Universal reference book for medicines
Product name: OLITID (OLITID)

Active substance: abacavir

Type: Antiviral drug active against HIV

Manufacturer: FARMASINTEZ (Russia)
Composition, form of production and packaging
The tablets covered with a film membrane
from light brown to brown color, round, biconcave;
on a cross-section of white color.
1 tab.

abacavir sulfate 175.5 mg,

which corresponds to the content of abacavir 150 mg

Excipients: giprolose 12 mg, sodium carboxymethyl starch 12 mg, silicon dioxide colloid 2 mg, magnesium stearate 2.5 mg, cellulose microcrystalline 49 mg.

Composition of the film shell: ready water-soluble film sheath 7 mg (hypromellose 74.2%, macrogol 6000 14.3%, titanium dioxide 3.5%, talc 2.3%, iron dye red oxide 1.4%, iron oxide oxide yellow 4.3%).

10 pieces.
- Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces.
- Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs.
- polymer cans (1) - packs of cardboard.
60 pcs.
- polymer cans (1) - packs of cardboard.
90 pcs.
- polymer cans (1) - packs of cardboard.
120 pcs.
- polymer cans (1) - packs of cardboard.
The tablets covered with a film membrane from light brown to brown color, oval, biconcave;
on a cross-section of white color.
1 tab.

abacavir sulfate 351 mg,

which corresponds to the content of abacavir 300 mg

Excipients: giprolose 24 mg, sodium carboxymethyl starch 24 mg, silicon dioxide colloid 4 mg, magnesium stearate 5 mg, cellulose microcrystalline 98 mg.

Composition of film shell: ready water-soluble film shell 14 mg (hypromellose 74.2%, macrogol 6000 14.3%, titanium dioxide 3.5%, talc 2.3%, iron dye red oxide 1.4%, iron oxide oxide yellow 4.3%).

10 pieces.
- Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces.
- Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs.
- polymer cans (1) - packs of cardboard.
60 pcs.
- polymer cans (1) - packs of cardboard.
90 pcs.
- polymer cans (1) - packs of cardboard.
120 pcs.
- polymer cans (1) - packs of cardboard.
The tablets covered with a film membrane from light brown to brown color, oval, biconcave;
on a cross-section of white color.
1 tab.

abacavir sulfate 702 mg,

which corresponds to the content of abacavir 600 mg

Excipients: giprolose 48 mg, sodium carboxymethyl starch 48 mg, silicon dioxide colloid 8 mg, magnesium stearate 10 mg, cellulose microcrystalline 196 mg.

Composition of the film shell: ready-made water-soluble film membrane 28 mg (hypromellose 74.2%, macrogol 6000 14.3%, titanium dioxide 3.5%, talc 2.3%, iron dye red oxide 1.4%, iron oxide oxide yellow 4.3%).

10 pieces.
- Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces.
- Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs.
- polymer cans (1) - packs of cardboard.
60 pcs.
- polymer cans (1) - packs of cardboard.
90 pcs.
- polymer cans (1) - packs of cardboard.
120 pcs.
- polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antiviral drug, nucleoside inhibitor of HIV reverse transcriptase.
It selectively suppresses 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 an active form of carbovir-5'-triphosphate-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-fold. 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 quickly and well absorbed from the digestive tract.
In adults, the absolute bioavailability of abacavir after oral administration is 83%. After ingestion of tablets, C max in the blood serum is achieved after 1.5 hours and is 3 μg / ml. The area under the pharmacokinetic curve "concentration-time" (AUC) for 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 the 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). 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 to AUC 0-24 with the same dose of the drug divided into 2 divided 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 mild liver function disorders (5-6 points on the Child-Pugh scale), the abacavir AUC was greater by an average of 1.89 times, and T 1/2 by 1.58 times.Dysfunction of liver function of mild degree does not affect the indices of 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).

DOSING MODE

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 a body weight of 14 to 21 kg 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 EFFECT

Hypersensitivity

According to clinical studies conducted before the screening for the presence of the HLA-B * 5701 allele, approximately 5% of patients taking abacavir had a hypersensitivity reaction, in rare cases fatal.
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 during the first 6 weeks of treatment (the median time of the onset of this reaction is 11 days).Symptoms of hypersensitivity reactions are given below.
From the skin and subcutaneous fat :? 10% - a 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.
On the part of 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.
From the hemopoietic system: lymphopenia is possible.

