Kaletra (Lopinavir and Ritonavir)

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Kaletra is a combination drug that contains lopinavir and ritonavir.

Lopinavir is an inhibitor of HIV-1 and HIV-2 proteases of the human immunodeficiency virus (HIV) and provides antiviral drug activity.

Ritonavir inhibits CYP3A isoenzyme-mediated metabolism of lopinavir in the liver, which contributes to an increase in the concentration of lopinavir in blood plasma. Ritonavir is also an HIV protease inhibitor.

Common indications of Kaletra

Kaletra is a drug intended for the treatment of HIV infection in adults and children from 3 years of age. Used as a part of combined therapy.

What are contraindications of generic Kaletra?

  • Hypersensitivity to lopinavir, ritonavir or its excipients;
  • Severe liver failure;
  • Children’s age up to 3 years.

Pay attention to the conditions you have:

  • Viral hepatitis B and C;
  • Cirrhosis of the liver;
  • Mild and moderate liver failure;
  • Increased activity of “liver” enzymes;
  • Pancreatitis;
  • Hemophilia A and B;
  • Dyslipidemia (hypercholesterolemia, hypertriglyceridemia).
  • Age over 65 years;
  • Patients with organic heart disease and preexisting cardiac conduction system disorders or patients taking drugs that extend the PR interval (such as verapamil or atazanavir).

What are side effects of Kaletra (Lopinavir/Ritonavir)

  • Immune system: infrequently: hypersensitivity reactions; seldom: a syndrome of restoration of immunity.
  • Digestive system: very common: diarrhea; often: abdominal pain, flatulence, nausea, vomiting, irregular stool; infrequently: dyspepsia, abdominal discomfort, dry mouth, hemorrhagic enterocolitis, fecal incontinence, gastritis, gastroesophageal reflux, pancreatitis, hepatitis; rarely: dysphagia, lower abdominal pain, constipation, duodenitis, enterocolitis, enteritis, belching, esophagitis, gastric ulcer, hemorrhoids, mouth ulcers, periodontitis, rectal bleeding, stomatitis, hepatomegaly, cholecystitis, jaundice, liver steatosis and pain in the liver.
  • Nervous system: often: headache; infrequently: insomnia, paresthesia, decreased libido, depression, sleep disturbance, anxiety, nervousness, dizziness, peripheral neuropathy, drowsiness, taste perversion; rarely: agitation, confusion, emotional lability, disorientation, impaired thinking, amnesia, ataxia, dyskinesia, encephalopathy, extrapyramidal syndrome, facial paresis, muscle tone, migraine, neuropathy, loss of taste and tremor.
  • Cardiovascular system: infrequently: vascular disorders; rarely: high blood pressure, angina pectoris, atrioventricular block, myocardial infarction, palpitations, tricuspid valve insufficiency, deep vein thrombosis, thrombophlebitis, varicose veins and vasculitis. Found in less than 2%: atrial fibrillation, orthostatic hypotension.
  • The skin and subcutaneous fat: often: lipodystrophy; not frequent: rash, acne, alopecia, allergic dermatitis, maculopapular rash, pruritus, and hyperhidrosis; rarely: dry skin, eczema, idiopathic capillary, exfoliative dermatitis, facial edema, impaired nail structure, seborrhea, discoloration of the skin, striae, skin ulcers.
  • Musculoskeletal system: infrequently: myalgia, arthralgia; rarely: osteoarthritis, lower back pain and bone necrosis, joint disease.
  • Metabolic disorders and disorders of the endocrine system: infrequently: dehydration, diabetes mellitus, Itsenko-Cushing’s syndrome, obesity, anorexia, decrease or increase in body weight; rarely: male hypogonadism, decreased or increased appetite, hyperamilasemia, hyperlipasemia, hyperuremia, hypophosphatemia, hypocholesterolemia, hypovitaminosis and hypothyroidism, lactic acidosis, lipomatosis.
  • Kidneys and urinary tract: rarely: hematuria, nephrolithiasis, nephritis and abnormalities in the laboratory parameters of urine, changes in the urine smell.
  • Reproductive system: infrequently: erectile dysfunction; rarely: amenorrhea, ejaculation disorder, breast enlargement, gynecomastia, menorrhagia.
  • Respiratory system: infrequently: bronchitis; rarely: cough, shortness of breath, pulmonary edema.
  • Blood system and blood-forming organs: rarely: anemia, leukopenia, and lymphadenopathy.
  • Sensory organs: infrequently: tinnitus; rarely: impaired vision, hyperacusis, and dizziness, imbalance.
  • Infections: rarely: bacterial infection, bronchopneumonia, inflammation of the subcutaneous fat, folliculitis, furunculosis, gastroenteritis, otitis media, perineal abscess, pharyngitis, rhinitis, sialadenitis, sinusitis and viral infection (including influenza).
  • Benign, malignant and unspecified neoplasms (including cysts and polyps): rarely: neoplasms (including benign skin neoplasms), cysts.
  • Common: often: asthenia.Infrequently: pain, pain in the sternum, fever, swelling, malaise; rarely: chills, peripheral edema, chest pain, splenomegaly.

Can I overdose?

The clinical experience of acute overdose of lopinavir/itonavir (Generic Kaletra) in humans is currently limited. There is no specific antidote. Treatment should include general supportive care measures, including monitoring vital signs and monitoring the patient’s clinical status. If necessary, unabsorbed drug is excreted by gastric lavage and activated charcoal. Since lopnnavir/ritonavir binds to a high degree to plasma proteins, the use of dialysis is ineffective.

What are possible interactions of Kaletra?

The simultaneous use of drugs that clearance is significantly dependent on metabolism through the CYP3A isoenzyme is prohibited. Such drugs include:

  • astemizole;
  • blonanserin;
  • terfenadine;
  • midazolam;
  • triazolam;
  • cisapride;
  • pimozide;
  • rifampicin;
  • salmeterol;
  • sildenafil/vardenafil;
  • voriconazole;
  • reductase inhibitors 3-hydroxy-3-methylglutaryl-CoA (lovastatin, simvastatin);
  • hypericum perforatum;
  • fosamprenavir.
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