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

Excipients: Hydroxypropylcellulose (Giprolose) 12.0 mg / 24.0 mg / 48.0 mg; carboxymethyl starch sodium (primogel) - 12.0 mg / 24.0 mg / 48.0 mg; silicon dioxide colloid (aerosil brand A-300) - 2.0 mg / 4.0 mg / 8.0 mg; magnesium stearate - 2.5 mg / 5.0 mg / 10.0 mg; cellulose microcrystalline - 49.0 mg / 98.0 mg / 196.0 mg.

Film Sheath: Finished water-soluble film shell - 7.0 mg, 14.0 mg, 28.0 mg.(Composition of the coating: hydroxypropylmethylcellulose (hypromellose) 74.2%, polyethylene glycol 6000 (Macrogol 6000) 14.3%, titanium dioxide 3.5%, talc 2.3%, iron dye red oxide 1.4% , iron oxide dye yellow oxide - 4.3%).

Description:

Dosage of 150 mg: round biconvex tablets covered with a film shell, from light brown to brown.

Dosage of 300 mg and 600 mg: oval, biconvex tablets, film-coated, from light brown to brown.

On a cross-section the tablets are white.

Pharmacotherapeutic group:Antiviral [HIV] agent

ATX: & nbsp

J.05.A.F.06 Abacavir

Pharmacodynamics:

Antiviral drug, nucleoside inhibitor of HIV reverse transcriptase. Selectively inhibits the replication of HIV-1 and HIV-2 (including HIV-1 strains resistant to zidovudine, lamivudine, zalcitabine, didanosine and nevirapine). Abacavir undergoes intracellular metabolism, becoming the active form of carbovir-5'-triphosphate, an analogue of deoxyguanosine-5'-triphosphate. The mechanism of action of the drug is associated with the inhibition of HIV reverse transcriptase, which leads to a breakdown in the synthesis of viral DNA and the cessation of HIV replication.Possible development of resistance is associated with changes in the genotype in a certain codon region of reverse transcriptase (codons M184V, K65R, L74V and Y115F). HIV resistance develops relatively slowly; Multiple mutations are required to increase the half inhibitory concentration (IC50) of the drug 8 times. The development of cross-resistance is unlikely. Increases the number of CD4 + cells in the blood and reduces the concentration of viral RNA (including in cerebrospinal fluid).

Pharmacokinetics:

Abacavir is rapidly and well absorbed from the gastrointestinal tract (GIT). In adults, the absolute bioavailability of abacavir after oral administration is 83%. After ingestion of tablets, the maximum concentration (C_max) in the blood serum is achieved after 1.5 hours and is 3 μg / ml. Area under the pharmacokinetic curve "concentration-time" (AUC) within 12 hours after taking the drug is 6 μg / ml / h. Food slows the absorption of abacavir and reduces C_max, but does not affect AUC. Penetrates through the blood-brain barrier, the concentration of abacavir in the cerebrospinal fluid is 30-44% of that in plasma. The connection with plasma proteins is low.Metabolised in the liver with the participation of acetaldehyde and the formation of glucuronide conjugates (5'-carboxylic acid and 5'-glucuronide). Half-life (T_1/2) - 1,5 hours. It is excreted by the kidneys: 83% in the form of metabolites and 2% in unchanged form; the remainder is excreted through the intestine. Do not cumulate.

Special patient groups

Children

Abacavir is well and rapidly absorbed when ingested in children. All pharmacokinetic parameters in children are comparable to those in adults. Pharmacokinetic studies in children showed that taking the drug 1 time per day is equivalent in terms of AUC_0-24reception of the same dose of the drug, divided into 2 doses. This will provide slightly higher average concentrations of abacavir in the blood plasma, so that in most children the therapeutic concentrations will be equivalent to the dosing regimen of 300 mg twice a day in adults.

