Olitide pills 300mg 60pcs

Composition

Active ingredient:

Abacavir sulfate: 351.0 mg, which corresponds to the content of abacavir: 300.0 mg,

Auxiliary substances:

Hydroxypropylcellulose (Giprolose) – 24.0 mg;

sodium carboxymethyl starch (primogel) – 24.0 mg;

colloidal silicon dioxide (aerosil brand A-300) – 4.0 mg;

magnesium stearate-5.0 mg;

microcrystalline cellulose-98.0 mg.

Film shell:  Ready-made water-soluble film shell – 14.0 mg. (Shell composition: hydroxypropylmethylcellulose (hypromellose) – 74.2%, polyethylene glycol 6000 (Macrogol 6000) – 14.3%, titanium dioxide-3.5%, talc – 2.3%, iron oxide red dye-1.4%, iron oxide yellow dye-4.3%).

Pharmacological action

Pharmacotherapy group: Antiviral [HIV]agentath: J. 05. A. F. 06 Abacavir Pharmacodynamics : Antiviral drug, a nucleoside reverse transcriptase inhibitor of HIV. Selectively inhibits HIV-1 and HIV-2 replication (including HIV-1 strains resistant to zidovudine, lamivudine, zalcitabine, didanosine and nevirapine). Abacavir undergoes intracellular metabolism, converting to the active form of carbovir-5’ – triphosphate-an analog of deoxyguanosine-5’ – triphosphate. The mechanism of action of the drug is associated with the inhibition of HIV reverse transcriptase, which leads to the interruption of viral DNA synthesis and the termination of HIV replication. The possible development of resistance is associated with genotype changes in a certain codon region of reverse transcriptase (codons M184V, K65R, L74V, and Y115F). HIV resistance develops relatively slowly; multiple mutations are needed to increase the half-inhibitory concentration (IC50) of the drug by 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 the cerebrospinal fluid). Pharmacokinetics:

Abacavir is rapidly and well absorbed from the gastrointestinal tract (GIT). In adults, the absolute bioavailability of abacavir after oral use is 83%. After oral use of tablets, the maximum concentration (Cmax) in the blood serum is reached in 1.5 hours and is 3 mcg / ml. Area under the concentration-time pharmacokinetic curve (AUC) within 12 hours after taking the drug is 6 mcg/ml/h. Food slows the absorption of abacavir and reduces Cmax, but does not affect the AUC. Penetrates the blood-brain barrier, the concentration of abacavir in the cerebrospinal fluid is 30-44% of that in plasma. Plasma protein binding is low. It is metabolized in the liver with the participation of acetaldehydrogenase and the formation of glucuronide conjugates (5′ – carboxylic acid and 5′ – glucuronide). The elimination half-life (T1 / 2) is 1.5 h. It is excreted by the kidneys: 83% in the form of metabolites and 2% in unchanged form; the rest is excreted through the intestine. It doesn’t accumulate.

Special patient groups

Children

Abacavir is well and quickly absorbed when taken orally in children. All pharmacokinetic parameters in children are comparable with the corresponding parameters in adults. Pharmacokinetic studies in children have shown that taking the drug once a day is equivalent in AUC0-24 to taking the same dose of the drug divided into 2 doses. This will provide slightly higher average plasma concentrations of abacavir, so that in most children, therapeutic concentrations will be equivalent to the dosage regimen of 300 mg 2 times a day in adults.

Elderly patients

The pharmacokinetics of abacavir in patients over 65 years of age have not been studied. When treating elderly patients, it is necessary to take into account more frequent violations of liver, kidney and heart function at this age, as well as concomitant diseases and medications taken.

Patients with impaired renal function

Abacavir is mainly metabolized in the liver, less than 2% of it is excreted unchanged by the kidneys. The pharmacokinetics of abacavir in patients with end-stage renal insufficiency practically do not differ from those in patients with normal renal function. In patients with impaired renal function, the dose of abacavir should not be reduced.

Patients with impaired liver function

In patients with mild hepatic impairment (Child-Pugh score 5-6), the AUC of abacavir was 1.89 – fold higher on average, and T1/2-1.58-fold higher. Mild hepatic impairment does not affect the AUC of abacavir metabolites, but the rate of formation and elimination of metabolites decreases in such patients.

