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Premarin 0.625mg/gm cream, 1.25mg, 0.3mg, 0.625mg tablets.

Pronounced: PREM-uh-rin
Generic name: Conjugated estrogens
Other brand names: Cenestin, Premphase, Prempro

Why is Premarin drug prescribed ?

Premarin is an estrogen replacement drug. The tablets are used to reduce moderate to severe symptoms of menopause, including feelings of warmth in the face, neck, and chest, and the sudden intense episodes of heat and sweating known as "hot flashes." Cenestin tablets, containing a synthetic form of conjugated estrogens, may also be prescribed for these symptoms.

In addition to the symptoms of menopause, Premarin tablets are prescribed for teenagers who fail to mature at the usual rate, and to relieve the symptoms of certain types of cancer, including some forms of breast and prostate cancer.

In addition, either the tablets or Premarin vaginal cream can be used for other conditions caused by lack of estrogen, such as dry, itchy external genitals and vaginal irritation.

Along with diet, calcium supplements, and exercise, Premarin tablets are also prescribed to prevent postmenopausal osteoporosis, a condition in which the bones become brittle and easily broken. Before taking Premarin solely for this purpose, you should carefully consider using alternative, nonestrogen therapies.

The addition of progesterone to estrogen-replacement therapy has been shown to reduce the risk of uterine cancer. Prempro combines estrogen and progesterone in a single tablet taken once daily. Premphase is a 28-day supply of tablets. The first 14 contain only estrogen. The second 14 supply both estrogen and progesterone. Both Prempro and Premphase are prescribed to reduce the symptoms of menopause, including vaginal problems, and to prevent osteoporosis.

Taking PREMARIN

To get the best results from PREMARIN, follow your health care professional's directions for taking your medication daily. Remember, it takes time to achieve results. If you have questions or concerns, don't hesitate to talk with your health care professional. He or she is always your best source for medical information.

Tips for Remembering to Take PREMARIN

If you find that you're missing doses, try to make PREMARIN part of a routine you already do every day. For example

• Keep your PREMARIN pack next to your toothbrush, with other daily medications, or wherever you'll see it at the same time each day.
  
• Set your e-mail program to send yourself a daily reminder to take your medication.
  
• Ask your partner or a friend to become your PREMARIN coach and remind you each day.

Be creative. You know yourself best, so come up with your own idea to remind yourself each day.

You'll achieve your best results with PREMARIN if you remember to take it every day, as prescribed by your health care professional.

What to Do If You Forget a Premarin Dose

Take the missed pill as soon as you remember it. If it is almost time for your next dose, just skip the pill you forgot. Do not take two doses at the same time.

Remember: the U.S. Food and Drug Administration (FDA) recommends that women who choose hormone therapy use the lowest effective dose for the shortest duration of time consistent with treatment goals and risks. PREMARIN offers five dosage strengths so your health care professional can choose the lowest effective dose to treat your menopausal hot flashes, night sweats, and vaginal dryness.

 
Important Safety Information  about Premarin

What is the most important information you should know about PREMARIN (estrogens), PREMPRO (a combination of estrogens and a progestin), or PREMARIN Vaginal Cream (a cream of estrogens)?

• Estrogens increase the chances of getting cancer of the uterus.

Report any unusual vaginal bleeding right away while you are using these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out 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 chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.

PREMARIN^® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).

PREMPRO^TM (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).

PREMARIN^® (conjugated estrogens) Vaginal Cream is used to treat dryness, itching, and burning, in and around the vagina due to menopause.

PREMARIN and PREMPRO should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you do not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN and PREMPRO solely for the prevention of postmenopausal osteoporosis.

In a clinical trial, the most commonly reported (>5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.

In a clinical trial, the most commonly reported (>5%) side effects that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg than with placebo were breast pain/enlargement, vaginitis due to yeast or other causes, leg cramps, vaginal spotting/bleeding, and painful menstruation. In a clinical trial, there was no difference in the commonly reported (>5%) side effects for women taking PREMPRO 0.3 mg/1.5 mg compared to those taking placebo.

The most commonly reported side effects of PREMARIN Vaginal Cream include vaginal discomfort or pain, breast pain, vaginitis, and itching.

PREMARIN, PREMPRO, and PREMARIN Vaginal Cream should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack in the past year, have or had blood clots, have liver problems, are allergic to any of the ingredients in PREMARIN, PREMPRO, or PREMARIN Vaginal Cream, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

How should you take Premarin medication?

Take Premarin exactly as prescribed. Do not share it with anyone else.

If you are taking calcium supplements as a part of the treatment to help prevent brittle bones, check with your doctor about how much to take.

You should take a few moments to read the patient package insert provided with your prescription.

If you are using Premarin vaginal cream, apply it as follows:
1. Remove cap from tube.
2. Screw nozzle end of applicator onto tube.
3. 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 as a guide.
4. Unscrew applicator from tube.
5. Lie on back with knees drawn up. Gently insert applicator deeply into the vagina and press plunger downward to its original position.

To cleanse the applicator, pull the plunger to remove it from the barrel, then wash with mild soap and warm water. Do not boil or use hot water.