Elderly patients

The pharmacokinetics of abacavir in patients older than 65 years has not been studied. In the treatment of elderly patients, it is necessary to take into account more frequent violations of the liver, kidney and heart function at this age, as well as concomitant diseases and medications taken.

Patients with impaired renal function

Abacavir is metabolized primarily in the liver, less than 2% of it is excreted by the kidneys unchanged. The pharmacokinetics of abacavir in patients with terminal stage of renal failure is practically the same as that of patients with normal renal function. In patients with impaired renal function, the dose of abacavir should not be decreased.

Patients with impaired hepatic function

In patients with impaired liver function of mild degree (5-6 points on the Child-Pugh scale) AUC Abacavir was more than an average of 1.89 times, and T_1/2 - in 1,58 times. Mild liver function disorders do not affect the performance AUC metabolites of abacavir, however, in such patients the rate of formation and excretion of metabolites decreases.

The pharmacokinetics of abacavir in patients with impaired liver function of moderate and severe degree has not been studied.

The use of Olitide in patients with hepatic insufficiency is contraindicated.

Indications:

HIV infection in adults and children (as part of combined antiretroviral therapy).

Contraindications:

Hypersensitivity to abacavir or any other component of the drug, liver failure, children under 3 years of age and body weight less than 14 kg (for this dosage form).

Carefully:

Pregnancy, patients with a possible risk of coronary heart disease.

Pregnancy and lactation:

Perhaps, if the expected effect of therapy exceeds the potential risk to the fetus (safety of use is not established). For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Olitide is taken internally, regardless of food intake.

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

The recommended daily dose is 600 mg. The drug is given in a dose of 300 mg 2 times a day or 600 mg once a day.

Children aged 3 years and over with a body weight of less than 30 kg

Children with body weight from 14 to 21 kg the recommended dose is 150 mg 2 times a day or 300 mg once a day.

Children with a body weight of more than 21 kg and less than 30 kg the recommended dose is 150 mg in the morning and 300 mg in the evening or 450 mg once a day.

Patients with impaired renal function:

In patients with impaired renal function, dose adjustment is not required.

Patients with impaired hepatic function

The use of Olitide in patients with hepatic insufficiency is contraindicated.

Side effects:

Hypersensitivity

According to clinical studies conducted before the screening for the presence of an allele HLA-B*5701, in about 5% of patients who took abacavir, there was a reaction of hypersensitivity, in rare cases with fatal outcome. Hypersensitivity to abacavir is characterized by multiple organ dysfunction. Most patients with hypersensitivity develop fever and rash (usually maculopapular or urticaria), although in some cases these manifestations are absent. Symptoms of hypersensitivity reactions may appear at any time after initiation of abacavir treatment, but most often they occur within the first 6 weeks of treatment (median time of onset of this reaction is 11 days). Symptoms of hypersensitivity reactions are given below.

From the skin and subcutaneous fat: ≥10% - rash (usually maculopapular or urticaria).

From the gastrointestinal tract: ≥10% - nausea, vomiting, diarrhea, abdominal pain; possible - ulceration of the oral mucosa.

From the liver and pancreas: ≥10% - increased activity of liver enzymes; liver failure is possible.

From the respiratory system: ≥10% - shortness of breath, cough; possible - sore throat, adult respiratory distress syndrome, respiratory failure.

From the nervous system: ≥10% - headache; Paresthesias are possible.

On the part of the hematopoiesis system: Lymphopenia is possible.

From the musculoskeletal system: ≥10% - myalgia; rarely - myolysis, arthralgia, increased activity of creatine phosphokinase (CK).

From the urinary system: possible - increased serum creatinine concentration, renal failure.

