Lamivudine - instructions for use, dose, side effects, contraindications

Description:Round biconvex tablets covered with a film coat of white or almost white color, with a risk. On the cross section, the nucleus is white or almost white in color.

Pharmacotherapeutic group:Antiviral [HIV] agent

ATX: & nbsp

J.05.A.F.05 Lamivudine

Pharmacodynamics:

Lamivudine is a highly effective selective inhibitor of HIV-1 and HIV-2 replication in vitro. Also active against HIV strains resistant to zidovudine. Inside the cells lamivudine is metabolized to 5'-triphosphate (active form), the half-life (T 1/2) of which from the cells is 16-19 hours. Lamivudine-5'-triphosphate to a small extent inhibits RNA and DNA-dependent reverse transcriptase of HIV.

The main mechanism of its action is the blocking of the synthesis of the growing DNA chain in the process of reverse transcription of HIV. Shown, that lamivudine has an additive or synergistic effect on other antiretroviral drugs, especially zidovudine. suppressing replication of HIV in cell culture.

Lamivudine does not interfere with the normal cellular metabolism of DNA and does not have a significant effect on the content of nuclear and mitochondrial DNA in mammalian cells.

In studies in vitro Lamivudine has little cytotoxic effect pas peripheral blood lymphocytes, as well as the lymphocyte and monocyte-macrophage cell lines, and a number of other bone marrow stem cells. In this way, in vitro lamivudine has a high therapeutic index.

One of the reasons for the development of HIV-1 resistance to lamivudine is the emergence of changes in M184V a viral genome that is closely linked to the active site of HIV reverse transcriptase. HIV-1 strains with mutations M184V can appear as in vitro, and in the body of patients receiving combined antiretroviral therapy, including lamivudine. Such strains of the virus are characterized by a reduced sensitivity to lamivudine and a weak ability to replicate in vitro. In vitro strains of HIV.resistant to zidovudine, can gain sensitivity to it in the case of simultaneous development of resistance to lamivudine. The clinical significance of this phenomenon is not established.

Mutations in the codon M184V lead to the emergence of cross-resistance of HIV only to drugs from the group of nucleoside reverse transcriptase inhibitors. Zidovudine and stavudine remain active in HIV-1 strains resistant to lamivudine. Abacavir antiretroviral activity against HIV-1 strains having M184V mutation resistant to lamivudine. In strains of HIV with M184V mutations determined no more than 4-fold decrease in sensitivity to didanosine and zalcitabine; the clinical significance of this phenomenon is not established. Tests on the sensitivity of HIV to various antiretroviral drugs in vitro They were not standardized and therefore, various methodological factors can influence their results.

According to clinical studies, the use of lamivudine in combination with zidovudine reduces the viral load of HIV-1 in the blood and increases the content of C04 lymphocytes. Determined that lamivudine in combination with zidovudine or zidovudine and other drugs significantly reduces the risk of progression of HIV infection and death. HIV strains isolated from patients who received lamivudine, there was a decrease in sensitivity to lamivudine in vitro.

Combination therapy with lamivudine and zidovudine in Nazi patients who had not previously received antiretroviral therapy, delayed the emergence of resistant to zidovudine HIV strains. Lamivudine was widely used as a component of combined antiretroviral therapy in combination with other nucleotide reverse transcriptase inhibitors or preparations from other groups (protease inhibitors, non-nucleoside reverse transcriptase inhibitors).

It is proven that combined antiretroviral therapy, including lamivudine, is effective against strains of HIV with mutations in codon M 184V.

To establish the relationship between the sensitivity of HIV to lamivudine in vitro and the clinical effect of therapy, additional studies are required.

Pharmacokinetics:

Suction

Lamivudine is well absorbed from the gastrointestinal tract. Bioavailability lamivudine in adults after oral administration is usually 80-85%. Average time (t_max) achieve maximum concentrations (C_ma_x) of lamivudine in the serum is about 1 hour. When lamivudine is administered at therapeutic doses (4 mg / kg / day in 2 divided doses at intervals of 12 hours) C_m_Oh is 1-1.9 μg / ml.

Taking lamivudine together with food causes an increase in t_max and a decrease in C_m_Oh (up to 47%), However, it does not affect the overall extent of absorption, calculated on the basis of the area under the pharmacokinetic concentration-time curve (AUC). Therefore, when taking lamivudine with food, dose adjustment is not required.

Distribution and binding to blood plasma proteins

With intravenous administration of lamivudine, the volume of distribution averages 1.3 l / kg, and (T_1/2) 5-7 hours.

