Last Updated on February 19, 2017 by Dr.Derek Fhisher

Zerit Stavudine 30, 40 mg
Most popular brand: Zerit
Active ingredient: Stavudine
Available dosage forms: 30, 40 mg
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Stavudine general information

HIV-positive individuals are shown to really have a shortage of carnitine. Oftentimes AIDS-related PN is really a side-effect of medications for example stavudine, zalcitabine, didanosine, and zidovudine. When it may not really be related to acetyl-l-carnitine, your physician will have the ability to diagnose and care for the problem. Some could elect to offer treatment without informing the patient.

In case that one is handicapped, disabled, or knows that an individual is dying of the terminal disease, an individual may decide to end an individual’s pain and suffering than permit it to slowly spend the life out of an individual. Even though the majority of people can quickly end their lives, others that are disabled may not be able do so in a respectful manner. In this respect, the line between what exactly is ethical and what’s not is blurred. This might consist of medical reports along with personal conversations.

Public health insurance plans exist for people who cannot afford this, but there are a few who earn just over the bare minimum due to which they don’t qualify for all these insurance plans. Patients are given the right to produce informed choices about the health care care they wish to and don’t want to get. It is thought that women in such countries might not be completely conscious of the risks and implications of the process and could enter it solely due to their financial condition.

Exercising near bedtime can boost your own level of alertness. A normal exercise program might also ease the symptoms. It really can be related to physical factors, including diet or exercise. It can produce a total awareness of fatigue. Add financial instability, needing to work work, family situations, health issues, family history, also it becomes a set up for mood disorders. All These are often used as a treatment for common medical issues.

There are various reasons for it. The next effort is to discover the reason for the issue. This will probably result in broken sleep. The sleep problem will go away when the stressful situation is resolved. Additionally, It raises your chance of heart attack, substantial blood pressure, and stroke. The essence of the particular cause is not important.

It’s hard to create the appropriate decisions when tired, regardless how much caffeine is really in the brain. I’m seeing a gain in caffeine abuse. They don’t have because many difficulties with alcohol, nonetheless they certainly love their caffeine. They are also able to result in heartburn. Melatonin is a pure hormone that is generated by the body. It’s quite likely that tolerance will build, and you will have to use an increasing number of alcohol to accomplish the exact results.

Insomnia is a typical sleep problem for those who suffer from depression. Anxiety might also result in insomnia. Some antidepressants may lead to insomnia. Others might suffer from one of several diagnosable and frequently treatable sleep disorders. Depression too can let you feel very sleepy during the day. It’s basically self-medicating with an extremely addictive drug.

Thats because sleep is a critical component to our general mental as well as physical health. Understanding these factors are able to help you overcome a sleep issue. Breathing disorders could also disrupt your sleep. A sleep disorder might also keep you from getting the sleep which you have to truly feel alert and well rested. This is going to have negative effect on your own sleep. It plays a function in telling the human body and brain when it’s time to sleep.

There are numerous kinds of sleep disturbance. Normally, this just worsens your sleep pattern. Common and productive treatments are offered for most sleep difficulties. This sleep hygiene tips may be used to boost sleep. Pain too can disrupt sleep. Steer clear of physical exertion too near bedtime.

If a lady continues to be possibly growing, 8-9 hours is advised. It generally does not improve with rest. Then they’re unable to return to sleep. She or He can decide how you can assist you to sleep better.

In a few cases, you might need to get referred to a sleep specialist. With the suitable medical attention, they can still be detected and treated. It can range between mild to severe. They are able to irritate the stomach and effect abdominal pain through the night.

The 3rd day, you feel a small bit better. They will afterwards be very tired a day later. They need to work 20-40 hours weekly merely to pay for school. In addition, It suggests that a household camping trip before school starts might be considered a healthful family experience.

