Caletra - Description of the drug, instructions for use, reviews. Caletra - instructions for use, side effects, reviews, analogues of Calelet ® or Reataz ®, what is better

Caletra is an innovative drug that produces a company from Britain Abbott laboratories.

The medication is an antiviral substance that has a serious impact on HIV infection. Doctors prescribe this tool for the treatment of detected HIV infection.

Under the influence of active compounds of this medication, the virus replication is braked, which provokes immunodeficiency in humans. Before applying the drug, it is important to know the dosage of the medicine and its composition.

Release form and composition

This medication is produced in several forms:

The following substances are active compounds in the composition of Tablets Caletra:

• lopinavir;
• ritonavir.

The following substances are the additional components in the composition of the Kaletra solution:

• sodium chloride;
• macrogol glycerilhydroxyistearate;
• sodium citrate.

The preparation in the form of tablets as additional components contains:

• kopovidon K28;
• sorbitan laurate;
• sodium stearilfumarate.

Indications for use

The instruction for use attached to the drug Caletra makes it possible to learn about the testimony for the use of this medication. In the reviews, too, you can learn about them. The main indication is the treatment of HIV infection. Kaletra can be used to brake development of HIV infection in adults, as well as in small patients from 3 years.

Application and dosage

Tablets Caletra are accepted inside. They are swallowed entirely, while it is not recommended to chew them or discern. You can take the drug not focusing on the reception time. The recommended dosage for adult patients is 400/100 mg two times during the day or 800/200 mg once a day. In such a dosage, only those patients who have not previously received antiretroviral therapy can take the drug.

For the same patients who previously passed such treatment, the dosage of the medication is 400 mg / 100 mg. The medicine in such quantities is accepted twice during the day. Experts do not prescribe such a dose once during the day.

If a patient has a decrease in lopinavir sensitivity, which was confirmed by laboratory and clinically, then in this case dose medication should be increased to 500/125 mg. The patient must take two pieces of 200/50 mg and one piece of 100/25 mg or take 5 pieces of 100/25 mg during the day in the case of a combination of fixed nonwaper, efavirenz.

Children who have weight 35 kilogram and body surface area more than 1.4 sq.mIt is recommended to assign a means in a dosage of 400/100 mg. The medicine is accepted twice during the day, and the reception of additional therapeutic means - nevirapine and efavirenz should be excluded. For small patients who have weight less than 35 kg and body surface area less than 0.6 sq. M., individually according to a special scheme calculate the dose of the drug. Patients of small age, which have a body surface area less than 0.6 square meters, a solution of claveters is recommended.

The preparation in the form of a solution is taken inside while eating. For adult patients, the dosage is 5 ml. During the day, therapeutic composition is taken twice. For patients who have not previously taken antiretroviral drugs, the dosage is 10 ml once within a day.

Patients who have previously carried out antiretroviral medication treatment, the solution is assigned to dosage 5 ml. The medicine is accepted twice during the day. A single daily dose for such patients is not recommended for such patients. If there was a decrease in the sensitivity to the Lopinavir, then the dosage of a solution of the calet persecution should be increased to 6.5 ml. The drug is accepted 2 times a day, subject to a combination of a drug with neviurapin or efavirenz.

In the dosage of the solution of the Kaletra in the treatment of children, the doctor should be repelled from a special scheme, in accordance with which the dosage of the drug depends on the combination of drugs, as well as the sensitivity of the patient to the Lopinavir, its weight and age. For children with a mass of body up to 15 kg, a single dose of the solution is determined, based on the following formula: 12/3 mg per 1 kg of the child's weight, and for children with a weight of 15 to 40 kg, it is guided by a normal 10 / 2.5 mg for 1 kg Weight.

A small patient must be determined for the patient a dosage of a medicinal solution twice during the day.

For children who have a weight of more than 40 kilograms, the daily dosage should not be more than 5 ml of solution. This amount of the patient should take 2 times during the day. With the simultaneous use of the main drug with ranitidine and the dose adjustment of the drug is not required. When carrying out combination therapy in adult patients using drugs such as nevirapin and Efavirenz, it is impossible to apply the taking a calerty once a day. And for a dose of 400/100 mg, which is accepted twice a day, the adjustment is not required.

During pregnancy

The early clinical studies have shown that during pregnancy in making adjustments to a prescribed dose, there is no need. Pregnant women are contraindicated with the use of Lopinavir and Ritonavir in the dosage 1 time during the day. This is due to the fact that there are few clinical and pharmacokinetic data on the influence on the body of women in the "interesting situation" of these substances.

Contraindications

Caletra, like any drug, has certain contraindications. From the application instructions, you can learn about the main restrictions to apply this tool. These include the following:

• severe liver diseases;
• simultaneous reception at once several means that affect the work of the heart, for example, statins, alkaloids of the ardines;
• treatment of newborns in the first six months of life;
• lactation period. If the drug Caletra is appointed for HIV therapy, for the period of treatment breast-feeding The child is stopped;
• pregnancy. But sometimes when entering the fetus, the reception of this medicine is prescribed. However, it occurs extremely rarely.

Side effects

On side effects that may occur in a patient when using this drug, you can learn from the instructions or reviews on the Internet. In patients during treatment, the following unpleasant symptoms arise:

Calewra: Price

The cost of the drug is the most important issue for each patient. Note that the drug Caletra in various pharmacies may have a different cost. This tool is quite expensive, so you need to be ready for serious spending on HIV-infection treatment with this drug. The minimum price tag on a caleter is 4322 rubles.

The highest price for this medication is 6338 rubles.

In order to reduce its costs for the purchase of this fund, you need to get acquainted with the prices in the nearest pharmacies, and then make a choice in favor of the best offer

You can also contact the Internet, where in electronic pharmacies this medicine is offered at an affordable price.

Calewra: Analogs

The absence of a drug or a lack of money for its acquisition can be a barrier to treat Kalelet. In such a situation, you can refer to the analogues of the medication, which are effective for the treatment of HIV infection. Some of them are more accessible compared to Calelet and can be effectively used to brake the development of HIV infection. The most common counterparts are the following drugs:

• Norvir;
• Rinvir;
• Ritonavir;
• Ritonavir 100.

Kaletra: instructions for use and reviews

Latin name: Kaletra.

ATX code: j05ae06

Active substance: Lopinavir + Ritonavir (Lopinavir + Ritonavir)

Manufacturer: Abbott (USA)

Actualization of the description and photo: 16.08.2019

Caletra - antiviral agent, active to the human immunodeficiency virus infection.

Release form and composition

Dosage forms:

• The solution for receiving inside: a transparent liquid of yellow or light yellow (60 ml in amber bottles of polyethylene terephthalate bucket with a dispenser, in a cardboard pack of 5 bottles and dispensers);
• Tablets covered with film shell: oval shape, with the engraving of the ebbott company logo, applied on one of the parties, and the letters "Al" on the tablets of red or "AC" - on pale pink (tablets with the engraving "Al" 120 pcs. , "AC" of 60 pcs. In high-blooded polyethylene bottles, in a cardboard pack of 1 bottle).

Active substances Calelet - Lopinavir and Ritonavir, their content (respectively):

• 1 ml of solution - 80 mg and 20 mg;
• 1 red tablet with engraving "Al" - 200 mg and 50 mg;
• 1 Pale pink tablet with engraving "AC" - 100 mg and 25 mg.

Auxiliary components:

• Solution: Sodium chloride, macrogol glycerylhydroxyistearate, sodium citrate, potassium acelifam, sodium saccharinate, lemonic acid Anhydrous, propylene glycol, ethanol, lemalentol, glycerol, povidone K-30, corn syrup with high content of fructose, Menthol oil, flavoring machine Motnamesvit 110 (2x) , Flavoring synthesized additive, vanilla flavor, purified water;
• Tablets: Kopovidon K28, sorbitan Laurat, silicon colloid dioxide, sodium stearilfumarate.

Additionally as part of a film shell tablets:

• Al-engraving tablets: Dajdray red - titanium dioxide, polysorbate 80, hypimloose 6 MPA, macrogol 400, hypimosellos 15 MPA, hypolosis, talc, macrogol 3350, silicon colloid dioxide, oxide dye (E172);
• Pavenk pink tablets with engraving "AC": Oddraya II pink 85F14399 - macrogol 3350, polyvinyl alcohol, talc, titanium dioxide, iron ocheside red (E172).

Pharmacological properties

Pharmacodynamics

Mechanism of action

Calelet is combined drugwhich contains ritonavir and Lopinavir.

Lopinavir - HIV-1 protease inhibitor and HIV-2 immunodeficiency virus (HIV). Provides antiviral effect. Thanks to the mechanism of inhibiting the HIV Kaletra protease, suppresses the synthesis of the virus proteins and prevents the GAG-POL polypeptide cleavage. This is the cause of the formation of an immature virus incapable of infection.

Ritonavir is an inhibitor of the Metabolism of Lopinavir in the liver indexed by CYP3A (the concentration of the latter in the blood plasma increases). In addition, Ritonavir inhibits HIV protease.

Resistance

In vitro were isolated HIV-1 isolates with reduced sensitivity to Lopinavir. In vitro The presence of ritonavir has not changed the release of Lopinavir resistant viruses.

When carrying out a clinical study, 37 patients who had previously received treatment, by 24, 32, 40 and / or 48 weeks, were analyzed in antiretroviral (ARV) therapy, 37 and / or 48 weeks was carried out with a plasma RNA content of more than 400 copies / ml. In all the evaluated patients undergoing ritonavir / lopinavir therapy, signs of phenotypic or genotypic resistance to ritonavir / Lopinavir were found. In children who have not previously received ARV treatment, the resistance to ritonavir / Lopinavir has also been detected.

