Kaletra (Lopinavir/Ritonavir) – Oral: Uses, Side Effects, Dosages, Interactions

What Is Kaletra?

Kaletra is a mix ritonavir-boosted protease inhibitor (PI) that features lopinavir and low-dose ritonavir. It’s used to deal with human immunodeficiency virus (HIV) an infection in adults and kids.

Kaletra works by inhibiting proteases (particular enzymes). This decreases viral load (quantity of HIV within the blood) and reduces the danger of growing infectious ailments as a consequence of a weakened immune system. Ritonavir boosts the extent of lopinavir within the physique by inhibiting cytochrome P450 3A4 (a selected liver enzyme). This strengthens the impact of the treatment general.

Kaletra is obtainable solely by prescription. It’s out there as a pill, soft-gel capsule, and an oral resolution for individuals who have issue swallowing.

Drug Facts

Generic Name: Lopinavir/Ritonavir

Brand Name(s): Kaletra

Drug Availability: Prescription

Therapeutic Classification: HIV protease inhibitors

Available Generically: No

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Lopinavir and Ritonavir

Dosage Form(s): Tablets, oral resolution

What Is Kaletra Used For?

Kaletra is a drugs possibility to forestall HIV-1-related infections in adults, adolescents, and kids above 14 days.

According to the Centers for Disease Control and Prevention (CDC), in 2019, round 38 million individuals had been residing with HIV all over the world. Around 690,000 individuals died from AIDS-related sicknesses in 2019. Kaletra isn’t a treatment for HIV, however these drugs might lower the prospect of growing HIV-related sicknesses and purchased immunodeficiency syndrome (AIDS).

Following the invention and widespread use of antiretroviral remedy (ART), comparable to protease inhibitors, the life expectancy of HIV-infected people has considerably elevated.

How to Take Kaletra

Always learn the prescription label and producer’s tips rigorously. Ask your pharmacist or healthcare supplier about something you do not perceive. 

Kaletra comes as a pill and an answer (liquid) to take by mouth, often twice a day or as prescribed. 

When taking tablets:

  • Take with or with out meals.
  • Swallow the tablets entire.
  • Do not cut up, chew, or crush them.

When taking Kaletra in resolution type:

  • You should take it with meals. 
  • Shake it nicely earlier than every use to combine the treatment evenly.
  • Use a dose-measuring spoon or cup to measure the dose appropriately.
  • Do not use a family spoon as it might trigger an incorrect dose measurement.

Other tips:

  • Take Kaletra doses exactly as prescribed.
  • Please don’t take extra, much less, or take it extra usually than prescribed.
  • Continue to take drugs even when you really feel nicely.
  • Do not cease taking with out speaking to your healthcare supplier.
  • If you’re taking doses lower than the prescribed or cease taking them without delay, your situation might grow to be tougher to deal with.

Storage

Store Kaletra tablets at room temperature and shield them from extra moisture. It is greatest to maintain the tablets within the container they got here in. Use the tablets inside two weeks when you take them out of the unique container.

Keep the oral resolution within the fridge at 36 to 46 levels Fahrenheit (two to eight levels Celsius) till the expiration date, or at room temperature for as much as two months.

Keep all of the drugs out of the attain of youngsters and pets, ideally locked in a cupboard or closet. Always hold the security lock on to keep away from unintentional poisoning.

If you propose to journey with Kaletra, get acquainted with your last vacation spot’s laws. In basic, make sure to make a replica of your Kaletra prescription. Try to maintain your treatment in its authentic container out of your pharmacy together with your title on the label. If you’ve any questions on touring together with your drugs, ask your pharmacist or healthcare supplier.

Discard all unused and expired medicine, however don’t pour them down the drain or bathroom. Ask your pharmacist or healthcare supplier about the perfect methods to eliminate this drugs. And take a look at drug take-back applications in your space.

Off-Label Uses

Kaletra (lopinavir, boosted with ritonavir) was used off-label to deal with COVID-19 throughout the pandemic. Evidence from medical trials does not assist the usage of Kaletra to deal with COVID-19.

How Long Does Kaletra Take to Work?

Kaletra isn’t a treatment however a remedy to keep away from problems and probabilities of getting HIV-related infections. It’s a long-term remedy and could also be required for an prolonged interval. Follow the rules of your healthcare supplier and take so long as advisable.

What Are the Side Effects of Kaletra?

