Drug Information for Premarin (Wyeth Pharmaceuticals Inc.): PATIENT COUNSELING INFORMATION

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  • See Section 17.5 for FDA-Approved Patient Labeling.

  • 17.1 Vaginal Bleeding

  • Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3)].

  • 17.2 Possible Serious Adverse Reactions With Estrogens

  • Inform postmenopausal women of possible serious adverse reactions of estrogen therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)].

  • 17.3 Possible Less Serious But Common Adverse Reactions With Estrogens

  • Inform postmenopausal women of possible less serious but common adverse reactions of estrogen therapy such as headache, breast pain and tenderness, nausea and vomiting.

  • 17.4 Instructions for Use of Applicator

    • Remove cap from tube.
    • Screw nozzle end of applicator onto tube.
    • Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator to measure the correct dose, as prescribed by your healthcare provider.
    • Unscrew applicator from tube.
    • Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.

    TO CLEANSE: Pull plunger to remove it from barrel. Wash with mild soap and warm water.

    DO NOT BOIL OR USE HOT WATER.

  • 17.5 FDA-Approved Patient Labeling

  • PREMARIN® (conjugated estrogens) Vaginal Cream

    Read this PATIENT INFORMATION before you start using PREMARIN Vaginal Cream and read what you get each time you refill your PREMARIN Vaginal Cream prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.

    What is the most important information I should know about PREMARIN Vaginal Cream (an estrogen mixture)?
    • Estrogens may increase the chance of getting cancer of the uterus.
    • Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
    • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia.Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women age 65 years or older. You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream.

    What is PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is a medicine that contains a mixture of estrogen hormones.

    What is PREMARIN Vaginal Cream used for?

    PREMARIN Vaginal Cream is used after menopause to:

    • Treat menopausal changes in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream to control these problems.
    • Treat painful intercourse caused by menopausal changes of the vagina.

    Who should not use PREMARIN Vaginal Cream?

    Do not start using PREMARIN Vaginal Cream if you:

    • Have unusual vaginal bleeding.
    • Currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use PREMARIN Vaginal Cream.
    • Had a stroke or heart attack.
    • Currently have or have had blood clots.
    • Currently have or have had liver problems.
    • Are allergic to PREMARIN Vaginal Cream or any of its ingredients.See the list of ingredients in PREMARIN Vaginal Cream at the end of this leaflet.
    • Think you may be pregnant.

    Tell your healthcare provider:

    • If you have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
    • About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
    • About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PREMARIN Vaginal Cream works. PREMARIN Vaginal Cream may also affect how your other medicines work.
    • If you are going to have surgery or will be on bedrest. You may need to stop using PREMARIN Vaginal Cream.
    • If you are breast feeding. The hormones in PREMARIN Vaginal Cream can pass into your milk.

    How should I use PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is a cream that you place in your vagina with the applicator provided with the cream.

    • Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you.
    • Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with PREMARIN Vaginal Cream.
    • Remove cap from tube.
    • Screw nozzle end of applicator onto tube.
    • Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator to measure the correct dose, as prescribed by your healthcare provider.
    • Unscrew applicator from tube.
    • Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.

    TO CLEANSE: Pull plunger to remove it from barrel. Wash with mild soap and warm water.

    DO NOT BOIL OR USE HOT WATER.

    What are the possible side effects of PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is only used in and around the vagina; however, the risks associated with oral estrogens should be taken into account.

    Side effects are grouped by how serious they are and how often they happen when you are treated.

    Serious, but less common side effects include:

    • Breast cancer
    • Cancer of the uterus
    • Stroke
    • Heart attack
    • Blood clots
    • Dementia
    • Gallbladder disease
    • Ovarian cancer
    • High blood pressure
    • Liver problems
    • High blood sugar
    • Enlargement of benign tumors of the uterus (“fibroids”)

    Some of the warning signs of these serious side effects include:

    • Breast lumps
    • Unusual vaginal bleeding
    • Dizziness and faintness
    • Changes in speech
    • Severe headaches
    • Chest pain
    • Shortness of breath
    • Pains in your legs
    • Changes in vision
    • Vomiting
    • Yellowing of the skin, eyes, or nail beds

    Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

    Less serious, but common, side effects include:

    • Headache
    • Breast pain
    • Irregular vaginal bleeding or spotting
    • Stomach/abdominal cramps, bloating
    • Nausea and vomiting
    • Hair loss
    • Fluid retention
    • Vaginal yeast infection
    • Reactions from inserting PREMARIN Vaginal Cream, such as vaginal burning, irritation, and itching

    These are not all the possible side effects of PREMARIN Vaginal Cream. For more information, ask your healthcare provider or pharmacist.

    What can I do to lower my chances of getting a serious side effect with PREMARIN Vaginal Cream?

    • Talk with your healthcare provider regularly about whether you should continue using PREMARIN Vaginal Cream.
    • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using PREMARIN Vaginal Cream.
    • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
    • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

    General information about the safe and effective use of PREMARIN Vaginal Cream

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use PREMARIN Vaginal Cream for conditions for which it was not prescribed. Do not give PREMARIN Vaginal Cream to other people, even if they have the same symptoms you have. It may harm them. Keep PREMARIN Vaginal Cream out of the reach of children.

    Latex or rubber condoms, diaphragms and cervical caps may be weakened and fail when they come into contact with PREMARIN Vaginal Cream.

    This leaflet provides a summary of the most important information about PREMARIN Vaginal Cream. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PREMARIN Vaginal Cream that is written for health professionals. You can get more information by calling the toll free number 1-800-934-5556.

