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Lopinavir, Ritonavir Oral solution

It is used with other medicines to treat HIV

Generic Name: lopinavir-ritonavir

Brand Names: Kaletra

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 03/08/2011] ISSUE: FDA notified healthcare professionals of serious health problems that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra) oral solution. Lopinavir/ritonavir oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems. Because the consequences of using lopinavir/ritonavir oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning.

BACKGROUND: Lopinavir/ritonavir oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults.

RECOMMENDATION: The use of lopinavir/ritonavir oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using lopinavir/ritonavir oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for lopinavir and ritonavir to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

LOPINAVIR; RITONAVIR (loe PIN a veer; ri TOE na veer) is two antiretroviral medicines in one tablet. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • diabetes
  • hemophilia
  • liver disease
  • an unusual or allergic reaction to lopinavir, ritonavir, other medicines, castor oil, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Use a specially marked spoon or container to measure the dose. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • alfuzosin
  • cerivastatin
  • cisapride
  • disulfiram
  • dofetilide
  • medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine
  • lovastatin
  • meperidine
  • metronidazole
  • midazolam
  • pimozide
  • ranolazine
  • red yeast rice
  • rifampin
  • rifapentine
  • simvastatin
  • St. John's wort
  • triazolam
  • voriconazole

This medicine may also interact with the following medications:

  • atovaquone
  • birth control pills
  • bupropion
  • clarithromycin
  • cyclosporine
  • dasatinib
  • dexamethasone
  • fentanyl
  • fluticasone
  • itraconazole
  • ketoconazole
  • medicines for erectile dysfunction like sildenafil, tadalafil, vardenafil
  • medicines for high blood pressure like felodipine, nicardipine, nifedipine
  • medicines for high cholesterol like atorvastatin
  • medicines for irregular heartbeat like amiodarone, bepridil, quinidine
  • medicines for seizures like carbamazepine, phenytoin
  • methadone
  • nilotinib
  • other medicines for HIV
  • rapamycin
  • rifabutin
  • salmeterol
  • tacrolimus
  • trazodone
  • warfarin

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.


Last Updated: June 17, 2010
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