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Generic Name: atazanavir (Oral route)

a-ta-ZAN-a-vir SUL-fate

Commonly used brand name(s)

In the U.S.

  • Reyataz

Available Dosage Forms:

  • Capsule
  • Powder

Therapeutic Class: Antiviral

Pharmacologic Class: Atazanavir

Uses For Reyataz

Atazanavir is used together with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Slideshow: Flashback: FDA Drug Approvals 2013

Atazanavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Atazanavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Reyataz

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of atazanavir in children less than 3 months of age. Use is not recommended in infants younger than 3 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atazanavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving atazanavir.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Amifampridine
  • Carbamazepine
  • Cisapride
  • Colchicine
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Dihydroergotamine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Eletriptan
  • Enzalutamide
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Eszopiclone
  • Everolimus
  • Fentanyl
  • Fluconazole
  • Fosphenytoin
  • Ibrutinib
  • Irinotecan
  • Ivabradine
  • Ketoconazole
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Mitotane
  • Nelfinavir
  • Pazopanib
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Primidone
  • Quetiapine
  • Ranolazine
  • Rifampin
  • Rifapentine
  • Romidepsin
  • Sildenafil
  • Silodosin
  • Simvastatin
  • St John's Wort
  • Tolvaptan
  • Trabectedin
  • Triazolam
  • Vemurafenib
  • Vilazodone
  • Vinflunine
  • Vorapaxar

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ado-Trastuzumab Emtansine
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Artemether
  • Atorvastatin
  • Avanafil
  • Axitinib
  • Bedaquiline
  • Boceprevir
  • Bosentan
  • Bosutinib
  • Brentuximab Vedotin
  • Buprenorphine
  • Cabazitaxel
  • Cabozantinib
  • Ceritinib
  • Cimetidine
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cyclophosphamide
  • Dasatinib
  • Delamanid
  • Dexlansoprazole
  • Diltiazem
  • Disopyramide
  • Docetaxel
  • Domperidone
  • Escitalopram
  • Eslicarbazepine Acetate
  • Esomeprazole
  • Etravirine
  • Famotidine
  • Felodipine
  • Fluoxetine
  • Fluticasone
  • Fosamprenavir
  • Garlic
  • Iloperidone
  • Imipramine
  • Indinavir
  • Ixabepilone
  • Lansoprazole
  • Lapatinib
  • Levomilnacipran
  • Lidocaine
  • Lofepramine
  • Lumefantrine
  • Macitentan
  • Minocycline
  • Nevirapine
  • Nicardipine
  • Nifedipine
  • Nilotinib
  • Nizatidine
  • Omeprazole
  • Ondansetron
  • Oxycodone
  • Pantoprazole
  • Piperaquine
  • Pomalidomide
  • Ponatinib
  • Quinidine
  • Rabeprazole
  • Ranitidine
  • Regorafenib
  • Retapamulin
  • Rifabutin
  • Rosuvastatin
  • Salmeterol
  • Saquinavir
  • Sevoflurane
  • Siltuximab
  • Simeprevir
  • Sunitinib
  • Tacrolimus
  • Tadalafil
  • Tamsulosin
  • Temsirolimus
  • Tenofovir Disoproxil Fumarate
  • Ticagrelor
  • Tipranavir
  • Toremifene
  • Trimipramine
  • Vandetanib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vincristine
  • Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cobicistat
  • Dapsone
  • Desogestrel
  • Didanosine
  • Dienogest
  • Drospirenone
  • Efavirenz
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Levonorgestrel
  • Lopinavir
  • Medroxyprogesterone Acetate
  • Mestranol
  • Methadone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pitavastatin
  • Telaprevir
  • Trazodone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Gallbladder problems or
  • Hemophilia (a bleeding problem) or
  • Hyperglycemia (high blood sugar) or
  • Kidney disease or
  • Liver disease (eg, hepatitis B or C)—Use with caution. May make these conditions worse.
  • Heart block or
  • Heart conduction problems (eg, prolonged PR interval)—May change the way your heart beats and increase your chance of getting side effects.
  • Kidney disease, severe or
  • Liver disease, severe—Should not be used in patients with these conditions.

Proper Use of Reyataz

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine may be taken in combination with other medicines that are used to treat HIV infection. Check with your doctor for information and dose amounts.

It is important that atazanavir be taken with food.

Swallow the capsule whole. Do not open it.

If you are also using antacids or didanosine (Videx®), take atazanavir 2 hours before or 1 hour after taking these medicines.

This medicine comes with a patient information leaflet. Read and follow this carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For HIV infection (patient already had HIV treatment):
      • Adults—300 milligrams (mg) with 100 mg of ritonavir (Norvir®) once a day.
      • Children 6 to 17 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 150 to 300 mg with 100 mg of ritonavir (Norvir®) once a day.
      • Children 3 months to less than 6 years of age—Use and dose must be determined by your doctor.
      • Children younger than 3 months of age—Use is not recommended.
    • For HIV infection (patient never had HIV treatment):
      • Adults—300 milligrams (mg) with 100 mg of ritonavir (Norvir®) once a day. For patients who are unable to tolerate ritonavir, the dose is usually 400 mg (without ritonavir) once day.
      • Children 6 to 17 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 150 to 300 mg with 100 mg of ritonavir (Norvir®) once a day. For children at least 13 years of age and 40 kilograms (kg) who are unable to tolerate ritonavir, the dose is usually 400 mg (without ritonavir) once day.
      • Children 3 months to less than 6 years of age—Use and dose must be determined by your doctor.
      • Children younger than 3 months of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine, use it as soon as you can. If your next regular dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available.

Precautions While Using Reyataz

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), indinavir (Crixivan®), irinotecan (Camptosar®), lovastatin (Altocor®, Mevacor®), nevirapine (Viramune®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John’s wort) or vitamin supplements.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having kidney stones. Check with your doctor right away if you or your child have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Birth control pills may not work as well while you are using atazanavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves' disease, polymyositis, or Guillain-Barré syndrome.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

This medicine may cause heart rhythm problems (eg, PR prolongation). Tell your doctor right away if you or your child get dizzy or lightheaded.

Reyataz Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach discomfort, fullness, or pain
  • bloating
  • blood in the urine
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • dark colored urine
  • decreased appetite
  • diarrhea
  • dizziness or lightheadedness
  • dry mouth
  • fainting
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • gaseous abdominal or stomach pain
  • general feeling of discomfort
  • headache
  • hives, itching, or skin rash
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • irregular heartbeat
  • loss of appetite
  • loss of consciousness
  • muscle pain or cramping
  • nausea
  • pain in the groin or genitals
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • recurrent fever
  • severe nausea or vomiting
  • sharp back pain just below the ribs
  • sleepiness
  • slow or irregular heartbeat
  • stomachache
  • sweating
  • swelling
  • tightness in the chest
  • trouble with breathing
  • unexplained weight loss
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • cough, increased
  • discouragement
  • extra body fat
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
Less common
  • Burning, numbness, tingling, or painful sensations
  • difficulty with moving
  • muscle stiffness
  • pain
  • pain in the joints
  • sleeplessness
  • unable to sleep
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Incidence not known
  • Hair loss or thinning of the hair
  • rash with flat lesions or small raised lesions on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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