Raltegravir chewable tablets

Pronunciation

Generic Name: raltegravir (ral-TEG-ra-vir)
Brand Name: Isentress

Raltegravir chewable tablets is used for:

Treating HIV infection. It is used along with other HIV medicines.

Raltegravir chewable tablets is an HIV-1 integrase strand transfer inhibitor. It works by blocking HIV-1 integrase, an enzyme needed for the HIV virus to replicate.

Do NOT use raltegravir chewable tablets if:

  • you are allergic to any ingredient in raltegravir chewable tablets

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using raltegravir chewable tablets:

Some medical conditions may interact with raltegravir chewable tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have phenylketonuria (PKU)
  • if you have a history of liver problems (eg, hepatitis B or C infection)
  • if you have a history of muscle problems or weakness (eg, myopathy, rhabdomyolysis), high creatine kinase blood levels, mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you are on dialysis

Some MEDICINES MAY INTERACT with raltegravir chewable tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Fenofibrate, gemfibrozil, statins (eg, simvastatin), or zidovudine because the risk of muscle problems may be increased
  • Darunavir/ritonavir because it may increase the risk of rash
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
  • Rifamycins (eg, rifampin) because it may decrease raltegravir chewable tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if raltegravir chewable tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use raltegravir chewable tablets:

Use raltegravir chewable tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with raltegravir chewable tablets. Talk to your pharmacist if you have questions about this information.
  • Take raltegravir chewable tablets by mouth with or without food.
  • Raltegravir chewable tablets can be either chewed or swallowed whole.
  • Certain antacids (eg, those that have aluminium or magnesium in them) should not be taken with raltegravir chewable tablets. Talk to your doctor about other antacids that you can take with raltegravir chewable tablets.
  • Take raltegravir chewable tablets on a regular schedule to get the most benefit from it. Taking raltegravir chewable tablets at the same time each day will help you remember to take it.
  • Continue to take raltegravir chewable tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of raltegravir chewable tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use raltegravir chewable tablets.

Important safety information:

  • Raltegravir chewable tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use raltegravir chewable tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Raltegravir chewable tablets may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start raltegravir chewable tablets.
  • Raltegravir chewable tablets is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Do not change your dose or stop taking raltegravir chewable tablets or any other medicine for HIV without checking with your doctor.
  • Do not change between raltegravir chewable tablets and the tablet or oral suspension doseforms without talking to your doctor.
  • Serious and sometimes fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and allergic reactions have been reported in some patients taking raltegravir chewable tablets. Contact your doctor right away if you develop blisters or sores in the mouth; fever; general ill feeling; muscle or joint aches; rash, including red, swollen, blistered, or peeling skin; red or swollen eyes; severe tiredness; trouble breathing; swelling of the mouth or face; symptoms of kidney problems (eg, decreased urination); or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or vomiting, stomach pain, yellowing of the eyes or skin).
  • This product contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your doctor or pharmacist before you take raltegravir chewable tablets.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking raltegravir chewable tablets, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Raltegravir chewable tablets does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Lab tests, including complete blood cell counts and liver function, may be performed while you take raltegravir chewable tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Raltegravir chewable tablets should be used with extreme caution in CHILDREN younger than 4 weeks old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking raltegravir chewable tablets while you are pregnant. It is not known if raltegravir chewable tablets is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or raltegravir chewable tablets to the baby.

Possible side effects of raltegravir chewable tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); back pain; blood in the urine; change in the amount of urine produced; decreased coordination; fever, chills, or persistent sore throat; general feeling of being unwell; mental or mood changes (eg, anxiety, paranoia, depression); mouth sores or blisters; muscle aches, pain, tenderness, or weakness; red, swollen, blistered, or peeling skin; redness or swelling of the eyes; severe or persistent dizziness; severe or persistent tiredness or weakness; shortness of breath; suicidal thoughts or actions; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or vomiting, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of raltegravir chewable tablets:

Store raltegravir chewable tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original package with the bottle tightly closed. Store away from heat, moisture, and light. Keep the drying agent (desiccant) in the bottle. Do not store in the bathroom. Keep raltegravir chewable tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about raltegravir chewable tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Raltegravir chewable tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take raltegravir chewable tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about raltegravir chewable tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to raltegravir chewable tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using raltegravir chewable tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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