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EMEND- aprepitant capsuleEMEND- aprepitant kit


  1. Patient Information
  2. Emend Is A Prescription Medicine Used In Adults To Prevent Nausea And Vomiting:
  3. Do Not Take Emend If You:
  4. Before You Take Emend, Tell Your Doctor If You:
  5. If You Are Receiving Cancer Chemotherapy, Emend Is Taken As 3 Doses Over 3 Days - Starting On The Day You Have Chemotherapy, And The Two Days After Chemotherapy. There Are Two Ways That Your Doctor May Prescribe Emend For You:
  6. If You Are Having Surgery:
  7. What Are The Possible Side Effects Of Emend?
  8. In People Taking Emend To Prevent Nausea And Vomiting Caused By Chemotherapy, The Most Common Side Effects Of Emend Include:
  9. In People Taking Emend To Prevent Nausea And Vomiting After Surgery, The Most Common Side Effects Are:
  10. How Should I Store Emend?
  11. Active Ingredient:
  12. Inactive Ingredients:
  13. Revised: 3/2010document Id:

Patient Information 

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Emend Is A Prescription Medicine Used In Adults To Prevent Nausea And Vomiting: 

  • caused by certain anti-cancer (chemotherapy) medicines. When used for this purpose, EMEND is always used with other medicines.
  • after surgery.

EMEND is not used to treat nausea and vomiting that you already have.

EMEND should not be used continuously for a long time (chronic use).

It is not known if EMEND is safe and effective in children.

Do Not Take Emend If You: 

  • are taking any of the following medicines:
    • ORAP (pimozide)
    • SELDANE (terfenadine)
    • HISMANAL (astemizole)
    • PROPULSID (cisapride)

Taking EMEND with any of these medicines could cause serious or life-threatening problems.

  • are allergic to any of the ingredients in EMEND.

Before You Take Emend, Tell Your Doctor If You: 

  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if EMEND can harm your unborn baby.

    Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a back-up method of birth control during treatment with EMEND and for up to 1 month after using EMEND to prevent pregnancy.

  • are breast-feeding. It is not known if EMEND passes into your milk and if it can harm your baby.

Tell your doctor about all the medicines you are taking or plan to take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

EMEND may cause serious life-threatening reactions if used with certain medicines.

  • Take EMEND exactly as prescribed.
  • If you take too much EMEND, call your doctor, local emergency department or poison control center right away.

If You Are Receiving Cancer Chemotherapy, Emend Is Taken As 3 Doses Over 3 Days - Starting On The Day You Have Chemotherapy, And The Two Days After Chemotherapy. There Are Two Ways That Your Doctor May Prescribe Emend For You: 

  1. Capsules of EMEND by mouth for all 3 doses:
    • You should get a package that has three capsules of EMEND.
    • Day 1 (Day of chemotherapy): Take one 125-mg capsule of EMEND (white and pink) by mouth 1 hour before you start your chemotherapy treatment.
    • Day 2 and Day 3 (the two days after chemotherapy): Take one 80-mg capsule of EMEND (white) by mouth, each morning for the 2 days after your chemotherapy treatment.

      Or

  2. Intravenous (IV) injection into a vein the first day, then capsules by mouth on the two days after chemotherapy:
    • Day 1 (Day of chemotherapy): EMEND will be given to you by intravenous (IV) injection in your vein 30 minutes before you start your chemotherapy treatment.
    • You should get a package that has two capsules of EMEND.
    • Day 2 and Day 3 (the two days after chemotherapy): Take one 80-mg capsule of EMEND (white) by mouth, each morning for the 2 days after your chemotherapy treatment.
  • If you are receiving chemotherapy, EMEND may be taken with or without food.

If You Are Having Surgery: 


  • Your doctor will prescribe a 40-mg capsule of EMEND for you before surgery. You take EMEND within three hours before surgery.
  • Follow your doctor s instructions about restrictions on eating and drinking before surgery.

  • If you take the blood thinner medicine warfarin sodium (COUMADIN , JANTOVEN ), your doctor may do blood tests after you take EMEND to check your blood clotting.
  • What Are The Possible Side Effects Of Emend? 

    EMEND may cause serious side effects,including:

    • Serious allergic reactions. Allergic reactions can happen with EMEND and may be serious. Stop taking EMEND and call your doctor right away if you have any of these signs or symptoms of an allergic reaction:
      • hives
      • rash
      • itching
      • trouble breathing or swallowing.

    In People Taking Emend To Prevent Nausea And Vomiting Caused By Chemotherapy, The Most Common Side Effects Of Emend Include: 

    • tiredness
    • nausea
    • hiccups
    • constipation
    • diarrhea
    • loss of appetite
    • headache
    • hair loss

    In People Taking Emend To Prevent Nausea And Vomiting After Surgery, The Most Common Side Effects Are: 

    • constipation
    • nausea
    • itch
    • fever
    • low blood pressure
    • headache

    Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of EMEND. For more information ask your doctor or pharmacist.

