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Kaletra (Lopinavir + Ritonavir)

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Kaletra is a co-formulation of lopinavir and ritonavir. It is used for treating infections with the human immunodeficiency virus (HIV).

Indications

This drug is used to treat HIV-infected patients, in combination with other antiretroviral drugs.

Contraindications

Kaletra is not used if the patient has an increased sensitivity (allergy). It is contraindicated in severe violations of the liver. It should not be used simultaneously with certain drugs, in particular: alfuzosin hydrochloride, fusidic acid, astemizole, terfenadine, blonanserin, midazolam, triazolam, cisapride, lovastatin, simvastatin, salmeterol, pimozide, amiodarone, ergot alkaloids, sildenafil. Do not use it togetherb with preparations containing St. John’s wort.

Dosage and administration

Recommended dosages (taken regardless of meals):

  • Patients who have not previously received antiretroviral therapy: 3 capsules 2 times a day or 6 capsules once a day;
  • Patients who have previously received antiretroviral therapy: 3 capsules 2 times a day.

In combination therapy with efavirenz, nevirapine, amprenavir or nelfinavir, the dose should be increased to 4 capsules 2 times a day.

Children over the age of 12 years and weighing more than 40 kg receive a dose of 3 capsules 2 times a day.

The duration of treatment is prescribed individually.

Patients with impaired liver function

Caution should be used in patients with viral hepatitis B and C, cirrhosis of the liver; mild and moderate liver failure, increased activity of liver enzymes.

The use of lopinavir / ritonavir is contraindicated in patients with severely impaired liver function.

Patients with impaired renal function

The pharmacokinetics of lopinavir in patients with renal failure has not been studied. Since the renal clearance of lopinavir and ritonavir is negligible, an increase in their plasma concentration is not expected to occur in patients with renal failure.

Use in children

Use of Kaletra in children under the age of 3 months is contraindicated.

The use of the combination of lopinavir / ritonavir 1 time / day in children and adolescents under the age of 18 is contraindicated.

Use in elderly patients

Caution should be used in elderly patients (over 65 years old).

Side effects

  • Laboratory indicators: hyperglycemia, increased activity of “liver” transaminases, hypercholesterolemia, hypertriglyceridemia;
  • Endocrine system: Cushing’s syndrome, hypothyroidism;
  • Digestive system: diarrhea, decreased appetite, cholecystitis, constipation, dry mouth, dyspepsia, dysphagia, enterocolitis, belching, esophagitis, fecal incontinence, flatulence, gastritis, gastroenteritis, hemorrhagic colitis, increased appetite, pancreatitis, sialditis, siald stomatitis;
  • Metabolism: vitamin deficiency, dehydration, impaired glucose tolerance, milk acidosis, obesity, peripheral edema and weight loss;
  • Nervous system: sleep disturbances, agitation, amnesia, anxiety, ataxia, orientation disorders, depression, dizziness, dyskinesia, emotional lability, encephalopathy, insomnia, decreased libido, nervousness, neuropathy, paresthesia, peripheral neuritis, drowsiness, impaired thinking tremor;
  • Sensory organs: visual impairment, otitis media, taste changes, tinnitus;
  • CCC: increased blood pressure, tachycardia, thrombophlebitis, vasculitis, an increase in the duration of the P-Q interval on the ECG;
  • Respiratory system: bronchitis, shortness of breath, pulmonary edema, sinusitis;
  • Hemopoietic organs: anemia, leukopenia, lymphadenopathy;
  • Skin: acne, alopecia, dry skin, exfoliative dermatitis, furunculosis, maculopapular rash, changes in the structure of nails, skin itching, benign neoplasms of the skin, changes in skin color and excessive sweating;
  • Musculoskeletal system: arthralgia, arthrosis, myalgia;
  • Genitourinary system: ejaculation disorders, gynecomastia, male hypogonadism, nephrourolithiasis, urination disorders;
  • Other: back pain, chest pain, chest pain, chills, face swelling, fever, flu-like syndrome, malaise.

Pregnancy and breastfeeding

During pregnancy, the potential benefits of taking the combination of lopinavir + ritonavir regarding the possible risk to the mother and child should be analyzed.

Women should stop breastfeeding.

Overdose

The clinical experience of acute overdose of Kaletra in humans is currently limited.