At the second stage, clinical studies of the drug were conducted with the involvement of 227 HIV-infected patients who were previously obtained or did not receive antiretroviral treatment. In 4 patients out of 23 people with virological inefficient therapy (more than 400 copies of RNA HIV / ml), the sensitivity to the Lopinavir decreased after 12-100 weeks of applying the drug Caletra. At the same time, 3 of 4 patients had previously taken any HIV protease inhibitor (Savinavir, Indinavir or Nelfinavir), 1 of 4 patients was held by the combined therapy Indinavir, Ritonavir and Savicinavir. In all 4 patients, at least 4 mutations are recorded, which are associated with the resistance to HIV protease inhibitors prior to the start of the application of the Calelet. A further increase in viral load is due to the emergence of additional mutations that are associated with resistance to HIV protease inhibitors. This information is not enough to identify those responsible for the emergence of resistance to Lopinavir mutations.

Cross resistance

Data on the occurrence of cross-resistance in the treatment of ritonavir / Lopinavir is not enough.

Virological response to the use of ritonavir / Lopinavir changed in the presence of three or more of the following amino acid substitutions in the HIV protease gene: K20M / N / R, L10F / I / R / V, L33F, L24I, I47V, M36i, I54L / T / V, G48V, I84V, V82A / C / F / S / T. During the clinical study in vitro, the value of lowering the sensitivity to Lopinavir was studied on the basis of a virological response to the treatment with rhythonavir / lopinavir due to the original genotype and the virus phenotype. The study (M98-957) was carried out with the involvement of 56 patients with the number of HIV RNA more than 1000 copies / ml, which was previously prescribed therapy with Indinavir, Nelfinavir, Ritonavir and Savicinavir. These patients took one of the recommended doses of Ritonavir / Lopinavir in combination with nucleoside inhibitors of reverse transcriptase and efavirenz. Prior to treatment, the concentration of EC 50 Lopinavir (the concentration of the drug, providing replication suppression of 50% of viruses) in relation to 56 different virus strains was 0.5-96 times more EU 50 concentrations, effective against a wild-type virus. In this case, 31 out of 56 strains (55%) of the virus recorded a decrease in lopinavir sensitivity 4 times or more. On average, for 31 strains, sensitivity decreased by 27.9 times.

48 weeks after the first reception of ritonavir / Lopinavir, nucleoside inhibitors of reverse transcriptase and efavirenz HIV RNA concentration of less than 400 copies / ml was recorded in 25% (in 2 of 8), 73% (in 11 out of 15) and 93% (in 25 of 25 27) patients with a decrease in the initial sensitivity to Lopinavir, respectively, in ≥ 40 times, 10-40 times and ≤ 10 times. The HIV RNA concentration of less than 50 copies / ml in these groups was, respectively, in 25% (2/8), 60% (9/15) and 81% (22/27) patients.

To identify mutations that determine the development of resistance to Lopinavir, not enough data.

Pharmacokinetics

Absorption

The Pharmacokinetics of Lopinavir in combination with Ritonavir was studied with the involvement of HIV-infected patients and healthy volunteers. The essential differences between the two specified groups are not detected. Lopinavir is almost completely metabolized under the influence of CYP3A isoenzyme, and the use of ritonavir inhibits Lopinavir metabolism, causing an increase in its concentration in plasma. In cases of applying a Lopinavir / Ritonavir combination at a dose of 400/100 mg 2 times a day, the average equilibrium concentration of Lopinavir in plasma in HIV-infected patients exceeded the average equilibrium ritonavir concentration of 15-20 times. At the same time, the content of ritonavir in the plasma was less than 7% of its concentration in the case of ritonavir administration at a dose of 600 mg 2 times a day. In vitro EU 50 Lopinavir approximately 10 times less than the EU 50 ritonavir. Consequently, the antiviral activity with joint reception of Ritonavir and Lopinavir determines Lopinavir.

In the course of a pharmacokinetic study, in which HIV-positive patients (N \u003d 19) took part, for 3 weeks 2 times a day, together with food, a combination of Lopinavira / Ritonavir on 400/100 mg was prescribed. The average maximum blood plasma concentration (C max) was 9.8 ± 3.7 μg / ml, and the achievement time C Max is about 4 hours. Before the morning dose, the average equilibrium concentration was 7.1 ± 2.9 μg / ml. Within the dosing interval, the minimum concentration was 5.5 ± 2.7 μg / ml. For Lopinavir, the area under the pharmacokinetic curve "Concentration - Time" (AUC) for 0.5 days after receiving a caletist, averaged 92.6 ± 36.7 μg · h / ml. In combination with ritonavir, the absolute bioavailability of the Lopinavir was not installed.

Effect of food on absorption

With oral administration of the Lopinavir / Ritonavir solution and fatty food (872 kcal, 56% of calorie content is provided at the expense of fat) with MAH and AUC Lopinavir increased, respectively, by 56% and 130% compared to similar characteristics when receiving an empty stomach. To increase bioavailability and minimize the variability of pharmacokinetics, the solution is recommended to be used during meals.

Distribution

In the equilibrium state, 98-99% of Lopinavira binds to blood plasma proteins. Lopinavir binds to albumin and alpha 1-sour glycoprotein (higher affinity is observed to last). Binding of plasma proteins in equilibrium state remains constant in the range of concentrations registered after taking Lopinavira / Ritonavir at a dose of 400/100 mg 2 times a day. This indicator is comparable to HIV-positive patients and healthy volunteers.

Metabolism

In vitro Lopinavir is metabolized mainly when exposed to the CYP3A isoenzyme system of the liver cytochrome. Since ritonavir is a powerful inhibitor of the CYP3A isoenzyme inhibiting the metabolism of the Lopinavir, the reception of the combination of ritonavir and Lopinavir provides an increase in the concentration of the latter in the plasma. After a single application of 14 C-labeled Lopinavira / Ritonavira in a dose of 400/100 mg of 89% of radioactivity, it provides the initial drug. In the human body, 13 Lopinavir metabolites were revealed. The induction of cytochrome isoenzyme R 450 ritonavir provides induction of its own metabolism. For long use The concentration of Lopinavir before taking the next dose with time decreased, stabilizing approximately 10-16 days after 10-16 days.

Election

After 8 days after the use of 400/100 mg of 14 C-labeled Lopinavir / Ritonavir approximately 82.6 ± 2.5% and 10.4 ± 2.3% of the 14 C-Lopinavir received, respectively, in feces and urine. At the same time, the proportion of unchanged Lopinavir is, respectively, 19.8% and 2.2%. After a long use of less than 3% of the dose of the adopted Lopinavir unchanged, excreted through the kidneys. When oral administration, Lopinavir clearance (CL / F) is 5.98 ± 5.75 l / h.

Reception Calet 1 time per day

Pharmacokinetics of Lopinavira / Ritonavir when taking 1 time per day estimated at HIV-infected patients who have not previously taken antiretroviral drugs. In the case of a long (for 4 weeks) of the daily use of 800/200 mg of Lopinavira / Ritonavir, in combination with 200 mg of embrycitabine and 300 mg of tenofovir, 1 time per day in combination with meals, the value of the average maximum concentration of Lopinavir in the plasma was 11.8 ± 3 , 7 μg / ml, and the time of reaching with MAs is about 6 hours. Before applying the morning dose, the value of the average equilibrium concentration of Lopinavir was 3.2 ± 2.1 μg / ml, value minimum concentration Lopinavir within the 24-hour dosing interval - 1.7 ± 1.6 μg / ml. When taking 1 time per day, the Lopinavir AUC was 154.1 ± 61.4 μg · h / ml.

Special groups of patients

Elderly patients, Pharmacokinetics of Lopinavir did not study. Significant pharmacokinetic differences depending on the floor or race of adult patients are not fixed.

In the course of the study of the use of a calet perspective in children with the involvement of 53 patients, 0.5-12 years old, Lopinavira / Ritonavir pharmacokinetics was studied in the case of admission 2 times a day at 300/75 or 230 / 57.5 mg / m 2. With twofold use of 230 / 57.5 mg / m 2 Lopinavir / ritonavir without nevirapin or 300/75 mg / m 2 Lopinavira / Ritonavir with a newarenine plasma, the concentrations of Lopinavir are fixed, similar to those in adult patients who are 400 / pressed twice a day. 100 mg of Lopinavir / Ritonavir without nevirapin. The single use of Lopinavira / Ritonavir per day in children was not investigated.

The average equilibrium with Mach, C MIN and AUC of Lopinavir after taking 230 / 57.5 mg / m 2 of Lopinavira / Ritonavir 2 times a day without nevirapin (n \u003d 12) was, respectively, 8.2 ± 2.9 μg / ml, 3.4 ± 2.1 μg / ml and 72.6 ± 31.1 μg · h / ml. In the case of two-time reception 300/75 mg / m 2 Lopinavira / Ritonavir and Nevirapin (N \u003d 12), these indicators were, respectively, 10 ± 3.3 μg / ml, 3.6 ± 3.5 μg / ml and 85.8 ± 36.9 μg · h / ml. The following nevirapine reception schemes were respected: 2 times a day of 4 mg / kg (for patients older than 8 years) and 7 mg / kg (for patients 0.5-8 years).

In patients with renal failure, the study of Lopinavir pharmacokinetics was not carried out, however, due to a minor renal clearance, the likelihood of a reduction in overall clearance for the specified category is low.

Metabolism and removal of Lopinavir is mainly carried out by the liver. With long-term use of 400/100 mg of Lopinavira / Ritonavir 2 times a day in patients with light and medium hepatic insufficiency infected with the hepatitis C and HIV virus at the same time, an increase in Lopinavir AUC by 30% and with MAs - by 20% (in comparison with therapy HIV-infected patients with normal liver function). In patients with hepatic insufficiency, binding to blood plasma proteins is lower (99.09%) than in control groups (99.31%). Pharmacokinetics of Lopinavir / Ritonavir in patients with severe hepatic insufficiency did not study.

