Solution for intake: transparent liquid of yellow or light yellow color (on 60 ml in bottles of amber color from polyethyleneterephthalate complete with the doser, in a cardboard pack on 5 bottles and dosers);
Tablets, film coated: an oval form, with an engraving of a logo of the company Abbott put on one of the parties and the letters "AL" on tablets of red color or "AC" – on light pink (tablets with an engraving of "AL" on 120 pieces, "AC" on 60 pieces in bottles from high density polyethylene, in a cardboard pack 1 bottle).

Active ingredients of Kaletra – лопинавир and ритонавир, their contents (respectively):

1 ml of solution – 80 mg and 20 mg;
1 tablet of red color with an engraving of "AL" – 200 mg and 50 mg;
1 tablet of light pink color with an engraving of "AC" – 100 mg and 25 mg.

Auxiliary components:

Solution: sodium chloride, a macrogoal глицерилгидроксистеарат, sodium citrate, potassium to atsesulfa, sodium saccharinate, citric acid anhydrous, propylene glycol, ethanol, left menthol, глицерол, K-30 povidone, syrup corn with the high content of fructose, oil menthol, fragrance magnasvit 110 (2X), the additive flavoring synthesized fragrance vanilla, the water purified;
Tablets: коповидон K28, sorbitan laurate, silicon dioxide colloid, the sodium stearylfumarating.

In addition as a part of a film cover of tablets:

Tablets of red color with an engraving of "AL": dye опадрай red – titanium dioxide, polysorbate 80, a gipromelloza of 6 mPa, a macrogoal 400, a gipromelloza of 15 mPa, a hypro rod, talc, a macrogoal 3350, silicon dioxide colloid, dye ferrous oxide (E172);
Tablets of light pink color with an engraving of "AC": опадрай the II pink 85F14399 – a macrogoal 3350, polyvinyl alcohol, talc, titanium dioxide, dye ferrous oxide red (E172).

Indications to use

Kaletra's use is shown as a part of a combination therapy of acquired immunodeficiency syndrome of the person (HIV infection) at adults and children.

Contraindications

Breastfeeding period;
Heavy liver failure;
Simultaneous use with vorikonazoly, terfenadiny, astemizoly, triazolamy, midazolam, tsizapridy, ergot alkaloids (for example, ergometrine and methylergometrine, ergotamine and dihydroergotamine), Pimozidum, lovastatiny, drugs of the St. John's Wort which is made a hole simvastatiny, rifampicin;
Hypersensitivity to drug components.

With care patients are recommended to appoint drug with cirrhosis, a viral hepatitis In and With, a slight and moderate liver failure, a superactivity of liver enzymes, hemophilia And yes In, a dislipidemiya (including a hypercholesterolemia, a gipertriglitseridemiya), and also the patient 65 years are more senior.

During pregnancy Kaletra's appointment is possible if the estimated advantage exceeds possible risk for a fruit and mother.

It is impossible to apply:

Solution: at babies up to 6 months;
Tablets: at children under 3 years.

With care patients with a heavy renal failure take a pill.

Route of administration and dosage

Tablets: accept inside, swallowing only entirely (it is impossible to break or chew), irrespective of meal. The recommended dosing for adults: on 400/100 mg 2 times a day or 800/200 mg of 1 times a day for the patients who were earlier not receiving anti-retrovirus therapy; to the patients who were earlier receiving anti-retrovirus therapy – on 400/100 mg 2 times a day, are not recommended purpose of a single dose of a daily dose. At the suspicion on decrease at the patient of sensitivity to a lopinavir confirmed laboratory or clinically it is necessary to increase a drug dose to 500/125 mg (2 pieces on 200/50 mg and 1 piece on 100/25 mg or 5 pieces on 100/25 mg) at a combination to not Virapinum, efavirenzy, nelfinaviry or amprenaviry. To children weighing more than 35 kg or with body surface area higher than 1,4 sq.m. the recommended dosing makes 400/100 mg 2 times a day without concomitant use of not Virapinum, an efavirenz, an amprenavir or a nelfinavir. To children weighing less than 35 kg and the doctor of body up to 0,6 sq.m. calculates a dose according to the special scheme individually. To children with body surface area Kaletra's solution is recommended to accept less than 0,6 sq.m.;
Solution: accept inside during food. The recommended dosing for adults: on 5 ml of solution 2 times a day or 10 ml of 1 times a day for the patients who were earlier not accepting anti-retrovirus drugs; to the patients receiving anti-retrovirus therapy – on 5 ml of solution a day, this category of patients reception of a daily dose once is not recommended to appoint 2 times. In case of alleged decrease in sensitivity to a lopinavir, it is recommended to increase Kaletra's dose to 6,5 ml 2 times a day at a combination to not Virapinum or efavirenzy. Dosing for children is determined by the doctor by the special scheme in the settlement way, it depends on a medicinal combination, sensitivity to a lopinavir, weight and age of the child. The single dose of solution for children with body weight to 15 kg is defined at the rate of 12/3 mg on 1 kg of weight of the child, and 10/2,5 mg on 1 kg – for children from 15 to 40 kg. Reception of the calculated volume of solution is appointed by 2 times a day. The daily dose for children weighing more than 40 kg should not exceed 5 ml of solution 2 times a day.