This isn’t a whole listing of negative effects and others might happen. A healthcare supplier can advise you on negative effects. If you expertise different results, contact your pharmacist or a healthcare supplier. You might report negative effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Kaletra might trigger some widespread negative effects:

  • Bloating
  • Diarrhea
  • Difficulty falling asleep or staying asleep
  • Headache
  • Heartburn
  • High ldl cholesterol, excessive lipids, and excessive triglycerides
  • Muscle ache
  • Numbness or tingling within the arms or ft
  • Nausea and vomiting
  • Stomach ache
  • Weight loss

Call your healthcare supplier if any of those signs worsen or don’t go away.

Severe Side Effects

Contact your healthcare supplier instantly when you develop any indicators of a extreme response. Call 911 in case your signs really feel life-threatening.

Serious negative effects and their signs embody:

  • Extreme tiredness
  • Loss of urge for food
  • Pain within the higher proper a part of the abdomen
  • Yellowing of the pores and skin or eyes
  • Nausea
  • Vomiting
  • Stomach ache
  • Itchy pores and skin
  • Dizziness
  • Lightheadedness
  • Fainting
  • Irregular heartbeat
  • Blisters
  • Rash

Report Side Effects

Kaletra might trigger different negative effects. Call your healthcare supplier you probably have any uncommon issues whereas taking this treatment.

If you expertise a severe aspect impact, you or your healthcare supplier might ship a report back to the FDA’s MedWatch Adverse Event Reporting Program or by telephone (800-332-1088).

Dosage: How Much Kaletra Should I Take?


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The dose of this drugs can be completely different for various sufferers. Follow your physician’s orders or the instructions on the label. The following data consists of solely the typical doses of this drugs. If your dose is completely different, don’t change it except your physician tells you to take action.

The quantity of drugs that you just take is determined by the energy of the medication. Also, the variety of doses you’re taking every day, the time allowed between doses, and the size of time you’re taking the medication depend upon the medical downside for which you might be utilizing the medication.

  • For remedy of HIV an infection:

    • For oral dosage type (resolution):

      • Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) two instances a day with meals or 800 mg of lopinavir and 200 mg of ritonavir (10 mL) as soon as a day with meals. Your physician might modify your dose as wanted.
      • Children 6 months and older—Dose is predicated on physique weight or physique dimension and have to be decided by your kid’s physician. The advisable dose is 10 to 12 milligrams per kilogram (mg/kg) of physique weight or 230 milligrams per sq. meter (mg/m[2]) of physique dimension for lopinavir and a pair of.5 to three mg/kg or 57.5 (mg/m[2]) for ritonavir two instances a day with meals. Your physician might modify your dose as wanted.
      • Children 14 days to six months of age—Dose is predicated on physique weight or physique dimension and have to be decided by your kid’s physician. The advisable dose is 16 milligrams per kilogram (mg/kg) of physique weight or 300 milligrams per sq. meter (mg/m[2]) of physique dimension for lopinavir and 4 mg/kg or 75 (mg/m[2]) for ritonavir two instances a day with meals.
      • Children youthful than 14 days of age—Use isn’t advisable, except your physician determines it’s protected to be given.
    • For oral dosage type (tablets):

      • Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) two instances a day or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) as soon as a day. Your physician might modify your dose as wanted.
      • Children 6 months and older—The little one should have the ability to swallow a pill entire. Dose is predicated on physique weight and have to be decided by your kid’s physician. The advisable dose is 200 to 400 milligrams (mg) of lopinavir and 50 to 100 mg of ritonavir (2 to 4 tablets) two instances a day. Your physician might modify your dose as wanted.
      • Children 14 days to six months of age—This dosage type is often not used for infants. Please confer with the oral resolution dosage type.
      • Infants youthful than 14 days of age—Use isn’t advisable, except your physician determines it’s protected to be given.

Modifications

The following modifications (adjustments) needs to be stored in thoughts when utilizing Kaletra:

Severe allergic response: Kaletra needs to be averted in individuals hypersensitive to lopinavir or any pill or oral resolution ingredient. Ask your pharmacist or healthcare supplier for an entire listing of the elements when you’re uncertain.

Pregnancy: Discuss together with your healthcare supplier if you’re or plan to grow to be pregnant and weigh the advantages and dangers of taking Kaletra throughout your being pregnant. It ought to solely be used if the potential advantages outweigh the dangers.

Breastfeeding: The CDC suggests that folks contaminated with HIV keep away from breastfeeding to keep away from the danger of giving their infants postnatal HIV-1. Breastfeeding needs to be averted whereas receiving Kaletra to forestall transmitting HIV-1 to their infants and stop extreme hostile reactions in nursing infants.

Adults over 65: Clinical research have not included a big sufficient variety of individuals on this age group to see whether or not they reply otherwise from youthful adults. In basic, warning is suggested concerning the higher frequency of hepatic (liver), renal (kidney), and cardiac (coronary heart) ailments and use with different drug therapies. 