In the therapeutic range of doses lamivudine has a linear pharmacokinetics and binds insignificantly to plasma proteins.

Determined that lamivudine penetrates into the central nervous system (CNS) and into the cerebrospinal fluid. 2-4 hours after oral administration, the ratio of the concentrations of lamivudine in the cerebrospinal fluid and serum was approximately 0.12.

Metabolism and excretion

On average, the systemic clearance of lamivudine is approximately 0.32 l / kg / h. Lamivudine is excreted mainly by the kidneys (more than 70%) by active tubular secretion (the system of transport of organic cations), and also by metabolism in the liver (less than 10 %).

The active form of lamivudine, intracellular lamivudine triphosphate, has a longer half-life of cells (16-19 hours) compared with the half-life of plasma from its plasma (5-7 hours). There are data that the pharmacokinetic parameters of lamivudine when taken at a dose of 300 mg once a day in the equilibrium state are equivalent to those when administered at a dose of 150 mg twice a day in terms of the area under the pharmacokinetic concentration-time curve for 24 hours (AUC24) and C_m_Oh for lamivudine triphosphate.

The likelihood of adverse interaction of lamivudine with other drugs is very small due to limited metabolism in the liver, a slight degree of binding to plasma proteins and almost complete excretion of lamivudine in unchanged form.

Special patient groups

Children. In general, the pharmacokinetics of lamivudine in children is similar to that of adults. However, absolute bioavailability (approximately 55-65%) was lower and more variable in children younger than 12 years.In addition, the systemic clearance indicators are higher in children of younger age group and decrease with age, reaching the level of adult patients by 12 years. Pharmacokinetic studies of lamivudine in children in the form of film-coated tablets have shown that taking the drug once a day is equivalent to taking the drug 2 times a day in terms of AUC₂₄. When taking lamivudine in the recommended doses, the average AUC₂₄ reached about 7.1-13.7 μg * h / ml, which is comparable with the indices AUC₂₄ in adults when taking the drug 1 time per day.

Elderly patients. Data on the pharmacokinetics of lamivudine in patients older than 65 years are absent.

Patients with impaired renal function. In patients with impaired renal function, the concentration of lamivudine in plasma is increased, since its excretion from the body is slowed. Patients with a creatinine clearance less than 50 mL / min should reduce the dose of lamivudine.

Patients with impaired liver function. Data on the use of lamivudine in patients with moderate to severe hepatic impairment indicate that a disturbed liver function does not significantly affect the pharmacokinetics lamivudine.

Pregnancy. The pharmacokinetics of lamivudine in pregnant women does not differ from its pharmacokinetics in non-pregnant women. Studies have shown that lamivudine penetrates the placenta. The concentration of lamivudine in the serum of newborns at the time of birth is the same as in the blood serum of the mother and blood from the umbilical cord.

Indications:

Treatment of HIV infection in combination antiretroviral therapy in adults and children.

Contraindications:

Hypersensitivity to lamivudine or other components of the drug. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Children under 3 years old, children weighing less than 14 kg.

Impaired renal function with creatinine clearance less than 30 ml / min.

Carefully:

Renal failure with creatinine clearance from 30 ml / min to 50 ml / min. Peripheral neuropathy (including in the anamnesis).

Pancreatitis (including in history).

Pregnancy and lactation:

Pregnancy

Data on the safety of lamivudine during pregnancy is currently insufficient. Studies have shown that lamivudine penetrates the placenta. Lamivudine It should be used during pregnancy only if the expected benefit for the mother exceeds the potential risk to the fetus. Although the results of animal experiments can not always be extrapolated to humans, research data on rabbits indicate a possible risk of spontaneous abortion in early pregnancy. In newborns and children under the age of 1 year, whose mothers during pregnancy and childbirth took drugs from the group of nucleoside reverse transcriptase inhibitors, cases of a slight transient increase in serum lactic acid concentration, apparently due to mitochondrial dysfunction, were described. The clinical significance of the temporary increase in the concentration of lactic acid in the serum ns is established. In addition, very rare cases of developmental delay, convulsive syndrome and other neurological disorders have been reported. However, the association of these complications with the intake of nucleoside reverse transcriptase inhibitors during pregnancy and its effect on postnatal development has not been proven. Therefore, HIV-infected women pregnancy, nevertheless, it is recommended to take antiretroviral drugs to prevent vertical transmission of HIV.