During pharmacokinetic studies, a slight decrease in Lopinavir's MAH and AUC in pregnant patients in the third trimester in comparison with II Trimester was found.

In the II trimester, HIV-infected pregnant patients, which were 400/100 mg of Lopinavira / Ritonavir, 2 times a day, were prescribed 400/100 mg of the tablets coated shell, the following pharmacokinetic parameters were recorded:

• AUC 0-12 - 68.7 μg · h / ml (variation ratio of 20.6%);
• With MAs - 7.9 μg / ml (variational coefficient 21.1%);
• the concentration of the drug in the blood before receiving the next dose (CPredose) is 4.7 μg / ml (variational coefficient 25.2%).

In the III trimester in HIV-infected pregnant patients, which were 400/100 mg of Lopinavira / Ritonavir in the tablet coated 2 times a day, the following pharmacokinetic parameters were recorded:

• AUC 0-12 - 61.3 μg · h / ml (variation coefficient 22.7%);
• With MAs - 7.5 μg / ml (variational coefficient 18.7%);
• CPREDOSE - 4.3 μg / ml (variational coefficient 39%).

In the postpartum period in HIV-infected pregnant patients, which were prescribed 400/100 mg of Lopinavira / Ritonavir in coated tablets 2 times a day, the following pharmacokinetic parameters were recorded:

• AUC 0-12 - 94.3 μg · h / ml (variation coefficient 30.3%);
• With MAs - 9.8 μg / ml (variational coefficient 24.3%);
• CPREDOSE - 6.5 μg / ml (variational coefficient 40.4%).

Medicinal interaction

In vitro Lopinavir / Ritonavir is a CYP3A isoenzyme inhibitor. In the case of the simultaneous use of Lopinavira / Ritonavir and drugs, metabolized by this isfeymol, the concentration of such drugs in the blood plasma may increase, and their side or therapeutic effect can be enhanced or extended.

Lopinavir / Ritonavir in therapeutic concentrations does not inhibit CYP2C9, CYP2D6, CYP2C1, CYP2D6, CYP2C1, CYP2C19, CYP1A2 or CYP2B6.

In vivo Lopinavir / Ritonavir induces its own metabolism, enhancing biotransformation of some drugs that are metabolized under the influence of the enzymes of the cytochrome system P 450 and by glucuron.

Since the isoenzyme CYP3A is involved in the metabolism of Lopinavira / Ritonavir, the receptions of the activity of this isoenzyme can lead to an increase in Lopinavir clearance, which in turn helps to reduce the concentration of Lopinavir in plasma. The simultaneous reception of Lopinavira / Ritonavir with other inhibitors of the CYP3A isoenzyme may be accompanied by an increase in plasma concentrations of Lopinavir.

Indications for use

According to the instructions, the kaletra is shown as part of the combined therapy of the human immunodeficiency syndrome (HIV infection) in adults and children.

Contraindications

• Breastfeeding period;
• Heavy liver failure;
• Simultaneous use with voriconazole, terpheneenadine, astemisol, triazolam, midazolam, cisapride, arcaloids (for example, ergometrine and methyl ergometrine, ergotamine and dihydroeergotamine), pimisid, lovastatin, jerobic preparations, printed, simvastatin, rifampicin;
• Increased sensitivity to the components of the drug.

With caution, it is recommended to prescribe a climbing patients with liver cirrhosis, viral hepatitis B and C, light and temperate liver failure, increased activity of hepatic enzymes, hemophilia A and B, dyslipidemia (including hypercholesterolemia, hyperitriglyceridemia), as well as patients over 65 years.

During pregnancy, the appointment of Calelet is possible if the estimated benefits exceed possible risk for the fetus and mother.

You can not apply:

• Solution: in babies up to 6 months;
• Tablets: in children under 3 years old.

Caution should take a patient's tablets with severe renal failure.

Instructions for use of Calelet: Method and Dosage

• Tablets: Take inside, swallowing only entirely (it is impossible to discern or chew), regardless of meals. Recommended dosing for adults: 400/100 mg 2 times a day or 800/200 mg 1 time per day for patients not previously received antiretroviral therapy; Patients previously obtained antiretroviral therapy - 400/100 mg 2 times a day, it is not recommended to assume a single daily dose reception. With suspected decline in the patient sensitivity to Lopinavir, confirmed laboratory or clinically, it is necessary to increase the dose of Calelet to 500/125 mg (2 pcs. By 200/50 mg and 1 pcs. 100/25 mg or 5 pcs. At 100/25 mg) with a combination with neviurapin, efavirenz, nelphinavir or amprenavir. Children with weight of more than 35 kg or with an area of \u200b\u200bbody surface top 1.4 sq.m. The recommended dosing is 400/100 mg 2 times a day without simultaneous reception of newaren, efavirenz, amprenavir or nonphinavir. Children with weight less than 35 kg and body surface area up to 0.6 sq.m. The doctor counts the dose of a special scheme individually. Children with an area of \u200b\u200bbody surface less than 0.6 sq.m. It is recommended to make a solution of a caleter;
• Solution: Take inside while eating. Recommended dosing for adults: 5 ml of solution 2 times a day or 10 ml 1 time per day for patients previously not taking antiretroviral drugs; Patients received antiretroviral therapy - 5 ml of solution 2 times a day, this category of patients is not recommended to assign a daily dose reception once. In the case of the estimated reduction in the sensitivity to Lopinavir, it is recommended to increase the dose of Calelet to 6.5 ml 2 times a day when combined with neuterapine or efavirenz. Dosing for children is determined by a physician according to a special circuit, it depends on the drug combination, sensitivity to Lopinavir, weight and age of the child. A single dose of solution for children with a body weight of up to 15 kg is determined at the rate of 12/3 mg per 1 kg of child weight, and 10 / 2.5 mg per 1 kg - for children from 15 to 40 kg. The method of calculated solution is prescribed 2 times a day. The daily dose for children with a weight of more than 40 kg should not exceed 5 ml of solution 2 times a day.

Correction of the dose of Calelet is not required while simultaneously use of ranitidine and omeprazole.

With the combined therapy of adults with neviurapin, Efavirenz, Nelphinavir, Amprenavir can not be appointed Calelet 1 time per day, and for a dose of 400/100 mg 2 times a day, the correction is not required.

Not studied the use of the drug in children 1 time per day.

Side effects

More than 2% of adult patients, the use of calet persecution causes serious and moderately pronounced side effects:

• General violations: fever, asthenia, chills;
• From the digestive system: diarrhea, abdominal pain, dyspepsia, nausea, meteorism, vomiting, dysphagia;
• From side nervous system: insomnia, headache, paresthesia;
• From the side of the cardiovascular system: arterial hypertension, vascular disorders;
• Mental disorders: depression, reduced libido;
• From the side of the skin and subcutaneous tissue: rash, lipodystrophy;
• From the metabolism and nutritional disorders: a decrease in body weight, anorexia;
• On the part of the musculoskeletal system: Malgy;
• Infections: bronchitis;
• From the endocrine system: amenorrhea, hypogonadism in men.

During the application of the Calelet, some (less than 2%) adult patients, the following side effects were observed, but their connection with the reception of the drug was not installed:

• General symptoms: malaise, chest pain and sternum, general and peripheral edema;
• Nourishing disorders and metabolism: dehydration, avitaminosis, diabetes mellitus, lactacidosis, increase in appetite, increase body weight, obesity;
• From side lymphatic system and blood: leukopenia, anemia, lymphadenopathy;
• From the side of the cardiovascular system: varicose extension veins, heartbeat, flickering arrhythmia, deep veins thrombosis, myocardial infarction, ortostatic hypotension, vasculitis, thrombophlebitis;
• From the side of the liver and biliary tract: cholecystitis, cholegitis, hepatitis, fatty deposits in the liver, hepatomegaly, jaundice, functional liver disorders;
• Infections: furunculosis, influenza-like syndrome, gastroenteritis, middle otitis, bacterial infections, pharyngitis, sinusitis, siastenitis, viral infections;
• From side immune system: allergic reactions;
• From the endocrine system: hypothyroidism, Cushing syndrome;
• From the nervous system: dizziness, drowsiness, neuropathy, amnesia, cerebral infarction, ataxia, cramps, encephalopathy, dyskinesia, extrapyramidal syndrome, muscular hypertonus, tremor, paralysis facial nerve, peripheral neuritis, migraine, perversion or loss of taste;
• Mental disorders: anxiety, sleep disorder, apathy, assessment, confusion, nervousness, emotional lability, impaired thinking;
• By the body of the vision: violation of vision;
• From the vestibular apparatus and organ of hearing: dizziness, noise in the ears;
• By the respiratory system: shortness of breath, asthma, rhinitis, cough strengthen, pulmonary swelling;
• From the digestive system: dry mouth, belching, constipation, enterocolit, enteritis, esophagitis, gastritis, incontinence, hemorrhagic colitis, stomatitis and ulcerative Stomatitis, periodontitis, pancreatitis;
• From the side of the skin and subcutaneous tissue: dry skin, itching, alopecia, acne, eczema, swelling of the face, exfoliative dermatitis, maculopapulous rash, seborrhea, skin color, strry, skin ulcers, sweating, changes in the structure of nails;
• From the kidneys and urinary tract: jade, kidney stones;
• Malignant, benign and unspecified tumors: benign tumors skin, cysts;
• From the reproductive system: impotence, gynecomastia, increase in informs, ejaculation disruption;
• On the side of the musculoskeletal system: pain in the back, muscle weakness, arthralgia, osteonecrosis, arthrosis, changes in the joints;
• Changes in laboratory indicators: an increase in total cholesterol and bilirubin, glucose content, triglycerides, amylase, uric acid, an increase in the activity of alaninotransferase (ALT), aspartataminotransferase (AST), GMMA-glutorattranspendase (GHT), neutropenia, reducing the level of inorganic phosphorus.