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

    How Should I Store Emend? 

    • Store EMEND at room temperature, between 68 F and 77 F (20 C and 25 C).
    • Keep EMEND and all medicines out of the reach of children.

    General information about EMEND

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EMEND for a condition for which it was not prescribed. Do not give EMEND to other people, even if they have the same symptoms you have. It may harm them.

    This Patient Information leaflet summarizes the most important information about EMEND. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about EMEND that is written for health professionals. For more information about EMEND call 1-800-622-4477 or go towww.emend.com.

    Active Ingredient: 

    aprepitant

    Inactive Ingredients: 

    sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule shell also contains red ferric oxide and yellow ferric oxide. The 40-mg capsule shell also contains yellow ferric oxide.


    U.S. Patent Nos.: 5,145,684; 5,719,147; 6,048,859; 6,096,742; 6,235,735


    The brands listed in the above sections Who should not take EMEND? and What should I tell my doctor before and during treatment with EMEND? are the registered trademarks of their respective owners and are not trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

    EMENDis a registered trademark of Merck Sharp & Dohme Corp., a subsidiary ofMerck & Co., Inc.
    Copyright 2003, 2005, 2006 Merck Sharp & Dohme Corp., a subsidiary ofMerck & Co., Inc.
    All rights reserved

    Issued March 2010

    Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Whitehouse Station, NJ 08889, USA

    9985410

    This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.

    PRINCIPAL DISPLAY PANEL - BiPack 80 mg

    80 mg

    EMEND
    (aprepitant) capsules

    You have already been given a dose of EMEND (fosaprepitant dimeglumine) for Injection or an EMEND (aprepitant) capsule to prevent nausea and vomiting before your chemotherapy on Day 1.

    Each capsule contains 80 mg of aprepitant.

    USUAL ADULT DOSAGE: See accompanying circular.

    Rx only

    Keep this and all drugs out of the reach of children.

    BiPack 80 mg

    TriPack
    3 capsules

    125 mg | 80 mg

    EMEND
    (aprepitant) capsules

    One 125-mg capsule contains 125 mg aprepitant.

    Two 80-mg capsules each containing 80 mg of aprepitant.

    USUAL ADULT DOSAGE: See accompanying circular.

    Rx only

    Keep this and all drugs out of the reach of children.

    TriPack 125 mg and 80 mg

    EMEND
    aprepitant capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5231(NDC:0006-0461)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APREPITANT(UNII: 1NF15YR6UY) (APREPITANT - UNII:1NF15YR6UY)APREPITANT80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE(UNII: C151H8M554)
    CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
    HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
    SODIUM LAURYL SULFATE(UNII: 368GB5141J)
    GELATIN(UNII: 2G86QN327L)
    TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
    SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
    Product Characteristics
    Colorwhite (white, opaque)Scoreno score
    ShapeCAPSULE (capsule)Size17mm
    FlavorImprint Code461;80;mg
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5231-22 in 1 DOSE PACK
    2NDC:54868-5231-34 in 1 DOSE PACK
    3NDC:54868-5231-11 in 1 CARTON
    36 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02154906/29/2005
    EMEND
    aprepitant kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5325(NDC:0006-3862)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5325-01 in 1 DOSE PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12
    Part 21
    Part 1 of 2
    EMEND
    aprepitant capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APREPITANT(UNII: 1NF15YR6UY) (APREPITANT - UNII:1NF15YR6UY)APREPITANT80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE(UNII: C151H8M554)
    CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
    HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
    SODIUM LAURYL SULFATE(UNII: 368GB5141J)
    GELATIN(UNII: 2G86QN327L)
    TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
    SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
    Product Characteristics
    Colorwhite (white, opaque)Scoreno score
    ShapeCAPSULE (capsule)Size17mm
    FlavorImprint Code461;80;mg
    Contains
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02154906/24/2005
    Part 2 of 2
    EMEND
    aprepitant capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APREPITANT(UNII: 1NF15YR6UY) (APREPITANT - UNII:1NF15YR6UY)APREPITANT125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE(UNII: C151H8M554)
    CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
    HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
    SODIUM LAURYL SULFATE(UNII: 368GB5141J)
    GELATIN(UNII: 2G86QN327L)
    TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
    SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
    FERRIC OXIDE RED(UNII: 1K09F3G675)
    FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
    Product Characteristics
    Colorwhite (opaque, white) , pink (opaque, pink)Scoreno score
    ShapeCAPSULE (capsule)Size18mm
    FlavorImprint Code462;125;mg
    Contains
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02154906/24/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02154906/24/2005
    Labeler -Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel

    Revised: 3/2010document Id: 

    f9ed7c72-2852-43af-ad96-a591f943f92fSet id: db16d6b9-3b89-431d-97f9-9b4a8300e913Version: 3Effective Time: 20100319Physicians Total Care, Inc.



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