Lactation

According to experts, all HIV-infected women should, whenever possible, refuse to breast-feed to prevent the transmission of the virus to the baby through breast milk. After oral administration lamivudine excreted in breast milk; while its concentration in breast milk is practically the same as its concentration in serum (1-8 μg / ml). Because HIV and lamivudine penetrate into breast milk, women taking lamivudine, breast-feeding should be discontinued.

Dosing and Administration:

The appointment of lamivudine is allowed only by a specialist with experience in the treatment of HIV infection.

Lamivudine is taken orally regardless of the meal (before, during or after a meal).

To ensure the accuracy of dosing, the tablet should be swallowed completely without division.

Adults and adolescents with a body weight of more than 30 kg

The recommended dose is 300 mg per day: 150 mg (1 tablet) 2 times a day or 300 mg (2 tablets) per day in one session.

Special patient groups

Children with a body weight of 21 - 30 kg

The recommended dose is 225 mg per day - 75 mg (1/2 tablet) in the morning and 150 mg (1 tablet) in the evening or one and a half tablets once a day.

Children with a body weight of 14-21 kg

The recommended dose is 150 mg (1 tablet) once a day or 75 mg (1/2 tablet) 2 times a day.

Elderly patients

Currently, data on the pharmacokinetics of lamivudine in this category of patients is not enough, however, special attention should be paid to this category of patients due to the age-related decline in the excretory function of the kidneys and changes in blood counts.

Patients with impaired renal function

In patients with impaired renal function of moderate and severe severity, the concentration of lamivudine in the plasma is increased due to a decrease in the clearance of lamivudine. Therefore, when creatinine clearance is less than 50 ml / min, the dose of the drug should be reduced, as shown in the table below. In children with impaired renal function, the same scheme to reduce the dose of the drug, depending on the value of creatinine clearance, as in adults.

Selection of a dose of lamivudine depending on the creatinine clearance in renal insufficiency in adults and adolescents with a body weight of at least 30 kg.

Clearance creatinine (ml / min)	The starting dose (the first dose of the drug)	The maintenance dose (the second dose of the drug (24 hours after the first dose) and subsequent doses)
from 30 to 50	150 mg	150 mg once a day
from 15 to 30	150 mg	It is necessary to use another dosage form - oral solution
from 5 to 15	150 mg	It is necessary to use another dosage form - oral solution
<5	It is necessary to use another dosage form - a solution for ingestion

Patients with impaired hepatic function

In patients with moderate to severe hepatic impairment, a dose reduction of lamivudine is not required, unless the liver function is accompanied by renal insufficiency.

Side effects:

The undesirable reactions described below were noted in the treatment of HIV infection with lamivudine, both as monotherapy and when combined with other antiretroviral drugs. However, for many unwanted reactions, it is unclear whether they are caused by medications or are complications of the actual HIV infection.

The frequency of unwanted reactions is as follows: very often (≥1 / 10 cases), often (≥1 / 100 and <1/10 cases) infrequently (≥1 / 1000 and <1/100 cases), rarely (≥1 / 10000 and <1/1000 cases) and very rarely (<1/10000 cases).

From the hematopoiesis: infrequently - neutropenia, anemia, thrombocytopenia: very rarely - aplasia of the erythroid bone marrow.

From the side of metabolism: often - increasing the concentration of lactic acid in the serum; infrequently - hypertriglyceridemia, hypercholesterolemia, insulin resistance; rarely - lactic acidosis; redistribution or accumulation of subcutaneous fat; the frequency of development depends on many factors, including from a specific combination of antiretroviral drugs.

From the nervous system: often - headache, insomnia; very rarely paresthesia; cases of development of peripheral neuropathy are described, but the association of this complication with lamivudine therapy has not been proved.

From the gastrointestinal tract: often - nausea, vomiting, pain in the upper abdominal parts, diarrhea; rarely - pancreatitis, although the association of this complication with therapy lamivudine has not been proved; increased serum amylase activity.

From the hepatobiliary system: infrequently - transient increase in activity "hepatic" enzymes; rarely - hepatitis.

From the skin and its derivatives: often - a rash, alopecia.

From the osteomuscular and connective tissue: often - arthralgia, muscle disorders; rarely rhabdomyolysis.

From the respiratory system and mediastinal organs: often - cough, nasal symptoms.

Allergic reactions: rarely - angioedema.

Other: often - a feeling of fatigue, malaise, fever. Osteonecrosis has been reported in patients with risk factors such as late stages of HIV infection or long-term combined antiretroviral therapy (incidence is unknown).