Unwanted phenomena in children from 6 months to 12 years old were similar to those in adults, most often observed properties of taste, rash, vomiting, diarrhea.

Individual cases of Stevens-Johnson's syndrome, hepatitis, bradiarhythmia, multifamine erythema were also observed.

Overdose

There are data on the cases of overdose of the riotra solution for oral reception. In case of accidental overdose, the premature babies were observed the following side effects: cardiomyopathy, full atrioventricular blockade, acute renal failure, lactate acidosis. The solution contains propylene glycol 15.3% (w / v) and ethanol (42.4% vol. / OB.), Therefore, to prevent the overdose of Lopinavir / Ritonavir, the accurate calculation of the dose of the drug should be performed very carefully (especially when it is prescribed to babies and early children).

Clinical data on acute overdose of Lopinavir / Ritonavir are limited. Specific antidote is absent. Therapy implies measures to maintain the life support of the body, including the control of vital functions of the body and clinical condition patient. If necessary, washing the stomach and the use of activated carbon.

Since Lopinavir / Ritonaviru with blood plasma proteins are high, the use of dialysis is inappropriate. At the same time, in the case of an overdose of the solution, the kaletra can be assigned dialysis to remove propylene glycol and ethanol.

special instructions

With extreme caution, it is recommended to assign simultaneous use of any intranasal and inhalation glucocorticosteroids (GKS), since there is a big risk of developing system side effects. If you need long-term use of GKS, it is advisable to assign other form of their form.

When combined with tadalaphil, sidenafil or vardenafil, their concentration in the blood plasma increases, this may lead to arterial hypotension and long-term erection.

Calelet must be taken as a standard dose for 10 days before the appointment of rifampicin, since their simultaneous reception causes a dose-dependent decrease in the concentration of Lopinavir in the blood plasma. Then under the careful control of the liver function, it is possible to title a dose of the caleter in the direction of magnification.

In patients with functional impairment of the liver, the concentration of active substances in the plasma is increasing, so they need to be treated under regular careful control of laboratory indicators, including AST activity, Alt.

Against the background of taking protease inhibitors in patients, there were cases of hyperglycemia, diabetic ketoacidase and decompensation sugar diabetesBut their connection and frequency are clinically not installed.

In patients with progressive HIV infection in the treatment of Kalelet, the likelihood of pancreatitis and hyperitriglyceridemia or the risk of exacerbation in patients with pancreatitis in history is increasing.

There is a different degree of severity of cross-resistance of protease inhibitors, the study of the effect of the calet perspective on the effectiveness of other protease inhibitors during subsequent therapy continues.

The therapy of protease inhibitors causes cases of bleeding, spontaneous formation of subcutaneous hematomas, the development of hemarrosis in patients with type A and V. Hemophilia

Against the background of the use of the drug in patients, there may be external changes associated with the Kushingoid and an increase in the mammary glands, the redistribution or accumulation of fatty sediments in the field of the back and neck with a simultaneous decrease in fat on the face and limbs.

Prior to the use of Calelet and the whole period of therapy, the level of cholesterol and triglycerides concentration should be regularly monitored, in the case of lipid disorders, the appointment of the corresponding medicines.

At the beginning of the combined antiretroviral therapy with Kalelet, the patients may be exacerbated by residual or asymptomatic opportunistic infections that cause a need for an additional survey and treatment.

Patients should be informed about the need to appeal to the doctor when stiffness and joint pain appear, impaired motor function, as these features may be associated with the development of osteozecosis.

Given the frequency of accompanying diseases, reducing the function of the kidneys, liver or heart and concomitant therapy in patients over 65 years, should be used with caleter in patients in this category.

During the period of therapy, patients are prohibited from managing vehicles and mechanisms and other potentially hazardous activities, the implementation of which requires the concentration of attention and high velocity of psychomotor reactions.

Application during pregnancy and lactation

During pregnancy, it is forbidden to apply Caletra in mode 1 time per day.

The effect of Lopinavira / Ritonavir in the form of tablets was estimated at 3366 pregnant women. These studies indicate that the reception of the drug does not lead to serious congenital deposits Development in comparison with the initial frequency of their occurrence. If necessary, Lopinavir / Ritonavir in the form of tablets can be used during pregnancy.

The solution in the form of a solution is allowed to apply in pregnant women if the expected benefits for the mother is higher than the potential risk for the fetus.

During the lactation period, when taking a kaletra, it is necessary to stop breastfeeding.

Childcare

It is forbidden to apply Calet's tablets for the treatment of patients under the age of 3 years (children of 0.5-3 years, the drug is prescribed as a solution for oral administration). Also, tablets are forbidden to apply for the treatment of patients under the age of 18 years per day.

Caletra in the form of a solution for oral administration is contraindicated to apply for the treatment of patients under the age of 6 months, and under the age of 18, it is necessary to use with caution.

With violations of the kidney function

In renal failure, the kaletra solution should be used with caution, and tablets - without restrictions.

When violations of the liver function

With severe liver failure, it is contraindicated to apply Calelet. With mild and medium liver failure, as well as with cirrhosis, the drug should be used with caution.

Application in old age

In the treatment of elderly patients (from 65 years), the caleter should be used with caution.

Medicinal interaction

An oncologist prescribes simultaneously taken preparations, given the high activity of the active substances of the cuelet, their dose and the age of the patient.

Analogs

Kaletra's analogues are: Alvia, Lopicipa, Emletra, Baratooth, Victakelis, Victor, Lamivudine, Viraspt, Indilir-400, Lopicipa, Nelvir, Olizio, Reataz, Ritam, TVZir.

Terms and conditions of storage

Store at temperatures: solution - 2-8 ° C, tablets - 15-30 ° C. Take care of children.

Shelf life: mortar - 2 years, tablets - 4 years.

Kaletra (Kaletra)

Structure

Each tablet Calelet contains:

Ritonavir - 25 mg;

Lopinavir - 100 mg;

Other components: silicon dioxide colloid, sorbitan laaurat, copovidon K28, sodium stearylfumarate, Oddraya II pink.

pharmachologic effect

Caletra - an antiviral drug used in HIV therapy. Kaletra is a complex means containing Ritonavir and Lopinavir.

Lopinavir is a substance of a group of inhibitors of proteases HIV-1 and HIV-2. Lopinavir warns the synthesis of virus proteins due to inhibition of HIV proteases, also prevents the cleavage of the GAG-POL polypeptide, as a result of which is unable to infect and immature virus.

Ritonavir - inhibits Lopinavir metabolism, which takes place with the participation of CYP3 A4 in the liver, which leads to an increase in serum Lopinavir levels. Ritonavir also has the activity of the HIV protease inhibitor.

Resistance

HIV-1 isolates having a reduced sensitivity to Lopinavir were selected in vitro (the presence of ritonavir did not affect the selection of strains of resistant to Lopinavir). In the course of research in all the evaluated patients who took Ritonavir / Lopinavir, there were no signs of phenotypic or genotypic resistance to therapy. Children who have not previously received antiretroviral therapy also did not have resistance.

At the second stage of clinical studies, Calelet in 227 patients with HIV, which were previously obtained or did not receive antiretroviral therapy, resistance was revealed in 4 of 23 patients with the absence of virological efficiency of therapy (HIV RNA indicators of more than 400 copies / ml). In these patients, the ability to reduce the efficiency of the kaletra was recorded after 12-100 weeks from the beginning of the reception, while 3 of the 4 patients received earlier therapy with one of the HIV protease inhibitors, and 1 of 4 patients received a combined treatment of protease HIV inhibitors. All 4 patients identified mutations that are associated with the insensitivity to the HIV protease inhibitors.

Cross resistance

Data on cross-resistance when using ritonavir / Lopinavir are limited.

Virological response Against the background of therapy with ritonavir / Lopinavir changed during the presence of 3 and more amino acid substitutions in HIV genes proteases (in particular I84V, L33F, L24I, K20M / N / R, I54L / T / V, G48V, I47V, L10F / I / R / V, V82A / C / F / S / T, M36I).

The clinical significance of a decrease in in vitro sensitivity to Lopinavir was studied on the basis of a virological response to the use of ritonavir / lopinavir, taking into account the original phenotype and the virus genotype in 56 patients with HIV RNA more than 1000 copies / ml, which were previously obtained Indinavir, Ritonavir, Nelfinavir or Savinavir. Patients recommended Ritonavir / Lopinavir in one of the doses in combination with nucleoside inhibitors of reverse transcriptase and efavirenz. Prior to treatment, the EC50 indicators of Lopinavir for 56 virus strains were higher than 0.5-96 times in comparison with the EC50 for the "wild" type virus. In 31 out of 56 strains determined the decrease in the sensitivity to Lopinavir in 4 or more times, the average loss of sensitivity among 31 strains reached 27.9 times. After 48 weeks from the start of ritonavir / Lopinavir, the nucleoside inhibitor of reverse transcriptase and efavirenz HIV RNA levels less than 400 copies / ml were recorded in 25 of 27, 11 of 15 and 2 of the patients, the initial sensitivity to the Lopinavir was reduced, respectively, Less than 10 times, 10-40 times and more than 40 times (HIV RNA concentration of less than 50 copies / ml was recorded in 22 of 27, 9 of 15 and 2 of 8 patients, respectively). For a more detailed study of mutations that lead to the development of leopavir resistance, additional research is required.

Pharmacokinetic profile of the drug Caletra

There were no significant differences in the pharmacokinetic profile of Ritonavir / Lopinavir at volunteers (healthy) and HIV-positive patients.

Lopinavir is almost completely transformed into a liver with the participation of CYP3 A4, while the rhythonavir is inhibited by the conversion of Lopinavir, leading to an increase in the serum levels of the latter.