Other: ≥10% - fever, feeling tired, malaise; possible - edema, lymphadenopathy, arterial hypotension, conjunctivitis, anaphylactic reactions. The hypersensitivity reaction can first be regarded as a respiratory disease (pneumonia, bronchitis, pharyngitis, respiratory viral infection), gastroenteritis, or unwanted reactions associated with taking other drugs. Continued use of abacavir in the development of a hypersensitivity reaction, as well as the resumption of its administration after the symptoms subsided, is fraught with serious consequences, up to a fatal outcome.Therefore, if any of these symptoms appear, a thorough examination of the patient is necessary to exclude the hypersensitivity reaction. If you can not exclude hypersensitivity reaction, then re-administration of Olitide or other abacavir-containing drugs is strictly contraindicated.

If the hypersensitivity reaction develops, patients continue to take abacavir, the clinical manifestations become more pronounced, and when abacavir is abolished, they usually undergo a reverse development.

The resumption of admission of abacavir by patients with a history of hypersensitivity leads to the development of a second reaction within a few hours. Repeated hypersensitivity reactions can occur more severely than the first, and manifest life-threatening arterial hypotension, up to a lethal outcome. When developing a hypersensitivity reaction, regardless of the carriage of the allele HLA-B*5701, should always abandon the use of Olitide and other preparations containing abacavir.

Sometimes a hypersensitivity reaction develops with the resumption of abacavir therapy after its withdrawal,caused by the appearance of just one of the main symptoms of this reaction (rash, fever, malaise, fatigue, disorders of the gastrointestinal tract or respiratory system).

In rare cases, this reaction occurs when resuming admission of abacavir by patients who had no symptoms of hypersensitivity before the drug was discontinued.

The nature of other undesirable phenomena other than the hypersensitivity reaction, but observed in patients receiving abacavir, to the end is not clear. Whether these undesirable effects are due to the use of abacavir or other drugs concomitantly prescribed with it, or they are caused by the disease itself, have not been established to date.

Many of the following undesirable effects associated with taking abacavir (nausea, vomiting, diarrhea, fever, fatigue, rash) may also occur with the development of a hypersensitivity reaction. Therefore, when any of these symptoms are manifested, a thorough examination of the patient is performed to confirm or exclude a hypersensitivity reaction. If abacavir was canceled due to suspicion of a hypersensitivity reaction, resumption of the drug is prohibited. To resume abacavir therapy after interruption in connection with the appearance of the above symptoms is possible only after exclusion of the hypersensitivity reaction and under direct medical supervision. Most of the undesirable reactions listed below do not limit the use of abacavir. Determination of the frequency of adverse reactions: very often (> 1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100), rarely (from 1/10 000 to 1/1000) and very rarely (frequency below 1/10 000).

From the side of metabolism: often - hyperlactatemia; rarely - lactic acidosis, fat accumulation / redistribution, hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia.

The frequency of these unwanted reactions depends on many factors, including from antiretroviral drugs used in combination with abacavir.

From the gastrointestinal tract: often - nausea, vomiting, diarrhea; rarely - pancreatitis (the cause-and-effect relationship with the use of abacavir is not exactly established).

From the hepatobiliary system: rarely - hepatitis, hepatomegaly, fatty liver.

From the nervous system: often a headache.

From the skin and subcutaneous fat: often - a rash (in the absence of systemic manifestations); very rarely - multi-form exudative erythema, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other: often - fever, drowsiness, fatigue, loss of appetite.

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).

In patients receiving abacavir or other antiretroviral drugs, possibly developing opportunistic infections or other complications of HIV infection.

Overdose:

Symptoms: In clinical trials, patients received single doses of abacavir up to 1200 mg and daily doses up to 1800 mg. There were no reports of adverse reactions. The effect of higher doses of abacavir is unknown.

Treatment: In case of an overdose, it is necessary to monitor the patient's condition in order to detect signs of intoxication and timely initiation of treatment.If necessary, symptomatic therapy is prescribed. There is no data on the possibility of excretion of abacavir by hemodialysis and peritoneal dialysis.

Interaction:

Research results in vitro and analysis of the main metabolic pathways of abacavir indicate that its interaction with other drugs, mediated by isoenzymes of the cytochrome P450 system, is unlikely.