--If you miss a dose...

Take the forgotten dose as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Never try to "catch up" by doubling the dose.

--Storage instructions...

Store at room temperature.

What side effects Premarin  may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor immediately. Only your doctor can determine whether it is safe to continue taking Premarin.

• Side effects of conjugated estrogens may include:
  Abdominal cramps, abnormal vaginal bleeding, allergic reactions, bloating, blood clots, blood pressure increase, breast cancer or cysts, breast pain or discharge, breast swelling and tenderness, decreased calcium in the blood, depression, dizziness, endometrial cancer, endometrial cell changes, enlargement of benign tumors in the liver or uterus, fluid retention, gallbladder disease, hair loss from the scalp, hives, increased body hair, increased triglycerides, inflammation of the pancreas, intolerance to contact lenses, irritability, itchy spots, joint pain, leg cramps, migraine headache, nausea, mood disturbances, nervousness, ovarian cancer, painful menstruation, sex-drive changes, skin darkening (especially on the face), skin rash or redness, swelling of wrists and ankles, vaginal yeast infection, vomiting, weight gain or loss, worsening of asthma or epilepsy, yellow eyes and skin

• Other possible side effects of Premphase and Prempro may include:
  Appetite changes, backache, changes in blood pressure, excessive flow of breast milk, eye disorders, fatigue, fever, headache, nervousness, sleep disturbances, twitching

• Other possible side effects of Cenestin may include:
  Constipation, cough, diarrhea, gas, heavy bleeding during menstruation, increased heartbeat, increased muscle tone, indigestion, infection, joint pain, leg cramps, muscle pain, pain, painful menstruation, runny nose, skin tingling, sore throat, weakness.

Why should Premarin drug not be prescribed?

Do not take Premarin if you have ever had a bad reaction to it, or have undiagnosed abnormal vaginal bleeding.

Except in certain special circumstances, you should not be given Premarin if you have ever had breast cancer, uterine cancer, or any other "estrogen-dependent" cancer.

Do not take Premarin if you have had any circulation problem involving blood clots, or have had a stroke or heart attack in the past year.

Do not take Premarin if you have liver disease or your liver is not working properly.

Do not use Premarin if you are pregnant or trying to become pregnant.

Special warnings about Premarin medication

For women who have not had a hysterectomy, the risk of endometrial and uterine cancer increases when estrogen-only drugs are used for a long time or taken in large doses. Estrogen therapy can also worsen endometriosis (uterine tissue growing outside the uterus). If you've ever had endometriosis, make sure the doctor is aware of it. If you've had a hysterectomy but still have residual endometriosis, your doctor may want you to use an estrogen/progesterone combination.

Certain studies have shown that women taking estrogen for prolonged periods of time (4 years or more) face an increased risk of breast cancer, and a study by the National Heart, Lung and Blood Institute (NHLBI) has confirmed an increased risk among women taking estrogen/progesterone combinations. Use combination products (and estrogen-only preparations, too) with special caution if you have a family history of breast cancer or have ever had an abnormal mammogram. Be sure to get an annual breast exam from your doctor, and do your own self-examination each month.

The NHLBI study also found an increased risk of dementia for women taking estrogen/progesterone combinations. It's unknown whether this applies to estrogen-only drugs.

Because Premarin can increase the risk of heart attack, stroke, blood clots, and certain estrogen-dependent cancers, contact your doctor right away if you notice any of the following:

Abdominal pain, tenderness, or swelling
Abnormal bleeding from the vagina
Breast lumps
Coughing up blood
Pain in your chest or calves
Severe headache, dizziness, or faintness
Sudden shortness of breath
Vision changes

Women who take Premarin after menopause are more likely to develop gallbladder disease.

Estrogens such as Premarin can cause hypercalcemia, a severe increase of calcium levels in the blood. Women with breast or bone cancer are especially at risk and should stop taking Premarin immediately if they develop hypercalcemia. In addition, women with the opposite problem--hypocalcemia, or a severe decrease of calcium in the blood--should use Premarin with caution.

Women who have not had a hysterectomy and take estrogen along with progesterone have a lower risk of precancerous endometrial changes. However, you should be aware that estrogen/progesterone combinations could increase "bad" LDL cholesterol and blood sugar levels as well as increase the risk of breast cancer.

There is a slight chance that estrogen therapy could cause an increase in blood pressure. Ask your doctor to check your blood pressure regularly.

If you have high levels of fat in your blood, specifically a high triglyceride level, conjugated estrogens such as Premarin are likely to cause side effects in the pancreas.

Use Premarin with caution if you have a history of liver problems, including jaundice. Call your doctor right away if you develop abdominal pain or yellowing of the skin.

Premarin can alter thyroid function. If you're taking thyroid medication, you may need your dosage adjusted.

Premarin can also cause fluid retention. Use the drug with caution if you have heart or kidney problems, or any other condition that's affected by excess fluid in the body.

Some studies have shown that using estrogen-only drugs, especially for 10 years or more, could increase the risk of ovarian cancer. It's unknown whether this also applies to estrogen/progesterone combinations.