The pharmacokinetics of abacavir in patients with moderate to severe hepatic impairment have 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).

Use during pregnancy and lactation

It is possible if the expected effect of therapy exceeds the potential risk to the fetus (safety of use has not been established). Breast-feeding should be discontinued for the duration of treatment.

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.

Side effects

Hypersensitivity

According to clinical studies conducted prior to screening for the HLA-B*5701 allele, approximately 5% of patients taking abacavir experienced a hypersensitivity reaction, in rare cases with a fatal outcome. Hypersensitivity to abacavir is characterized by multiple organ damage. Most patients with hypersensitivity develop fever and rash (usually maculopapular or urticular) when this reaction develops, although in some cases these manifestations are absent. Symptoms of a hypersensitivity reaction may occur at any time after starting treatment with abacavir, but most often they occur during the first 6 weeks of treatment (the median time of onset of this reaction is 11 days). Symptoms of a hypersensitivity reaction are listed below.

Skin and subcutaneous fat disorders: ≥10% – rash (usually maculopapular or urticular).

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; possible liver failure.

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

Nervous system disorders: ≥10% – headache; possible paresthesias.

From the hematopoietic system:  possible lymphopenia.

Musculoskeletal disorders: ≥10% – myalgia; rarely-myolysis, arthralgia, increased creatine phosphokinase (CPK) activity.

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

Other: ≥10% – fever, fatigue, malaise; possible-edema, lymphadenopathy, hypotension, conjunctivitis, anaphylactic reactions. A hypersensitivity reaction can initially be regarded as a respiratory disease (pneumonia, bronchitis, pharyngitis, respiratory viral infection), gastroenteritis, or as undesirable reactions associated with taking other medications. Continuing to take abacavir with the development of a hypersensitivity reaction, as well as resuming its use after the symptoms subside, is fraught with serious consequences, up to a fatal outcome. Therefore, if any of the listed symptoms appear, a thorough examination of the patient is necessary to exclude a hypersensitivity reaction. If a hypersensitivity reaction cannot be excluded, then repeated use of Olitide or other abacavir-containing drugs is strictly contraindicated.

If patients continue to take abacavir with the development of a hypersensitivity reaction, the clinical manifestations become more pronounced, and when abacavir is discontinued, they usually reverse development. Resumption of abacavir treatment in patients with a history of hypersensitivity reaction leads to the development of a repeated reaction within a few hours. A repeated hypersensitivity reaction can be more severe than the first, and manifest itself in life-threatening arterial hypotension, up to a fatal outcome. If a hypersensitivity reaction develops, regardless of the carrier of the HLA-B*5701 allele, the use of Olitid and other drugs containing abacavir should be permanently discontinued.

Sometimes a hypersensitivity reaction develops when abacavir therapy is resumed after its withdrawal, caused by the appearance of only one of the main symptoms of this reaction (rash, fever, malaise, fatigue, gastrointestinal or respiratory disorders).

In rare cases, this reaction occurs when abacavir is resumed by patients who have not experienced any symptoms of hypersensitivity before discontinuation of the drug.

The nature of other adverse events other than a hypersensitivity reaction, but observed in patients receiving abacavir, is not fully clear. Whether these adverse events are due to the use of abacavir or other concomitant medications, or whether they are caused by the disease itself, has not yet been established.Many of the following undesirable effects associated with taking abacavir (nausea, vomiting, diarrhea, fever, fatigue, rash) can also occur with the development of a hypersensitivity reaction. Therefore, if any of these symptoms occur, a thorough examination of the patient is indicated to confirm or exclude a hypersensitivity reaction. If abacavir has been discontinued due to a suspected hypersensitivity reaction, it is prohibited to resume taking the drug. It is possible to resume abacavir therapy after interruption due to the appearance of the above symptoms only after excluding a hypersensitivity reaction and under direct medical supervision. Most of the adverse reactions listed below do not limit the use of abacavir. Determination of the frequency of adverse reactions: very common (> 1/10), common (1/100 to 1/10), infrequent ( 1/1000 to 1/100), rare (1/10 000 to 1/1000) and very rare (frequency below 1/10 000).

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

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

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

From the side of the hepatobiliary system: rarely – hepatitis, hepatomegaly, fatty liver disease.

Nervous system disorders: often – headache.