Abacavir does not inhibit the metabolism processes involving the enzyme CYP3A4. In studies in vitro shown, that abacavir does not suppress the activity of isoenzymes CYP3A4, CYP2C9 or CYP2D6. In the course of clinical studies, there was no evidence of induction of hepatic metabolism of exogenous substances under the action of the drug. Thus, the interaction of abacavir with HIV protease inhibitors and other drugs metabolized with the participation of the main isoenzymes of the cytochrome P450 system is unlikely.

Clinical studies have shown no clinically relevant interactions between abacavir, zidovudine and lamivudine.

The use of abacavir concomitantly with rifampicin, phenobarbital and phenytoin (inductors of UDP-glucuronyltransferase) can lead to a slight decrease in plasma abacavir concentrations.

Ethanol slows the metabolism of abacavir, which leads to an increase AUC abacavir by 41%. However, the clinical significance of this change is small. Abacavir does not affect the metabolism of ethanol.

According to pharmacokinetic studies, the use of abacavir at a dose of 600 mg twice a day in combination with methadone reduces C_m_Oh abacavir in serum by 35%, increases the time to reach the maximum serum concentration for 1 h, but does not change AUC. The clinical significance of these changes is small. The same study found that abacavir increases the total clearance of methadone by 22%. In most cases, these changes are also considered clinically insignificant, but in certain situations, a dose change in methadone may be required. Retinoids, for example isotretinoin, are derived with the participation of alcohol dehydrogenase, so they can interact with abacavir, but so far, no special studies have been conducted.

With simultaneous administration of abacavir and ribavirin, a decrease in the concentration of phosphorylated ribavirin metabolites is possible, which in turn can lead to a decrease in the effectiveness of treatment in patients infected with both HIV and hepatitis C virus,receiving therapy with pegylated interferon and ribavirin. Special care should be taken when concurrent administration of abacavir and ribavirin.

Special instructions:

Hypersensitivity

According to clinical studies conducted before the screening for the presence of an allele HLA-B*5701, in about 5% of patients taking abacavir, hypersensitivity to the drug develops, in rare cases with a fatal outcome.

Risk factors. In clinical studies, it has been shown that the carriage of an allele HLA-B*5701 significantly increases the risk of developing a hypersensitivity reaction to abacavir. In a prospective clinical study CNA106030 (PREDICT-1) patients with an allele HLA-B*5701 preparations containing abacavirwere not administered, which significantly reduced the incidence of a clinically suspected hypersensitivity reaction from 7.8% (66 patients out of 847) to 3.4% (27 patients out of 803) (p <0.0001), and the incidence of hypersensitivity reaction , confirmed by the skin-application sample from 2.7% (23 patients from 842) to 0.0% (0 patients from 802) (p <0.0001). Thus, based on the results of this study, it was shown that 48-61% of patients carrying alleles HLA-B*5701 a hypersensitivity reaction develops in comparison with 0-4% of patients in whom this allele is absent.

It is recommended that doctors screen for carriage of an allele HLA-B*5701 in HIV-infected patients who have not previously been prescribed drugs containing abacavir. Screening is recommended before the re-appointment of abacavir in patients with unknown HLA-B * 5701-status, who previously tolerated abacavir well.

Use of abacavir drugs is not recommended in patients who have an allele HLA-B*5701, and should be considered only in exceptional cases under close medical supervision, when the potential benefit exceeds the risk associated with the use of the drug.

Clinical diagnosis of suspected hypersensitivity reactions should remain the basis for deciding whether to use drugs containing abacavir, in all patients. Even in the absence of an allele HLA-B*5701 Abacavir should be discontinued and not restarted in all cases where the hypersensitivity reaction can not be ruled out, guided by clinical data, because of the potential risk of serious adverse effects or even death.

Clinical picture. Hypersensitivity to abacavir is characterized by the appearance of symptoms indicating multiorgan lesion. Most patients report a fever and / or rash as part of the syndrome.