Children: The security and efficacy of Kaletra haven’t been established in individuals beneath 14 days.

Other modifications: Kaletra is metabolized by the liver; due to this fact, hepatic impairment (liver situations) may cause an increase in lopinavir concentrations within the physique. Caution is required in individuals with hepatic impairment to keep away from negative effects. 

Administration modifications: Take the tablets with or with out meals. But if taking an oral resolution, you could take it with meals.

Missed Dose

If you by accident forgot your Kaletra dose, take it as quickly as you bear in mind. However, if it is already near your subsequent scheduled dose, skip the missed dose and take the next dose at your subsequent scheduled dosing time. Don’t attempt to double as much as make up for the missed dose.

Try to assist your self bear in mind to maintain your appointments and take your treatment routinely. If you miss too many doses, Kaletra may be much less efficient at stopping HIV.

Overdose: What Happens If I Take Too Much Kaletra?

If you’ve taken an unintentional overdose of Kaletra and have life-threatening signs, search instant medical consideration.

If a baby drinks greater than the prescribed dose of the Kaletra resolution, search instant medical assist. Kaletra resolution incorporates a considerable amount of alcohol and different elements that might be very dangerous to a baby.

What Happens If I Overdose on Kaletra?

If you suppose you or another person might have overdosed on Kaletra, name a healthcare supplier or the Poison Control Center (800-222-1222).

If somebody collapses or is not respiratory after taking Kaletra, name 911 instantly.

Precautions


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It is essential that your physician test the progress of you or your little one at common visits to guarantee that this drugs is working correctly. Blood and urine checks could also be wanted to test for negative effects.

Do not use this drugs when you or your little one are additionally utilizing alfuzosin (Uroxatral®), apalutamide (Erleada®), cisapride (Propulsid®), colchicine (Colcrys®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Methergine®, or Migranal®), lomitapide (Juxtapid®), lovastatin (Advicor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®).

Pancreatitis might happen if you are utilizing this drugs. Check together with your physician instantly when you or your little one have sudden and extreme abdomen ache, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check together with your physician instantly when you or your little one have ache or tenderness within the higher abdomen, pale stools, darkish urine, lack of urge for food, nausea, uncommon tiredness or weak spot, or yellow eyes or pores and skin. These might be signs of a severe liver downside.

This drugs might improve blood sugar ranges. Check together with your physician when you or your little one discover a change within the outcomes of your blood or urine sugar checks.

This drugs might trigger coronary heart rhythm issues, together with PR or QT prolongation. It might change the way in which your coronary heart beats and trigger fainting or severe negative effects in some sufferers. Contact your physician instantly when you or your little one have any signs of coronary heart rhythm issues, comparable to quick, pounding, or irregular heartbeats.

This drugs might improve the quantity of ldl cholesterol and fat in your blood. If this situation happens, your physician might offer you some medicines that may decrease the quantity of ldl cholesterol and fat within the blood. Talk to your physician when you or your little one have considerations.

If you or your little one develop a pores and skin rash, hives, or any allergic response to this drugs, test together with your physician as quickly as attainable.

If you take the oral liquid, it is best to restrict the quantity of alcohol you drink. The Kaletra® oral liquid incorporates 42% alcohol. Talk to your physician when you or your little one are taking, or plan to take, metronidazole (Flagyl®) or disulfiram (Antabuse®).

Birth management drugs that comprise estrogen might not work as nicely if you are utilizing this drugs. To hold from getting pregnant, use a further type of contraception alongside together with your drugs. Other types of contraception embody condoms, a diaphragm, or contraceptive foam or jelly.

Your immune system might get stronger while you begin taking HIV medicines. Tell your physician instantly when you discover any adjustments in your well being. Sometimes the immune system will begin to battle infections that had been hidden in your physique, comparable to pneumonia or tuberculosis, or might lead to a flare-up of a hidden autoimmune dysfunction comparable to Graves illness, polymyositis, or Guillain-Barré syndrome.

This drugs might trigger you to have extra physique fats. Tell your physician when you or your little one discover adjustments in your physique form, comparable to an elevated quantity of fats within the higher again and neck, or across the chest and abdomen space. You may also lose fats from the legs, arms, and face.

This drugs might improve the danger of bleeding in sufferers with hemophilia (a bleeding dysfunction). Talk together with your physician about this threat.

This drugs won’t hold you from giving HIV to your associate throughout intercourse. Make positive you perceive this and apply protected intercourse, even when your associate additionally has HIV, through the use of a latex condom or different barrier methodology. This drugs can even not hold you from giving HIV to different individuals if they’re uncovered to your blood. Do not re-use or share needles with anybody.