There are reports of the development of lactic acidosis, and severe hepatomegaly with steatosis, including fatal outcome due to antiretroviral therapy with nucleoside analogues.

The use of combined antiretroviral therapy has been associated with the redistribution of adipose tissue (lipodystrophy) in patients with HIV, a reduction in the subcutaneous fat layer on the face and limbs, an increase in intra-abdominal and visceral fat, dorsocervical fat deposition ("buffalo buffalo"), an increase in mammary glands, concentration of lipids and glucose in blood plasma, both individually and together.

In some patients receiving combined antiretroviral therapy, metabolic disorders such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia have been described.

In HIV-infected patients with severe immunodeficiency, the onset of combined antiretroviral therapy may exacerbate the inflammatory process resulting from an asymptomatic or slow-moving opportunistic infection. Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) were observed against the background of restoration of immunity, but the time of primary manifestations varied, and the disease could occur many months after the initiation of therapy and have an atypical course.

Osteonecrosis cases have been reported, especially in patients with recognized risk factors, late HIV infection and / or long-term combined antiretroviral therapy. The frequency of occurrence of this phenomenon is unknown.

If any of the unwanted reactions listed in the manual is aggravated, or if you notice other undesirable effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: there are few data on the consequences of acute overdose of lamivudine in humans. There were no lethal outcomes, the condition of all patients was normalized. There were no specific signs or symptoms of lamivudine overdose.

Treatment: it is recommended to monitor the patient's condition and conduct standard maintenance therapy. Because the lamivudine is excreted from the body by dialysis, it is possible to use continuous hemodialysis, but no special studies have been performed.

Interaction:

Studies and interactions were conducted only with the participation of adult patients.

The likelihood of metabolic interaction of lamivudine with other drugs is extremely low, since lamivudine is very poorly metabolized, binds to a small extent with plasma proteins and is excreted mainly by the kidneys in unchanged form.

Lamivudine is excreted from the body mainly by active tubular secretion through the transport system of organic cations. Should be considered the possibility of lamivudine interaction with drugs having the same mechanism excretion, for example with trimethoprim. Other drugs (for example, ranitidine, cimetidine) are only partially excreted by this mechanism and do not interact with lamivudine. Drugs that are excreted primarily through active renal secretion through the transport system of organic anions or through glomerular filtration do not appear to enter into clinically significant interactions with lamivudine.

Zidovudine. With the simultaneous use of lamivudine and zidovudine, a moderate (by 28%) increase in C_m_Oh zidovudine in plasma, while AUC significantly ns varies. Zidovudine does not affect the pharmacokinetics of lamivudine.

Trimethoprim / sulfamethoxazole. Simultaneous use of trimethoprim / sulfamethoxazole (co-trimoxazole) at a dose of 160/800 mg increases the concentration of lamivudine in blood plasma by approximately 40 % (due to interaction with trimethoprim). However, in the absence of impaired renal function, a dose reduction of lamivudine is not required. On the pharmacokinetics of trimethoprim and sulfamethoxazole lamivudine does not affect. It is not recommended simultaneous application of lamivudine with high doses of co-trimoxazole, which is prescribed for the treatment of pneumocystis pneumonia and toxoplasmosis.

Zalcitabine. With the simultaneous administration of lamivudine and zalcitabine lamivudine can inhibit intracellular phosphorylation of the latter. In this regard, this combination of drugs is not recommended.

Cladribine. With the simultaneous administration of lamivudine and cladribine, lamivudine can inhibit intracellular phosphorylation of cladribine. In this regard, this combination of drugs is not recommended.

Interferon and ribavirin. There is no evidence of possible pharmacokinetic and pharmacodynamic interactions in the co-administration of ribavirin and lamivudine, but fatal cases of hepatic insufficiency in co-infected patients (HIV and hepatitis C) who received antiretroviral therapy together with interferon alfa and ribavirin were noted.

Emtricitabine. With simultaneous application lamivudine can slow down intracellular phosphorylation of emtricitabine. In addition, the development mechanism resistance to both lamivudine and emtricitabine is associated with a mutation in the same codon of the reverse transcriptase gene (M184V), and therefore therapeutic efficacy these drugs in combination therapy may be limited. Application lamivudine in combination with emtricitabine or fixed dose combinations containing emtricitabine, Not recommended.

Special instructions:

The use of lamivudine as a monotherapy is not recommended.

