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AMBRISENTAN tablet, film coated


  1. Inform Female Patients (and Their Guardians, If Applicable) Of The Following Notable Requirements:
  2. Instruct Patients That The Risks Associated With Ambrisentan Tablets Also Include The Following:
  3. Disclaimer:
  4. Manufactured By:
  5. What Is The Most Important Information I Should Know About Ambrisentan Tablets?
  6. Active Ingredient:
  7. Females Who Are Able To Get Pregnant Are Females Who:
  8. Females Who Are Not Able To Get Pregnant Are Females Who:
  9. Can Cause Serious Side Effects Including:
  10. Include:
  11. Manufactured For:
  12. Patient Information
  13. Who Should Not Take Ambrisentan Tablets?
  14. , Tell Your Doctor If You:
  15. Can Cause Liver Problems. Tell Your Doctor If You Get Any Of These Symptoms Of A Liver Problem While Taking Ambrisentan Tablets:
  16. Embryo-fetal Toxicity:
  17. Ambrisentan Risk Evaluation And Mitigation Strategy (rems):
  18. Hepatic Effects:
  19. Hematological Change:
  20. Other Risks Associated With Ambrisentan Tablets:
  21. Administration:
  22. Do Not Take Ambrisentan Tablets If:
  23. Before You Take Ambrisentan Tablets, Tell Your Doctor If You:
  24. How Should I Take Ambrisentan Tablets?
  25. What Should I Avoid While Taking Ambrisentan Tablets?
  26. Ambrisentan Tablets Can Cause Serious Side Effects Including:
  27. The Most Common Side Effects Of Ambrisentan Tablets Include:
  28. Some Medicines That Are Like Ambrisentan Tablets Can Cause Liver Problems. Tell Your Doctor If You Get Any Of These Symptoms Of A Liver Problem While Taking Ambrisentan Tablets:
  29. How Should I Store Ambrisentan Tablets?
  30. Active Ingredient:
  31. Inactive Ingredients:

Inform Female Patients (and Their Guardians, If Applicable) Of The Following Notable Requirements: 

  • All female patients must sign an enrollment form.
  • Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements[see Use in Specific Populations (8.3)].
  • Female of reproductive potential must be counseled on the use of emergency contraception in the event of unprotected sex or known or suspected contraceptive failure.
  • Pre-pubertal females must report any changes in their reproductive status immediately to their prescriber.

Review the ambrisentan tablets Medication Guide and PS-Ambrisentan REMS educational material with female patients.

Ambrisentan tablets are available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product.

Hepatic Effects

Advise patients of the symptoms of potential liver injury and instruct them to report any of these symptoms to their physician.

Hematological Change

Advise patients of the importance of hemoglobin testing.

Other Risks Associated with Ambrisentan tablets

Instruct Patients That The Risks Associated With Ambrisentan Tablets Also Include The Following: 

  • Decreases in sperm count
  • Fluid overload

Administration

Advise patients not to split, crush, or chew tablets.

Disclaimer: 

Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured By: 

Cipla Limited,

Patalganga, India

What Is The Most Important Information I Should Know About Ambrisentan Tablets? 

  • Serious birth defects.

    Ambrisentan tablets can cause serious birth defects if taken during pregnancy.

    • Females must not be pregnant when they start taking ambrisentan tablets or become pregnant during treatment with ambrisentan tablets.
    • Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with ambrisentan tablets, each month during treatment with ambrisentan tablets, and one month after stopping ambrisentan tablets. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do a pregnancy test, and will order a pregnancy test for you depending on your menstrual cycle.
      • Females whoare ableto get pregnant are females who:
        • have entered puberty, even if they have not started their menstrual period,and
        • have a uterus,and
        • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
      • Females whoare not ableto get pregnant are females who:
        • have not yet entered puberty,or
        • do not have a uterus,or
        • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed,or
        • who are infertile for any other medical reason and this infertility is permanent and cannot be reversed.