    What are the ingredients in PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components, including sodium sulfate conjugates: 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin. PREMARIN Vaginal Cream also contains cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.

    PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP.

    Combination package: Each contains a net wt. 1.5 oz (42.5 g) tube with one plastic applicator calibrated in 0.5 g increments to a maximum of 2 g (NDC 0046-0872-93).

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    Wyeth®

    Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101

    «TEAR HERE

    PATIENT INFORMATION

    PREMARIN® (conjugated estrogens) Vaginal Cream

    Read this PATIENT INFORMATION before you start using PREMARIN Vaginal Cream and read what you get each time you refill your PREMARIN Vaginal Cream prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.

    What is the most important information I should know about PREMARIN Vaginal Cream (an estrogen mixture)?
    • Estrogens may increase the chances of getting cancer of the uterus.
    • Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
    • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia.Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women age 65 years or older. You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream.

    What is PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is a medicine that contains a mixture of estrogen hormones.

    What is PREMARIN Vaginal Cream used for?

    PREMARIN Vaginal Cream is used after menopause to:

    • Treat menopausal changes in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream to control these problems.
    • Treat painful intercourse caused by menopausal changes of the vagina.

    Who should not use PREMARIN Vaginal Cream?

    Do not start using PREMARIN Vaginal Cream if you:

    • Have unusual vaginal bleeding.
    • Currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use PREMARIN Vaginal Cream.
    • Had a stroke or heart attack.
    • Currently have or have had blood clots.
    • Currently have or have had liver problems.
    • Are allergic to PREMARIN Vaginal Cream or any of its ingredients.See the list of ingredients in PREMARIN Vaginal Cream at the end of this leaflet.
    • Think you may be pregnant.

    Tell your healthcare provider:

    • If you have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
    • About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
    • About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PREMARIN Vaginal Cream works. PREMARIN Vaginal Cream may also affect how your other medicines work.
    • If you are going to have surgery or will be on bedrest. You may need to stop using PREMARIN Vaginal Cream.
    • If you are breast feeding. The hormones in PREMARIN Vaginal Cream can pass into your milk.

    How should I use PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is a cream that you place in your vagina with the applicator provided with the cream.

    • Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you.
    • Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with PREMARIN Vaginal Cream.
    • Remove cap from tube.
    • Screw nozzle end of applicator onto tube.
    • Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator to measure the correct dose, as prescribed by your healthcare provider.
    • Unscrew applicator from tube.
    • Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.

    TO CLEANSE: Pull plunger to remove it from barrel. Wash with mild soap and warm water.

    DO NOT BOIL OR USE HOT WATER.

    What are the possible side effects of PREMARIN Vaginal Cream?

    PREMARIN Vaginal Cream is only used in and around the vagina; however, the risks associated with oral estrogens should be taken into account.

    Side effects are grouped by how serious they are and how often they happen when you are treated.

    Serious, but less common side effects include:

    • Breast cancer
    • Cancer of the uterus
    • Stroke
    • Heart attack
    • Blood clots
    • Dementia
    • Gallbladder disease
    • Ovarian cancer
    • High blood pressure
    • Liver problems
    • High blood sugar
    • Enlargement of benign tumors of the uterus (“fibroids”)

    Some of the warning signs of these serious side effects include:

    • Breast lumps
    • Unusual vaginal bleeding
    • Dizziness and faintness
    • Changes in speech
    • Severe headaches
    • Chest pain
    • Shortness of breath
    • Pains in your legs
    • Changes in vision
    • Vomiting
    • Yellowing of the skin, eyes, or nail beds

    Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

    Less serious, but common, side effects include:

    • Headache
    • Breast pain
    • Irregular vaginal bleeding or spotting
    • Stomach/abdominal cramps, bloating
    • Nausea and vomiting
    • Hair loss
    • Fluid retention
    • Vaginal yeast infection
    • Reactions from inserting PREMARIN Vaginal Cream, such as vaginal burning, irritation, and itching

    These are not all the possible side effects of PREMARIN Vaginal Cream. For more information, ask your healthcare provider or pharmacist.

    What can I do to lower my chances of getting a serious side effect with PREMARIN Vaginal Cream?

    • Talk with your healthcare provider regularly about whether you should continue using PREMARIN Vaginal Cream.
    • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using PREMARIN Vaginal Cream.
    • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
    • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

    General information about the safe and effective use of PREMARIN Vaginal Cream

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use PREMARIN Vaginal Cream for conditions for which it was not prescribed. Do not give PREMARIN Vaginal Cream to other people, even if they have the same symptoms you have. It may harm them. Keep PREMARIN Vaginal Cream out of the reach of children.

    Latex or rubber condoms, diaphragms and cervical caps may be weakened and fail when they come into contact with PREMARIN Vaginal Cream.

    This leaflet provides a summary of the most important information about PREMARIN Vaginal Cream. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PREMARIN Vaginal Cream that is written for health professionals. You can get more information by calling the toll free number 1-800-934-5556.

    What are the ingredients in PREMARIN Vaginal Cream

    PREMARIN Vaginal Cream contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components, including sodium sulfate conjugates: 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin. PREMARIN Vaginal Cream also contains cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.

    PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP.

    Combination package: Each contains a net wt. 1.5 oz (42.5 g) tube with one plastic applicator calibrated in 0.5 g increments to a maximum of 2 g (NDC 0046-0872-93).

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1‑800‑934‑5556.

    Wyeth®

    Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101

    W10413C015ET01Rev 11/08

  • Drug Information Provided by National Library of Medicine (NLM).
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