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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.
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).
PREMPROTM
(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 ?
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
Premarin
regrets premarin
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