Premarin (Conjugated Estrogens Tablets)

Premarin (Conjugated Estrogens Tablets)
© The Swiss Pharmacy

Premarin (Conjugated Estrogens Tablets) is used as
Hormone replacement therapy for estrogen deficiency
symptoms in postmenopausal women.
Premarin tablets are also used for the prevention of
osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of, or contraindicated
for, other medicinal products approved for the prevention
of osteoporosis.

Premarin Tablets are manufactured by Pfizer Ireland
Pharmaceuticals in Ireland.

Chemical Structure – Equilin Sulfate

Chemical Structure – Estrone Sulfate

The active ingredient contained in Premarin tablets
is Conjugated Estrogens.
Each sugar coated Premarin tablet contains 0.625mg
or 0.3mg of Conjugated Estrogens in their naturally
occurring, water-soluble congugated form.
Conjugated Estrogens is a mixture of the sodium salts of
Estrogen conjugates, such as Estrone Sulfate and Equilin
Sulfate.

Uses of Premarin 0.625 mg and 0.3 mg Tablets:
Premarin (Conjugated Estrogens Tablets) is a female
hormone. It is used by women to help reduce symptoms of
menopause (such as hot flashes, vaginal dryness). These
symptoms are caused by the body making less estrogen.
In case you are using this medication to treat symptoms only
in and around the vagina, products applied directly inside the
vagina should be considered before medications that are
taken by mouth, absorbed through the skin, or injected.

Uses of Premarin 0.625 mg and 0.3 mg Tablets:
Certain estrogen products may also be used by women after menopause
to prevent bone loss (osteoporosis). However, there are other
medications (such as Raloxifene, Bisphosphonates including
Alendronate) that are also effective in preventing bone loss and may be
safer. These medications should be considered for use before estrogen
treatment.
Certain estrogen products may also be used by men and women to treat
cancers (certain types of prostate cancer, breast cancer that has spread to
other parts of the body) and by women who are not able to produce
enough estrogen (for example, due to hypogonadism, primary ovarian
failure).

Recommended Adult Dosage
Premarin (Conjugated Estrogens Tablets) is is an estrogen only
HRT.
Premarin 0.3mg to 1.25mg daily is the usual starting dose for women
without a uterus. Continuous administration is recommended.
Treatment of Postmenopausal Symptoms: For initiation and
continuation of treatment of postmenopausal symptoms, the lowest
effective dose for the shortest duration should be used.
Treatment to control menopausal symptoms should be initiated with
Premarin 0.3 mg. If symptoms are not adequately controlled, higher
doses of Premarin may be prescribed.

Once treatment is established the lowest effective dose necessary for the relief of
symptoms should be used. Patients should be re-evaluated periodically to determine
if treatment for symptoms is still necessary.
Starting or Changing Treatment:
In women who are not taking hormone replacement therapy or women who switch
from a continuous combined hormone replacement therapy product, treatment may
be started on any convenient day. In women transferring from a sequential hormone
replacement therapy regimen, treatment should begin the day following completion
of the prior regimen.
Concomitant Progestogen Use For Women With A Uterus:
In women with a uterus, where the addition of a progestogen is necessary it should
be added for at least 12 to 14 days every 28 day cycle to reduce the risk to the
endometrium.

Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a progestogen in hysterectomised women. The
benefits of the lower risk of endometrial hyperplasia and endometrial
cancer due to adding progestogen should be weighed against the increased
risk of breast cancer.
Forgotten Tablet: If a tablet is forgotten, it should be taken as soon as the
patient remembers, therapy should then be continued as before. If more
than one tablet has been forgotten only the most recent tablet should be
taken, the patient should not take double the usual dose to make up for
missed tablets.
Missed pills may cause breakthrough bleeding in women with a uterus.

