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INDICATIONS

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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 Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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.

Important safety information:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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INDICATIONS

Indinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Indinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body. It is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

INSTRUCTIONS

Take indinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take indinavir with a full glass (8 ounces) of water or skim milk. You may also drink juice, coffee, or tea with this medication. Drink at least 6 glasses of water each day to prevent kidney stones while you are taking indinavir. Indinavir should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you prefer to take the medication with food, eat only a light meal, such as dry toast with jelly, or corn flakes with skim milk and sugar. Avoid eating a high-fat meal.

It is important to use indinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 2 hours late in taking your indinavir, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Usual Adult Dose for HIV Infection

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.

Usual Adult Dose for Nonoccupational Exposure

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Adult Dose for Occupational Exposure

800 mg orally every 8 hours 800 mg orally every 8 hours plus lamivudine-zidovudine,
or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours plus lamivudine-zidovudine.
Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure. The exact duration of therapy may differ based on the institution’s protocol.

Liver Dose Adjustments

Mild to moderate hepatic insufficiency: 600 mg orally every 8 hours.

Dose Adjustments

Consider reducing the dose to 600 mg every 8 hours if delavirdine, itraconazole, or ketoconazole are administered concomitantly. Increase the dose to 1000 mg every 8 hours if rifabutin is given concurrently, and decrease the rifabutin dose by half.
Precautions

Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.

Adequate hydration (1.5 liters/day) is crucial during therapy to reduce the risk of nephrolithiasis. A brief interruption (usually 1 to 3 days) or total discontinuation may be necessary if nephrolithiasis occurs.

Discontinue indinavir if hemolytic anemia occurs. Consider discontinuation if severe leukocyturia develops.

STORAGE

Store indinavir at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with indinavir capsules.

Do not take this medication if you are allergic to indinavir.
Do not take indinavir with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

Before taking indinavir, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • kidney disease, or
  • a history of kidney stones;
  • diabetes;
  • a bleeding disorder such as hemophilia; or
  • high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indinavir.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.
You should not breast-feed while you are using indinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indinavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • pain in your side or lower back, blood in your urine;
  • easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, bloating;
  • numbness or tingling, especially around your mouth;
  • tired feeling;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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 Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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.

Important safety information:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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INDICATIONS

Indinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Indinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body. It is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

INSTRUCTIONS

Take indinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take indinavir with a full glass (8 ounces) of water or skim milk. You may also drink juice, coffee, or tea with this medication. Drink at least 6 glasses of water each day to prevent kidney stones while you are taking indinavir. Indinavir should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you prefer to take the medication with food, eat only a light meal, such as dry toast with jelly, or corn flakes with skim milk and sugar. Avoid eating a high-fat meal.

It is important to use indinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 2 hours late in taking your indinavir, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Usual Adult Dose for HIV Infection

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.

Usual Adult Dose for Nonoccupational Exposure

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Adult Dose for Occupational Exposure

800 mg orally every 8 hours 800 mg orally every 8 hours plus lamivudine-zidovudine,
or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours plus lamivudine-zidovudine.
Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure. The exact duration of therapy may differ based on the institution’s protocol.

Liver Dose Adjustments

Mild to moderate hepatic insufficiency: 600 mg orally every 8 hours.

Dose Adjustments

Consider reducing the dose to 600 mg every 8 hours if delavirdine, itraconazole, or ketoconazole are administered concomitantly. Increase the dose to 1000 mg every 8 hours if rifabutin is given concurrently, and decrease the rifabutin dose by half.
Precautions

Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.

Adequate hydration (1.5 liters/day) is crucial during therapy to reduce the risk of nephrolithiasis. A brief interruption (usually 1 to 3 days) or total discontinuation may be necessary if nephrolithiasis occurs.

Discontinue indinavir if hemolytic anemia occurs. Consider discontinuation if severe leukocyturia develops.

STORAGE

Store indinavir at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with indinavir capsules.

Do not take this medication if you are allergic to indinavir.
Do not take indinavir with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

Before taking indinavir, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • kidney disease, or
  • a history of kidney stones;
  • diabetes;
  • a bleeding disorder such as hemophilia; or
  • high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indinavir.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.
You should not breast-feed while you are using indinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indinavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • pain in your side or lower back, blood in your urine;
  • easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, bloating;
  • numbness or tingling, especially around your mouth;
  • tired feeling;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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INDICATIONS

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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 Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

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  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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.