Dose adjustment of drug is not required at simultaneous use of ranitidine and an omeprazol.

At a combination therapy of adults with not Virapinum, efavirenzy, nelfinaviry, amprenaviry it is impossible to appoint Kaletra's reception 1 time a day, and for a dose of 400/100 mg 2 times a day correction is not required.

Use of drug for children of 1 times a day was not studied.

Side effects

Kaletra's use causes the serious and moderately expressed side effects in more than 2% of adult patients:

General disturbances: fever, adynamy, fever;
From the alimentary system: diarrhea, abdominal pain, dyspepsia, nausea, meteorism, vomiting, dysphagy;
From a nervous system: sleeplessness, headache, paresthesias;
From cardiovascular system: arterial hypertension, vascular disorders;
Mental disorders: a depression, the lowered libido;
From skin and hypodermic cellulose: rash, lipodystrophy;
From a metabolism and disturbance of food: weight reduction of a body, anorexia;
From a musculoskeletal system: mialgiya;
Infections: bronchitis;
From endocrine system: an amenorrhea, a hypogonadism at men.

During Kaletra's use for some (less than 2%) adult patients the following side effects were observed, but their connection with administration of drug is not established:

General symptoms: an indisposition, thorax pain and behind a breast, the general and peripheral hypostases;
Disturbances of food and metabolism: dehydration, avitaminosis, diabetes mellitus, лактацидоз, increase in appetite, increase in body weight, obesity;
From lymphatic system and blood: leukopenia, anemia, lymphadenopathy;
From cardiovascular system: varicosity, heartbeat, ciliary arrhythmia, deep vein thrombosis, myocardial infarction, orthostatic hypotension, vasculitis, thrombophlebitis;
From a liver and biliary tract: cholecystitis, a cholangitis, hepatitis, fatty deposits in a liver, a hepatomegalia, jaundice, functional disturbances of a liver;
Infections: furunculosis, grippopodobny syndrome, gastroenteritis, average otitis, bacterial infections, pharyngitis, sinusitis, sialadenitis, viral infections;
From immune system: allergic reactions;
From endocrine system: hypothyroidism, Cushing's syndrome;
From a nervous system: dizziness, drowsiness, neuropathy, amnesia, cerebral heart attack, ataxy, spasms, encephalopathy, dyskinesia, extrapyramidal syndrome, muscle hyper tone, tremor, paralysis of a facial nerve, peripheral neuritis, migraine, perversion or loss of taste;
Mental disorders: alarm, sleep disorder, apathy, agitation, confusion of consciousness, nervousness, emotional lability, disturbance of thinking;
From an organ of sight: vision disorder;
From a vestibular mechanism and an acoustic organ: dizziness, sonitus;
From respiratory system: short wind, asthma, rhinitis, strengthening of cough, fluid lungs;
From the alimentary system: dryness in a mouth, an eructation, a lock, a coloenteritis, enteritis, an esophagitis, gastritis, an incontience a calla, hemorrhagic colitis, stomatitis and a stomacace, periodontitis, pancreatitis;
From skin and hypodermic cellulose: xeroderma, itch, alopecia, acne, eczema, face edema, exfoliative dermatitis, makulopapulezny rash, seborrhea, discoloration of skin, striya, skin ulcer, perspiration, changes of structure of nails;
From kidneys and urinary tract: nephrite, stones in kidneys;
The malignant, benign and not specified tumors: benign tumors of skin, cyst;
From reproductive system: impotence, gynecomastia, increase in chest glands, disturbance of an ejaculation;
From a musculoskeletal system: dorsodynia, muscular weakness, arthralgias, osteonecrosis, arthrosis, changes in joints;
Changes of laboratory indicators: increase in the general cholesterol and bilirubin, content of glucose, triglycerides, amylases, uric acid, increase in activity of alaninaminotranspherase (ALT), aspartate aminotransferase (nuclear heating plant), gamma глутамилтранспептидазы (GGT), neutropenia, decrease in level of inorganic phosphorus.

