Kaletra (Lopinavir + Ritonavir)

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Kaletra is an antiretroviral medicine that contains the active substances lopinavir and ritonavir. It belongs to a group of medicines called protease inhibitors.

How does it work?

This drug belongs to the group of antiviral drugs, protease inhibitors, used systemically for the treatment of HIV.

Lopinavir prevents the breakdown of a particular polyprotein, which causes the production of a virus that is immature and non-infectious. Ritonavir is a peptidomimetic inhibitor of two types of HIV viruses (1 and 2).

Indications

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

How to take it?

The drug is taken orally, regardless of meals.

Recommended dosages:

  • 400/100 mg (2 tablets of 200/50 mg) 2 times a day;
  • 800/200 mg (4 tablets of 200/50 mg) once a day in patients with less than three lopinavir-associated mutations.

You should consider the need to increase the dose of lopinavir / ritonavir to 500/125 mg (2 tablets of 200/50 mg and 1 tablet of 100/25 mg) when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir in patients who have previously received treatment, and which may include a decrease in sensitivity to lopinavir.

Children weighing 40 kg or more or with a body surface area of ​​1.4 – 2 square meters or more receive an adult dose of 400/100 mg 2 times a day (without the concomitant use of efavirenz, nevirapine, nelfinavir or amprenavir).

Contraindications

  • Hypersensitivity to the components of the drug (lopinavir, ritonavir and others);
  • Severe liver failure;
  • Children under 2 years of age;
  • Pregnancy;
  • Period of breastfeeding.

With caution: viral hepatitis B and C, hemophilia A and B, dyslipidemia (hypercholesterolemia, hypertriglyceridemia).

Side effects

  • Diarrhea, nausea, vomiting;
  • Urticaria, allergic edema;
  • Migraine, insomnia;
  • Hypertension;
  • Muscle pain;
  • Renal failure;
  • State of weakness.

Pregnancy and lactation

Kaletra can be used in the treatment of pregnant women but with increased caution and only in case of urgent need.

If there is a need to take this drug during lactation, you need to stop breastfeeding.

Overdose

Cases of overdose have not been reported.

In case of overdose, it is necessary to carry out gastric lavage, take sorbents, establish monitoring of the patient’s condition, and, if necessary, carry out a complex of standard supportive symptomatic therapy.

There is no specific antidote.

Interaction

  • In vitro, lopinavir and ritonavir inhibit the CYP3A isoenzyme. The simultaneous administration of the drug and drugs primarily metabolized by the CYP3A system can increase or prolong their therapeutic effect and side effects: astemizole, terfenadine, midazolam, triazolam, cisapride, pimozide, amiodarone, ergot alkaloids – ergotamine and dihydroergotamine;
  • The in vitro drug also inhibits CYP2D6 but to a lesser extent than CYP3A. The clinical significance of this phenomenon is unknown. Until more detailed information is obtained, it should not be used simultaneously with drugs whose metabolism depends on the activity of CYP2D6 (for example, propafenone), and an increase in the concentration of which in the plasma can lead to serious or life-threatening side effects;
  • Hypericum perforatum, rifampicin reduce the concentration of lopinavir / ritonavir in plasma, which can lead to a decrease in the therapeutic effect and the development of resistance;
  • Didanosine should be taken 1 hour before or 2 hours after taking the drug (dosage forms of didanosine resistant to the action of gastric juice should be taken 2 hours after meals);
  • The drug reduces the concentration of zidovudine and abacavir in plasma;
  • The results of the study in HIV-positive children revealed a decrease in the concentration of lopinavir while concomitantly with nevirapine. The effect of nevirapine on HIV-positive adult patients is likely to be similar to the effect on HIV-infected children (leading to a decrease in lopinavir concentration);
  • The drug increases the plasma concentrations of HIV protease inhibitors indinavir, nelfinavir and saquinavir;
  • Antiarrhythmic drugs (bepridil, lidocaine and quinidine): the concentration of these drugs can increase with the use of the drug;
  • Concentrations of warfarin may vary with simultaneous administration (recommended monitoring of blood coagulation);
  • The drug increases the concentration of BMCC (felodipine, nifedipine, nicardipine) in plasma;
  • Inhibitors of HMG-CoA reductase (lovastatin and simvastatin) are significantly metabolized by CYP3A4, and their concentration in plasma can significantly increase (risk of myopathy and rhabdomyolysis). The combined purpose of these drugs is not recommended;
  • Dexamethasone can induce CYP3A4 and reduce the concentration of lopinavir in the blood;
  • Simultaneous use of the drug with sildenafil is not recommended, and the dose of sildenafil should not exceed 25 mg per 48 h;
  • The drug can increase the concentration of cyclosporine and tacrolimus in the blood;
  • Plasma concentrations of ketoconazole and itraconazole may increase (doses higher than 200 mg / day are not recommended);
  • The drug moderately increases the AUC of clarithromycin, therefore, patients with renal / hepatic insufficiency need a dose reduction of clarithromycin;
  • Oral contraceptives may become less effective. Alternative or additional methods of contraception should be used;
  • When Kaletra is used together with rifabutin for 10 days, the Cmax and AUC of rifabutin increases 3.5 and 5.7 times, respectively, it is recommended to reduce the dose of rifabutin by 75% (it may be necessary to further reduce the dose of rifabutin);
  • The drug can increase the concentration of medicines that cause a prolongation of the Q-T interval (chlorphenamine, quinidine, erythromycin, clarithromycin), which increases the risk of rhythm disturbances;
  • Antiepileptic drugs (phenobarbital, phenytoin, carbamazepine) reduce the concentration of lopinavir.

Precautions

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions. The drug can cause side effects that affect these abilities (for example, dizziness), it is recommended to refrain from driving vehicles and controlling machinery. Studies of the ability to drive vehicles and control mechanisms have not been conducted.

Storage

Keep out of reach of children and pets. Store at room temperature, awat from direct sunlight, heat and moisture. Discard the expired medicine.

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