From the musculoskeletal system :? 10% - myalgia;
rarely - myolysis, arthralgia. increased activity of creatine phosphokinase (CK).
From the urinary system: possible - an increase in the concentration of serum creatinine, 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 a hypersensitivity reaction, then the re-administration of Olitide or other abacavir-containing medications is strictly contraindicated.
If patients continue to take abacavir during the development of the hypersensitivity reaction, the clinical manifestations become more pronounced, and when abacavir is abolished, they usually undergo 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 the hypersensitivity reaction develops, regardless of the carrier of the HLA-B * 5701 allele, the use of Olitide and other preparations containing abacavir should be permanently discontinued.
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, gastrointestinal or respiratory system disorders).

In rare cases, this reaction occurs when the abacavir is resumed in patients who had no symptoms of hypersensitivity before the drug was discontinued.

The nature of other adverse events other than the hypersensitivity reaction, but observed in patients receiving abacavir, is not fully understood.
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 has been 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 degeneration of the 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 aitiretroviral therapy (incidence is unknown).
Patients taking abacavir or other antiretroviral drugs may develop opportunistic infections or other complications of HIV infection.

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).

With caution: 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.
APPLICATION FOR FUNCTIONS OF THE LIVER

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

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

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

APPLICATION FOR CHILDREN

Children with a body weight of 14 to 21 kg 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.

Contraindicated for children under 3 years of age and weighing less than 14 kg.

SPECIAL INSTRUCTIONS

Hypersensitivity

According to clinical studies conducted before the screening for the presence of the HLA-B * 5701 allele, approximately 5% of patients taking abacavir.
develops a hypersensitivity to the drug, in rare cases with a fatal outcome.
Risk factors.
In clinical studies, carriage of the HLA-B * 5701 allele has been shown to significantly increase the risk of a hypersensitivity reaction to abacavir. In a prospective clinical trial of CNA106030 (PREDICT-1), patients with the presence of the HLA-B * 5701 allele did not receive drugs containing abacavir, 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), as well as the incidence of hypersensitivity reaction confirmed by the skin-application test from 2.7% (23 patients out of 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 carriers carrying the HLA-B * 5701 allele develop a hypersensitivity reaction compared to 0-4% of patients who do not have this allele.
Physicians are advised to screen for carriage of the HLA-B * 5701 allele 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 therapy.