The usage of tobacco prior to going to bed can impact your sleep. Kids and pets may also make an impact on your sleep. In both instances, it might be hard that you return to sleep once you’re awakened. Avoid naps over the course of the day.

If you’re up late studying or just require a bit more energy, try a little energy-boosting snack rather than a caffeinated beverage. Have a light, nutritious snack prior to going to bed. A normal meal schedule can also assist you get a great night’s sleep. Keep the nap to about thirty minutes and strive to do it at the exact same time every day before 3pm. You’re going to be able enough to breathe normally whenever you go to bed through the night.

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Stavudine – an antiviral agent for the treatment of HIV – infected patients with marked clinical manifestations of AIDS and the ineffectiveness or intolerance to zidovudine (ZDV including after care), didanosine and other antiretrovirals

Product form: Capsules 30 mg, 40 mg.

At 7, 10, 14 capsules in blisters of PVC film and aluminum foil printed patent.

On 56, 112 or 224 capsules in a polymer or glass jar.

At 1, 3, 4, 5, 6 contour cell packages or 1 bank, with instructions for use placed in a pile of cardboard.

Ingredients: for 1 capsule

Active substance: Stavudine – 30 mg, 40 mg;

Other ingredients: lactose monohydrate, crospovidone, microcrystalline cellulose, magnesium stearate;

excipients into hard gelatin capsules â„–3: gelatin, titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate;

excipients into hard gelatin capsules â„–1: gelatin, titanium dioxide, patent blue dye, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Indications for use:. HIV – infection (in combination therapy)

Dosage and administration: Inside, regardless of meals. Dose depends on the body weight. If swallowing the capsules is difficult, you should carefully open the capsule and take the contents with a small amount of food.

Adults and children with a body weight of & ge; 60 kg – 40 mg every 12 hours for adults and children weighing at least 30 kg and not more than 60 kg – 30 mg every 12 hours.

The course of treatment -. Long

In adult patients with chronic renal failure with CC than 50 ml / min and with a body weight ≥ 60 kg – the usual dose is 40 mg 2 times a day with an interval of 12 hours; QC at 50 ml / min and a body weight less than 60 kg – 30 mg 2 times a day at intervals of 12 hours, i.e. the usual dose, its correction is not required.

The exact recommendations for children with impaired renal function are not available. In children with chronic renal failure should be used oral solution.

Conditions of supply: prescription

ATC code: [J05AF04]

Registration number: LSR – 006943/10

Dosage Form. Capsules

Ingredients: for 1 capsule

active substance: stavudine – 30 mg, 40 mg;

auxiliaries: lactose monohydrate, crospovidone, microcrystalline cellulose, magnesium stearate;

aids for capsules of hard gelatin â„–3 . gelatin, titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate;

aids for capsules of hard gelatin â„–1 . gelatin, titanium dioxide, dye blue patented, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Description: 30 mg Capsules . â„– hard gelatin capsules with the body 3 and a lid white;

40 mg Capsules . â„– hard gelatin capsules with the body 1 and cap blue.

The contents of capsules – powder white or white with a yellowish tint.

Pharmacotherapeutic group: antiviral [HIV] means

Pharmacodynamics: The use of stavudine in combination therapy leads to an increase in the number of CD4 + – lymphocytes, which is caused by decreased activity of the human immunodeficiency virus (HIV), a decrease in HIV RNA level.

Stavudine – an antiviral agent, a synthetic nucleoside analogue of thymidine. It suppresses the replication of HIV in cultured human cells and cell lines in vitro . Phosphorylated by cellular enzymes to its active form – stavudintrifosfata that inhibits the activity of HIV reverse transcriptase by competing with the natural substrate dioksitimidintrifosfatom and disturbs the replication of HIV. Stavudintrifosfat also increases viral DNA chain termination due to the absence in the molecule 3 & rsquo; – Hydroxyl group necessary for the construction of DNA, inhibits the cellular DNA – polymerase & gamma ;, reduces the synthesis of mitochondrial DNA.