Skin and subcutaneous fat disorders: often-rash (in the absence of systemic manifestations); very rarely-erythema multiforme, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other services: often – fever, drowsiness, fatigue, loss of appetite.

Cases of osteonecrosis have been reported in patients with risk factors such as advanced HIV infection or long-term combination antiretroviral therapy (frequency unknown).

Patients taking abacavir or other antiretroviral drugs may develop opportunistic infections or other complications of HIV infection.

Interaction

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

Abacavir does not inhibit the metabolic processes involving the CYP3A4 enzyme. In vitro studies have shown that abacavir does not inhibit the activity of CYP3A4, CYP2C9, or CYP2D6 isoenzymes. Clinical studies did not reveal the 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 that are metabolized with the participation of the main cytochrome P450 isoenzymes is unlikely.

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

The use of abacavir concomitantly with rifampicin, phenobarbital, and phenytoin (UDP-glucuronyltransferase inducers) may result in a slight decrease in abacavir plasma concentrations.

Ethanol slows down the metabolism of abacavir, resulting in a 41% increase in the AUC of abacavir. 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 2 times a day in combination with methadone reduces the Cmax of abacavir in serum by 35%, increases the time to reach the maximum concentration in serum by 1 h, but does not change the AUC. The clinical significance of these changes is low. 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, it may be necessary to change the dose of methadone. Retinoids, such as isotretinoin, are eliminated with the participation of alcohol dehydrogenase, so they can interact with abacavir, but so far no special studies have been conducted.

Concomitant use of abacavir and ribavirin may reduce the concentration of phosphorylated ribavirin metabolites, which in turn may 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 prescribing abacavir and ribavirin at the same time.

How to take, course of use and dosage

The drug Olitide is taken orally, regardless of food intake.

Adults, children and adolescents weighing more than 30 kg

The recommended daily dose is 600 mg. The drug is prescribed at a dose of 300 mg 2 times a day or 600 mg 1 time a day.

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

For children with a body weight of 14 to 21 kg, the recommended dose is 150 mg 2 times a day or 300 mg 1 time a day.

For children weighing 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, no dose adjustment is required.

Patients with impaired liver function

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

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 overdose, it is necessary to monitor the patient’s condition in order to detect signs of intoxication and start treatment in a timely manner. If necessary, symptomatic therapy is prescribed. There are no data on the possibility of elimination of abacavir by hemodialysis and peritoneal dialysis.

Special instructions

Hypersensitivity

According to clinical studies conducted prior to screening for the HLA-B*5701 allele, approximately 5% of patients taking abacavir develop hypersensitivity to the drug, in rare cases with a fatal outcome. Risk factors. In clinical studies, it has been shown that carriage of the HLA-B*5701 allele significantly increases the risk of developing a hypersensitivity reaction to abacavir. In the prospective clinical study CNA106030 (PREDICT-1), patients with the HLA-B*5701 allele were not prescribed abacavir-containing drugs, 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 a hypersensitivity reaction confirmed by a skin application test from 2.7% (23 patients out of 842) to 0.0% (0 patients from 802) (pThus, based on the results of this study, it was shown that 48-61% of patients carrying the HLA-B*5701 allele develop a hypersensitivity reaction, compared to 0-4% of patients who do not have this allele. Doctors are advised to screen for the HLA-B*5701 allele in HIV-infected patients who have not previously been prescribed drugs containing abacavir. Screening is recommended prior to re-prescribing abacavir in patients with unknown HLA-B*5701 status who previously tolerated abacavir therapy well.

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

The clinical diagnosis of a suspected hypersensitivity reaction 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 discontinued and not resumed in all cases where a hypersensitivity reaction cannot be excluded based on clinical data, due to the potential risk of serious adverse effects or even death.

Clinical picture. Hypersensitivity to abacavir is characterized by the appearance of symptoms that indicate multiple organ damage. Most patients report fever and / or rash as part of the syndrome.

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

Hypersensitivity symptoms may occur at any time after starting treatment with abacavir, but most often they occur within the first six weeks. If abacavir treatment continues with the onset of hypersensitivity symptoms, they become more pronounced and may become life-threatening. After discontinuation of the drug, the symptoms of hypersensitivity usually reverse.