    Females who are able to get pregnant must use two acceptable forms of birth control during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body.

    • If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods can be used alone and no other form of birth control is needed.
    • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets.
    • If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.

    • Ambrisentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
    • Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
    • When taken with tadalafil, ambrisentan tablets are used to reduce the risk of your disease progressing, to reduce the risk of hospitalization due to worsening pulmonary arterial hypertension (PAH), and to improve your ability to exercise.
    • It is not known if ambrisentan tablets are safe and effective in children.

Active Ingredient: 

ambrisentan.

Females Who Are Able To Get Pregnant Are Females Who: 

  • have entered puberty, even if they have not started their menstrual period, and
  • have a uterus, and
  • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
  • Females Who Are Not Able To Get Pregnant Are Females Who: 

  • have not yet entered puberty, or
  • do not have a uterus, or
  • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
  • who are infertile for any other medical reason and this infertility is permanent and cannot be reversed
  • Females who are able to get pregnant must use two acceptable forms of birth control during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body.

    • If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods can be used alone and no other form of birth control is needed.
    • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets.
    • If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.

    • Aambrisentan tablet is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
    • Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
    • It is not known if ambrisentan tablet is safe and effective in children.

    Who should not takeambrisentan tablets?

    Do not takeambrisentan tabletsif:

    • you are pregnant, plan to become pregnant, or become pregnant during treatment withambrisentan tablets.Ambrisentan tabletscan cause serious birth defects.(

      Before you takeambrisentan tablets

    Can Cause Serious Side Effects Including: 

    • "
    • Swelling all over the body(fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
    • Decreased sperm count.Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.
    • Low red blood cell levels(anemia) can happen during the first weeks after starting ambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan tablets. Your doctor may also do these tests during treatment with ambrisentan tablets.

    The most common side effects ofambrisentan tablets

    Include: 

    • swelling of hands, legs, ankles and feet (peripheral edema)
    • stuffy nose (nasal congestion)
    • inflamed nasal passages (sinusitis)
    • hot flashes or getting red in the face (flushing)

    Some medicines that are likeambrisentan tabletscan cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while takingambrisentan tablets:

    • loss of appetite
    • nausea or vomiting
    • fever
    • achiness
    • generally do not feel well
    • pain in the upper right stomach (abdominal) area
    • yellowing of your skin or the whites of your eyes
    • dark urine
    • itching

    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 ambrisentan tablets. 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 storeambrisentan tablets?

    Store ambrisentan tablets at room temperature between 68 F to 77 F (20 C to 25 C), in the package it comes in.

    Keepambrisentan tabletsand all medicines out of the reach of children.

    General information about the safe and effective use ofambrisentan tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan tablets to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

    What are the ingredients inambrisentan tablets?

    Manufactured For: 

    Cipla USA, Inc.

    1560 Sawgrass Corporate Parkway,

    Suite 130, Sunrise, FL 33323

    For more information call 1-866-604-3268.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Revised: 9/2019

    Patient Information 

    Ambrisentan Tablets

    (am bri SEN tan)

    Read this Medication Guide before you start taking ambrisentan tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
    What is the most important information I should know aboutambrisentan tablets?
    • Serious birth defects.

    Ambrisentan tabletscan cause serious birth defects if taken during pregnancy.

    • Females must not be pregnant when they start takingambrisentan tabletsor become pregnant during treatment withambrisentan tablets.
    • Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with ambrisentan tablets, each month during treatment with ambrisentan tablets, and one month after stopping ambrisentan tablets. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do a pregnancy test, and will order a pregnancy test for you depending on your menstrual cycle.
    • Females whoare ableto get pregnant are females who:
    • have entered puberty, even if they have not started their menstrual period,and
    • have a uterus,and
    • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
    • Females whoare not ableto get pregnant are females who:
    • have not yet entered puberty,or
    • do not have a uterus,or
    • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed,or
    • who are infertile for any other medical reason and this infertility is permanent and cannot be reversed

    Females who are able to get pregnant must use two acceptable forms of birth control during treatment withambrisentan tablets, and for one month after stoppingambrisentan tabletsbecause the medicine may still be in the body.