Contraindications
➔
Premarin Tablets are contraindicated in patients with a known
hypersensitivity to Conjugated Estrogens or any component of the tablet.
➔
Known, suspected or history of breast cancer.
➔
Undiagnosed genital bleeding
➔
Untreated endometrial hyperplasia
➔
Previous or current venous thromboembolism (e.g. deep vein thrombosis,
pulmonary embolism)
➔
Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin
deficiency)

Contraindications
➔
Active or recent arterial thromboembolic disease (e.g. angina,
myocardial infarction)
➔
Acute liver disease or history of liver disease where the liver function
tests have failed to return to normal.
➔
Porphyria

Storage Instructions
Premarin Tablets (Conjugated Estrogens Tablets)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C
(59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Cardiovascular Disorders: An increased risk of stroke and DVT has been reported
with estrogen-alone therapy. An increased risk of PE, DVT, stroke and MI has been
reported with estrogen plus progestin therapy. Should any of these events occur
or be suspected, estrogen with or without progestin therapy should be
discontinued immediately.
Endometrial Cancer: An increased risk of endometrial cancer has been reported
with the use of unopposed estrogen therapy in a woman with a uterus. The
reported endometrial cancer risk among unopposed estrogen users is about 2 to
12 times greater than in non-users, and appears dependent on duration of
treatment and on estrogen dose. Most studies show no significant increased risk
associated with use of estrogens for less than 1 year.

Warnings
Breast Cancer: The overall evidence shows an increased risk of breast cancer in
women taking combined estrogen-progestogen or estrogen-only HRT, that is
dependent on the duration of taking HRT.
Ovarian Cancer: Ovarian cancer is much rarer than breast cancer.
Epidemiological evidence from a large meta-analysis suggests a slightly increased
risk in women taking estrogen-only or combined estrogen-progestogen HRT,
which becomes apparent within 5 years of use and diminishes over time after
stopping.
Venous Thromboembolism: Hormone replacement therapy (HRT) is associated
with a 1.3-3 fold risk of developing venous thromboembolism (VTE) i.e. deep vein
thrombosis or pulmonary embolism. The occurrence of such an event is more
likely in the first year of HRT than later.

Warnings
Coronary Artery Disease (CAD): There is no evidence from randomised
controlled trials of protection against myocardial infarction in women with
or without existing CAD who received combined estrogen-progestogen or
estrogen-only HRT. Randomised controlled data found no increased risk of
CAD in hysterectomised women using estrogen-only therapy..
Ischaemic Stroke: Combined estrogen-progestogen and estrogen-only
therapy are associated with an up to 1.5 fold increase in risk of ischaemic
stroke. The relative risk does not change with age or time since
menopause. However, as the baseline risk of stroke is strongly age-
dependent, the overall risk of stroke in women who use HRT will increase
with age.

Warnings
Probable Dementia: In the WHIMS estrogen-alone ancillary study of WHI, a
population of 2,947 hysterectomized women 65 to 79 years of age was
randomized to daily CE (0.625 mg)-alone or placebo.
After an average follow-up of 5.2 years, 28 women in the estrogen-alone group
and 19 women in the placebo group were diagnosed with probable dementia. The
relative risk of probable dementia for CE-alone versus placebo was 1.49
Gallbladder Disease: A 2- to 4-fold increase in the risk of gallbladder disease
requiring surgery in postmenopausal women receiving estrogens has been
reported.
Hypercalcemia: Estrogen administration may lead to severe hypercalcemia in
patients with breast cancer and bone metastases. If hypercalcemia occurs, use of
the drug should be stopped and appropriate measures taken to reduce the serum
calcium level.

Warnings
Visual Abnormalities: Retinal vascular thrombosis has been reported in patients
receiving estrogens. Discontinue medication pending examination if there is
sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia,
or migraine. If examination reveals papilledema or retinal vascular lesions,
estrogens should be permanently discontinued.
Anaphylactic Reaction and Angioedema: Cases of anaphylaxis, which developed
within minutes to hours after taking Premarin tablets and require emergency
medical management, have been reported in the postmarketing setting. Skin
(hives, pruritis, swollen lips-tongue-face) and either respiratory tract (respiratory
compromise) or gastrointestinal tract (abdominal pain, vomiting) involvement has
been noted.