Patients who are prescribed treatment with abacavir should be carefully monitored for hypersensitivity during the first two months of treatment with consultations every two weeks, although it should be remembered that such a reaction may occur later, at any time.

Treatment. If symptoms of hypersensitivity to abacavir occur, the patient, regardless of the carrier of the HLA-B*5701 allele, should immediately consult the attending physician for advice. Diagnosis of a hypersensitivity reaction to abacavir requires immediate discontinuation of the drug. Resumption of treatment with Olitide or another drug containing abacavir in patients with a history of hypersensitivity reactions is strictly contraindicated, since within a few hours after taking the drug, the reaction may develop again in a more severe form, up to life-threatening hypotension or death. If hypersensitivity to abacavir cannot be ruled out, then in order to avoid late diagnosis and to minimize the risk of developing life-threatening conditions, abacavir is permanently discontinued, even if a different diagnosis is possible (for example, respiratory tract and lung disease, flu-like syndrome, gastroenteritis, or the undesirable effect of other drugs). Do not resume treatment with Olitide or any other drug containing abacavir, even if symptoms of hypersensitivity occur with repeated use of alternative medications. Special instructions for treatment after a break in abacavir therapy. Regardless of the carrier of the HLA-B*5701 allele, if treatment with this drug is expected to resume after abacavir withdrawal, it is necessary to find out the reason for withdrawal and make sure that the patient has not experienced symptoms of hypersensitivity. If it is impossible to exclude a hypersensitivity reaction, then treatment with any drug containing abacavir is prohibited. A few cases of hypersensitivity reactions have been described when abacavir treatment is resumed after discontinuation due to the appearance of any of the typical symptoms of hypersensitivity (rash, fever, malaise, fatigue, gastrointestinal disorders and respiratory disorders). Since in all such cases it is impossible to exclude a hypersensitivity reaction and, taking into account the data on its more severe course with repeated use of abacavir, it is not recommended to resume therapy with a drug containing abacavir in these patients. However, if in such cases the question of re-prescribing abacavir is resolved positively, then treatment with it is carried out only under direct medical supervision. Hypersensitivity reactions are noted, although extremely rarely, even when patients who have not previously experienced symptoms of this reaction resume treatment with abacavir-containing drugs, and the interruption in taking the drug containing abacavir was associated with other causes. In this case, it is possible to resume taking the drug, but it requires that the patient or people around him have quick access to medical care.

Screening for carriage of the HLA-B*5701 allele is recommended before re-prescribing abacavir in patients with unknown HLA-B*5701 status who previously tolerated abacavir therapy well. Repeated use of abacavir to patients carrying the HLA – B*5701 allele is not recommended and can only be considered in exceptional cases under close medical supervision, when the potential benefit of treatment with the drug exceeds all possible risks.

Essential information for patients

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

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

– the patient should be warned that even in the absence of the HLA-B*5701 allele, a hypersensitivity reaction may develop. Thus, all patients at the onset of symptoms, which may be due to hypersensitivity reactions should immediately contact their doctor, patients with hypersensitivity to abacavir should be warned about the inadmissibility of the resumption of drug Olite or other products containing abacavir, regardless of HLA-B*5701 status;

– to avoid re-use of the drug Olite patients who have had a hypersensitivity reaction, they are advised to return the remaining pills of the drug the doctor;

– patients for some reason interrupted treatment with Olite (especially in relation to possible adverse reactions or complications of treatment), before a resumption of taking the drug should consult your doctor.

Lactic acidosis, hepatomegaly, and fatty liver disease

Lactic acidosis, hepatomegaly and fatty liver disease, including fatal cases, have been reported due to antiretroviral therapy with nucleoside analogues, including abacavir, taken both individually and in combination. In most cases, these complications occur in women.

Symptoms that indicate lactic acidosis include general weakness, decreased appetite, rapid weight loss of unknown etiology, gastrointestinal disorders, and respiratory disorders (shortness of breath and tachypnea).

The use of abacavir-containing drugs in any patient requires caution, especially in the presence of risk factors for liver damage. If clinical or laboratory signs of lactic acidosis or hepatotoxicity appear (hepatomegaly and fatty liver disease may occur, even in the absence of a pronounced increase in aminotransferase activity), abacavir treatment 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 its deposition on the trunk, neck (“buffalo hump”), a significant decrease in the subcutaneous fat layer on the limbs and face, gynecomastia, increased serum lipids and blood glucose levels.