    • If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods can be used alone and no other form of birth control is needed.
    • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets.
    • If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.

    • Ambrisentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
    • Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
    • It is not known if ambrisentan tablets are safe and effective in children.

    Who Should Not Take Ambrisentan Tablets? 

    Do not take ambrisentan tabletsif:

    • you are pregnant, plan to become pregnant, or become pregnant during treatment with ambrisentan tablets. Ambrisentan tabletscan cause serious birth defects.()

    Serious birth defects from ambrisentan tablets happen early in pregnancy.

    • you have a condition called Idiopathic Pulmonary Fibrosis (IPF)
    What should I tell my doctor before takingambrisentan tablets?

    Before you takeambrisentan tablets

    , Tell Your Doctor If You: 

    • have been told that you have a low red blood cell level (anemia)
    • have liver problems
    • have any other medical conditions

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.

    Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune).Your doctor may need to change your dose of ambrisentan tablets.

    How should I takeambrisentan tablets?
    • Ambrisentan tablets will be mailed to you by a certified pharmacy. Your doctor will give you complete details.
    • Take ambrisentan tablets exactly as your doctor tells you to take it. Do not stop taking ambrisentan tablets unless your doctor tells you to stop.
    • You can take ambrisentan tablets with or without food.
    • Do not split, crush or chew ambrisentan tablets.
    • It will be easier to remember to take ambrisentan tablets if you take it at the same time each day.
    • If you take more than your regular dose of ambrisentan tablets, call your doctor right away.
    • If you miss a dose, take it as soon as you remember that day. Take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
    What should I avoid while takingambrisentan tablets?
    • Do not get pregnantwhile taking ambrisentan tablets. () If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
    • It is not known if ambrisentanpasses into your breast milk. You should not breastfeedif you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.
    What are the possible side effects ofambrisentan tablets?

    Ambrisentan tablets

    Can Cause Liver Problems. Tell Your Doctor If You Get Any Of These Symptoms Of A Liver Problem While Taking Ambrisentan Tablets: 

    • loss of appetite
    • nausea or vomiting
    • fever
    • achiness
    • generally do not feel well
    • pain in the upper right stomach (abdominal) area
    • yellowing of your skin or the whites of your eyes
    • dark urine
    • itching

    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 ambrisentan tablets. 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 storeambrisentan tablets?

    Store ambrisentan tablets at room temperature between 68 to 77 F (20 to 25 C), in the package it comes in.

    Keepambrisentan tabletsand all medicines out of the reach of children.

    General information about the safe and effective use ofambrisentan tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan tablets to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

    What are the ingredients inambrisentan tablets?

    Active ingredient: ambrisentan

    Inactive Ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

    The tablets are film-coated with a coating material containing FD&C Red #40 / allura red ac aluminum lake, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

    For more information, call Par Pharmaceutical at 1-800-828-9393.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    The brands listed are trademarks of their respective owners and are not trademarks of the Par Pharmaceutical. The makers of these brands are not affiliated with and do not endorse Par Pharmaceutical or its products.

    Embryo-fetal Toxicity: 

    Instruct patients on the risk of fetal harm when ambrisentan tablets are used in pregnancy[seeWarnings and Precautions (5.1)andUse in Specific Populations (8.1)].Female patients must enroll in the Ambrisentan REMS. Instruct females of reproductive potential to immediately contact their physician if they suspect they may be pregnant.

    Ambrisentan Risk Evaluation And Mitigation Strategy (rems): 

    For female patients, ambrisentan tablets are only available through a restricted program called the Ambrisentan REMS[seeContraindications (4.1),Warnings and Precautions (5.2)].Male patients are not enrolled in the Ambrisentan REMS.