Transmission of HIV infection

Patients should be warned that treatment with antiretroviral drugs, including lamivudine, does not prevent the risk of HIV transmission to other people during sexual intercourse or blood transfusion. Therefore, patients should take appropriate precautions.

Opportunistic infections

In patients receiving lamivudine or other antiretroviral drugs, opportunistic infections or other complications of HIV infection may develop, so patients should be carefully monitored by a physician with experience in treating patients with HIV-associated diseases.

Impaired renal function

In patients with impaired function of moderate and severe severity, lamivudine concentration in the blood plasma is increased due to a decrease in the clearance of lamivudine, therefore dose adjustment is required.

Triple therapy with nucleoside analogues

A high incidence of virological response and early resistance was reported when co-administration of lamivudine with tenofovir with dizoproxil fumarate and abacavir, as well as with tenofovir dizoproxil fumarate and didanosine in the dosing regimen once a day was reported.

Pancreatitis

In patients who took lamivudine, rare cases of development of pancreatitis are described. However, it is not established whether this complication is caused by medications or the underlying disease - HIV infection. Treatment with the drug must be stopped immediately if clinical symptoms or laboratory evidence of pancreatitis develops (abdominal pain, nausea, vomiting, or increased biochemical markers). It is necessary to stop taking the drug before the diagnosis of pancreatitis is excluded.

Lactic acidosis and severe hepatomegaly with steatosis

There have been reports of the development in patients (predominantly in women) of lactic acidosis, severe hepatomegaly with steatosis, including fatal outcomes due to antiretroviral therapy with nucleoside analogues in the form of individual drugs, including lamivudine and its combination.

Clinical signs of developing lactic acidosis are: general weakness, anorexia, rapid unexplained weight loss, disorders of the gastrointestinal tract and respiratory organs (dyspnea and tachypnea).

Caution should be exercised when using lamivudine to treat any patient (especially obese women) with hepatomegaly, hepatitis, or other known risk factors for liver disease and steatosis of the liver (including the use of certain drugs and alcohol use). Patients with co-infection with hepatitis C and patients who receive treatment with alpha interferon and ribavirin may constitute a special risk group. The drug should be discontinued when clinical or laboratory signs of lactic acidosis or hepatotoxicity appear (including hepatomegaly and steatosis, even in the absence of a significant increase in aminotransferase activity).

Lipodystrophy

In some patients receiving combined antiretroviral therapy, there may be a redistribution and / or accumulation of subcutaneous fat, including obesity by the central type,dorsocervical fat deposition ("buffalo buffalo"), a reduction in the subcutaneous fat layer on the face and extremities, enlargement of the mammary glands, increased serum lipid concentrations and glucose concentrations in the blood, either individually or together.

Although all preparations from classes of protease inhibitors and nucleoside reverse transcriptase inhibitors can cause one or more of the above unwanted reactions associated with a general syndrome, often called lipodystrophy, the accumulated evidence suggests that there are differences between individual representatives of these classes of drugs in the ability to induce these undesirable reaction.

It should also be noted that lipodystrophy syndrome has a multifactorial etiology: for example, the stage of HIV infection, the elderly age and the duration of antiretroviral therapy play an important, possibly synergistic role in the development of this complication.

The long-term consequences of these undesirable phenomena are still unknown.

During the clinical examination, attention should be paid to the signs of redistribution of subcutaneous fat.It is necessary to closely monitor the serum lipids concentration and blood glucose concentration. If the lipid metabolism is disturbed, an appropriate treatment is prescribed.

Immunodeficiency Syndrome

If HIV-infected patients with severe immunodeficiency have asymptomatic opportunistic infections or their residual effects at the time of initiation of antiretroviral therapy, such therapy may lead to an increase in the symptoms of opportunistic infections or other severe consequences. Typically, these reactions occur within the first weeks or months after initiation of antiretroviral therapy. Typical examples are cytomegalovirus retinitis, generalized or focal infection caused by mycobacteria, and pneumonia caused by Pneumocystis jiroveci (R. carinii). The appearance of any symptoms of inflammation requires immediate examination and, if necessary, treatment.

Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) were observed against the background of restoration of immunity, but the time of primary manifestations varied, and the disease could occur many months after the initiation of therapy and have an atypical course.

Co-infection of HIV and viral hepatitis B or C.

Patients with chronic hepatitis B or C who are using combination antiretroviral therapy have an increased risk of developing severe and potentially lethal side effects from the liver. In the case of the joint use of lamivudine with other antiviral drugs for the treatment of hepatitis B and C, the appropriate instruction for the medical use of these drugs should be followed.

