LOPINAVIR-RITONAVIR- lopinavir-ritonavir solution
Lannett Company, Inc.
Lopinavir and Ritonavir
(loe pin' a vir) (ri ton' na vir)
Oral Solution USP
|What is the most important information I should know about lopinavir and ritonavir?
Lopinavir and ritonavir may cause serious side effects, including:
° stomach-area (abdominal) pain
° loss of appetite
° yellow skin and whites of eyes (jaundice)
° dark-colored urine
° pale colored stools
° itchy skin
° stomach area (abdominal) pain
° have a history of abnormal heart rhythm or certain types of heart problems.
° take other medicines that can affect your heart rhythm during treatment with lopinavir and ritonavir.
Tell your healthcare provider right away if you have any of these symptoms:
° sensation of abnormal heartbeats
See “What are the possible side effects of lopinavir and ritonavir?” for more information about serious side effects.
|What is lopinavir and ritonavir?
Lopinavir and ritonavir is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
It is not known if lopinavir and ritonavir is safe and effective in children under 14 days old.
|Who should not take lopinavir and ritonavir?
Do not take lopinavir and ritonavir if you:
° colchicine, if you have kidney or liver problems.
° ergot containing medicines including:
° sildenafil (Revatio®), when used for the treatment of pulmonary arterial hypertension
° midazolam when taken by mouth
° St. John’s Wort (Hypericum perforatum®)
Serious problems can happen if you or your child takes any of the medicines listed above with lopinavir and ritonavir.
|Before taking lopinavir and ritonavir, tell your healthcare provider about all of your medical conditions, including if you:
° Lopinavir and ritonavir oral solution contains alcohol (ethanol) and propylene glycol. You should not take lopinavir and ritonavir oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Tell your healthcare provider if you become pregnant during treatment with lopinavir and ritonavir.
° Lopinavir and ritonavir may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with lopinavir and ritonavir.
° Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
° You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
° Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines interact with lopinavir and ritonavir. Keep a list of your medicines to show your healthcare provider and pharmacist.
You can ask your healthcare provider or pharmacist for a list of medicines that interact with lopinavir and ritonavir.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take lopinavir and ritonavir with other medicines. Your healthcare provider may need to change the dose of other medicines during treatment with lopinavir and ritonavir.
|How should I take lopinavir and ritonavir?
◦ Take didanosine either 1 hour before or 2 hours after taking lopinavir and ritonavir oral solution.
◦ Avoid use of lopinavir and ritonavir oral solution.
◦ Tell your healthcare provider if your child’s weight changes.
° Use the dosing cup (supplied) or an oral syringe with mL (milliliter) markings to give the prescribed dose of lopinavir and ritonavir oral solution to your child. Your pharmacist should provide an oral syringe to you.
° Lopinavir and ritonavir oral solution contains propylene glycol and a large amount of alcohol (ethanol). Lopinavir and ritonavir oral solution should not be given to babies younger than 14 days of age unless your healthcare provider thinks it is right for your baby.
|What are the possible side effects of lopinavir and ritonavir?
Lopinavir and ritonavir can cause serious side effects, including:
° urinate more often than usual
° increased hunger or thirst
° unusual weight loss
° increase in your blood sugar levels
Your healthcare provider may need to start you on medicine to treat high blood sugar or change your diabetes medicines.
Common side effects of lopinavir and ritonavir include:
These are not all of the possible side effects of lopinavir and ritonavir. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|How should I store lopinavir and ritonavir?
Lopinavir and ritonavir oral solution:
Keep lopinavir and ritonavir and all medicines out of the reach of children.
|General information about the safe and effective use of lopinavir and ritonavir.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lopinavir and ritonavir for a condition for which it was not prescribed. Do not give lopinavir and ritonavir to other people, even if they have the same condition you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about lopinavir and ritonavir that is written for health professionals.
|What are the ingredients in lopinavir and ritonavir?
Active ingredients: lopinavir and ritonavir
Lopinavir and ritonavir oral solution: bubble gum flavor, ethanol, glycerin, high fructose corn syrup, malic acid, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, sodium hydroxide, sucralose, and water.
For more information about lopinavir and ritonavir call 1-844-834-0530.
The brands listed are trademarks of their respective owners and are not trademarks of Lannett Company, Inc. The makers of these brands are not affiliated with and do not endorse Lannett Company, Inc. or its products.
Lannett Company, Inc.
Philadelphia, PA 19136
This Medication Guide has been approved by the U.S. Food and Drug Administration.