Pharmacokinetics: Adult Absorption of ingestion – rapid and complete.. The time to maximum concentration (TC max ) after multiple administration at doses of 0.5 mg / kg is observed in less than 1 hour, the maximum plasma concentration (C max ) proportsionalnouvelicheniyu increasing doses of the drug and is about 810 ng / ml. Bioavailability – 78 – 86%. Cumulation stavudine when used every 6, 8 or 12 hours is observed. Use of the drug before or after a meal does not significantly affect the pharmacokinetics – the area under the curve « concentration – time » (AUC) of stavudine in HIV – infected patients with no symptoms of the disease did not differ from mealtime. A small part binds to plasma proteins, about half – with the formed elements of blood. The apparent volume of distribution following single administration of the drug is on average 46 liters and is independent of dose. It penetrates the blood-brain barrier and is defined in the cerebrospinal fluid (CSF). Stavudine after single oral dose of 40 mg of the CSF concentration in healthy volunteers, averaged 63 ng / ml (44 – 71 ng / ml) for 4 – 5 hours. Stavudine CSF concentration was on average 40% (31 – 45%) of the plasma concentration. After a single dose or multiple dose stavudine. 34 & plusmn; 5% and 40 ± 12% constant stavudine, respectively, was detected in the urine. Inside the cell is phosphorylated to stavudintrifosfata, the active substrate for HIV reverse transcriptase. The half-life (T 1/2 ) in adults is 1.44 hours and is independent of dose. Renal clearance (237 ± 98 ml / min) is about 40% of the total clearance (594 ± 164 ml / min) and nearly twice the clearance of endogenous creatinine, indicating active tubular secretion in deriving stavudine through the kidneys along with glomerular filtration . There was a reduction in clearance of stavudine with a decrease in creatinine clearance. Recommended dose adjustments in patients with impaired renal function. If abnormal liver function pharmacokinetics similar to that of healthy patients (does not require correction dosing regimen). The pharmacokinetics of the drug in patients older than 65 years have not been studied.

Children The absolute bioavailability of the drug in HIV -. Deteysostavlyaet infected with an average of 76.9%. The pharmacokinetics after a single dose of the drug is similar to the pharmacokinetics in adults and is independent of dose. Pharmacokinetics after a single dose of the drug is similar to pharmacokinetics after repeated receptions, suggesting no accumulation of stavudine. CSF drug concentration after single and repeated oral administration comprise from 16 to 125% of the plasma concentration. Cumulation stavudine when receiving a dose of 0.125 – 2 mg / kg every 12 hours is observed. T ½ is to average 1 hour Approximately 34.5% of the drug is excreted through the kidneys unchanged.. The apparent total clearance of the drug – 14 ml / min / kg. With impaired renal function, the clearance of stavudine decreases. Recommended correction mode.

Indications for use:. HIV – infection (in combination therapy)

Contraindications: Hypersensitivity to stavudine and / or any of the components of the drug, children weighing less than 30 kg, chronic renal failure (CRF) with creatinine clearance (CC) of less than 50 ml / min, the deficit lactase, lactose intolerance, glucose – galaktaznaya malabsorption, simultaneous use with hydroxyurea, the simultaneous use of zidovudine.

Precautions: Alcoholism; CRF (KK at 50 ml / min); liver dysfunction, including hepatic failure, chronic active hepatitis in an active stage; peripheral neuropathy, including the anamnesis; pancreatitis; concomitant use of doxorubicin and ribavirin.

Pregnancy and lactation: There are no adequate and well-controlled studies of the use of stavudine have not been conducted in pregnant women. Reported cases of lactic acidosis in pregnant women who received the combination of stavudine and didanosine with other antiretroviral drugs.

Use of the drug in combination therapy during pregnancy is possible only if strict indications and only in those cases where the intended benefits to the mother outweighs the potential risk to the fetus. Patients receiving stavudine during pregnancy should be monitored carefully in connection with the possible development of lactic acidosis and hepatic steatosis.

