Prezista

Prezista Medication Information:

Prezista medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Prezista 600 mg
Prezista 800 mg

About Prezista

What Prezista is used for

PREZISTA is an oral tablet used for the treatment of HIV (Human Immunodeficiency Virus) infection in adults, when co-administered with ritonavir and other antiretroviral medications. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZISTA is a type of anti-HIV drug called a protease (PRO-tee-ase) inhibitor.

PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to 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. Never use or share dirty needles.

Ask your doctor if you have any questions on how to prevent passing HIV to other people.

What Prezista does

PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA can help to reduce the amount of HIV in your blood (called “viral load”) and increase your CD4+ (T) cell count. HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system.

PREZISTA is always taken with and at the same time as 100 mg of ritonavir (NORVIR), in combination with other anti-HIV medicines. PREZISTA should also be taken with food.

PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Because of this, it is very important for you to remain under the care of a doctor.

When Prezista should not be used

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

Do not take PREZISTA

  • if you are allergic to darunavir or any of the other ingredients in PREZISTA (see What the nonmedicinal ingredients are:)

  • if you are allergic to ritonavir (NORVIR)

  • if you have severe liver disease

  • if you take any of the following types of medicines because you could experience serious side effects:

    Type of Drug Examples of Generic Names (Brand Names)
    Antiarrhythmics (to treat abnormal heart rhythms) bepridila lidocaine quinidineamiodarone (Cordarone)
    Antihistamines (to treat allergy symptoms) astemizoleaterfenadinea
    Antimycobacterials (to treat tuberculosis) rifampin (Rifadin, Rifater)
    Ergot Derivatives (to treat migraine and headaches) dihydroergotamine (Migranal) ergonovine ergotamine (Cafergot)methylergonovine
    Gastrointestinal Motility Agents (to treat some digestive conditions) cisapridea
    Herbal products (to improve mood) St. John’s Wort
    HMG-CoA Reductase Inhibitors also known as statins (to lower cholesterol) lovastatin (Mevacor) simvastatin (Zocor)
    Neuroleptics (to treat psychiatric conditions) pimozide (Orap)
    Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) midazolamtriazolam (Halcion)
    a. Bepridil, astemizole, terfenadine and cisapride are no longer marketed in Canada.

What the medicinal ingredient is

The active substance is darunavir.

Each 300 mg tablet contains 325.23 mg of darunavir ethanolate, corresponding to 300 mg of darunavir.

Each 400 mg tablet contains 433.64 mg of darunavir ethanolate, corresponding to 400 mg of darunavir.

Each 600 mg tablet contains 650.46 mg of darunavir ethanolate, corresponding to 600 mg of darunavir.

What the nonmedicinal ingredients for Prezista are

The other ingredients are colloidal anhydrous silica, crospovidone, magnesium stearate, and microcrystalline cellulose. The tablet film coating contains polyethylene glycol, polyvinyl alcohol—partially hydrolyzed, sunset yellow FCF aluminum lake, talc, and titanium dioxide.

What dosage forms Prezista comes in

300 mg, 400 mg and 600 mg tablets.


Warnings and Precautions

BEFORE you use PREZISTA talk to your doctor or pharmacist if you:

  • have diabetes. In general, anti-HIV medicines, such as PREZISTA, might increase sugar levels in the blood.

  • have liver problems, including hepatitis B and/or C.

  • have hemophilia. Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding.

  • are pregnant or planning to become pregnant. It is not known if PREZISTA can harm your unborn baby. You and your doctor will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.

  • are breast-feeding. Do not breast-feed if you are taking PREZISTA. You should not breast-feed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

  • are allergic to sulpha medications.


Interactions with Prezista

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John’s wort (Hypericum perforatum). PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines (see When it should not be used:).

PREZISTA should not be combined with phenobarbital, phenytoin, rifampin or St. John’s wort because the combination may significantly lower the amount of PREZISTA in your blood and reduce the effects of PREZISTA.

PREZISTA should not be combined with vardenafil, because you may be at increased risk of side effects of vardenafil such as low blood pressure, visual changes and penile erection lasting more than 4 hours.

Tell your doctor if you are taking estrogen-based contraceptives. PREZISTA might reduce the effectiveness of estrogen-based contraceptives (birth control). You must take additional precautions for birth control such as a condom.

Tell your doctor if you take other anti-HIV medicines. PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended.

Tell your doctor if you are taking any of the following medicines:

Type of Drug Examples of Generic Names (Brand Names)
Anticoagulants (to prevent the clotting of red blood cells) warfarin (Coumadin)
Anticonvulsants (to treat epilepsy and prevent seizures) carbamazepine (Tegretol) phenobarbital phenytoin (Dilantin)
Anti-infectives (to treat bacterial infections) clarithromycin (Biaxin)
Antifungals (to treat fungal infections) ketoconazole (Nizoral) itraconazole (Sporanox)voriconazole (Vfend)
Antimycobacterials (to treat bacterial infections) rifabutin (Mycobutin) rifampin (Rifadin, Rifater)
Calcium Channel Blockers (to treat heart disease) felodipine nifedipine (Adalat)nicardipine
Corticosteroids (to treat inflammation or asthma) dexamethasonefluticasone propionate (Advair Diskus, Cutivate, Flonase, Flovent Diskus)
HMG-CoA Reductase Inhibitors (to lower cholesterol levels) atorvastatin (Lipitor) lovastatin (Mevacor) pravastatin (Pravachol) simvastatin (Zocor)rosuvastatin (Crestor)
Immunosuppressants (to prevent organ transplant rejection) cyclosporine (Sandimmune, Neoral) tacrolimus (Prograf)sirolimus (Rapamune)
Narcotic Analgesics methadone
PDE-5 Inhibitors (to treat erectile dysfunction) sildenafil (Viagra) vardenafil (Levitra)tadalafil (Cialis)
Selective Serotonin Reuptake Inhibitors (SSRIs) (to treat depression, anxiety, or panic disorder) paroxetine (Paxil)sertraline (Zoloft)

Tell your doctor if you are taking any medicines that you obtained without a prescription.

