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Evista®
(raloxifene hydrochloride) Tablet for Oral
Use
See:
Estradiol Mircette
Activella Alora
Climara Pro
CombiPatch Delestrogen
Esclim Estraderm
Estring Estrace Tablets
Evamist Vagifem Vivelle-Dot
Drug Uses
Evista is a prescription medicine used by women
after menopause to treat or prevent a condition called osteoporosis. You should
take calcium and vitamin D along with Evista if you do not get enough calcium
and vitamin D in your diet.
How Taken
The recommended dosage is one 60-mg Evista tablet
daily, which may be administered any time of day without regard to meals.
Warnings/Precautions
Before taking this medication, tell your doctor
if you have a history of blood clots; stroke; cancer; increased triglycerides (a
type of fat in the blood); or liver disease. You may not be able to take Evista,
or you may require a dosage adjustment or special monitoring during treatment if
you have any of the conditions listed above. Evista is in the FDA pregnancy
category X. This means that Evista is known to cause birth defects in an unborn
baby. Do not take Evista if you are pregnant or if you could become pregnant
during treatment. It is not known whether Evista passes into breast milk. Do not
take this medication without first talking to your doctor if you are
breast-feeding a baby.
Missed Dose
Take the missed dose as soon as you remember.
However, if it is almost time for the next dose, skip the missed dose and take
only the next regularly scheduled dose. Do not take a double dose of this
medication.
Possible Side Effects
An infrequent but serious side effect of taking
Evista is the development of blood clots in the veins. These blood clots can
stop blood flow and cause serious medical problems, disability or death. Call
your doctor right away if you have or have had any of the following signs of
blood clots in the legs, lungs or eyes: leg pain or a feeling of warmth in the
calves, swelling of the legs, hands or feet, sudden chest pain, shortness of
breath or coughing up blood, sudden change in your vision, such as loss of
vision or blurred vision. Most of the side effects of Evista are mild and
usually do not cause women to stop taking Evista. The most common side effects
of Evista are hot flashes and leg cramps. Hot flashes are more common during the
first 6 months after starting treatment. If you have any problems or questions
that concern you while taking Evista, ask your doctor or pharmacist for more
information.
Storage
Store at controlled room temperature, 20o to 25oC
(68o to 77oF); allows excursions between 15o and 30oC (59o and 86oF).
Overdose
Incidents of overdose in humans have not been
reported. There is no specific antidote for Evista.
More Information
Before having any surgery, tell your doctor that
you are taking Evista. Treatment with Evista may need to be stopped temporarily
if you require an extended period of bed rest. Avoid sitting still for long
periods of time during travel while taking Evista. Alcohol and cigarette smoking
may cause increased bone loss. Discuss with your doctor the use of these
products.
EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly
referred to as a selective estrogen receptor modulator (SERM) that belongs to
the benzothiophene class of compounds.
The chemical designation is
methanone,
[6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-,
hydrochloride.
Raloxifene hydrochloride (HCl) has the empirical formula
C28H27NO4S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene
HCl is an off-white to pale-yellow solid that is very slightly soluble in water.
EVISTA is supplied in a tablet dosage form for oral administration. Each EVISTA
tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71
mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax,
crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate,
magnesium stearate, modified pharmaceutical glaze, polyethylene glycol,
polysorbate 80, povidone, propylene glycol, and titanium dioxide.
WARNING
INCREASED RISK OF VENOUS THROMBOEMBOLISM AND
DEATH FROM STROKE
Increased risk of deep vein thrombosis and pulmonary embolism have been reported
with EVISTA (see PRECAUTIONS). Women with active or past history of venous
thromboembolism should not take EVISTA (see CONTRAINDICATIONS).
Increased risk of death due to stroke occurred in a trial in postmenopausal
women with documented coronary heart disease or at increased risk for major
coronary events. Consider risk-benefit balance in women at risk for stroke (see
PRECAUTIONS, Clinical Studies).
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