Kaletra (Lopinavir + Ritonavir)

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Kaletra is an oral medication that contains lopinavir and ritonavir. It is used for treating infections with the human immunodeficiency virus (HIV).

Pharmachology

Combined antiviral agent. Lopinavir is an HIV-1 and HIV-2 protease inhibitor. Inhibition of HIV proteases prevents the breakdown of the gag (group-specific antigens) -polymerase bond of the polyprotein, which leads to the formation of an immature and infectious virus.

Ritonavir inhibits in the liver the CYP3A4-mediated metabolism of lopinavir, which leads to an increase in plasma lopinavir concentration.

Indications

The drug is used and prescribed in combination therapy with other antiretroviral drugs for the treatment of HIV infection.

How to use Kaletra?

For oral use. Adults and teenagers – 400/100 mg (3 capsules or 5 ml of oral solution) 2 times a day with meals. Based on the experience, an increase in the dose of the drug to 533/133 mg (4 capsules) 2 times a day can be considered with simultaneous administration with nevirapine, especially in patients with possible reduced sensitivity to lopinavir.

In patients who have previously been prescribed protease inhibitors, when used in combination with efavirenzem, the dose should also be increased to 533/133 mg (4 capsules) 2 times a day. This change in dose may be insufficient in some patients.

Children over 2 years of age – 3 capsules 2 times a day with meals. Children whose body surface is less than 1.3 sq.m are prescribed a solution for oral administration – 230 / 57.5 mg / sq.m 2 times a day with meals; the maximum dose is 400/100 mg 2 times a day. A dose of 230 / 57.5 mg / m2 may be insufficient in some children who take nevirapine or efavirenz at the same time. In this case, it is necessary to increase the dose to 300/75 mg / sq.m. Dosing should be carried out using a dosing syringe.

Patients with renal failure do not need dose adjustment.

Side effects

This drug can cause the following adverse reactions:

  • rash, bullous rash, itching, allergic urticaria, anaphylactic shock;
  • cellulitis, folliculitis;
  • rash, acne, eczema, dermatitis, allergic dermatitis;
  • arthralgia, osteoarthritis, myalgia, pain in the limbs;
  • benign and malignant neoplasms;
  • anemia, leukopenia, lymphadenopathy, neutropenia;
  • hypogonadism (in men), Cushing’s syndrome, hypothyroidism;
  • flu-like syndrome, otitis media, pharyngitis, bronchitis, rhinitis, sinusitis, furunculosis, sialadenitis, gastroenteritis, bacterial or viral infection, bronchopneumonia;
  • hypovitaminosis, dehydration, edema, increased appetite, lactic acidosis, obesity, anorexia, diabetes mellitus, hyperglycemia, hypocholesterolemia, lipomatosis;
  • headache, including migraine, paresthesia, facial paralysis, convulsions, intracranial hypertension, neuropathy;
  • violations of the organs of vision, hearing;
  • palpitations, myocardial infarction, atrial flutter, arterial hypertension, thrombophlebitis, orthostatic hypotension, vasculitis, varicose veins, deep vein thrombosis, vasodilation, angina pectoris;
  • pulmonary edema, shortness of breath, cough, asthma;
  • sleep disturbance, mood changes, anxious dreams, agitation, anxiety, apathy, confusion, depression, dyskinesia, decreased libido, nervousness, impaired thinking;
  • diarrhea, nausea, vomiting, abdominal pain, dyspepsia, flatulence, constipation, gastroesophageal reflux, dry mouth, dysphagia, enterocolitis, colitis, belching, esophagitis, fecal incontinence, gastritis, enteritis, gastroenteritis, hemorrhagic enteritis, mucous rheumatoid arthritis , pancreatitis, stomatitis, periodontitis, abdominal discomfort, pain in the lower abdomen, duodenitis, stomach and intestinal ulcers, rectal bleeding, gastrointestinal bleeding rarely – hemorrhoids;
  • cholecystitis, hepatitis, hepatomegaly, fatty liver, soreness of the liver, jaundice, cholangitis;
  • nephrolithiasis, nephritis, hyperuricemia, hematuria, renal failure;
    ejaculation disorders, amenorrhea, gynecomastia, erectile dysfunction, menorrhagia.

Contraindications

Do not take Kaletra if you are havingany of the following conditions: use of drugs which clearance is significantly dependent on metabolism by means of SURZA isoenzyme (astemizole, terfenadine, midazolam (oral), triazolam, pimozide, salmeterol, sildenafil and tadalafil, vardenafil, avanafil, voriconazole, ergotamine, etc.), HMG-CoA reductase inhibitors (lovastatin, simvastatin), fosamprenavir, fuzuzid, (in the treatment of skin infections), amiodarone; quetiapine); use of St. John’s wort, simeprevir; use of rifampicin; use of tipranavir; the use of carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, amprenavir or nelfinavir; use with ketoconazole and itraconazole in high doses (more than 200 mg / day); the age under 3 years; pregnant women.

Pregnancy and lactation

Available data show that Kaletra does not increase the risk of common serious congenital malformations compared with the initial incidence of congenital malformations. If necessary, this drug can be used during pregnancy.

Studies in rats have revealed that lopinavir is excreted in maternal milk. It is not known whether lopinavir and ritonavir are excreted in human milk. If it’s necessary to take the drug during lactation, breastfeeding should be stopped.

Restrictions on use

Viral hepatitis B and C; cirrhosis of the liver; mild to moderate liver failure; increased activity of liver enzymes; pancreatitis hemophilia A and B; dyslipidemia (hypercholesterolemia, hypertriglyceridemia); simultaneous use with drugs for the treatment of erectile dysfunction (sildenafil, tadalafil); concomitant use with fentanyl, rosuvastatin, bupropion, inhaled or nasally administered GCS (for example fluticasone, budesonide), antiarrhythmic drugs (for example bepridil, lidocaine, quinidine), digoxin, lamotrigine, valproic acid; simultaneous use with drugs that extend the QT interval; patients with organic heart diseases, a history of cardiac conduction system disorders or taking drugs that extend the PR interval (such as verapamil or atazanavir); advanced age (over 65 years).

Overdose

Treatment: gastric lavage, intake of activated charcoal, maintaining the function of vital systems of the body, monitoring the clinical condition. Dialysis is ineffective (high degree of protein binding). There is no specific antidote.

Storage

Store in a dry place, out of the reach of children, at room temperature, away from sunlight and moisture. Do not use the medicine that has expired.