NDC 0006-3603 Isentress

Raltegravir Granule, For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0006-3603
Proprietary Name:
Isentress
Non-Proprietary Name: [1]
Raltegravir
Substance Name: [2]
Raltegravir Potassium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0006
    FDA Application Number: [6]
    NDA205786
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    12-20-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - PINK)
    ORANGE (C48331 - PALE ORANGE)
    YELLOW (C48330 - PALE YELLOW)
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    OVAL (C48345)
    ROUND (C48348)
    Size(s):
    16 MM
    15 MM
    8 MM
    Imprint(s):
    227
    MERCK;LOGO;477
    MERCK;LOGO;473
    Score:
    1
    2
    Flavor(s):
    ORANGE BANANA (C73405)
    BANANA (C73364)

    Product Packages

    NDC Code 0006-3603-60

    Package Description: 60 PACKET in 1 CARTON / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)

    NDC Code 0006-3603-61

    Package Description: 60 PACKET in 1 CARTON / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)

    Product Details

    What is NDC 0006-3603?

    The NDC code 0006-3603 is assigned by the FDA to the product Isentress which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Isentress is raltegravir. The product's dosage form is granule, for suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0006-3603-60 60 packet in 1 carton / 1 granule, for suspension in 1 packet (0006-3603-01), 0006-3603-61 60 packet in 1 carton / 1 granule, for suspension in 1 packet (0006-3603-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Isentress?

    Raltegravir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Raltegravir is known as an integrase inhibitor. It blocks the virus from growing and infecting more cells. Raltegravir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

    What are Isentress Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • RALTEGRAVIR POTASSIUM 100 mg/1 - A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION.

    Which are Isentress UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Isentress Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Isentress?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Isentress?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Raltegravir


    Raltegravir is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children who weigh at least 4.5 lbs (2 kg). Raltegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood. Although raltegravir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.
    [Learn More]


    HIV Medicines


    What is HIV?

    HIV stands for human immunodeficiency virus. It harms your immune system by destroying CD4 cells. These are a type of white blood cells that fight infection. The loss of these cells makes it hard for your body to fight off infections and certain HIV-related cancers.

    Without treatment, HIV can gradually destroy the immune system and advance to AIDS. AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.

    What is antiretroviral therapy (ART)?

    The treatment of HIV with medicines is called antiretroviral therapy (ART). It involves taking a combination of medicines every day. ART is recommended for everyone who has HIV. The medicines do not cure HIV infection, but help people with HIV live longer, healthier lives. They also reduce the risk of spreading the virus to others.

    How do HIV medicines work?

    HIV medicines reduce the amount of HIV (viral load) in your body, which helps by:

    • Giving your immune system a chance to recover. Even though there is still some HIV in your body, your immune system should be strong enough to fight off infections and certain HIV-related cancers.
    • Reducing the risk that you will spread HIV to others.

    What are the types of HIV medicines?

    There are many different types (called classes) of HIV medicines. Some work by blocking or changing enzymes that HIV needs to make copies of itself. This prevents HIV from copying itself, which reduces the amount of HIV in the body. Several types of medicines do this:

    • Nucleoside reverse transcriptase inhibitors (NRTIs) block an enzyme called reverse transcriptase
    • Non-nucleoside reverse transcriptase inhibitors (NNRTIs) bind to and later change reverse transcriptase
    • Integrase inhibitors, also called integrase strand transfer inhibitors (INSTIs), block an enzyme called integrase
    • Protease inhibitors (PIs) block an enzyme called protease

    Some types of HIV medicines interfere with HIV's ability to infect CD4 immune system cells:

    • Fusion inhibitors block HIV from entering the cells
    • CCR5 antagonists and post-attachment inhibitors block different molecules on the CD4 cells. To infect a cell, HIV has to bind to two types of molecules on the cell's surface. Blocking either of these molecules prevents HIV from entering the cells.
    • Attachment inhibitors bind to a specific protein on the outer surface of HIV. This prevents HIV from entering the cell.

    Pharmacokinetic enhancers are another type of medicine. They are sometimes taken along with certain other HIV medicines. Pharmacokinetic enhancers increase the effectiveness of the other medicine. They work by slowing the breakdown of the other medicine. This allows that medicine to stay in the body longer at a higher concentration.

    There are also multidrug combinations, which include a combination of two or more different types of HIV medicines.

    When do I need to start taking HIV medicines?

    It's important to start taking HIV medicines as soon as possible after your diagnosis, especially if you:

    • Are pregnant
    • Have AIDS
    • Have certain HIV-related illnesses and infections
    • Have an early HIV infection (the first 6 months after infection with HIV)

    What else do I need to know about taking HIV medicines?