When using Ritonavir / Lopinavir at a dose of 100/400 mg twice a day, the average equilibrium levels of Lopinavir serum 15-20 times higher than the levels of ritonavir, the levels of ritonavir were no more than 7% of the 600 mg at the reception.

EC50 Lopinavir in vitro is 10 times lower for ritonavir (the antiviral efficiency of the calet persecution is determined mainly by the action of Lopinavir).

Peak levels of Lopinavir in serum when taking a Tablet Kaletra (4 twice a day) make up about 9.8 ± 3.7 μg / ml and are reached on average 4 hours after taking tablets. The average equilibrium levels in front of the morning dose reached 7.1 ± 2.8 μg / ml, minimal levels between dose meters were 5.5 ± 2.7 μg / ml.

Up to 99% of Lopinavir serum is associated with proteins. Ritonavir / Lopinavir with urine and feces are excreted.

In the elderly patients, the pharmacokinetics of Tablets Kaletra did not study.

When taking doses of the drug Caletra, corresponding age recommendations Dosing, children noted the similarity of pharmacokinetics with such in adult patients.

Kaletra was not studied in patients with kidney failure; If we take into account the low clearance of Lopinavir kidneys, we can say that significant changes in the pharmacokinetics of the drug in such patients are not expected.

With moderate liver failure, an increase in Lopinavir AUC is 30% and maximum concentrations by 20%. With severe liver failure, the drug Caletra has not been studied.

Indications for use

Caletre is used in the combined treatment of adults and children over 3 years old with HIV infection.

Mode of application

Tablets Calelet are designed to receive orally. When taking, it is necessary to maintain the integrity of the shell. It is allowed to use Tablets Caletra regardless of food.

Dosing in adult patients:

An alternative scheme is to receive 8 tablets of Caletra once a day. This scheme can be recommended only to patients who have revealed no more than 3 mutations that are related to the mechanisms for the development of resistance to the action of Lopinavir.

If omeprazole or ranitidine is used in integrated therapy, the dose correction of the caleter tablets is not required.

If the patient is prescribed a complex therapy using efavirenza, amprenavir, nevirapine or nonphinavir (with suspicion of low sensitivity to Lopinavir, including if the patient received antiretroviral therapy), the dose of the drug Caletra increases to 5 tablets twice a day.

Dosing in children:

Adult doses of the drug Caletra (4 tablets twice a day) can be assigned to patients without combined therapy with NTFIFINAVIM, Efavirenz, newarenin or amprenavir if the body's mass and body surface area are more than 35 kg and 1.4 m2.

The dose of Tablets Caletra for children with a body weight to 35 kg and an area of \u200b\u200bbody surface (PPT) 0.6-1.4 m2 is determined individually:

Without appointing Efavirenz, Amprenavir, Nevirapine or Neverphinavir:

At PPT 0.6-0.9 m2 and the mass of 15-25 kg is prescribed 2 tablets of Caleter twice a day.

With PPT 0.9-1.4 m2 and a mass of 25-30 kg, 3 tablets of Caletra are prescribed twice a day.

With PPT more than 1.4 m2 and mass more than 35 kg, 4 tablets of Caletra are prescribed twice a day.

With the combined appointment of Efavirenz, Amprenavir, Nevirapine or Never Nephinavir:

At PPT 0.6-0.8 m2 and weight of 15-20 kg, 2 tablets of Caletra are prescribed twice a day.

With PPT 0.8-1.2 m2 and weight of 20-30 kg, 3 tablets of Caleter are prescribed twice a day.

At PPT 1.2-1.7 m2 and mass 30-45 kg, 4 tablets of Caletra are prescribed twice a day.

With PPT more than 1.7 m2 and mass of more than 45 kg, 5 tablets of Caletra are prescribed twice a day.

Children under 3 years old, as well as at PPT less than 0.6 m2, the caleter tablets are not prescribed.

Side effects

In adult patients, the development of diarrhea was most often registered in the course of research. Adults also registered such unwanted phenomena:

• Immune system: immunity restoration syndrome, hypersensitivity.
• GCT: Chair disorders, epigastric pain, vomiting, nausea, changing the frequency of chair, flatulence, dry mouth, gastritis, hemorrhagic enterocolitis, discomfort, incontinence, hepatitis, pancreatitis. Rarely: pain in abdominal area, duodenitis, dysphagia, enteritis, belching, enterocolitis, ulcer of the stomach, esophagitis, ulceration of the mucous membrane, hepatomegaly, hemorrhoids, periodontitis, stomatitis, cholecystitis, jaundice, rectal bleeding, liver steatosis, cholangitis.
• CNS: paresthesia, headache, reduction of libido, sleep disorders, depressive condition, dizziness, nervousness, anxiety, drowsiness, peripheral neuropathy, change in taste. Rarely: confusion of consciousness, ataxia, impaired thinking, disorientation, excitation, dyskinesia, extrapyramidal syndrome, encephalopathy, muscular tone, fairy nerve paresis, migraine, tremor, apathy, cramps, cerebral infarction.
• CSS: vascular pathologies, angina, hypertension, myocardial infarction, triple valve defact, atrioventricular blockade, heartbeat feeling, thrombophlebitis, deep vein thrombosis, varicose veins, vasculitis. Rarely: Ortostatic hypotension, atrial fibrillation.
• Leather and subcutaneous fabrics: lipodystrophy, allergic dermatitis, alopecia, rash, acne, itching, hyperhydrosis, maculopapulous rash. Rarely: idiopathic capillarijah, edema, eczema, exfoliative dermatitis, dry skin, change the structure of nails, strlicas, change in pigmentation, seborrhea, ulcers, skin hypertrophy.
• Bone-muscular system: arthralgia, Malgia, bone necrosis, arthritis, osteoarthritis, muscle weakness.
• Urinary system: nephrolithiasis, hematuria, variation of odor and laboratory indicators of urine, nephritis.
• Reproductive system: amenorrhea, erectile dysfunction, increase in the mammary glands, ejaculation disorders, menorragia, gynecomastia.
• Respiratory system: cough, bronchitis, lung swelling, shortness of breath, bronchospasm.
• Blood system: leukopenia, lymphadenopathy, anemia.
• Mechanical metabolism: Itsenko - Cushing syndrome, dehydration, obesity, diabetes, changing body weight, anorexia. Rarely: hypocholesterinemia, hyperuricemia, appetite change, male hypogonadism, hyperlipasemia, hyperamilasemia, hypophosphatemia, hypovitaminosis, lactatacidosis, hypothyroidism, lipomatosis. In addition, it is possible to increase the total cholesterol, hyperitriglyceridemia, an increase in the activity of gamma-glutamaltranspendase, an increase in serum glucose levels, an increase in the activity of AST / ALT and SFF, a decrease in creatinine clearance, an increase in the activity of lipase, hyperbilirubinemia, a decrease in the level of hemoglobin, an increase in creatine phosphocainase activity.
• Infections: bronchopneumonia, bacterial infection, folliculitis, gastroenteritis, furunculese, inflammation of subcutaneous fat fabric, rhinitis, pharyngitis, perineal abscess, average otitis, power adornit, sinusitis, flu.
• Others: violations of vision, equilibrium changes, ears, hyperactus, cyst, neoplasm, weakness, swelling, chills, chest pain, splenomegaly.

Unwanted phenomena in children

Side effects that were registered in children are similar to those in adults. The most frequent undesirable phenomena were diarrhea, a change in taste, rash and vomiting. In addition, the development was recorded viral infections, fever, constipation, hepatomegaly, pancreatitis, dry skin, reduction of hemoglobin, changes in mineral metabolism (levels of potassium, sodium and calcium), hyperbilirubinemia, reducing the number of platelets. The development of an increase in AST / Alt activity, hypercholesterolemia, an increase in amylase activity, hyperuricemia, multiform erythema, hepatitis, toxic epidermal necroliza, bradiarhythmia and Stevenson-Johnson syndrome is also reported.

Postmarketing research

In patients with chronic hepatitis or cirrhosis that received appropriate therapy, the development of hepatic dysfunction was recorded (including lethal) against the background of therapy of the Tablets of the Kaletra progressive HIV infection. The causal direct link with the reception of ritonavir / Lopinavir was not installed. Patients with kidney diseases are recommended to control the level of AST / Alt.

In some patients, on the background of receiving Tablets, the Caletre was noted the exacerbation or occurrence of diabetes mellitus, which required the appointment / correction of the dose of insulin or oral preparations for the treatment of diabetes. After the end of the reception of the Tablets, Kaletra in some patients retained hyperglycemia.

Against the background of therapy with ritonavir / Lopinavir, the development of pancreatitis in patients with a significant increase in triglycerides was recorded. Some cases of pancreatitis were fatal, while the direct connection between Ritonavir / Lopinavir with the development of pancreatitis is not established, but the risk of increasing the level of triglycerides increases the possibility of pancreatitis. In the treatment of progressive HIV infection It is necessary to control the level of triglycerides.

When developing side effects, an urgent consultation of a specialist is necessary.

Contraindications

Tablets Caletra are contraindicated in such states:

• intolerance to the existing and additional components;
• pronounced violations of liver functions;
• therapy with drugs that have pronounced effect on the CYP3 A4 isoenzyme (see "Interactions with other drugs").

Tablets Calelet are not used in pediatrics for the treatment of children under 3 years.

• viral hepatitis C and B;
• moderate I. light form liver failure;
• an increase in AST / Alt activity;
• pancreatitis;
• violations of lipid metabolism;
• age more than 65 years.

Organic Heart Diseases and Previously Existing Heart Performance Disorders, as well as therapy with drugs that contribute to the elongation of the PR interval.

It is necessary to adhere to caution when driving a car against the background of receiving Ritonavir / Lopinavir.

Pregnancy

Against the background of women therapy, the drug Caletra shows the cessation of breastfeeding.

During pregnancy, the Tablet Calelet is prescribed solely in cases where the benefits for the mother exceeds the possible negative consequences for the fetus.