The undesirable phenomena at children from 6 months to 12 years were similar to similar at adults, food faddisms, rash, vomiting, diarrhea were most often noted.

Also separate cases of a syndrome of Stephens-Johnson, hepatitis, a bradyarrhythmia, a mnogoformny erythema were observed.

Special instructions

With extra care it is recommended to appoint simultaneous use of any intranasal and inhalation glucocorticosteroids (GKS) as there is a big risk of development of system side effects. In need of long use of GKS purpose of other their form is reasonable.

At a combination with tadalafily, sildenafily or vardenafily their concentration in a blood plasma increases, it can lead to arterial hypotension and a long erection.

Kaletr needs to accept in a standard dose within 10 days before purpose of rifampicin as their concomitant use causes dozozavisimy decrease in concentration of a lopinavir in a blood plasma. Then under careful control of function of a liver titration of a dose of drug towards increase is possible.

At patients with functional disturbances of a liver concentration of active ingredients increases in plasma therefore treatment at them needs to be carried out under regular careful control of laboratory indicators, including activities of nuclear heating plant, ALT.

Against the background of reception of inhibitors of protease at patients cases of development of a hyperglycemia, diabetic ketoacidosis and a decompensation of a diabetes mellitus were observed, but their communication and frequency are clinically not established.

At patients with the progressing HIV infection at treatment by Kaletra the probability of development of pancreatitis and a gipertriglitseridemiya or risk of an aggravation at patients with pancreatitis in the anamnesis increases.

Various degree of manifestation of cross resistance of inhibitors of protease is noted, studying of influence of drug on efficiency of other inhibitors of protease at the subsequent therapy continues.

Therapy by inhibitors of protease causes bleeding cases, spontaneous formation of hypodermic hematomas, development of a hemarthrosis in patients with hemophilia of type A and B.

Against the background of use of drug for patients there can be external changes connected with cushingoid and increase in mammary glands, redistribution or accumulation of fatty deposits in a back and a neck with simultaneous decrease in fat on a face and extremities.

Prior to drug use, and the entire period of therapy, it is regularly necessary to control the level of concentration of cholesterol and triglycerides, in case of existence of lipidic disturbances purpose of the corresponding medicines is shown.

At the beginning of the combined anti-retrovirus therapy with Kaletra at patients exacerbations of residual or asymptomatic opportunistic infections which cause the need for additional inspection and treatment can be observed.

Patients have to be informed on need of the address to the doctor at emergence of constraint and a joint pain, disturbance of motive function as these signs can be connected with development of an osteonecrosis.

Considering the frequency of associated diseases, depressions of function of kidneys, a liver or heart and the accompanying therapy at patients are more senior than 65 years, it is necessary to use with care drug at patients of this category.

During therapy patients are forbidden to be engaged in management of vehicles and mechanisms and other potentially dangerous types of activity which performance demands concentration of attention and high speed of psychomotor reactions.

Medicinal interaction

The oncologist appoints at the same time accepted drugs, considering high activity of active ingredients of Kaletra, their dose and age of the patient.

Terms and storage conditions

To store at a temperature: solution – 2-8 °C, tablets – 15-30 °C. To protect from children.

Period of validity: solution – 2 years, tablets – 4 years.

The prices in Internet drugstores:

Name of drug

Price

Drugstore

Kaletra of piece tablet 200+50mg 120

6300 rub.

To buy

Apteka вер.ру, LLC

To look at all offers from drugstores

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