Important safety information:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
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  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
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  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
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  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
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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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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INDICATIONS

Indinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Indinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body. It is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

INSTRUCTIONS

Take indinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take indinavir with a full glass (8 ounces) of water or skim milk. You may also drink juice, coffee, or tea with this medication. Drink at least 6 glasses of water each day to prevent kidney stones while you are taking indinavir. Indinavir should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you prefer to take the medication with food, eat only a light meal, such as dry toast with jelly, or corn flakes with skim milk and sugar. Avoid eating a high-fat meal.

It is important to use indinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 2 hours late in taking your indinavir, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Usual Adult Dose for HIV Infection

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.

Usual Adult Dose for Nonoccupational Exposure

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Adult Dose for Occupational Exposure

800 mg orally every 8 hours 800 mg orally every 8 hours plus lamivudine-zidovudine,
or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours plus lamivudine-zidovudine.
Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure. The exact duration of therapy may differ based on the institution’s protocol.

Liver Dose Adjustments

Mild to moderate hepatic insufficiency: 600 mg orally every 8 hours.

Dose Adjustments

Consider reducing the dose to 600 mg every 8 hours if delavirdine, itraconazole, or ketoconazole are administered concomitantly. Increase the dose to 1000 mg every 8 hours if rifabutin is given concurrently, and decrease the rifabutin dose by half.
Precautions

Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.

Adequate hydration (1.5 liters/day) is crucial during therapy to reduce the risk of nephrolithiasis. A brief interruption (usually 1 to 3 days) or total discontinuation may be necessary if nephrolithiasis occurs.

Discontinue indinavir if hemolytic anemia occurs. Consider discontinuation if severe leukocyturia develops.

STORAGE

Store indinavir at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with indinavir capsules.

Do not take this medication if you are allergic to indinavir.
Do not take indinavir with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

Before taking indinavir, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • kidney disease, or
  • a history of kidney stones;
  • diabetes;
  • a bleeding disorder such as hemophilia; or
  • high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indinavir.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.
You should not breast-feed while you are using indinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indinavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • pain in your side or lower back, blood in your urine;
  • easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, bloating;
  • numbness or tingling, especially around your mouth;
  • tired feeling;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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INDICATIONS

Indinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Indinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body. It is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

INSTRUCTIONS

Take indinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take indinavir with a full glass (8 ounces) of water or skim milk. You may also drink juice, coffee, or tea with this medication. Drink at least 6 glasses of water each day to prevent kidney stones while you are taking indinavir. Indinavir should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you prefer to take the medication with food, eat only a light meal, such as dry toast with jelly, or corn flakes with skim milk and sugar. Avoid eating a high-fat meal.

It is important to use indinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 2 hours late in taking your indinavir, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Usual Adult Dose for HIV Infection

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.

Usual Adult Dose for Nonoccupational Exposure

800 mg orally every 8 hours or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Adult Dose for Occupational Exposure

800 mg orally every 8 hours 800 mg orally every 8 hours plus lamivudine-zidovudine,
or indinavir 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours plus lamivudine-zidovudine.
Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure. The exact duration of therapy may differ based on the institution’s protocol.

Liver Dose Adjustments

Mild to moderate hepatic insufficiency: 600 mg orally every 8 hours.

Dose Adjustments

Consider reducing the dose to 600 mg every 8 hours if delavirdine, itraconazole, or ketoconazole are administered concomitantly. Increase the dose to 1000 mg every 8 hours if rifabutin is given concurrently, and decrease the rifabutin dose by half.
Precautions

Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.

Adequate hydration (1.5 liters/day) is crucial during therapy to reduce the risk of nephrolithiasis. A brief interruption (usually 1 to 3 days) or total discontinuation may be necessary if nephrolithiasis occurs.

Discontinue indinavir if hemolytic anemia occurs. Consider discontinuation if severe leukocyturia develops.

STORAGE

Store indinavir at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with indinavir capsules.

Do not take this medication if you are allergic to indinavir.
Do not take indinavir with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

Before taking indinavir, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • kidney disease, or
  • a history of kidney stones;
  • diabetes;
  • a bleeding disorder such as hemophilia; or
  • high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indinavir.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.
You should not breast-feed while you are using indinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indinavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • pain in your side or lower back, blood in your urine;
  • easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, bloating;
  • numbness or tingling, especially around your mouth;
  • tired feeling;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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INDICATIONS

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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 Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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.

Important safety information:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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INDICATIONS

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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 Premarin.

STORAGE

Store Premarin between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

Some medicines may interact with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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.

Important safety information:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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