Estrogens such as Premarin have been known to make certain conditions worse, including asthma, diabetes, epilepsy, migraine, porphyria (a genetic enzyme deficiency), lupus, and liver tumors.

If you are using Premarin vaginal cream, you should be aware that this product can weaken latex condoms, diaphragms, and cervical caps.

Possible food and drug interactions when taking Premarin medication

If Premarin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Premarin with the following:

Barbiturates such as phenobarbital
Blood thinners such as Coumadin
Carbamazepine (Tegretol)
Clarithromycin (Biaxin)
Drugs used for epilepsy, such as Dilantin
Erythromycin
Grapefruit juice
Itraconazole (Sporanox)
Ketoconazole (Nizoral)
Major tranquilizers such as Thorazine
Oral diabetes drugs such as Micronase
Rifampin (Rifadin)
Ritonavir (Norvir)
St. John's wort
Steroid medications such as Deltasone
Thyroid preparations such as Synthroid
Tricyclic antidepressants such as Elavil and Tofranil
Vitamin C

Special information on Premarin if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, notify your doctor immediately. Premarin and conjugated estrogens should not be taken during pregnancy because of the possibility of harm to the unborn child. Premarin cannot prevent a miscarriage. Estrogens can decrease the quantity and quality of breast milk, and progestins appear in breast milk. Your doctor may advise you not to breastfeed while you are taking this drug.

Premarin Recommended dosage

Your doctor will start therapy with this medication at a low dose and adjust the dosage according to your response. He or she will want to check you periodically at 3- to 6-month intervals to determine the need for continued therapy.

PREMARIN TABLETS

Hot flashes associated with menopause

The usual starting dosage is 0.3 milligrams daily, taken continuously or in cycles such as 25 days on Premarin and 5 days off.

Tissue degeneration in the vagina

The usual starting dosage is 0.3 milligrams daily, taken continuously or in cycles.

Low estrogen levels due to reduced ovary function

The usual dosage is 0.3 to 0.625 milligrams daily, taken cyclically.

Ovary removal or ovarian failure

The usual dosage is 1.25 milligrams daily, taken cyclically.

Prevention of osteoporosis (loss of bone mass)

The usual starting dosage is 0.625 milligram daily, taken continuously or in cycles.

Advanced androgen-dependent cancer of the prostate, for relief of symptoms only

The usual dosage is 1.25 to 2.5 milligrams 3 times daily.

Breast cancer (for relief of symptoms only) in appropriately selected women and men with metastatic disease

The suggested dosage is 10 milligrams 3 times daily for a period of at least 3 months. Tell your doctor if you have any unusual bleeding.

PREMARIN VAGINAL CREAM

Given cyclically for short-term use only.

Degeneration of genital tissue or severe itching in the genital area

The recommended dosage is one-half to 2 grams daily, inserted into the vagina, depending on the severity of the condition. You will use the cream for 3 weeks, then stop for 1 week. Tell your doctor if you notice any unusual bleeding.

PREMPHASE TABLETS

Follow a 28-day cycle. Take 1 maroon Premarin tablet (equal to 0.625 milligrams estrogen) every day for the first 14 days; on the 15th day, begin taking 1 light-blue tablet (equal to 0.625 milligrams estrogen/5 milligrams progesterone) daily.

PREMPRO TABLETS

The usual starting dose is one 0.45-milligram/1.5-milligram tablet once a day. If this dose proves insufficient, your doctor may increase the dose to one 0.625-milligram/0.25- or 0.5-milligram tablet once a day.

CENESTIN TABLETS

The usual starting dose is 0.625 milligrams a day. If this proves insufficient, the doctor may gradually increase the dose up to a maximum of 1.25 milligrams daily.

Premarin Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose of Premarin, seek medical attention immediately.

Symptoms of conjugated estrogen overdose may include:
Nausea, vomiting, withdrawal bleeding

Most important fact about Premarin drug

Because estrogens have been linked with an increased risk of uterine and endometrial cancer (cancer in the lining of the uterus), it is essential to have regular checkups and to report any unusual vaginal bleeding to your doctor immediately.

Premarin and other estrogen drugs, with or without progesterone, should not be used to prevent heart disease. Recent studies have confirmed an increased rate of heart attack, stroke, and dangerous blood clots among women taking estrogen or estrogen combinations for 5 years. Blood clots can lead to phlebitis, stroke, heart attack, a loss of blood supply to the lungs, a blockage in the blood vessels serving the eye, and other serious disorders.

Why is Premarin drug prescribed ?     Taking PREMARIN       Tips for Remembering to Take PREMARIN      What to Do If You Forget a Premarin Dose  

Important Safety Information  about Premarin     How should you take Premarin medication?  What side effects Premarin  may occur?

Why should Premarin drug not be prescribed?  Special warnings about Premarin medication   Possible food and drug interactions when taking Premarin medication

Special information on Premarin if you are pregnant or breastfeeding   Premarin Recommended dosage   PREMARIN TABLETS   PREMPRO TABLETS

PREMARIN VAGINAL CREAM PREMPHASE TABLETS   CENESTIN TABLETS  Premarin Overdosage   Most important fact about Premarin drug

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