Data on the penetration of stavudine in breast milk is not. In connection with the inability to eliminate the risk of transmission of infection and the possibility of side effects of the drug in a child during treatment with the drug during lactation should stop breastfeeding.

Dosage and administration: Inside, regardless of meals. Dose depends on the body weight. If swallowing the capsules is difficult, you should carefully open the capsule and take the contents with a small amount of food.

Adults and children with a body weight of & ge; 60 kg – 40 mg every 12 hours for adults and children weighing at least 30 kg and not more than 60 kg – 30 mg every 12 hours.

The course of treatment -. Long

In adult patients with chronic renal failure with CC than 50 ml / min and with a body weight ≥ 60 kg – the usual dose is 40 mg 2 times a day with an interval of 12 hours; QC at 50 ml / min and a body weight less than 60 kg – 30 mg 2 times a day at intervals of 12 hours, i.e. the usual dose, its correction is not required.

The exact recommendations for children with impaired renal function are not available. In children with chronic renal failure should be used oral solution.

Side effects: The most common side effects associated with the use of stavudine in combination therapy: peripheral neuropathy, lactic acidosis, pancreatitis, hepatitis, liver failure.

The following is the frequency of adverse reactions with the use of the drug stavudine in combination therapy in accordance with the generally accepted classification:

Very often (≥1 / 10); often (≥1 / 100, < 1/10); infrequently (≥1 / 1000, < 1/100); rarely (≥1 / 10000, < 1/1000); very rare (< 1/10000).

On the part of the central and peripheral nervous system: often – depression, the application of the scheme stavudine + lamivudine + efavirenz dose-related peripheral neuropathy (in 19 – 24% of adults), paresthesia , bilateral symmetric numbness, tingling and pain in the feet, hands, peripheral neuritis, headache, insomnia, abnormal dreams, drowsiness, dizziness, asthenic syndrome, anxiety, emotional lability.

From the digestive system: often – diarrhea, abdominal pain, nausea, dyspepsia; rarely – pancreatitis (1%) of varying severity, including cases with fatal outcome, hepatomegaly with steatosis, vomiting, decreased appetite, hepatitis or liver failure, sometimes fatal.

part of the endocrine system and metabolism: often – lipoatrophy, lipodystrophy; infrequently – gynecomastia, anorexia, lactic acidosis varying severity, including cases with fatal outcome. Symptoms of lactic acidosis: nausea, vomiting, abdominal pain, dyspnea, tachypnea, muscle weakness.

From the blood and blood-forming organs: anemia, neutropenia, thrombocytopenia.

From the musculo – skeletal system: rare – arthralgia, myalgia.

Allergic reactions: often – skin rash, rarely – hives.

Other: often – fatigue, fat redistribution, immune reactivation syndrome.

From the digestive system: often – diarrhea, nausea, vomiting.

On the part of the central and peripheral nervous system: very often – peripheral neuropathy, paresthesia, peripheral neuritis, headache.

From the digestive system: often – diarrhea, nausea, vomiting.

On the part of the central and peripheral nervous system: often peripheral neuropathy, paresthesia, peripheral neuritis.

Allergic reactions: very often – skin rash

Post-marketing data on the side effects reported with the use of stavudine

Metabolic disorders: often – asymptomatic hyperlactatemia; the frequency is unknown – lactic acidosis;

From the endocrine system: the frequency is unknown – diabetes, hyperglycemia;

From the liver. the frequency is unknown – hepatic steatosis, hepatitis and hepatic failure;

From the nervous system: the frequency is not known – severe muscle weakness (most often in hyperlactatemia or lactic acidosis);

Changes in laboratory parameters of stavudine in combination therapy with other drugs:

During the combination therapy stavudine + lamivudine + indinavir may increase serum bilirubin levels (> 2,6 x upper limit of normal (ULN), observed in 7% of cases); AST activities (> 5 x ULN – 5%), ALT (> 5 x ULN – 6%), lipase (> 2 x ULN – 6%).

