Kaletra: Advanced Protease Inhibitor for HIV-1 Management
| Product dosage: 250mg | |||
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Synonyms | |||
Kaletra is a fixed-dose combination antiretroviral medication containing lopinavir and ritonavir, designed for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients. As a protease inhibitor, it works by blocking the viral protease enzyme, thereby inhibiting the replication of HIV and helping to reduce viral load. It is indicated for use in combination with other antiretroviral agents as part of a comprehensive HIV management strategy. Kaletra is formulated to offer a high genetic barrier to resistance and is backed by extensive clinical evidence supporting its efficacy and safety profile.
Features
- Contains lopinavir 200 mg and ritonavir 50 mg per tablet
- Available as film-coated tablets and oral solution
- Does not require refrigeration for tablets; oral solution must be refrigerated
- Bioavailability enhanced by ritonavir boosting
- Manufactured under strict quality control standards
Benefits
- Effectively suppresses HIV-1 viral load to undetectable levels
- Helps restore and maintain CD4+ cell counts
- Reduces the risk of HIV-related complications and disease progression
- Supports long-term adherence with a convenient twice-daily dosing regimen
- Demonstrates a high barrier to the development of resistance
- Suitable for use across diverse patient populations, including pediatric patients
Common use
Kaletra is prescribed as part of combination antiretroviral therapy (cART) for the management of HIV-1 infection. It is used in both treatment-naïve and treatment-experienced patients, including those who have developed resistance to other protease inhibitors. The medication is often utilized in scenarios where a boosted protease inhibitor is indicated due to its pharmacokinetic advantages and robust antiviral activity.
Dosage and direction
The recommended adult dosage of Kaletra is 400 mg lopinavir/100 mg ritonavir (two tablets) twice daily taken with or without food. For treatment-naïve adults, an alternative once-daily dosing regimen of 800 mg lopinavir/200 mg ritonavir (four tablets) may be considered. Pediatric dosing is based on body weight or body surface area and should be calculated precisely according to prescribing guidelines. Tablets should be swallowed whole and not chewed, crushed, or split. The oral solution must be administered using the provided dosing syringe or cup to ensure accuracy.
Precautions
Patients should be monitored for potential liver function abnormalities, as Kaletra may cause hepatotoxicity. Use with caution in patients with underlying hepatic impairment, including hepatitis B or C coinfection. Pancreatitis has been reported; discontinue use if clinical signs or symptoms arise. Kaletra may cause PR interval prolongation—caution is advised in patients with pre-existing cardiac conduction abnormalities. Lipid elevations, including triglycerides and cholesterol, may occur and should be managed appropriately. Patients should be advised that Kaletra is not a cure for HIV and does not reduce the risk of transmitting HIV to others.
Contraindications
Kaletra is contraindicated in patients with known hypersensitivity to lopinavir, ritonavir, or any component of the formulation. Coadministration with drugs highly dependent on CYP3A or CYP2D6 for clearance and for which elevated plasma concentrations are associated with serious or life-threatening events is contraindicated. This includes, but is not limited to, alfuzosin, amiodarone, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil (for pulmonary arterial hypertension), triazolam, and oral midazolam.
Possible side effect
Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, headache, and insomnia. Laboratory abnormalities may include elevated triglycerides, elevated cholesterol, elevated liver enzymes, and hyperglycemia. Less frequently, rash, weakness, and pancreatitis have been reported. Immune reconstitution syndrome has been observed in some patients initiating antiretroviral therapy.
Drug interaction
Kaletra is a potent inhibitor of CYP3A and CYP2D6 and may increase plasma concentrations of drugs metabolized by these enzymes. It may also induce CYP enzymes and glucuronosyl transferase, potentially reducing concentrations of some coadministered drugs. Significant interactions occur with other antiretrovirals, anticonvulsants, antifungals, antidepressants, sedatives, statins, and oral contraceptives. A comprehensive review of the patient’s medication list is essential prior to initiation and during therapy.
Missed dose
If a dose is missed within 6 hours of the scheduled time, the patient should take it as soon as possible and resume the normal dosing schedule. If more than 6 hours have passed, the missed dose should be skipped and the next dose taken at the regular time. Patients should not double the dose to make up for a missed one.
Overdose
There is limited experience with Kaletra overdose. Management should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. Since lopinavir and ritonavir are highly protein-bound, dialysis is unlikely to be beneficial. If overdose occurs, contact a poison control center or healthcare provider immediately.
Storage
Kaletra tablets should be stored at room temperature, 20–25°C (68–77°F), in the original container to protect from moisture. The oral solution should be refrigerated at 2–8°C (36–46°F); do not freeze. If stored at room temperature, the oral solution must be used within 2 months. Keep out of reach of children and pets.
Disclaimer
This information is intended for healthcare professionals and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider for personalized recommendations. Dosage and administration may vary based on individual patient factors, including renal or hepatic function, concomitant medications, and treatment history.
Reviews
Clinical studies and post-marketing surveillance have demonstrated Kaletra’s efficacy in achieving and maintaining viral suppression. It is regarded as a reliable option within antiretroviral regimens, particularly where resistance or tolerability issues limit other choices. Healthcare providers note its utility in complex cases, though attention to drug interactions and adverse effect management is emphasized. Patient feedback often highlights the convenience of the tablet formulation, though gastrointestinal side effects can impact tolerability in some individuals.