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

The 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 the HLA-B * 5701 allele, abacavir should be abolished and not restarted in all cases where the hypersensitivity reaction can not be ruled out, based on clinical data, because of the risk of developing serious adverse effects or even a fatal outcome.
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 starting treatment with abacavir.
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 who received treatment with abacavir should be carefully observed for the occurrence of hypersensitivity during the first two months of treatment with consultations every two weeks, although it must be remembered that such a reaction may occur later, at any time.
Treatment.
When the symptoms of hypersensitivity to abacavir patient, regardless of the carrier allele HLA-B * 5701, should immediately contact your doctor for advice. Diagnosis of hypersensitivity reactions to abacavir requires immediate discontinuation. The resumption of treatment Olitid or other preparation comprising abacavir, patients with hypersensitivity reaction history strictly contraindicated because for several hours after taking the drug may re-growth reaction in a more severe form, up to life-threatening hypotension or death.
If we exclude hypersensitivity to abacavir should not be, in order to avoid late diagnosis and minimize the risk of developing life-threatening conditions, ABC canceled forever, even if there is another diagnosis (eg, a disease of the respiratory tract and lungs, influenza-like syndrome, gastroenteritis or undesirable effect of other drugs). No drug treatment should be resumed Olitid or other preparation containing abacavir, even in case of occurrence of symptoms giperchuvstvitelyyusti with repeated use of alternative medicines.
Specific guidance on the treatment after a break of therapy with abacavir.Regardless of the carrier allele HLA-B * 5701. if after the abolition of abacavir is expected resumption of treatment with this drug, you must determine the cause of the cancellation, and make sure that the patient was not observed symptoms of hypersensitivity. If we can not exclude giperchuvstvitelyyusti reaction, the treatment of any drug containing abacavir, is prohibited.
Described a few cases of hypersensitivity reaction when resuming treatment with abacavir after its cancellation in connection with the appearance of any one of the typical symptoms of hypersensitivity (rash, fever, malaise, fatigue, gastrointestinal disorders and disorders of the respiratory system). As in all such cases it is impossible to exclude hypersensitivity reaction, and taking into account the data of the more serious it within with repeated use of abacavir. the resumption of drug therapy containing abacavir in these patients is not recommended. However, if in such cases the question of the re-appointment of abacavir is solved positively, the treatment it is only carried out with the direct medical supervision.
Hypersensitivity reactions occur, albeit rarely, even with the resumption of treatment that contain the drug abacavir, patients who have symptoms of this reaction has not been seen before, and a break in the administration of drugs containing Abacavir has been associated with other causes. In this case, the resumption of the drug is possible, but requires the patient or the people around him quick access to medical care.
Screening for carriage of the allele HLA-B * 5701 is recommended to re-appointment of abacavir in patients of unknown HLA-B * 5701 status. previously well-tolerated therapy abacavir. Reappointment of abacavir patsentam carrier allele HLA-B * 5701 is not recommended and can be considered only in exceptional cases the floor close medical supervision, where the potential benefits of drug treatment exceeds possible risks.
Required information for the patients
physician prescribers should inform the patient with the following information on the hypersensitivity reaction:
- the patient must be aware of the possibility of life-threatening hypersensitivity symptoms and the risk of death, as well as an increased risk of hypersensitivity reactions in carriers of the allele HLA-B * 5701;
- the patient must be warned that even in the absence of the allele HLA-B * 5701 may develop giperchuvstvitelyyusti reaction. Thus, all patients for symptoms that may be due to hypersensitivity reactions should immediately contact your doctor;
- Patients with giperchuvstvitelnostyo to abacavir should be warned of non Olitid resumption of the drug or other preparations containing abacavir, regardless of HLA-B * 5701 -Status;
- in order to avoid re-use of the drug Olitid patients undergoing hypersensitivity reaction, it is recommended to recover the remaining drug tablets doctor;
- Patients, for any reason, have interrupted drug treatment Olitid (especially in relation to possible adverse reactions or complications of treatment), before the resumption of the drug should consult a doctor.
Lactic acidosis, hepatomegaly, and fatty liver
There have been reports of lactic acidosis development, hepatomegaly and hepatic steatosis, including deaths due to antiretroviral therapy, nucleoside analogs, including abacavir. taken either singly or in combination. In most cases, these complications occur in women.
Symptoms indicative of lactic acidosis include general weakness, loss of appetite, rapid weight loss of unknown etiology, disorders of the gastrointestinal tract and disorders of the respiratory system (dyspnea and tachypnea).
Use of abacavir-containing regimen in any patient requires caution, especially in the presence of risk factors of liver damage. When a clinical or laboratory signs of lactic acidosis or hepatotoxicity (may manifest hepatomegaly and hepatic steatosis, even in the absence of pronounced increase of aminotransferases) abacavir treatment should be discontinued.
Subcutaneous fat Redistribution
Combination antiretroviral therapy may be associated with the development of one or more of the following symptoms: obesity, redistribution of subcutaneous fat deposition it on the trunk, the neck ( "buffalo hump"), a significant reduction in subcutaneous fat in the limbs and face, gynecomastia, increased lipid concentrations in serum and blood glucose levels.
All these symptoms are manifestations of lipodystrophy. One or more of these symptoms may occur in the treatment of any inhibitors of HIV protease inhibitors and nucleoside reverse traiskriptazy. However, the risk of these adverse reactions depends on the preparation used.
Lipodystrophy syndrome has a complex etiology and may develop under the influence of different factors which can act synergistically. An important role in its development of the game itself, HIV infection, advanced patient age and duration of antiretroviral therapy.
Clinical examination of patients should pay attention to the redistribution of subcutaneous fat. Laboratory evaluation should include determination of serum lipid concentrations and blood glucose levels. In case of violation of lipid metabolism prescribe appropriate treatment.
mitochondrial dysfunction
Under conditions in vitro and in vivo ability vyyalena nucleotides and nucleoside analogues cause mitochondrial damage of varying degrees. There are reports of mitochondrial dysfunction in HIV-negative children exposed to the influence of nucleoside analogues in utero or shortly after birth. The main manifestations of mitochondrial dysfunction, often transient, were anemia, neutropenia, hyperlactatemia and increase the activity of lipase in the blood plasma. There have also been more recent manifestations of disorders: muscle hypertonicity, seizures, abnormal behavior.
Immune reconstitution syndrome
In the presence of HIV-infected patients with severe immune deficiency asymptomatic or oligosymptomatic opportunistic infections at the start of antiretroviral therapy (APT), the holding of such therapy may lead to increased symptoms of opportunistic infections or other serious consequences. Usually these reactions occur within the first weeks or months after the beginning of the APT. Typical examples are cytomegalovirus retinitis, lobular or generalized infection caused by a mycobacterium and pneumonia caused by Pneumocystis jiroveci (P. carinii). The appearance of any symptoms of inflammation requires immediate inspection and, if necessary, treatment. Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) observed on a background of immune reconstitution, however, the time of primary manifestations varied,and the disease could occur many months after initiation of therapy and have an atypical course.
Opportunistic infections
of abacavir or other antiretroviral drugs does not preclude the development of opportunistic infections and other complications of HIV infection, so patients must remain under the supervision of a physician who is experienced in the treatment of HIV-associated diseases.
Impaired Renal Function
In patients with impaired renal function dose adjustment of abacavir is necessary.
Liver failure