Do not take different medicines except they’ve been mentioned together with your physician. This consists of prescription and nonprescription (over-the-counter [OTC]) medicines, and natural (eg, St. John’s wort) or vitamin dietary supplements.

What Are Reasons I Shouldn’t Take Kaletra?

Kaletra should not be used with sure situations and with sure drugs. Avoid utilizing Kalerta in people who find themselves hypersensitive (allergic) to any of its elements. Hypersensitivity reactions embody: 

Kaletra should not be used with medicine which might be metabolized by the liver enzyme CYP3A4. Taking these collectively can improve concentrations of the medicine within the physique. This may cause life-threatening reactions. 

Kaletra additionally should not be used with medicine which might be potent CYP3A4 inducers. Taking these collectively can cut back lopinavir concentrations within the physique, making Kaletra much less efficient and likewise rising the potential for drug resistance.

Certain medicine are contraindicated with Kaletra. These medicine, when taken with lopinavir, may cause extreme negative effects comparable to:

  • Cardiac arrhythmias (irregular coronary heart charge)
  • Increased plasma focus of medication resulting in hostile results
  • A lower in Kaletra’s potential to battle the HIV virus

The following medicine are contraindicated with Kaletra:

Alpha 1­ Adrenoreceptor Antagonists

Antiarrhythmics

Anti-gout drugs

Antimycobacterials

Antipsychotics

  • Latuda (lurasidone)
  • Orap (pimozide)

Ergot Derivatives

  • D.H.E. 45 (dihydroergotamine)
  • Ergomar (ergotamine)
  • Methergine (methylergonovine)

GI Motility Agent

Hepatitis C Direct-Acting Antivirals

  •  Zepatier (elbasvir/grazoprevir)

Herbal Products 

 HMG-CoA Reductase Inhibitors 

  • Altoprev (lovastatin)
  • Zocor (simvastatin)

PDE5 Inhibitor

 Sedative/Hypnotics 

What Other Medications Interact With Kaletra?

Most of the next drug interactions may end up in sure life-threatening conditions, comparable to cardiac arrhythmias (adjustments in coronary heart rhythm) and adjustments in focus of various medicine within the physique, which might trigger hostile results. Always seek the advice of your pharmacist or healthcare supplier earlier than taking any treatment with Kaletra. Use warning when taking Kaletra with the next drugs:

Anticancer medicine:

  • Vincristine
  • Vinblastine
  • Sprycel (dasatinib)
  • Tasigna (nilotinib)

Antiarrhythmics:

  • Lidocaine (systemic)
  • Nexterone (amiodarone)
  • Tikosyn (dofetilide)
  • Rhythmol (propafenone)
  • Quinidine

Anticoagulants:

Anticonvulsants:

  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Valproate

Antidepressants:

Anti-infectives:

Anti-gout:

Antifungals:

  • Ketoconazole
  • Onmel (itraconazole)*
  • Vfend (voriconazole)

Antimycobacterials:

  • Mycobutin (rifabutin)
  • Sirturo (bedaquiline)

Antiparasitics:

Antipsychotics:      

Benzodiazepines:

  • Xanax (alprazolam)
  • Tranxene (clorazepate)
  • Valium (diazepam)
  • Flurazepam
  • Intravenously administered midazolam

Calcium channel blockers:

Corticosteroids:

Endothelin receptor antagonists:

HMG-CoA reductase inhibitors:

Hepatitis C direct-acting performing antivirals:

  • Victrelis (boceprevir)
  • Olysio (simeprevir)
  • Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir)

HIV protease inhibitors:

  • Atazanavir
  • Crixivan (indinavir)
  • Kaletra (lopinavir/ritonavir)
  • Aptivus (tipranavir/ritonavir)

Immunosuppressants:

Inhaled or intranasal steroids:

  • Flonase (fluticasone)
  • Pulmicort (budesonide)

Long-acting beta-adrenoceptor agonists:

Narcotic analgesics:

  • Methadose (methadone)
  • Abstral (fentanyl)

Nucleoside reverse transcriptase inhibitors:

  • Videx (didanosine)
  • Ziagen (abacavir )
  • Retrovir (zidovudine)

Non-nucleoside reverse transcriptase inhibitors:

  • Rescriptor (delavirdine) 
  • Sustiva (efavirenz)
  • Viramune (nevirapine)

Oral contraceptives:

PDE5 inhibitors (phosphodiesterase sort 5 inhibitors):

Sedatives/hypnotics:

  • Parenterally (by injection) administered midazolam

This might not be a whole listing of medication, and others may cause drug-drug interactions. Keep an inventory of all of the medicines you’re taking and seek the advice of together with your healthcare supplier. Talk together with your pharmacist or healthcare supplier for extra detailed details about treatment interactions with Kaletra.