All these symptoms relate to the manifestations of 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 adverse reactions depends on the drug used

Lipodystrophy syndrome has a complex etiology and can develop under the influence of various factors that can act synergistically. HIV infection itself, the patient’s advanced age, and the duration of antiretroviral therapy play an important role in its development.

During clinical examination of patients, it is necessary to pay attention to the redistribution of subcutaneous fat. Laboratory testing should include determination of serum lipids and blood glucose levels. If there is a violation of lipid metabolism, appropriate treatment is prescribed.

Mitochondrial dysfunction

In vitro and in vivo studies revealed the ability of nucleotide and nucleoside analogues to cause various degrees of mitochondrial damage. There are reports of mitochondrial dysfunction in HIV-negative children exposed to nucleoside analogues in utero or immediately after birth. The main manifestations of mitochondrial dysfunction, often transient, were anemia, neutropenia, hyperlactatemia, and increased plasma lipase activity. There were also more recent manifestations of this disorder: hypertonicity of muscles, convulsions, behavioral abnormalities.

Immune recovery syndrome

If HIV-infected patients with severe immunodeficiency have asymptomatic or low-symptomatic opportunistic infections at the time of initiation of antiretroviral therapy (APT), such therapy may lead to increased symptoms of opportunistic infections or other severe consequences. These reactions usually occur within the first weeks or months after the start of APT. Typical examples are cytomegalovirus retinitis, generalized or focal infection caused by mycobacteria, and pneumonia caused by Pneumocystis jiroveci (P. 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 during immune recovery, but the time of initial manifestations varied, and the disease could occur many months after the start 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 doctor who has experience in treating HIV-associated diseases.

Impaired renal function

In patients with impaired renal function, no dose adjustment of abacavir is 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 effects of antiretroviral drugs in patients with co-infection with HIV and hepatitis B or C virus is higher than in the presence of HIV infection alone. Therefore, patients with chronic hepatitis B or C who are simultaneously taking antiretroviral drugs are at an increased risk of adverse effects on the liver with a possible fatal outcome.Such patients should be carefully monitored, both clinically and in the laboratory.

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

Concomitant use of abacavir and ribavirin may reduce the concentration of phosphorylated ribavirin metabolites, which in turn may 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 prescribing abacavir and ribavirin at the same time.

HIV transmission

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

Myocardial infarction

As a result of a prospective, observational, epidemiological study to study the incidence of myocardial infarction in patients receiving combined antiretroviral therapy, a link was found between the previous 6-month intake of abacavir and an increased risk of myocardial infarction. According to a generalized analysis of clinical trials, there was no increase in the risk of myocardial infarction associated with taking abacavir. The biological mechanisms that explain the potentially increased risk are unknown. In general, the available data obtained from cohort observations and controlled clinical trials do not allow us to unambiguously determine the relationship between abacavir therapy and the risk of myocardial infarction.

However, caution should be exercised when prescribing antiretroviral therapy, including drugs containing abacavir, to patients with a possible risk of coronary heart disease. All measures should be taken to minimize risk factors (such as hypertension, dyslipidemia, diabetes mellitus, and smoking).

Pancreatitis

There have been cases of pancreatitis in patients treated with abacavir, but the causal relationship with the use of the drug is not precisely established. If abdominal pain, nausea, vomiting, or characteristic changes in biochemical parameters occur in a patient receiving abacavir, pancreatitis should be excluded. You should stop taking the drug until the diagnosis of pancreatitis is excluded.

Osteonecrosis

Although the etiology of osteonecrosis is considered to be multifactorial (for example, corticosteroid use, alcohol consumption, acute immunosuppression, and elevated body mass index play an important role in the development of this complication), such cases are reported especially in patients with progressive HIV infection and/or long-term antiretroviral therapy. Patients should consult their healthcare provider if they experience symptoms such as lethargy, stiffness, joint pain, or difficulty moving. Influence on the ability to drive vehicles and mechanisms:

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

However, patients taking abacavir should take precautions, or avoid driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as the drug can cause side effects such as drowsiness, headache.

Storage conditions

Store in the original manufacturer’s packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package

Active ingredient

Abacavir

Conditions of release from pharmacies

By prescription

Dosage form

Tablets