Generic Kaletra (Lopinavir 200mg/Ritonavir 50mg)

Introduction

Kaletra is a fixed-dose combination tablet that contains the antiretroviral agents lopinavir (200 mg) and ritonavir (50 mg). The product is classified as a protease-inhibitor combination and is used primarily to treat human immunodeficiency virus type 1 (HIV-1) infection in adults. It is supplied in bottles of 60 tablets. The medication belongs to the broader group of HIV-1 protease inhibitors and is sometimes prescribed off-label in investigational protocols for emerging viral infections.

What is Kaletra?

Kaletra is aaged oral tablet that delivers 200 mg of lopinavir together with 50 mg of ritonavir in a single pill. Lopinavir is the active antiviral; ritonavir is included at a low dose to inhibit the metabolic breakdown of lopinavir, thereby boosting its plasma concentration. The combination was developed by Abbott Laboratories (now part of AbbVie) and received regulatory approval in the early s for use in combination antiretroviral therapy (cART).

The same lopinavir/ritonavir formulation is marketed under other brand names, such as Aluvia in the United States and Kaletra ® in many other regions. Generic versions of the combination are widely available and provide a cost-effective alternative to the branded products.

How Kaletra Works

Lopinavir binds to the active site of the HIV-1 protease enzyme, preventing the cleavage of viral poly-protein precursors. This blocks the maturation of infectious virions, leading to a decline in viral load. Ritonavir, while also an HIV protease inhibitor, is used at sub-therapeutic levels to inhibit cytochrome P450 3A4 (CYP3A4) in the liver and intestinal wall. By reducing CYP3A4 activity, ritonavir slows the metabolism of lopinavir, increasing its systemic exposure and prolonging the antiviral effect. The combined tablet therefore achieves high intracellular concentrations of lopinavir without the need for separate booster dosing.

Onset of viral suppression typically occurs within 2-4 weeks of initiating therapy, and steady-state drug levels are reached after about 5 days of twice-daily dosing. The drug’s half-life is prolonged by ritonavir boosting, allowing predictable pharmacokinetics across a broad patient population.

Conditions Treated with Kaletra

• HIV-1 infection in adults - Kaletra is approved as part of combination antiretroviral therapy for treatment-naïve and treatment-experienced patients. The drug reduces plasma HIV-1 RNA levels, improves CD4⁺ T-cell counts, and delays disease progression when used with nucleoside reverse transcriptase inhibitors (NRTIs) or integrase inhibitors.

The efficacy of Kaletra in these indications has been demonstrated in pivotal trials such as CAST (the Combination Antiretroviral Therapy study) and the ACTG A5142 trial, which showed comparable viral suppression to other protease-inhibitor regimens.

Off-Label and Investigational Uses of Kaletra

• Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection - Early in the COVID-19 pandemic, lopinavir/ritonavir was investigated as a potential antiviral because of in-vitro activity against coronaviruses. Randomized controlled trials (e.g., the RECOVERY and SOLIDARITY trials) did not demonstrate a clinically meaningful benefit in hospitalized patients. Consequently, regulatory agencies such as the FDA and EMA have not approved Kaletra for COVID-19 treatment.

• Emerging flavivirus infections (e.g., dengue, Zika) - Small case-series and pre-clinical studies have suggested modest inhibition of viral replication. No large-scale clinical data exist, and use remains experimental.

• Hepatitis C virus (HCV) genotype 4 - A limited number of open-label studies reported reductions in viral load when lopinavir/ritonavir was added to standard interferon-based regimens. The approach is not part of current HCV guidelines.

All off-label applications should only be pursued under the direct supervision of a qualified healthcare professional, and patients must be informed that efficacy and safety have not been formally established for these indications.

Is Kaletra the Right Medication for You?

Kaletra is appropriate for adult patients who:

• Have confirmed HIV-1 infection and require a protease-inhibitor-based regimen.
• Are able to take medication with food, as food increases lopinavir absorption and reduces gastrointestinal discomfort.
• Do not have contraindications such as severe hepatic impairment (Child-Pugh class C) or known hypersensitivity to lopinavir, ritonavir, or any tablet excipients.