Other symptoms of hypersensitivity to abacavir are: fatigue, malaise, gastrointestinal disturbances, including vomiting, nausea, diarrhea, and abdominal pain; disorders of the respiratory system, including shortness of breath, sore throat, cough, lung damage (mainly in the form of local infiltrative changes detected by chest x-ray).

Symptoms of hypersensitivity may appear at any time after initiation of abacavir treatment, but most often they occur within the first six weeks. If, when hypersensitivity symptoms appear, abacavir treatment continues, they become more pronounced and can take a life-threatening character. After the drug is discontinued, hypersensitivity symptoms are usually reversed.

Patients treated with abacavir should be observed with particular care for hypersensitivity during the first two months of treatment, with consultations every two weeks, although it should be remembered that,that such a reaction may appear later, at any time.

Treatment. When hypersensitivity symptoms to abacavir appear, the patient, regardless of the carriage of the allele HLA-B*5701, immediately should consult a doctor for advice. The diagnosis of a hypersensitivity reaction to abacavir requires immediate withdrawal of the drug. Renewal of treatment with Olitide or another drug containing abacavir, in patients with a history of hypersensitivity reaction, is strictly contraindicated, since within a few hours after taking the drug, a re-development of the reaction in a more severe form, up to the life threatening arterial hypotension or lethal outcome is possible.

If you can not exclude hypersensitivity to abacavir, then to avoid late diagnosis and to minimize the risk of life-threatening conditions, abacavir is canceled forever, even if another diagnosis is possible (for example, respiratory and lung disease, flu-like syndrome, gastroenteritis, or undesirable effects of other drugs). Do not resume treatment with Olitide or another drug containing abacavir, even if hypersensitivity symptoms appear in the re-use of alternative medications.

Special instructions for treatment after interruption of abacavir therapy. Regardless of the carriage of the allele HLA-B*5701, if after the abacavir withdrawal is supposed to resume treatment with this drug, you need to find out the reason for the cancellation, and make sure that the patient did not have symptoms of hypersensitivity. If the hypersensitivity reaction can not be excluded, then treatment with any drug containing abacavir, forbidden. A few cases of development of a hypersensitivity reaction during the resumption of treatment with abacavir after its withdrawal due to the appearance of any one of the typical symptoms of hypersensitivity (rash, fever, malaise, fatigue, gastrointestinal disturbances and respiratory system disorders) are described. Since in all such cases it is impossible to exclude the hypersensitivity reaction and, taking into account the data on its more severe course with repeated use of abacavir, the resumption of therapy with a drug containing abacavir, these patients are not recommended. However, if in such cases the question of re-appointment of abacavir is resolved positively, then the treatment is conducted only with direct medical supervision.

The hypersensitivity reaction is noted, although extremely rare, even with the resumption of treatment with abacavir-containing medication in patients who had not previously experienced symptoms of this reaction and a break in taking the drug containing abacavir, was associated with other causes. In this case, the resumption of taking the drug is possible, but requires the patient or people around him to have quick access to medical care.

Screening for carriage of an allele HLA-B*5701 It is recommended that the patient be re-assigned to abacavir in patients with unknown HLA-B * 5701 -status, previously well tolerated abacavir therapy. The re-administration of abacavir to the allele carriers HLA-B*5701 is not recommended and can be considered only in exceptional cases under careful medical supervision, when the potential benefit from drug treatment exceeds all possible risks.

Necessary information for patients

The doctor prescribing the drug should familiarize the patient with the following information about the hypersensitivity reaction:

- the patient should be aware of the possibility of life-threatening symptoms of hypersensitivity and the risk of death, as well as the increased risk of hypersensitivity reactions in the carriers of the allele HLA- B * 5701;

- patient should be warned that even in the absence of an allele HLA-B*5701 may develop a hypersensitivity reaction. Therefore, all patients should immediately contact their doctor if symptoms appear that may be due to the hypersensitivity reaction, patients with hypersensitivity to abacavir should be warned about the inadmissibility of resuming the use of Olitide or other preparations containing abacavir, regardless HLA-B*5701 -Status;

- In order to avoid the repeated use of Olitide in patients with hypersensitivity reactions, they are recommended to return the remaining tablets to the doctor;

- patients who for any reason interrupted treatment with Olitide (especially in connection with possible adverse reactions orcomplications of treatment), before resumption of taking the drug should consult a doctor.