During the combination therapy stavudine + didanosine + indinavir may increase serum bilirubin levels (> 2,6 x ULN in 16% of cases); AST activities (> 5 x ULN in 7%), ALT (> 5 x ULN in 8%), lipase (> 2 x ULN 5%).

Changes in laboratory parameters in patients receiving antiretroviral therapy for the first time:

During the combination therapy stavudine + lamivudine + efavirenz may increase serum AST activity (> 5 x ULN in 3% of cases), ALT (> 5 x ULN – 3%) lipase (> 2 x ULN – 3%).

Overdose: The doses of the drug at 12 times the recommended daily dose in adults do not cause symptoms of acute toxicity. In chronic overdose may experience peripheral neuropathy and hepatic dysfunction. Treatment is symptomatic. Stavudine is removed by hemodialysis (clearance rate of 120 ± 18 ml / min). Peritoneal dialysis is not effective.

Interaction with other medicinal products: The study of the inhibitory activity of stavudine in combination with AZT has shown that both drugs are phosphorylated by cellular thymidine kinase. The conversion to the active form of zidovudine is faster than the conversion of the active metabolite stavudine stavudintrifosfat. In combination with zidovudine marked reduction antiviral effect, because in the presence of zidovudine reduces conversion to active metabolite stavudine. Therefore combination therapy with these drugs is not recommended.

The phosphorylation of stavudine is also slowing down in the presence of doxorubicin and ribavirin.

Stavudine hardly binds to blood proteins, therefore, does not displace other medications (drugs) from places of protein binding.

didanosine, lamivudine, nelfinavir do not affect the antiviral activity of stavudine.

In an application with didanosine increases the risk of side effects.

Stavudine does not inhibit the major cytochrome P450 isoforms (CYP3A4, CYP2D6, CYP2D9, CYP1A2, CYP2C19), so the interaction between stavudine with drugs metabolized by using data of enzymes are unlikely.

It is not recommended concomitant drugs that cause peripheral neurological disorders (chloramphenicol, cisplatin, dapsone, didanosine, ethambutol, ethionamide, hydralazine, isoniazid, lithium, drugs, metronidazole, nitrofurantoin, phenytoin, vincristine, zalcitabine).

Special instructions: The drug should be used with caution in patients at increased risk of developing peripheral neuropathy and peripheral neuropathy in history, with advanced HIV – infection. The risk of this effect increases with simultaneous use of didanosine. Numbness, tingling, or pain in the limbs may indicate the development of peripheral neuropathy. These symptoms may disappear soon after stopping treatment. When these symptoms should temporarily discontinue the drug. Resuming drug treatment is possible only after the complete disappearance

symptoms. It may be necessary to adjust the dose. In addition to the dose, the frequency of these phenomena depends on and / or from the stage of the disease (in the early stages registered rarely). Sometimes after discontinuation of treatment of neuropathy symptoms do not disappear, but rather temporarily strengthened.

The drug should be used with caution in patients at increased risk of developing pancreatitis. The risk of recurrence is increased in patients with a history of pancreatitis: pancreatin when stavudine was observed in 5% of patients with a history of pancreatitis and 2% – with no history of pancreatitis. Pancreatitis varying severity, including cases with fatal outcome, may develop in patients at different stages of treatment, regardless of the degree of immunosuppression. If symptoms of pancreatitis drug treatment should be discontinued. With the reappointment of the drug to exclude the simultaneous use of didanosine and hydroxyurea. Of particular risk are patients with a history of pancreatitis. With a view to the early detection of pancreatitis often necessary to check the function of the pancreas.

Keep out of the reach of children.

Do not use beyond the expiration date printed on the package.

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