Treatment: there is no specific antidote. Treatment consists of activities aimed at maintaining the body’s life support, including monitoring vital systems and monitoring the patient’s clinical condition. If necessary, unabsorbed drugs are removed by gastric lavage. Administration of activated carbon may be useful. Since lopinavir and ritonavir are highly bound to plasma proteins, the use of dialysis is impractical.

Interaction

  • Do not use Kaletra simultaneously with any of the following drugs: astemizole, blonanserin, terfenadine, midazolam (for oral administration), triazolam, cisapride, pimozide, salmeterol, sildenafil, tadalafil, vardenafil, avanafil, voriconazole, ergot alkaloids, HMG-CoA reductase inhibitors, fosamprenavir, alfuzosin, fusidic acid, amiodarone, quetiapine, St. John’s wort, boceprevir, ketoconazole and itraconazole in high doses (more than 200 mg / day), rifampicin, tipranavir, carbamazepine, phenobarbital or phenytoin, nevirapine, amprenavir or nelfinavir, simeprevir;
  • Drugs that are not recommended for simultaneous use with Kaletra: simultaneous use of lopinavir / ritonavir and fluticasone, as well as other corticosteroids that are metabolized by the CYP3A4 isoenzyme, such as budesonide, unless the potential benefit of such therapy outweighs the risk of systemic corticosteroid effects including Cushing’s syndrome and inhibition of adrenal cortex function. The combined use of rivaroxaban and Kaletra may increase the risk of bleeding. The combined use of Kaletra and colchicine is not recommended due to the potential increase in neuromuscular toxicity of colchicine (including rhabdomyolysis), especially in patients with renal or hepatic insufficiency;
  • Drugs that should be used with caution: verapamil, atazanavir, pheniramine, quinidine, erythromycin, clarithromycin, sildenafil, tadalafil, vanomine, roslamine, bupropion, antiarrhythmic drugs, digoxin, lamotrigine, valproic acid, razodonom.

Special instructions

  • Lopinavir and ritonavir are primarily metabolized and excreted by the liver, therefore, in patients with liver failure, their plasma concentration may increase (there is currently no experience with the drug in this category of patients);
  • In patients with hepatitis B or C, the risk of increased activity of hepatic transaminases in the blood increases;
  • There were cases of increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with type A and B hemophilia treated with protease inhibitors, while some patients needed coagulation factor VIII (in more than half of these cases, treatment with protease inhibitors was continued or started again if it was interrupted);
  • Treatment with the drug can lead to an increase (sometimes significant) in the concentration of total cholesterol and TG, the concentration of which should be determined before and during therapy (patients with progression of HIV infection have an increased risk of increasing the concentration of TG). Treatment of lipid metabolism disorders should be carried out in accordance with the methods adopted in clinical practice;
  • Cases of pancreatitis were noted in patients receiving the drug (in most cases, patients suffered from pancreatitis earlier and / or took other drugs that could contribute to the development of pancreatitis). Severe hypertriglyceridemia is a risk factor for pancreatitis. The possibility of developing pancreatitis should be considered if there are clinical symptoms (nausea, vomiting, abdominal pain) or changes in laboratory parameters (increased serum lipase or amylase). If such signs and clinical manifestations are detected, treatment with the drug should be temporarily suspended;
  • The first diagnosed cases of diabetes mellitus, hyperglycemia, or decompensation of existing diabetes mellitus were noted in patients who were prescribed protease inhibitors. In some cases, hyperglycemia manifested in severe form (sometimes accompanied by ketoacidosis). Many patients had concomitant diseases, some of which required drug therapy, which could provoke diabetes mellitus or hyperglycemia;
  • There is limited evidence of drug use in patients previously treated with protease inhibitors. The greatest experience in the use of the drug has been accumulated in patients who have not previously received other antiretroviral drugs;
  • The choice of drug in the treatment of patients infected with HIV-1 and previously treated with protease inhibitors should be based on an individual determination of the resistance of the virus and previous therapy;
  • A clinical examination should include an assessment of the physical signs of redistribution of fat, determination of the concentration of lipids and glucose in plasma during treatment. The mechanism of this effect and its long-term consequences (for example, an assessment of the risk of developing cardiovascular diseases) have not yet been established;
  • The experience of using the drug in children under 2 years of age, as well as in pregnant women and during lactation, is absent;
  • The drug does not reduce the risk of HIV transmission through sexual contact or through blood (appropriate preventive measures are required). Patients taking the drug may develop infectious or other diseases associated with HIV infection and AIDS.