Kaletra may be less suitable for patients who:

• Have uncontrolled hepatitis B or C co-infection with advanced liver disease.
• Are taking medications that are strong CYP3A4 inducers (e.g., carbamazepine, St. John’s wort) because these can markedly reduce lopinavir exposure.
• Are pregnant or breastfeeding without thorough risk-benefit assessment; ritonavir is classified as pregnancy category C, and data are limited.

Clinical decision-making should involve a comprehensive assessment of viral genotype, resistance patterns, co-morbid conditions, and potential drug-drug interactions.

Risks, Side Effects, and Interactions

Common

• Diarrhea
• Nausea and vomiting
• Abdominal discomfort
• Hyperlipidaemia (elevated triglycerides and cholesterol)
• Dysgeusia (altered taste)

Rare

• Pancreatitis
• Severe hepatotoxicity (elevated transaminases > 5 × ULN)
• Peripheral neuropathy
• Stevens-Johnson syndrome / toxic epidermal necrolysis

Serious

• Immune reconstitution inflammatory syndrome (IRIS) in patients with advanced immunosuppression
• Life-threatening cardiac arrhythmias when combined with other QT-prolonging agents (e.g., certain antiarrhythmics, some antipsychotics)
• Acute liver failure

Drug-Drug Interactions

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) can increase lopinavir/ritonavir concentrations, raising the risk of toxicity. Dose adjustment or avoidance is recommended.
• CYP3A4 inducers (e.g., rifampin, efavirenz) markedly lower lopinavir levels and may lead to virologic failure. Alternative antiretroviral agents are preferred.
• Statins (especially simvastatin, lovastatin) can cause severe myopathy when combined with ritonavir; use pravastatin or rosuvastatin at the lowest effective dose.
• Anticoagulants such as warfarin may have altered INR values; frequent monitoring is advised.

Drug-Food Interactions

• High-fat meals increase lopinavir absorption; the tablet should be taken with food to improve tolerability and plasma concentrations.
• Grapefruit juice, a known CYP3A4 inhibitor, should be avoided as it can raise drug levels unpredictably.

Use: Dosing, Missed Dose, Overdose

Standard dosing for treatment-naïve adults: two tablets (each containing 200 mg lopinavir/50 mg ritonavir) taken twice daily with a meal, totaling 800 mg/200 mg per day. The 60-tablet bottle supplies a30-day supply at this schedule.

Dose adjustments may be required in hepatic impairment (reduce to one tablet twice daily for Child-P B) or in the presence of strong CYP3A4 inhibitors (consider reducing to one tablet twice daily).

Missed dose: If a dose is omitted and it is less than 8 hours until the next scheduled dose, take the missed tablet as soon as remembered. If the next dose is due in less than 2 hours, skip the missed dose and continue with the regular schedule. Do not double-dose.

Overdose: Acute overdose may manifest as severe gastrointestinal symptoms, hyperlipidaemia, or liver enzyme elevations. Seek immediate medical attention. Supportive care, including activated charcoal if presentation is early, and monitoring of hepatic function are recommended.

Practical precautions

• Take tablets with food or a substantial snack.
• Avoid alcohol excess, which can increase hepatic strain.
• Do not operate heavy machinery if you experience dizziness or severe gastrointestinal upset.

FAQ

• What should I know about storing Kaletra in hot climates?   Kaletra tablets should be kept at 20-25 °C (68-77 °F) and protected from moisture. In regions with high ambient temperatures, store the bottle in a cool, dry place such as a closed cabinet away from direct sunlight.

• Can I travel internationally with Kaletra tablets?   Yes, but carry the medication in its original packaging with a copy of the prescription (or a doctor’s letter if required) to satisfy customs regulations. Some countries restrict the import of antiretrovirals, so verify local rules before departure.

