patients may experience headaches or migraines while taking Viramune.
3. Nausea and vomiting: These side effects may occur in some patients at the start of treatment with Nevirapine.
4. Fatigue or weakness: Some patients may feel tired or weak while taking the drug.
5. Abnormal dreams or insomnia: Some patients may experience dreams or insomnia.
6. Increase in liver enzyme levels: Changes in liver function tests may occur in some patients.
7. Muscle pain or arthralgia: Some patients may experience muscle or joint pain.
8. Hypersensitivityto sunlight: Some patients may experience hypersensitivity to sunlight or photosensitivity.
9. Changes in fat metabolism: Nevirapine may cause changes in fat metabolism, such as an increase in cholesterol or triglyceride levels.
10. Increased risk of allergic reactions: Allergic reactions to nevirapine, including anaphylaxis, may occur in some patients.

It is important to note that these side effects may occur in varying degrees of severity from patient to patient, and some may diminish or disappear over time with continued treatment.

Overdose

Viramune overdose can lead to serious side effects and complications. Symptoms of overdose can vary and may include:

1. Hypersensitivity to the drug: Including a sharp increase in side effects such as nausea, vomiting, dizziness, drowsiness and others.
2. Liver damage: Viramune can cause toxic liver damage, and in overdose this damage can be severe.
3. Neurologic symptoms: Including headache, disorders of consciousness, seizures and other neurologic manifestations.
4. Cardiotoxicity: In rare cases, Viramune overdose may cause cardiac abnormalities, including arrhythmias and increased heart rate.
5. Other systemic symptoms: Other symptoms and complications associated with overdose such as hypotension, hypoglycemia and others may also occur.

In case of suspected overdose with Viramune, medical attention should be sought immediately. Treatment of overdose may include symptomatic therapy, maintenance of the functions of organs and body systems, as well as active removal of the drug from the body, for example, by gastric lavage or use of activated charcoal.

Interactions with other drugs

Viramune may interact with other drugs, which may alter their effectiveness, safety, or cause unwanted side effects. Some of the known interactions are summarized below:

1. Drugs metabolized via cytochrome P450 enzymes: Viramune is an inhibitor of cytochrome P450 3A4 enzyme, therefore it may alter the metabolism of other drugs metabolized via this pathway. This may result in an increase or decrease in blood concentrations of these drugs, which may require dosage adjustments. Some of these drugs include antiretrovirals, antibiotics, antifungals, and others.
2. Antiepileptic drugs (e.g. Phenytoin, carbamazepine): Viramune may decrease the concentration of antiepileptic drugs in the blood, which may require an increase in their dosage.
3. Antiretroviral drugs: Viramune may interact with other antiretroviral drugs such as protease or integrase inhibitors, altering their blood concentrations and requiring dosage adjustments.
4. Drugs affecting cardiotoxicity: Viramune may increase the cardiotoxicity of some drugs, such as antiarrhythmic drugs or drugs for the treatment of hypertension.
5. Blood pressure-lowering drugs: Viramune may increase the hypotensive effect of blood pressure-lowering drugs.
6. Hormonal medications: Viramune may interact with hormonal medications such as contraceptives, altering their effectiveness and the need for dosage adjustments.

Storage conditions

It is important to store Viramune correctly to maintain its stability and efficacy. Usually, recommendations for storage conditions include the following guidelines:

1. Temperature: Viramune should be stored at room temperature, between 20°C and 25°C (68°F and 77°F).
2. Protection from light: The drug should be stored in its original packaging or in a dark container to protect it from exposure to direct light.
3. Humidity: Avoid storing the preparation in places with high humidity, as this may adversely affect the stability of the preparation.
4. Children and pets: Viramune should be kept out of the reach of children and animals to prevent accidental use.
5. Packaging: Before use, make sure that the packaging of the preparation is not damaged. If the packaging is damaged, it may result in loss of sterility or stability of the drug.
6. Expiration date: Always check the expiration date indicated on the package of Viramune. Do not use the drug after the expiration date.
7. Special storage conditions: Viramune does not require special storage conditions, but it is important to avoid extremes of temperature and humidity.