Warnings
Addition Of A Progestin When A Woman Has Not Had A Hysterectomy: Studies
of the addition of a progestin for 10 or more days of a cycle of estrogen
administration or daily with estrogen in a continuous regimen, have reported a
lowered incidence of endometrial hyperplasia than would be induced by estrogen
treatment alone. Endometrial hyperplasia may be a precursor to endometrial
cancer.
Elevated Blood Pressure: In a small number of case reports, substantial increases
in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a
large, randomized, placebo-controlled clinical trial, a generalized effect of
estrogen therapy on blood pressure was not seen.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen
therapy may be associated with elevations of plasma triglycerides leading to
pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.

Warnings
Hepatic Impairment and/or Past History of Cholestatic Jaundice:
Estrogens may be poorly metabolized in patients with impaired liver function. For
women with a history of cholestatic jaundice associated with past estrogen use or
with pregnancy, caution should be exercised, and in the case of recurrence,
medication should be discontinued.
Hypothyroidism: Estrogen administration leads to increased thyroid-binding
globulin (TBG) levels. Women with normal thyroid function can compensate for
the increased TBG by making more thyroid hormone, thus maintaining free T4
and T3 serum concentrations in the normal range. Women dependent on thyroid
hormone replacement therapy who are also receiving estrogens may require
increased doses of their thyroid replacement therapy. These women should have
their thyroid function monitored in order to maintain their free thyroid hormone
levels in an acceptable range.

Warnings
Fluid Retention: Estrogens may cause some degree of fluid retention.
Women with conditions that might be influenced by this factor, such as
cardiac or renal dysfunction, warrant careful observation when estrogen
alone is prescribed.
Hypocalcemia: Estrogen therapy should be used with caution in
individuals with hypoparathyroidism as estrogen-induced hypocalcemia
may occur.
Hereditary Angioedema: Exogenous estrogens may exacerbate symptoms
of angioedema in women with hereditary angioedema.

Warnings
Exacerbation of Endometriosis: A few cases of malignant transformation
of residual endometrial implants have been reported in women treated
post-hysterectomy with estrogen-alone therapy. For women known to have
residual endometriosis post-hysterectomy, the addition of progestin should
be considered.
Exacerbation of Other Conditions: Estrogen therapy may cause an
exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria,
systemic lupus erythematosus, and hepatic hemangiomas and should be
used with caution in women with these conditions.

Possible Side Effects
Most common Premarin (Conjugated Estrogens Tablets) side effects with an
incidence rate of greater than or equal to 1% during clinical trials and greater
than placebo are: Abdominal pain, Asthenia, Back pain, Chest pain, Generalized
edema, Headache, Moniliasis, Pain, Pelvic pain, Hypertension, Migraine,
Palpitation, Vasodilatation, Constipation, Diarrhea, Dyspepsia, Eructation,
Flatulence, Increased appetite, Nausea, Hyperlipidemia, Peripheral edema, Weight
gain, Arthralgia, Leg cramps, Myalgia, Anxiety, Depression, Dizziness, Emotional
lability, Hypertonia, Insomnia, Nervousness, Acne, Alopecia, Hirsutism, Pruritus,
Rash, Skin discoloration, Sweating, Breast disorder, Breast enlargement, Breast
neoplasm, Breast pain, Cervix disorder, Dysmenorrhea, Endometrial disorder,
Endometrial hyperplasia, Leukorrhea, Metrorrhagia, Urinary tract infection,
Uterine fibroids enlarged, Uterine spasm, Vaginal dryness, Vaginal hemorrhage,
Vaginal moniliasis and Vaginitis.

Premarin Tablets Overdosage
Overdosage of Estrogen (Premarin tablets) may cause
nausea, vomiting, breast tenderness, abdominal pain,
drowsiness and fatigue, and withdrawal bleeding may occur
in women.
Treatment of overdose consists of discontinuation of
Premarin tablets therapy with institution of appropriate
symptomatic care.

Premarin Tablets During Pregnancy
Premarin Tablets (Conjugated Estrogens Tablets) has been
classified by the US FDA as Pregnancy Category X.
Premarin Tablets (Conjugated Estrogens Tablets) should not be
used during pregnancy.
There appears to be little or no increased risk of birth defects in
children born to women who have used estrogens and progestins
as an oral contraceptive inadvertently during early pregnancy.

Premarin Tablets are manufactured by Pfizer
Ireland Pharmaceuticals, Ireland.
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Premarin (Conjugated Estrogens Tablets)

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