Application Olitid the drug in patients with hepatic impairment is contraindicated.
Patients with chronic hepatitis B or C,
risk of hepatotoxicity of antiretroviral drugs in patients with sochetanpoy HIV infection and hepatitis B or C higher than when only HIV. Therefore, patients with chronic hepatitis B or C which simultaneously receive antiretrovirals are at increased risk of adverse effects on the liver which can be fatal. For such patients should be closely monitored, both clinical and laboratory.
Abacavir and ribavirin share the same phosphorylation way, so you should consider the possibility of interaction between these drugs. When concomitant administration of abacavir and ribavirin may decrease the concentration of metabolites fosforilirovanpyh ribavirin, which in turn may reduce the effectiveness of treatment for patients infected with both HIV and hepatitis C virus who are receiving therapy with pegylated interferon and ribavirin. Be particularly careful while appointing abacavir and ribavirin.
HIV transmission
Carrying antirstrovirusnoy therapy, including abacavir. It does not exclude the possibility of sexual transmission or by contact with infected blood and therefore does not eliminate the need to observe proper precautions.
Myocardial infarction
In a prospective, observational, epidemiological study to examine the incidence of myocardial infarction in patients receiving an antiretroviral combination therapy, found an association prior, during 6 months, abacavir with an increased risk of myocardial infarction. According to a generalized analysis of clinical trials, no increased risk of myocardial infarction, conjugated abacavir. Biological mechanisms that explain the increased risk of potentially unknown. In general, the available data from monitoring cohorts and controlled clinical trials did not conclusively determine the relationship of therapy with abacavir and the risk of myocardial infarction.
Nevertheless, caution should be given antiretroviral therapy, including drugs containing Abacavir. patients with a possible risk of ischemic heart disease. It is necessary to take all measures to minimize the risk factors (such as hypertension, dyslipidemia, diabetes mellitus, and smoking).
Pancreatitis
Cases of developing pancreatitis in patients treated with abacavir, but a causal relationship to the use of the drug is not certain. When the pain in the abdomen, nausea, vomiting, or characteristic changes in biochemical parameters in patients receiving abacavir should exclude pancreatitis. Should stop taking the drug until such time as the diagnosis of pancreatitis will not be excluded.
osteonecrosis
Although the etiology of osteonecrosis is considered multifactorial (eg, corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index plays an important role in the development of this complication) of these cases reported, particularly in patients with advanced HIV infection / or duration of antiretroviral therapy. Patients should consult a doctor with the appearance of symptoms such as fatigue, stiffness, joint pain, or the appearance of difficulty in movement.
Impact on the ability to drive vehicles and mechanisms

Not conducted specific studies on the effect of abacavir on the ability to drive and use machines.
However, patients taking abacavir, you must take precautions or avoid driving and busy with other potentially hazardous activities that require high concentration and speed of psychomotor reactions, because the drug can cause side effects such as drowsiness, headache.
OVERDOSE

Symptoms: In clinical studies, patients received single doses up to 1200 mg of abacavir, and daily doses of up to 1800 mg. Reports of adverse reactions was not. Effect of higher doses of abacavir is unknown.
Treatment: In case of overdose is necessary to monitor the patient for evidence of toxicity, and the timely start of treatment. If necessary, symptomatic treatment is appointed. No data on the possible elimination of abacavir by hemodialysis and peritoneal dialysis.
DRUG INTERACTION

The results of in vitro studies and analysis of the major metabolic pathways of abacavir indicate that its interaction with other drugs, mediated by cytochrome P450 isozymes system is unlikely. Abacavir does not inhibit metabolism by CYP3A4 enzyme. In in vitro studies have shown that ABC does not suppress the activity izofe
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