    Hepatic Effects: 

    Advise patients of the symptoms of potential liver injury and instruct them to report any of these symptoms to their physician.

    Hematological Change: 

    Advise patients of the importance of hemoglobin testing.

    Other Risks Associated With Ambrisentan Tablets: 

    Instruct patients that the risks associated with ambrisentan tablets also include the following:

    Decreases in sperm count
    Fluid overload

    Administration: 

    Advise patients not to split, crush, or chew tablets.

    Do Not Take Ambrisentan Tablets If: 

    you are pregnant, plan to become pregnant, or become pregnant during treatment with ambrisentan tablets. Ambrisentan tablets can cause serious birth defects.()Serious birth defects from ambrisentan tablets happen early in pregnancy.
    you have a condition called Idiopathic Pulmonary Fibrosis (IPF)

    Before You Take Ambrisentan Tablets, Tell Your Doctor If You: 

    have been told that you have a low red blood cell level (anemia)
    have liver problems
    have any other medical conditions

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.

    Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune).Your doctor may need to change your dose of ambrisentan tablets.

    How Should I Take Ambrisentan Tablets? 

    Ambrisentan tablets will be mailed to you by a certified pharmacy. Your doctor will give you complete details.
    Take ambrisentan tablets exactly as your doctor tells you to take them. Do not stop taking ambrisentan tablets unless your doctor tells you to stop.
    You can take ambrisentan tablets with or without food.
    Do not split, crush or chew ambrisentan tablets.
    It will be easier to remember to take ambrisentan tablets if you take them at the same time each day.
    If you take more than your regular dose of ambrisentan tablets, call your doctor right away.
    If you miss a dose, take it as soon as you remember that day. Take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

    What Should I Avoid While Taking Ambrisentan Tablets? 

    Do not get pregnantwhile taking ambrisentan tablets. () If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
    It is not known if ambrisentan passes into your breast milk. You should not breastfeedif you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.

    Ambrisentan Tablets Can Cause Serious Side Effects Including: 

    Swelling all over the body(fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
    Decreased sperm count.Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.
    Low red blood cell levels(anemia) can happen during the first weeks after starting ambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan tablets. Your doctor may also do these tests during treatment with ambrisentan tablets.

    The Most Common Side Effects Of Ambrisentan Tablets Include: 

    swelling of hands, legs, ankles and feet (peripheral edema)
    stuffy nose (nasal congestion)
    inflamed nasal passages (sinusitis)
    hot flashes or getting red in the face (flushing)

    Some Medicines That Are Like Ambrisentan Tablets Can Cause Liver Problems. Tell Your Doctor If You Get Any Of These Symptoms Of A Liver Problem While Taking Ambrisentan Tablets: 

    loss of appetite
    nausea or vomiting
    fever
    achiness
    generally do not feel well
    pain in the upper right stomach (abdominal) area
    yellowing of your skin or the whites of your eyes
    dark urine
    itching

    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 ambrisentan tablets. 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 Ambrisentan Tablets? 

    Store ambrisentan tablets at room temperature between 20 to 25 C (68 to 77 F), in the package they come in.

    Keep ambrisentan tablets and all medicines out of the reach of children.

    General information about the safe and effective use of ambrisentan tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which they were not prescribed. Do not give ambrisentan tablets to other people, even if they have the same symptoms that you have. They may harm them.

    This Medication Guide summarizes the most important information about ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

    Active Ingredient: 

    ambrisentan

    Inactive Ingredients: 

    anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

    Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

    Manufactured by: Mylan Laboratories Limited, Hyderabad 500 096, India

    The brands listed are trademarks of their respective owners.

    For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Manufactured by:
    Mylan Laboratories Limited
    Hyderabad 500 096, India

    75069501

    Revised: 8/2019
    MX:AMBR:R5



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