Medicinal interaction

Ritonavir and Lopinavir inhibit the CYP3 A isoenzyme, so their combined use with drugs, the transformation of which passes with the participation of this enzyme, can lead to an increase in serum levels of such drugs.

There is more than a three-time increase in the AUC drugs, which are widely metabolized by CYP3 A, with a combined reception with Tablets Caletra.

Cayletter is metabolized with the participation of CYP3 A, drugs that influence this enzyme can change plasma levels, efficacy and toxicity of Lopinavir and Ritonavir.

Interaction with preparations intended for HIV therapy

There was no interaction between Ritonavir / Lopinavir with student and lamivudine.

If you need a combined reception with a didanosin, it is recommended to use didanosine on an empty stomach, and the Tablets of the Caletra separately from food.

Ritonavir / Lopinavir, with simultaneous reception, can reduce the levels of abacavir and zidovudine in serum.

It is possible to raise the level of tenofovir in serum when a combined reception with a taletter tablets. The mechanism of this phenomenon is unclear, if necessary, a combined reception must be monitored by the patient's condition, given the risk of development. unwanted effects Tenofovir.

With a combined reception of the tablets of a caleter with nucleoside inhibitors of reverse transcriptase, the development of Malgia is possible, increasing the activity of creatine phosphocainase, as well as the appearance of rhabdomyolysis.

Devirdin, with a combined reception with Tablets, Caletra can increase the whey levels of Lopinavir.

There is a decrease in the level of Lopinavir and an increase in the level of amprenavir with a combined reception of the amprenavir and the Tablets of Caletra. Simultaneous reception of these drugs is not recommended.

It should not be prescribed a caleter tablets combined with phosparenavir (due to a decrease in the level of phosamprenavir and Lopinavira).

Calewra, while at the same time, increases the whey levels of Indinavir, if necessary, such a combination of the Dose of Indinavir should be adjusted.

There is a decrease in the level of the Lopinavir and an increase in the level of nonphinavir with a combined reception. It is not recommended to take these drugs in one day.

Kaletra increases serum levels of Savinavir with a combined reception, which may require a dose correction of the latter.

Tablets Calelet should not be used combined with a typewide.

The interaction of the drug Caletre with other drugs

It should be borne in mind that the kaletra with a combined reception can increase the levels of fentanyl, bipridyl, amiodarone, lidocaine, chinidine, digoxin, some antitumor drugs, and also increase the side effects of these drugs.

Kaletra can change plasma levels of anticoagulants, if necessary, simultaneous use must be monitored by an international normalized relationship.

Kaletra reduces the serum levels of bupropion while simultaneously use.

The combined use of the drug Kaletra with Trazodon leads to an increase in serum levels of the latter.

Carbamazepine, phenytoin and phenobarbital with combined use with a caleter drug can lead to a decrease in the level of Lopinavir due to the effect on CYP3 A4. The effect of the drug Kaletra at the levels of phenyotine during reception in one day is not excluded. Simultaneous reception of Ritonavir / Lopinavir with anticonvulsant drugs is not recommended.

Lopinavir and ritonavir with combined use can change whey levels of mineraconazole, ketoconazole and voriconazole.

Against the background of therapy, the Caretromycin serum levels can be changed by Clarithromycin, if you need a combined reception of these drugs, a dose of clarithromycin should be adjusted (especially in patients with impaired kidney and liver functions).

With simultaneous reception of the drug, the rifabutin rifabutin, there was an increase in rifabutin levels and its active derivative, respectively, by 3.5 and 5.7 times. Considering this effect, if necessary, combined use is recommended to reduce the dose of rifabutin by 75%, depending on the individual variability of pharmacokinetic indicators, a further decrease in the dose of rifabutin may be required.

With a combined reception of the drug Caletra with rifampicin, a decrease in the level of the Lopinavir and the loss of a virological response, as well as the development of resistance to ritonavir / Lopinavir and other inhibitors of HIV proteases is possible. In addition, with a combined reception of rifampicin and caleters, it is possible to raise AST / Alt levels. If necessary, combined reception therapy with ritonavir / Lopinavir should begin 10 days before receiving rifampicin; In addition, the dose of Ritonavira / Lopinavir must be increased when rifampicin is taking. Patients receiving a similar combination require regular control of liver functional activity.

Caletre can reduce the therapeutic activity of the athusakhon at simultaneous reception.

Dexamethasone with combined use can reduce whey levels of Lopinavir.

Caletter with combined use can increase whey levels of fluticasone and reduce the concentration of cortisol. With the combined use of these drugs, it is possible to develop a significant systemic effect of corticosteroids, including Izhenko-Cushing syndrome. Such effect is possible in the inhalation use of other corticosteroids, which turn like fluticasone (for example, when using budesonide). Must be observed special caution When appointing a similar combination and adjust the dose of corticosteroid when monitoring general and local reactions to the drug. An alternative option is the appointment of corticosteroids, which are metabolized without the participation of CYP3 A4, for example, beclomethazone.

Kaletra can raise levels of nifedipine, feelodipine and nippine with a combined reception.

With a combined reception of the drug Caleter with phosphodiesterase 5 inhibitors (including Tadalafil and Sildenafil), a significant increase in the levels of the latter and an increase in the frequency of side effects, including hypotension and priapism, is possible. Sildenafil and Tadalafil combined with a caleter preparation to be applied only in low doses (not more than 25 mg and 10 mg, respectively) with special control of side effects, it is prohibited to combined receiving these drugs to patients with pulmonary hypertension.

The simultaneous reception of the drug Kaletra with Vardenafil is prohibited.

Hypericum preparations reduce serum levels of ritonavir / Lopinavir, simultaneous reception of these drugs is contraindicated.

Caletre can change the levels of GMG-CoA reductase inhibitors, the greatest effect of the drug Caletra is noted on the levels of Lovastatin and Simvastatin, to a lesser extent, the kaletra increases the levels of Atorvastatin and Rosuvastatin. A combined reception of the drug Caletra with Atorvastatin and Rosuvastatin, subject to the dose correction, is allowed.

The pharmacokinetic interaction of the drug of a caleter with pravastatin and fluvastatin (metabolism of these drugs does not depend on CYP3 A4), if the patient needs therapy gMG-CoA inhibitors Reductases Against the background of taking the drug Kaletra, it is recommended to give preference when appointing pravastatin and fluvastatin.

Caletre can raise the levels of tacrolimus, syrolimus and cyclosporine with combined application, it is recommended to control the levels of these drugs to their full stabilization.

Kaletra reduces whey concentrations Methadone.

Kaletra reduces the effectiveness of oral contraceptives, as well as hormonal contraceptives in the form of a patch; During the reception of the drug Kaletra to women who use hormonal contraceptives, additional contraception is needed.

Overdose

Data on acute overdose of the drug Kaletra is limited. There is no data on the specific antidote.

Reduce absorption in the first hours after an overdose can be washing the stomach and assigning sorbents to the patient.

Theoretically, hemodialysis is ineffective in the overdose of the drug Caletra, as active ingredients have high degree Links with plasma proteins.

Form Releaser:

Abbott Laboratories.

Additional information about the manufacturer

Manufacturer country - Germany.

Authors

Attention!
Description of the drug " Caletra"This page is a simplified and supplemented version. official instruction for use. Before purchasing or using the drug, you should consult a doctor and familiarize yourself with the annotation approved by the manufacturer.
Information about the preparation is provided solely with an informational purpose and should not be used as a guide to self-medication. Only a doctor may decide on the appointment of the drug, as well as determine the doses and methods for its use.

Composition of tablets: lopinavir + Ritonavir, Copovidone, silicon dioxide, sodium stearylfumarate, the dedrage red, macrogol, dye iron oxide, talc, hypolosis, polysorbat.

The composition of the solution to inside: lopinavir + Ritonavir, Alcohol, Corn, Magnacweet, Glycerin, Vanilla, Propylene glycol, sodium sodium, sodium citrate, sodium chloride, citric acid, mentholic oil, potassium acesulpha, purified water.

Form release

• Tablets in the film sheath of oval shape in a polyethylene bottle of 100 mg + 25 mg to 60 pcs. packaged.
• Tablets in the film shell of oval shape in a polyethylene bottle of 200 mg + 50 mg of 120 pcs. packaging.
• The solution for receiving inside is 80 mg + 20 mg / ml in a 60 ml polyethylene bottle. With a dispenser. Group packaging - 5 bottles (300 ml) in a cardboard pack.

pharmachologic effect

Antiviral.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Actively active ingredient lopinavir inhibits protease ( human immunodeficiency virus ), but ritonavir in the liver, inhibits the metabolism of Lopinavir, which contributes to an increase in the concentration of Lopinavir in the blood. HIV inhibition proteases contributes to the formation of an immature and defective virus incapable of infection.

Pharmacokinetics

The maximum concentration of HIV infected when taking the drug for 3 to 4 weeks in a dose of 400/100 mg twice a day is reached four hours after its reception.

Lopinavir is actively associated with blood proteins (98-99%). Under the influence of the CYP3A isoenzyme, the Lopinavir is subjected to intensive metabolism, forming 13 oxidative metabolites, the main of which are oxo- and hydroxymethibolic isomeric pairs, which have high antiviral activity.

Ritonavir, which is a CYP3A inhibitor inhibits Lopinavir metabolism, thereby providing an increase in its blood in its blood. With repeated reception of the concentration of Lopinavir in the blood, it is stabilized on an average of two weeks. The half-life of Lopinavir when taking an interval in 12-hours is about six hours.

Indications for use

Applied in complex treatment (HIV infections) in adults and children from 3 years.

Kaletra is included in the list of drugs studied by WHO's efficiency when dealing with. Also, it is one of the medicines that the Ministry of Health of the Russian Federation recommends.