• Do the tablets contain any allergens such as latex or soy?  &nbspThe inactive ingredients include microcrystalline cellulose, magnesium stearate, and titanium dioxide. The formulation does not contain latex, soy, or gluten.

• How does Kaletra differ from Aluvia?   Both products contain the same lopinavir/ritonavir ratio (200 mg/50 mg) and are bioequivalent. Differences may lie in manufacturer, packaging, and pricing; clinical efficacy is identical when used at the recommended dose.

• Is there a difference in effectiveness when Kaletra is taken with a high-fat versus a low-fat meal?   A high-fat meal modestly increases lopinavir absorption, leading to higher plasma concentrations. However, taking the tablet with any substantial meal (≈ 300 kcal) is sufficient for consistent drug exposure.

• Can Kaletra be crushed for patients with swallowing difficulties?   Crushing is not recommended because it can affect the ritonavir-mediated boosting effect and increase gastrointestinal irritation. If swallowing is problematic, discuss alternative formulations (e.g., oral solution) with a healthcare professional.

• What impact does Kaletra have on laboratory test results?   Ritonavir can elevate serum bilirubin and alkaline phosphatase without indicating true liver injury. It may also affect lipid panels, raising triglycerides and LDL cholesterol. Inform laboratory personnel that you are on lopinavir/ritonavir.

• Are there specific vaccine considerations while on Kaletra?   Live attenuated vaccines (e.g., yellow fever, varicella) should be administered before initiating antiretroviral therapy when possible. Inactivated vaccines are generally safe but may have reduced immunogenicity; timing should be discussed with a provider.

• How long can a patient remain on Kaletra before needing a regimen change?   Guidelines recommend monitoring virologic response every 3-6 months. If viral suppression is maintained and tolerability is acceptable, continuation is appropriate indefinitely. Resistance or intolerable side effects prompt a regimen switch.

• What is the shelf-life of a Kaletra bottle?   The expiration date printed on the bottle is typically 24 months from the date of manufacture, provided storage conditions are obeyed. Do not use tablets past this date.

Glossary

Protease inhibitor

A class of antiviral drugs that block the action of the HIV protease enzyme, preventing the maturation of infectious viral particles.

Boosting

The pharmacokinetic enhancement of one drug’s plasma concentration by co-administering a second drug that inhibits its metabolism (e.g., ritonavir boosting lopinavir).

CYP3A4

A liver enzyme responsible for metabolizing many medications; inhibition or induction of CYP3A4 can dramatically alter drug exposure.

Immune reconstitution inflammatory syndrome (IRIS)

An exaggerated inflammatory response that can occur after initiating antiretroviral therapy in patients with severely compromised immunity.

Buying Kaletra from Our Online Pharmacy

Kaletra can be obtained conveniently through our online pharmacy. We source the medication from licensed, verified suppliers that meet stringent quality standards, ensuring each batch matches the approved formulation.

• Cost-effective pricing - Because we purchase near-manufacturer cost, the price is significantly lower than many retail outlets.
• Verified quality - Every shipment is accompanied by a Certificate of Analysis and undergoes independent testing for potency and purity.
• Discreet, reliable delivery - Packages are sent in unmarked envelopes, with tracking available for both express (approximately 7 days) and standard airmail (about 3 weeks).
• International accessibility - Our pharmacy broker service works with overseas licensed pharmacies, making it possible for patients in regions with limited local supply to receive the medication safely.

By choosing our service, patients gain a trusted, private, and affordable pathway to obtain Kaletra when conventional channels are unavailable or prohibitively expensive.

Disclaimer

The information presented about Kaletra is intended for general educational purposes and does not substitute for professional medical advice. Treatment choices, including any off-label use, must be made under the guidance of a qualified healthcare provider. Readers are assumed to be responsible adults capable of making informed health decisions. Our online pharmacy supplies Kaletra to individuals who may encounter barriers accessing the drug through traditional pharmacies or insurance plans, offering a cost-effective generic alternative. Always discuss any medication changes, initiation, or discontinuation with a qualified clinician before proceeding.