And make sure to speak together with your healthcare supplier about another medicines you’re taking or plan to take, together with over-the-counter, nonprescription merchandise, nutritional vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

The FDA authorized medicine beneath the category of HIV protease inhibitors (PIs) embody:

  • Invirase (saquinavir) was developed by F. Hoffmann-La Roche Ltd (Basel, Switzerland). Invirase was the primary FDA-approved HIV protease inhibitor in 1995. 
  • Norvir (ritonavir) was authorized by the FDA in 1996. It boosts the circulating focus of different HIV protease inhibitors by inhibiting cytochrome P450 3A4 (a liver enzyme). 
  • Crixivan (indinavir) was developed by Merck & Co, Inc. (Whitehouse Station, NJ, USA) and authorized in 1996.
  • Viracept (nelfinavir) was developed by Agouron Pharmaceuticals (Pfizer, Inc., New York, NY, USA) and authorized in 1997.
  • Reyataz (atazanavir) is an aza-dipeptide analog with potent anti-HIV exercise and was authorized in 2003.
  • Lexiva (fosamprenavir), developed by GlaxoSmithKline plc (Brentford, UK), was authorized by the FDA in 2003.
  • Aptivus (tipranavir) is the one non-peptidomimetic HIV protease inhibitor authorized by FDA in 2005.
  • Prezista (darunavir) Darunavir authorized in 2006, is the most recent HIV protease inhibitor available on the market.

Some manufacturers are used as mixture medicine like Kaletra, combining two or extra antiviral remedy medicine from completely different lessons right into a single pill. These FDA-approved mixture protease inhibitors embody:

  • Prezcobix (cobicistat/darunavir)
  • Evotaz (atazanavir/cobicistat)

Using different HIV protease inhibitors with Kaletra needs to be averted because it might trigger life-threatening interactions. Always take the prescribed model as directed and do not change between manufacturers.

Frequently Asked Questions

  • What is Kaletra?

    Kaletra is a mix drug containing lopinavir and ritanovir. The FDA authorized it to deal with HIV infections in adults and kids above 14 days previous. Kaletra is used with different antiviral medicine. 

  • Does Kaletra treatment HIV/AIDS?

    Kaletra doesn’t treatment HIV, however it might lower the danger of growing acquired immunodeficiency syndrome (AIDS) and HIV-related ailments, together with severe infections or most cancers. Always apply safer intercourse and make different life-style adjustments to keep away from the danger of transmitting HIV to different individuals.

  • What are the negative effects of Kaletra?

    Kaletra might have negative effects comparable to diarrhea, nausea, vomiting, abdomen upset, irritation of the pancreas, bloating, headache, issue falling asleep, lack of urge for food, itchy pores and skin, irregular heartbeat, and so on. If any of those negative effects worsen, name your healthcare supplier. 

  • What is one of the simplest ways to take Kaletra?

    You can take Kaletra tablets with or with out meals. However, when you take an oral resolution, you could take it with meals.

  • Does Kaletra have an effect on my potential to drive or function equipment?

    Kaletra’s results on the flexibility to drive or function equipment have not been examined. It’s higher to not drive a automobile or function equipment till you know the way it impacts you (inflicting nausea, dizziness, or headache).

How Can I Stay Healthy While Taking Kaletra?

Protease inhibitors, together with Kaletra, play a big function in HIV-related infections comparable to AIDS. Although these drugs usually are not a treatment, they assist cut back the problems of the illness. However, negative effects and particular drug interactions are widespread disadvantages of those medicines. Your healthcare supplier will prescribe probably the most appropriate treatment, relying in your want and medical situation. Refer under for some basic tips to assist your well being:

  • Take HIV infection-related drugs as advisable by your healthcare supplier.
  • Practice safer intercourse and keep away from utilizing contaminated syringes, razors, and different private objects to forestall transmission of an infection.
  • Achieve and keep a wholesome weight to forestall a worsening situation.
  • Consider assist teams or working with a healthcare supplier that will help you discover coping methods and provide help to keep away from transmitting the an infection to others.
  • Always take drugs often as prescribed to get the utmost therapeutic impact.

Medical Disclaimer

Verywell Health’s drug data is supposed for instructional functions solely and isn’t meant as a substitute for medical recommendation, analysis, or remedy from a healthcare supplier. Consult your healthcare supplier earlier than taking any new treatment(s). IBM Watson Micromedex offers a number of the drug content material, as indicated on the web page.

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