This is not a complete list of medicines that you should tell your doctor that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your doctors and pharmacists any time you get a new medicine. Both your doctor and your pharmacist can tell you if you can take these other medicines with PREZISTA. Do not start any new medicines while you are taking PREZISTA without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with PREZISTA.


Proper Use of Prezista

Always use PREZISTA exactly as your doctor has told you. You must check with your doctor if you are not sure.

Usual adult dose

Take PREZISTA tablets every day exactly as prescribed by your doctor. You must take ritonavir (NORVIR) at the same time as PREZISTA.

  • For adults who have never taken anti-HIV medicines the usual dose is 800 mg (two 400 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR), once daily every day.

  • For adults who have taken anti-HIV medicines in the past the usual dose is 600 mg (one 600 mg tablet or two 300 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR), twice daily every day.

If you have questions about when to take PREZISTA and ritonavir (NORVIR), your doctor can help you decide which schedule works for you.

You should always take PREZISTA and ritonavir (NORVIR) together with food. The type of food is not important.

Continue taking PREZISTA and ritonavir (NORVIR) unless your doctor tells you to stop. Take the exact amount of PREZISTA and ritonavir (NORVIR) that your doctor tells you to take, right from the very start. To help make sure you will benefit from PREZISTA and ritonavir (NORVIR), you must not skip doses or interrupt therapy. If you don’t take PREZISTA and ritonavir (NORVIR) as prescribed, the beneficial effects of PREZISTA and ritonavir (NORVIR) may be reduced or even lost.

If you have also been prescribed enteric-coated didanosine as well as PREZISTA and ritonavir, take didanosine 2 hours before or after the PREZISTA/ritonavir combination.

Overdose

Contact your doctor, pharmacist or your regional poison control centre immediately.

Missed dose

Patients taking 800 mg of PREZISTA once daily:

If you miss a dose of PREZISTA (two 400 mg tablets) or ritonavir (NORVIR) by more than 12 hours, wait and then take the next dose of PREZISTA (two 400 mg tablets) and ritonavir (NORVIR) at the regularly scheduled time. If you miss a dose of PREZISTA (two 400 mg tablets) or ritonavir (NORVIR) by less than 12 hours, take your missed dose of PREZISTA (two 400 mg tablets) and ritonavir (NORVIR) immediately. Then take your next dose of PREZISTA (two 400 mg tablets) and ritonavir (NORVIR) at the regularly scheduled time.

Patients taking 600 mg of PREZISTA twice daily:

If you miss a dose of PREZISTA (one 600 mg tablet or two 300 mg tablets) or ritonavir (NORVIR) by more than 6 hours, wait and then take the next dose of PREZISTA (one 600 mg tablet or two 300 mg tablets) and ritonavir (NORVIR) at the regularly scheduled time. If you miss a dose of PREZISTA (one 600 mg tablet or two 300 mg tablets) or ritonavir (NORVIR) by less than 6 hours, take your missed dose of PREZISTA (one 600 mg tablet or two 300 mg tablets) and ritonavir (NORVIR) immediately. Then take your next dose of PREZISTA (one 600 mg tablet or two 300 mg tablets) and ritonavir (NORVIR) at the regularly scheduled time.

If a dose of PREZISTA or ritonavir (NORVIR) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA or ritonavir (NORVIR) at any one time.

Do not stop using PREZISTA without talking to your doctor first.


Side Effects for Prezista and What to Do About Them

Like all prescription drugs, PREZISTA can cause side effects. The following is not a complete list of side effects reported with PREZISTA when taken either alone or with other anti-HIV medicines. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

Rash has been reported in 10.3% of subjects receiving PREZISTA. In some patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your doctor if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped.

Other relevant severe side effects reported at an uncommon or rare frequency were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat.

The most common side effects include diarrhea, nausea, headache, abdominal pain and vomiting.

Some side effects are typical for anti HIV medicines in the same family as PREZISTA. These are:

  • high blood sugar (hyperglycemia) and diabetes. This can happen in patients taking PREZISTA or other protease inhibitor medicines. Some patients have diabetes before starting treatment with PREZISTA, which gets worse. Some patients get diabetes during treatment with PREZISTA. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine.

  • increased bleeding in patients with hemophilia. This may happen in patients taking PREZISTA as it has been reported with other protease inhibitor medicines.

  • changes in body fat. These changes can happen in patients taking anti-HIV medicines. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.

  • increases in triglycerides and cholesterol (forms of fat that are found in your blood). Your doctor may order blood testing for you.

  • development of pancreatitis (inflammation of the pancreas) with symptoms such as abdominal pain, nausea and vomiting. If you suffer these symptoms while taking PREZISTA, contact your doctor.

  • immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.


 

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