Lactic acidosis, hepatomegaly and fatty liver

There are reports of the development of lactic acidosis, hepatomegaly and fatty liver disease, incl. with a fatal outcome, due to antiretroviral therapy with nucleoside analogues, including abacavir, taken either individually or in combination. In most cases, these complications occur in women.

Symptoms that indicate lactic acidosis include general weakness, decreased appetite, rapid weight loss of unclear etiology, gastrointestinal disturbances and respiratory system disorders (dyspnea and tachypnea).

The use of abacavir-containing drugs in any patient requires caution, especially in the presence of risk factors for liver damage. At the appearance of clinical or laboratory signs of lactic acidosis or hepatotoxicity (hepatomegaly and fatty liver disease, even in the absence of a pronounced increase in aminotransferase activity), treatment with abacavir should be discontinued.

Redistribution of subcutaneous fat

Combined antiretroviral therapy may be accompanied by the development of one or more of the following symptoms: obesity, redistribution of subcutaneous fat with deposition on the trunk, neck (buffalo hump), a significant reduction in the subcutaneous fat layer on the limbs and face, gynecomastia, increased serum lipid concentration and the level of glucose in the blood.

All these symptoms are related to lipodystrophy. One or more of these symptoms may occur when treated with any HIV protease inhibitors and nucleoside reverse transcriptase inhibitors. However, the risk of these unwanted reactions depends on the drug used

The syndrome of lipodystrophy has a complex etiology and can develop under the influence of various factors that can act synergistically. An important role in its development is played by HIV infection itself, the elderly patient's age and the duration of antiretroviral therapy.

When clinical examination of patients, it is necessary to pay attention to the redistribution of subcutaneous fat. The laboratory examination should include the determination of serum lipid concentrations and blood glucose levels.If the lipid metabolism is disturbed, an appropriate treatment is prescribed.

Mitochondrial dysfunction

In conditions in vitro and in vivo the ability of nucleotide and nucleoside analogs to cause damage to mitochondria of different degrees was revealed. There are reports of mitochondrial dysfunction in HIV-negative children who have been exposed to nucleoside analogues in utero or immediately after birth. The main manifestations of mitochondrial dysfunction, often transient, were anemia, neutropenia, hyperlactatemia and increased lipase activity in blood plasma. There were also later manifestations of this disorder: hypertonus of the muscles, convulsions, anomalies of behavior.

Immunodeficiency Syndrome

In the presence of HIV-infected patients with severe immunodeficiency asymptomatic or asymptomatic opportunistic infections at the time of initiation of antiretroviral therapy (Apt), the conduct of such therapy may lead to an increase in the symptoms of opportunistic infections or other severe consequences. Usually, these reactions occur within the first weeks or months after the onset Apt. 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.

Opportunistic infections

The use of abacavir or other antiretroviral drugs does not exclude the possibility of developing opportunistic infections or other complications of HIV infection, so patients should remain under the supervision of a physician with experience in the treatment of HIV-associated diseases.

Impaired renal function

In patients with impaired renal function, dose adjustment for abacavir is not required.

Liver failure

The use of Olitide in patients with hepatic insufficiency is contraindicated.

Patients with chronic hepatitis B or C

The risk of hepatotoxic effect of antiretroviral drugs in patients with co-infected HIV infection and the hepatitis B or C virus is higher than in the presence of only HIV infection. Therefore, patients with chronic hepatitis B or C who simultaneously take antiretroviral drugs are at increased risk of adverse effects on the liver with possible fatal outcome. These patients should be carefully monitored, both clinically and laboratory.