    You and your health care provider will work together to come up with a personal treatment plan. This plan will be based on many factors, including:

    • The possible side effects of HIV medicines
    • Potential drug interactions with any other medicines you take
    • How many medicines you will need to take every day
    • Any other health problems you may have

    It's important to take your medicines every day, according to the instructions from your provider. If you miss doses or don't follow a regular schedule, your treatment may not work, and the HIV virus may become resistant to the medicines.

    HIV medicines can cause side effects. Most of these side effects are manageable, but a few can be serious. Tell your provider about any side effects that you are having. Don't stop taking your medicine without first talking to your provider. There may be steps you can take to help manage the side effects. In some cases, your provider may decide to change your medicines.

    What are HIV PrEP and PEP medicines?

    HIV medicines are not just used for treatment. Some people take them to prevent HIV. PrEP (pre-exposure prophylaxis) is for people who don't already have HIV but are at very high risk of getting it. PEP (post-exposure prophylaxis) is for people who have possibly been exposed to HIV.

    NIH: Office of AIDS Research


    [Learn More]


    HIV: PrEP and PEP


    What are PrEP and PEP?

    PrEP and PEP are medicines to prevent HIV. Each type is used in a different situation:

    • PrEP stands for pre-exposure prophylaxis. It is for people who don't already have HIV but are at risk of getting it. PrEP is medicine that can reduce this risk. It can either be a pill that you take every day or an injection that you get every two months. With PrEP, if you do get exposed to HIV, the medicine can stop HIV from taking hold and spreading throughout your body.
    • PEP stands for post-exposure prophylaxis. PEP is for people who have possibly been exposed to HIV. It is only for emergency situations. PEP must be started within 72 hours after a possible exposure to HIV.

    PrEP (pre-exposure prophylaxis)

    Who should consider taking PrEP?

    PrEP can help protect you if you don't have HIV and any of these applies to you:

    • You have had anal or vaginal sex in the past 6 months and:
      • Have a sexual partner with HIV,
      • Have not consistently used a condom, OR
      • Have been diagnosed with a sexually transmitted disease in the past 6 months
    • You inject drugs and:
      • Share needles or other equipment to inject drugs OR
      • Have an injection partner with HIV
    • You have been prescribed PEP and:
      • Continue engaging in high-risk behaviors OR
      • Have used multiple courses of PEP

    If you have a partner who is HIV-positive and are considering getting pregnant, talk to your health care provider about PrEP. Taking it may help protect you and your baby from getting HIV infection while you try to get pregnant, during pregnancy, or while breastfeeding.

    How well does PrEP work?

    PrEP is very effective when you take it consistently. It reduces the risk of getting HIV from sex by about 99%. In people who inject drugs, it reduces the risk of HIV by at least 74%. PrEP is much less effective if you do not take it consistently.

    PrEP does not protect against other STDs, so you should still use latex condoms every time you have sex. If your or your partner is allergic to latex, you can use polyurethane condoms.

    You must have an HIV test every 3 months while taking PrEP, so you'll have regular follow-up visits with your health care provider. If you are having trouble taking PrEP every day or if you want to stop taking PrEP, talk to your provider.

    Does PrEP cause side effects?

    Some people taking PrEP may have side effects, like nausea. The side effects are usually not serious and often get better over time. If you are taking PrEP, tell your provider if you have a side effect that bothers you or that does not go away.

    PEP (post-exposure prophylaxis)

    Who should consider taking PEP?

    If you are HIV-negative and you think you may have been recently exposed to HIV, contact your health care provider immediately or go to an emergency room right away.

    You may be prescribed PEP if you are HIV negative or don't know your HIV status, and in the last 72 hours you may have been exposed to HIV:

    • During sex, for example if a condom broke during sex with someone who could have HIV,
    • Through the sharing of needles or drug preparation equipment, OR
    • Through sexual assault

    Your provider or emergency room doctor will help to decide whether PEP is right for you.

    PEP may also be given to a health care worker after a possible exposure to HIV at work, for example, from a needlestick injury.

    When should I start PEP and how long do I need to take it?

    PEP must be started within 72 hours (3 days) after a possible exposure to HIV. The sooner you start it, the better; every hour counts.

    You need to take the PEP medicines every day for 28 days. You will have to see your provider at certain times during and after taking the PEP, so you can have an HIV screening test and other testing.

    Does PEP cause side effects?

    Some people taking PEP may have side effects, like nausea. The side effects are usually not serious and often get better over time. If you are taking PEP, tell your provider if you have a side effect that bothers you or that does not go away.

    PEP medicines may also interact with other medicines that a person is taking (called a drug interaction). So it's important to tell your provider about any other medicines that you take.

    Can I take PEP every time I have unprotected sex?

    PEP is only for emergency situations. It is not the right choice for people who may be exposed to HIV frequently - for example, if you often have sex without a condom with a partner who is HIV-positive. In that case, you should talk to your health care provider about whether PrEP (pre-exposure prophylaxis) would be right for you.


    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".