Ritocom Patient Counseling Information

Information For Patients: Patients or parents of patients should be informed that: General Information: They should pay special attention to accurate administration of their dose to minimize the risk of accidental overdose or underdose of lopinavir and ritonavir.
They should inform their healthcare provider if their children's weight changes in order to make sure that the child's lopinavir and ritonavir dose is the correct one.
They should take the prescribed dose of lopinavir and ritonavir as directed and to set up a daily routine in order to do so.
Lopinavir and Ritonavir tablets may be taken with or without food.
Sustained decreases in plasma HIV-1 RNA have been associated with a reduced risk of progression to AIDS and death. Patients should remain under the care of a physician while using lopinavir and ritonavir. Patients should be advised to take lopinavir and ritonavir and other concomitant antiretroviral therapy every day as prescribed. Lopinavir and Ritonavir must always be used in combination with other antiretroviral drugs. Patients should not alter the dose or discontinue therapy without consulting with their doctor. If a dose of lopinavir and ritonavir is missed patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped the patient should not double the next dose.
Lopinavir and Ritonavir is not a cure for HIV-1 infection and that they may continue to develop opportunistic infections and other complications associated with HIV-1 disease. The long-term effects of lopinavir and ritonavir are unknown at this time. Patients should be told that there are currently no data demonstrating that therapy with lopinavir and ritonavir can reduce the risk of transmitting HIV-1 to others through sexual contact, sharing needles, or being exposed to their blood. For their health and the health of others, it is important that they always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. They should also be advised to never re-use or share needles.
Drug Interactions: Lopinavir and Ritonavir may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription, non-prescription medication or herbal products, particularly St. John's Wort.
Lopinavir and Ritonavir tablets can be taken at the same time as didanosine without food.
If they are receiving sildenafil, tadalafil, or vardenafil, there may be at an increased risk of associated adverse reactions including hypotension, visual changes, and sustained erection, and should promptly report any symptoms to their doctor.
If they are receiving estrogen-based hormonal contraceptives, additional or alternate contraceptive measures should be used during therapy with lopinavir and ritonavir.
Potential Adverse Effects: Skin rashes ranging in severity from mild to Stevens Johnson syndrome and Erythema multiforme have been reported in patients receiving lopinavir and ritonavir or its components lopinavir and/or ritonavir. Patients should be advised to contact their healthcare provider if they develop a rash while taking lopinavir and ritonavir. The healthcare provider will determine if treatment should be continued or an alternative antiretroviral regimen used.
Pre-existing liver disease including Hepatitis B or C can worsen with use of lopinavir and ritonavir. This can be seen as worsening of transaminase elevations or hepatic decompensation. Patients should be advised that their liver function tests will need to be monitored closely especially during the first several months of lopinavir and ritonavir treatment and that they should notify their healthcare provider if they develop the signs and symptoms of worsening liver disease including loss of appetite, abdominal pain, jaundice, and itchy skin.
New onset of diabetes or exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during lopinavir and ritonavir use. Patients should be advised to notify their healthcare provider if they develop the signs and symptoms of diabetes mellitus including frequent urination, excessive thirst, extreme hunger or unusual weight loss and/or an increased blood sugar while on lopinavir and ritonavir as they may require a change in their diabetes treatment or new treatment.
Lopinavir and Ritonavir might produce changes in the electrocardiogram (e.g., PR and/or QT prolongation). Patients should consult their physician if they experience symptoms such as dizziness, lightheadedness, abnormal heart rhythm or loss of consciousness.
They should seek medical assistance immediately if they develop a sustained penile erection lasting more than 4 hours while taking lopinavir and ritonavir and a PDE 5 Inhibitor such as Sildenafil, Tadalafil, Vardenafil.
Redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long term health effects of these conditions are not known at this time.
Patients should be informed that there may be a greater chance of developing diarrhea with the once daily regimen as compared with the twice daily regimen.