Abacavir and ribavirin have the same phosphorylation pathways, therefore, the possibility of interaction between these preparations should be considered.

With simultaneous administration of abacavir and ribavirin, a decrease in the concentration of phosphorylated ribavirin metabolites is possible, which in turn can lead to a decrease in the effectiveness of treatment in patients infected simultaneously with HIV and hepatitis C receiving pegylated interferon and ribavirin therapy. Special care should be taken when concurrent administration of abacavir and ribavirin.

Transmission of HIV infection

Antiretroviral therapy, incl.abacavir, does not exclude the possibility of sexual transmission of HIV or in contact with infected blood and therefore does not negate the need for appropriate precautions.

Myocardial infarction

As a result of a prospective, observational, epidemiological study in order to study the incidence of myocardial infarction in patients receiving combined antiretroviral therapy, a previous connection, within 6 months, of abacavir with an increased risk of myocardial infarction was found. According to the generalized analysis of clinical studies, there was no increase in the risk of myocardial infarction associated with abacavir. Biological mechanisms that explain a potentially increased risk are unknown. In general, the available data from observing cohorts and controlled clinical studies do not allow one to unequivocally determine the relationship between abacavir therapy and the risk of myocardial infarction.

However, care should be taken to prescribe antiretroviral therapy, including drugs containing abacavir, patients with a possible risk of coronary heart disease.It is necessary to take all measures to minimize risk factors (such as arterial hypertension, dyslipidemia, diabetes and smoking).

Pancreatitis

Cases of development of pancreatitis in patients who received abacavir, but the cause-and-effect relationship with the use of the drug is not exactly established. When there is abdominal pain, nausea, vomiting, or characteristic changes in biochemical parameters in a patient receiving abacavir, pancreatitis should be excluded. It is necessary to suspend the drug until the diagnosis of pancreatitis is not ruled out.

Osteonecrosis

Although the etiology of osteonecrosis is considered multifactorial (for example, taking corticosteroids, drinking alcohol, acute immunosuppression, increased body mass index play an important role in the development of this complication), these cases are reported in particular in patients with progressive HIV infection / or long-term antiretroviral therapy. Patients should seek medical advice from a physician if symptoms such as lethargy, stiffness, joint pain or difficulty with movement occur.

Effect on the ability to drive transp. cf. and fur:

No special studies have been conducted to study the effect of abacavir on the ability to drive and work with machinery.

Nevertheless, patients receiving abacavir, it is necessary to observe precautions, or to avoid driving and other potentially hazardous activities requiring increased attention and speed of psychomotor reactions, since the drug can cause side effects such as drowsiness, headache.

Form release / dosage:

Tablets, film-coated, 150 mg, 300 mg and 600 mg.

Packaging:

Primary packaging of medicinal product.

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 30, 60, 90, 120 tablets in a can of polymer with a lid pulled with the control of the first opening. Free space is filled with cotton wool. Labels are applied to cans from paper label or writing or from polymeric materials, self-adhesive.

Secondary packaging of medicinal product.

For 3, 6 contour mesh packages together with the instruction for use, a pack of cardboard is placed forconsumer tare subgroups chrome or chrome-ersatz or other similar quality. The packets are placed in a shipping container.

On 1 bank together with the instruction on application place in a pack from a cardboard for consumer tare of subgroups chrome or chrome - ersatz or other similar quality. The packets are placed in a shipping container.

Storage conditions:

In the original packaging of the manufacturer 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 expiration date indicated on the package

Terms of leave from pharmacies:On prescription

Registration number:LP-002263

Date of registration:04.10.2013 / 16.05.2016

Expiration Date:04.10.2018

The owner of the registration certificate:FARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Manufacturer: & nbsp

FARMSINTEZ, JSC Russia

Representation: & nbspFARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Information update date: & nbsp06.06.2017

Illustrated instructions

Instructions

Olitid (Olitid)