Kaletra I. interferon beta-1b are not harmless in the dosage indicated by the Ministry of Health and have serious side effects, they should be accepted only with the severe course of the disease and under constant control of honey. personnel.

Contraindications

• hypersensitivity to the drug;
• children under 3 years old;
• pronounced liver failure as a result or after the disease and;
• hemophilia ;
• age after 65 years;
• period of pregnancy and lactation.

Contraindicated use simultaneously with preparations in which the clearance depends on CYP3A-metabolism ( Asthemisol , , blonancer , , Triazola , , Pimozide , salmetterol. , alkaloids ardines ( , , methyl ergometrin ), drugs hypericum printed .

Side effects

• hyperglycemia , raising in the blood plasma triglycerides and general ;
• , lymphoenopathy , lakeing ;
• hypothyroidism , ;
• dehydration, milk acidosis , obesity, violation of glucose tolerance, decrease in body weight and peripheral swelling;
• sleep disorders , concern, excitement, ataxia , , orientation disorders, dizziness, emotional lability, , , reduced libido, neuropathy , nervousness, peripheral neurites , , drowsiness, violation of thinking processes;
• , noise in the ears, violation of vision, changes in taste;
• , arterial hypertension , ;
• , , sinusitis ;
• , , constipation, anorexia, dry mouth, dysphagia, , belching, incontinence , , , Colitis hemorrhagic , , sialadenit , increasing appetite ,;
• , dry skin, , dermatitis, maculo Papulse Rash , furunculosis , skin itching, changes in the structure of nails, excessive sweating, benign skin neoplasms;
• arthrosis , malgy , arthralgia ;
• nephrolithiasis , urination disorders, ejaculation, gynecomastia ;
• underworld pain, swelling of the face, fever, chills, general ailment, influenza-like syndrome.

Caletra, instructions for use (method and dosage)

Tablets Calelet are taken inside, entirely, not shredding and not chewing, without focusing on meals. The recommended dose of the drug is 2 tablets (400/100 mg) twice a day, and for patients with no more than two mutations or with the development of resistance to the drug - 4 tablets (800/200 mg) once a day.

With simultaneous appointment , or The reception of the kaletra according to the scheme once a day is contraindicated. When combining the drug with and Dose correction is not required.

Overdose

There is no sufficient and reliable data and clinical experience of acute overdose of HIV-infected patients with a drug Caletra.

Interaction

Simultaneous reception of Caletra and medicines metabolizing through CYP3A ( , Asthemisol , Triazola , Pimozide , Cisaprid , , Methyl ergometrin ) It can extend or strengthen their therapeutic effects, and may also cause side effects.

Caletra can not be taken simultaneously with drugs and Flebunide whose metabolism depends on the activity of CYP2D6 and the increase in the concentration of which in the blood can cause side effects threatening life.

Calelet reduces concentration Abacavir and blood.

Accept Didanosin It is necessary per hour before or 2 hours after taking a calerty.

With simultaneous reception with Neustic Lopinavir concentration is reduced.

Antiarrhythmic LS concentrations ( , Bepridila ,) With a simultaneous purpose with Kalelet can increase.

St. John's wort and Reduces the concentration of Lopinavir in the blood, which significantly reduces the therapeutic effect of the caleter and contributes to the development of the resistance of the latter.

With simultaneous purpose, concentrations may change from the caleter.

, , (Antiepileptic preparations) reduce the concentration of Lopinavir.

It is necessary to use additional alternative and contraceptive methods while taking a kaletra and estrogen-containing contraceptives .

Terms of sale

On prescription.

Storage conditions

Soft capsules and solution must be stored in the refrigerator at 2 - 8 ° C. If the drug Kaletra is used for 6 weeks, storage in the refrigerator is not required, but the storage temperature should not be more than 25 ° C.

Shelf life

Analogs

Coincidences on the ATX 4 level code:

Preparations with similar active substance: Kalidavir , Lopirita .

Preparations with similar therapeutic effects :, , Victreis , Virjor , Viasept. , Individual-400. , Nelvir , Olizio , Reataz , Ritam , Television other.

Latin name:Kaletra.
ATH code: J05A E, J05A R10
Active substance: Lopinavir, Ritonavir
Manufacturer:Abbott (England, Germany),
Aesica Queenborough (England)
Pharmacy vacation condition: On prescription

Caletra - Antiviral LS, designed to combat HIV infection.

Indications for use

The medical preparation is used for HIV therapy, including children.

The composition of the drug

Caletra pills are represented by pills with different content of active substances - Lopinavir and Ritonavir:

• 200 and 50 mg. Additional components: COLOVIDON, Sorbitan Laurat, Aerosil. Ingredients of the 2nd layer - Sodium Stearil Fumarat, Aerosil. The substances included in the coating: dyes, titanium derivative, macrogol, aerosil, PET, hypigolosis and other elements.
• 100 and 25 mg. The composition of the auxiliary ingredients is identical to the first type of funds.

Solution: in one ml contains 80 mg of Lopinavir, 20 mg of ritonavir. Other components: macrogol glycerylhydroxyistearate, sodium and potassium derivatives, lemon, anhydrous, alcohol, PET, L-menthol, poverant, saturated fructose corn syrup, mint oil, Vanilla's framing and flavoring additive, water.

Medical properties

The drug Kaletra refers to the group of combined drugs. Therapeutic effect Provided by two active ingredients:

• Lopinavir has an antiviral action, the coal protease of HIV-1 and HIV-2. This prevents the activation of proteins and contributes to the formation of weak particles of HIV, which are incapable of further synthesizing and spreading full-fledged viruses.
• Ritonavir suppresses the metabolism of Lopinavir in the liver, which helps to increase its concentration in the blood and prolonged action. In addition, the substance also has inhibiting HIV proteases, although more moderate than Lopinavir.

Thus, in all pharmaceuticals of the medical process, the main action is provided by Lopinavir, the second component provides an increase in its action. The joint effect of two ingredients of drugs contributes to the active formation of defective cells of HIV pathogens incapable of reproduction. As a result of therapy, the intensity of infection decreases, the content of viruses in the blood of patients decreases.

Lopinavir pharmacokinetics studies in combination with ritonavir on healthy volunteers and infected patients did not find fundamental differences between these groups.

After penetrating inside the components of the drug bind to plasma proteins, peak values \u200b\u200bof the Lopinavir concentration after one-time reception appear four hours later. Metabolites in significant quantities are outlined together with the feces, the rest is through the urinary system.

Forms of release

The drug is presented in several forms:

Cost: (120 pcs.) - 5258 rubles.

Tablets (200/50) - red oval pills. Enclosed in film coating. On one of the surfaces there is an embossed logo of the firm and the inscription "AL". Pills are packaged 60 or 120 pieces into dense polymer banks. In the package from the cardboard - one bank, manual for use.

Average price: (60 pcs.) - 4817 rubles.

Tablets (100/25) - oval shape pills in the pinkish film coating. On one surface there is a engraved logo of the manufacturer of ebbot and abbreviation AU. Tablets are facing 60 pieces into dense polyethylene jars embedded in cardboard packaging with annotation.

Price in Internet pharmacies: from 5000 rubles.

Capsules - soft pills in an orange case from gelatin. On the surface of black, the logo and the abbreviation of the Republic of Kazakhstan is applied. Filling capsules - clear solution. Pills are packaged in plastic banks of 90 pieces or in blisters of 6, which are packaged in boxes. In cardboard packaging with annotation - 2 cans or 5 boxes, each of which 6 plates are 6.

The average cost: 7457 rubles.

The solid is oral - pale yellow or yellow liquid, without suspension. 60 ml refers to plastic bottle with a metering device. In the cardboard package - one bottle, abstract.

Mode of application

Drinking in tablets or capsules Instructions for use recommends regardless of meals, and oral solution - during meals. LAN solid forms can not be rolled or broke - take them only entirely.

Tablets (200/150):

An adult who had previously not held the course of ARV therapy is recommended to drink two pills twice a day or doubled the dose once a day. Previously treated people, pills can be applied only in the first diagram, one-time reception is undesirable for them.

Children dosage are calculated, based on the mass or body surface. Those who weigh more than 40 kg are offered to drink two pills twice a day. Kids whose weight is less than this value, it is not recommended to receive tablets, they are replaced with a solution.

Children from the age of 2, the dosage is calculated, focusing on the surface area of \u200b\u200bthe body. It is calculated by multiplying growth indicators into cm on body weight in kg, then the value obtained is divided by 3600.

If the value is 1.3 m 2 and more, then kids can drink 3 pills in the morning and in the evening. Children with lower capsule indicators need to be replaced with a solution until the correct process of swallowing is formed.

• Adults: 5 ml in the morning and in the evening along with food or once a day - 10 ml (for patients who have not received ARV treatment).
• Children from 2 years: Recommended Quantity - 230 / 57.5 mg / sq. m, the maximum permissible amount - 400/100 mg (or 5 ml) twice a day.

In disruption of the liver or kidney, the reception is carried out under the supervision of doctors, is not prescribed during severe forms.

During pregnancy and breastfeeding

Musual security data for pregnant women are missing. Therefore, the use of drugs is contraindicated during this period. Purpose can be done in case of extreme need when it is not possible to replace the caletur with a different drug. At the same time, a detailed analysis of benefits for the female organism and harm to the fetus is carried out.

If the HIV-infected woman fed a baby, then in the case of the appointment of the medical process, the HB should be interrupted.

Contraindications

The medical preparation is not appointed if there is an individual immunity by the body of its components. Contraindications are also:

• Heavy liver diseases
• Co-use with drugs, in which the clearance is largely depends on the metabolism of CYP3A enzymes: astemisol, terphenenedine, triazolam, rifampicin, alkaloids, pepperconds, medical preparations based on Hypericum, etc.
• Combining with antiepileptic LS (carbamazelin, phenytio et al.)
• Children's age: up to 3 years (tablets), up to 2 (capsules), up to 6 months (solution)
• Pregnancy, guv.