Research in vitro showed that ribavirin can reduce the phosphorylation of analogues of pyrimidine nucleosides such as lamivudine. Although data on the pharmacokinetic interaction of ribavirin with lamivudine are not available, there have been cases of decompensated liver function (sometimes fatal) in patients infected with HIV-1 with concomitant hepatitis C. receiving antiretroviral therapy for HIV-1 and interferon-alpha with ribavirin and without ribavirin. Patients receiving lamivudine and interferon alpha with ribavirin and without ribavirin should be carefully monitored for the toxicity of drug interactions, especially hepatic decompensation, neutropenia, and anemia.If clinical manifestations of toxicity, especially hepatic decompensation, are aggravated, lower doses or abolish alpha interferon should be avoided, ribavirin or both.

Clinical studies and post-registration data on the use of lamivudine suggest that in some patients with concomitant viral hepatitis B (HBV) Clinical or laboratory signs of hepatitis relapse after stopping lamivudine may appear, which may have more severe consequences in patients with uncompensated liver damage. After the termination of lamivudine therapy in patients with co-infection caused by HIV and hepatitis B virus, it is necessary to monitor the biochemical parameters of the liver function and markers of hepatitis B virus replication.

Mitochondrial dysfunction

Research in vitro and in vivo showed that the analogues of nucleosides and nucleotides can cause a different degree of damage to the mitochondria. Have been recorded cases of mitochondrial dysfunction in HIV-negative children who received intrauterine and / or post-nucleoside analogues. The main undesirable reactions were hematologic disorders (anemia, neutropenia), metabolic disorders substances (giperlactatemia, hyperlipazemia). These undesirable reactions are often transient. Some neurological disorders have been reported with late onset (increased muscle tone, convulsions, behavioral disorders). Are whether these neurological disorders are transient or permanent in the present time is unknown. Any child, even HIV-negative, exposed The intrauterine effect of analogues of nucleosides and nucleotides must pass Clinical and laboratory examination to exclude mitochondrial Dysfunction in case of revealing of corresponding signs or symptoms. This data do not influence the current national recommendations on the use of antiretroviral therapy in pregnant women for the prevention of vertical transmission of HIV infection.

Diseases of the liver

Patients with pre-existing liver dysfunction, including active chronic hepatitis, have an increased incidence of liver dysfunction during combined antiretroviral therapy and should be monitored in accordance with accepted practice.It is necessary to consider the possibility of suspending or stopping treatment in the event of a worsening of liver disease in such patients.

Osteonecrosis

Although the etiology of this disease is multifactorial (including the intake of glucocorticosteroids, alcohol consumption, severe immunosuppression, high body mass index), cases of osteonecrosis were most often encountered in patients at a late stage of HIV infection and / or who took long-term combined antiretroviral therapy. Patients should consult a doctor if they experience pain and stiffness in the joints or difficulty moving.

Preventive maintenance after probable infection of a HIV

According to international recommendations, if a person infected with HIV is likely to be infected via the blood, for example, through an injection needle), it is urgent (within 1-2 hours after the infection) to prescribe a combination therapy with zidovudine and lamivudine. In the case of a high risk of infection, a drug from the protease inhibitor group should be included in the antiretroviral regimen. Preventive treatment is recommended for 4 weeks.Data on the effectiveness of preventive treatment after accidental HIV infection have not been accumulated enough, no controlled studies have been conducted.

Despite the rapid onset of treatment with antiretroviral drugs, seroconversion can not be ruled out.

Effect on the ability to drive transp. cf. and fur:Special studies of the influence of lamivudine on the ability to drive vehicles and work with mechanisms have not been carried out. However, based on the pharmacological properties of lamivudine, this effect is unlikely. However, when assessing a patient's ability to drive vehicles or perform work that requires increased attention and speed of psychomotor reactions, his general condition and the nature of the adverse reactions of lamivudine should be considered.

Form release / dosage:Tablets, film-coated, 150 mg.

Packaging:

By 10, 12, 15, 20 tablets in a planar cell pack of film polyvinylchloride and aluminum foil printed lacquered.

By 2, 3, 4, 5, 6 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002982

Date of registration:29.04.2015

Expiration Date:29.04.2020

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

EvoFarm Ltd. Russia

Information update date: & nbsp11.02.2018

Illustrated instructions

Instructions

Lamivudine (Lamivudine)