Kaletra Prescription Drug Pharmaceutical Information

This page provides details of the prescription pharmacy drug Kaletra. For further information please click one of the links below:

Pharmacy Drug Brand Name: Kaletra®
Active Ingredient(s): lopinavir/ritonavir
Strength(s) / Dose(s): 133.3/33.3 mg Capsules and 80/20 mg/mL Oral Solution
Delivery / Dosage Form(s): Capsules and Oral Solution
Company Manufacturer Name: Abbott
Availability / Prescription: Prescription only
FDA Approval Date *: September 15, 2000

* Approval by the FDA does not necessarily mean that this drug is available for consumers at this time.

What is Kaletra used for?

Who should not take Kaletra?

Together with your doctor, you need to decide whether Kaletra is right for you.

  • Taking certain drugs with Kaletra could cause serious side effects that could cause death. Before you start Kaletra you must tell your doctor about ALL the drugs you are taking or are planning to take. These include other prescription and non-prescription medicines and herbal supplements such as St. John’s wort.
  • For more information about medicines you should not take with Kaletra, and medicines that require dosage adjustments click on the link below to Kaletra’s approved labeling and patient information.
  • Do not take Kaletra if you have had a serious allergic reaction to Kaletra or any of its ingredients, including ritonavir or lopinavir.

Special Warnings with Kaletra:

  • Kaletra may cause liver problems. Liver disease or damage such as Hepatitis B and Hepatitis C may worsen when Kaletra is taken. In studies, it is unclear if Kaletra caused these liver problems because some patients had other illnesses or were taking other medications.
  • Some people taking Kaletra develop serious problems with their pancreas (pancreatitis), which may cause death. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if have nausea, vomiting, or abdominal pain or discomfort. These may be signs of pancreatitis.
  • Changes in body fat happen in some people taking anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast and abdomen (stomach area). Loss of fat from the face, legs, and arms may also happen. The cause and long-term health effects of these conditions are not known at this time.
  • Some patients with hemophilia have increased bleeding with this type of drug.
  • If you are taking oral contraceptives ("the pill") to prevent pregnancy, you should use an additional or different type of contraception since Kaletra may reduce the effectiveness of oral contraceptives.

What should I tell my doctor or health care (healthcare) provider?

Tell your doctor or health care (healthcare) provider if you:

  • Are trying to become pregnant, are already pregnant, or are breast-feeding
  • Have liver problems
  • Have diabetes or an increase in thirst or frequent urination
  • Have hemophilia

What are some possible side effects of Kaletra? (This is not a comprehensive list of possible side effects assosciated with Kaletra. Your doctor or pharmacist can provide expert advice on the possible side effects of this drug.)

The most commonly reported side effects that are thought to be drug related are:

  • Abnormal stools (bowel movements)
  • Diarrhea
  • Feeling weak/tired
  • Headache
  • Nausea
  • Children taking Kaletra may sometimes get a skin rash
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