The drug can be assigned to the compliance with the set of conditions when:

• Hepatitis B, with
• Liver failure in mild or medium form
• Increased liver enzyme activity, cirrhosis
• Pancreatitis
• Problems with blood clotting, hemophilia
• Increasing blood lipids
• Old age (65 +)
• Heart diseases or if a course of verapamil is held, Atazanavir
• Combining LAN for erectile dysfunction therapy
• The course of inhalation or intranasal GKS.

Precautions

In the treatment of Caletra, it is necessary to take into account the features of its main components:

• Substances are transformed into the liver, so in patients with its insufficiency there is an increase in concentration.
• In people suffering from hepatitis B, s, there is often an increase in the activity of transaminase. For this reason, it is necessary to carefully sequen the patient's condition after taking a caleter.
• The medicine can provoke bleeding, hematoma on the skin and hemorrhage in the joints in people with a diagnosis of hemophilia.

Lipids

LS treatment can provoke the growth of lipid concentration. Therefore, before the start of the course it is necessary to check their level, and then monitor throughout therapy. This is especially true of people with initially high indicators. In the event of an increase in concentration, the relevant therapy is carried out.

Pancreatitis

The inflammation of the pancreas during the course of the Caletra may occur in people who have previously suffered from this ailment or a course of drugs that provoked it. In the risk area there are also sick HIV with the progressive course of infection. In the case of nausea, vomiting and pain is conducted on pancreatitis. In the event of confirmation of the diagnosis, the reception of the calet persecution is temporarily stopped.

Hyperglycemia

During the course of Kaletra there were cases of diabetes, increasing the level of glucose, CD decompensation. In addition to protease inhibitors, the cause of pathologies could have been the previously conducted treatment with medical preparations with this side effect.

Violation of exchange processes

In the treatment of protease inhibitors in some patients, a redistribution of adipose tissue can occur. With a decrease in deposits on hand, legs and face, the "pillows" grow in the center of the body, on the back, in the neck area. In addition, numerous cases of malfunction of normal metabolism were noted. There are no reliable data on the mechanism of this phenomenon. To minimize the risks of unwanted consequences when primary examination An analysis of the distribution of adipose tissue, lipid and glucose indicators, and during treatment - periodically check these indicators to carry out the relevant therapy in time.

Immune reduction syndrome

As the HIV decreases infection, protective forces may occur. Therefore, in the penetration of pathogens of other diseases, the organism may produce a strong reaction to pathogenic microorganisms. If symptoms occur, there is an appropriate diagnosis and therapy is assigned.

Other precautions include:

• Patients who receive therapy with therapy by Kaletra should be taken into account that it does not heal from HIV, does not prevent the transmission of infection during sexual contacts or through blood. Therefore, it is impossible to abandon prevention and protection measures.
• Tablets and capsules can not be used for toddler therapy, which has no two years due to insufficient data on their safety and performance. For small patients from 6-months, an oral solution is used.
• As part of the capsules there is a dye that can provoke allergies. It is especially important to remember this to people with sensitivity or intolerance to aspirin.
• During the course of the kaletra, the development of drowsiness, lethargy, reduction of the concentration of attention is not excluded. Therefore, at the time of therapy should be abandoned potentially dangerous species Activities requiring a quick response.

Cross drug interactions

In the treatment of Kalelet, it must be borne in mind that the Active LS active substance is able to react with the components of other drugs:

• Considering that the main action of the calet persecution is the suppression of isofratems, it cannot be combined with LS, metabiritated by these enzymes (immunosuppressants, PDE-5, calcium channel blockers, etc.). A similar combination will lead to an increase in their concentration, which will inevitably distort the action.
• Combining the LS, activating the synthesis of the isoenzymes, will reduce the content of the Lopinavir in the blood and, accordingly, its action.
• During the course with the Didanosin, it is necessary to take into account that it is taken on an empty stomach, so a combination of tablets drink an hour before meat or two hours after it.
• Kaletra reduces the content of Zidovudine, Abacavir, but increases the concentration of tenofovir, Nelfinavir, Indinavir, Savinavir, Rivaroksabana. In the latter case, it can provoke bleeding.
• When appropriate with phosamprenavir - mutual weakening of action.
• The concentration of the kaletra decreases if it is drunk with newaren, therefore the dosage correction is performed.
• The content of blood calet persecution increases under the action of Devilladin, Amprenavir.
• When combined with antitumor means, the strengthening of their side effects.

Side effects

In the treatment of Caletra, it is possible to deteriorate well-being, which is manifested in the form of individual hypersensitivity of the body. In addition, multiple reactions from various internal systems and organs are not excluded.

Digestive system:

• Diarrhea
• Irregular chair, incontinence
• Nausea, bouts of vomiting
• Meteorism, bloating
• Stomach ache
• GERB, Gastritis
• Dry B. oral cavity, ulcers
• Periodontitis
• Belching
• Stomatitis.

• Head pain
• Sleep breakdown, insomnia
• Reduced sexual attraction
• Depressive states
• Increased nervousness, irritability
• Drowsiness
• Changes in taste sensations
• Perpudence consciousness
• Sharp change mood
• Disorientation
• Cognitive violations
• Memory losses
• Migraine
• Fire shakes
• Apathy
• Cramps.

• Deterioration of the state of the vessels
• Height of hell
• Av-blocade
• Strengthening heartbeat
• Angina
• Myocardial infarction
• Thrombosis
• Phlebeurysm
• Ortostatic hypotension.

Leather:

• Pathology of adipose tissue (lipodystrophy)
• Rash, acne
• Hair loss
• Dermatitis
• Changing the structure of nails
• Dryness of dermis, eczema
• Pampering
• Strong skin atrophy ("Stretching").

• Malgy
• Pain in the lower back, joints
• Osteoarthritis
• Muscle weakness.

Metabolism:

• Dehydration
• Obesity or sharp slimming
• Deterioration or strengthening
• Hyovitaminosis
• Reducing the production of hormones thyroid gland (hypothyroidism)
• Acidosis lactic acid
• Lipomatosis.

Endocrine and urinary systems:

• Diabetes
• Increased blood content in the urine
• Education of renal stones
• Deviation from the norm of urine indicators, the change in its smell.

Sex system:

• erectile dysfunction
• Painful menstruation
• Increased mammary glands.

Respiratory system:

• Bronchitis
• Cough
• Labored breathing
• Pulmonary edema
• Bronchi spasms.

Bloodmarkes: Anemia, reducing leukocyte formation.

Feeling authorities: Dizziness, impairment of vision, Tinnitus, malfunction.

Other adverse reactions:

• Lost, weakness
• Attachment infection
• Furunculosis
• Foreign states
• Euchness
• Neof formation
• Pain in the chest.

In children, the symptoms of side effects are generally similar to manifestations in adults, but the rashes are most often, the attacks of vomiting, diarrhea, dryness of the dermis or mucosa of the oral cavity, distortion of taste. Also, the change in blood composition, the development of infectious diseases, febrile conditions is not excluded.

Overdose

Today there are scarce data on the features of the development of overdose by Kalelet.

When using a medical preparation, it is necessary to take into account that has not yet been developed a special antidote, which would have stopped negative symptoms. Therefore, in the case of the development of intoxication, the specificity of treatment is determined by manifested signs. Therapy should be aimed at maintaining the body, ensuring the operation of the internal systems, continuous monitoring of the patient's condition. If possible, it is necessary to remove HP from the body by washing the stomach, give activated coal.

There are more specific data on the development of overdose after the use of superclocking of a solution in the form of a solution. So, in children born ahead of time, was recorded:

• Full AB blockade (violation of the heart rhythm or blood flow via vessels)
• Cardiomyopathy (heart muscle damage)
• Lactat-acidosis
• Acute renal failure.

In addition, due to the content in ethanol solution, the development is not excluded. alcoholic intoxicationIf the drug was drank in large quantities. To eliminate overdose, the same activities are used as with pills or capsules. But if in their case the dialysis is ineffective, then when poisoning with a solution, it is used to eliminate the effects of alcohol and propylene glycol.

Conditions and shelf life

The drug is suitable for use for 2 years from the date of release, oral solution - 18 months. The means should be kept in a place removed from sunlight and moisture sources. Temperature regime - 2-8 ° C. Eliminate access for children!

Analogs

To date, there are many medical staff to combat HIV infection. Each of them has its own, specific effects, has advocacy and contraindications. Therefore, to say with the go, it will better affect - Caletra or Reataz, or Lamivudine, Navir, Regist, Dysverox, etc. - can only a specialist after a detailed analysis of the patient's condition.

Riest

"Pharmacezinz" (RF)

Cost: 100 mg (30 pcs.) - 798 rubles.

Medicreparation with anti-virus action, designed for use in the treatment of HIV-1 as additional means. Not used for monotherapy, otherwise addiction is possible.

The therapeutic effect is achieved due to the active component - Efavirense. The substance refers to the NNIOT group (nanucleoside inhibitors of reverse transcriptase).

After penetrating inside the body, the virus invested in the early stages of its development, contributes to the development of immune bodies, inhibits the progression of the disease. Therefore, the registry copes well with acute infections.

The drug is shown for therapy, starting from 3 years, provided if the patient's weight is not less than 13 kg. Due to the lack of data on the effect on the fruit, the roarist is not recommended to be prescribed pregnant. He is also contraindicated during lactation.

The tool is made in tablet form - the pills of a golden or brownish shade. There are several types of tablets with different content of the main component: 100, 300, 400, 600 mg.

Contraindications for the use of regasters are the individual reactions of the body into the components of the substance, the gestational period, GW, children's age.

Dosage and duration of reception is determined by doctors individually for each patient.

Pros:

• Strong action.

Disadvantages:

• Possible psyche disorders, suicidal intentions.