Progynova (Estradiol Valerate Tablets)

Progynova Tablets
© Clearsky Pharmacy
Progynova (Estradiol Valerate Tablets) is used as a
Hormone Replacement Therapy (HRT) to alleviate the
oestrogen deficiency symptoms like such as hot flushes,
sweats, sleep disturbances, depressive moods, irritability,
dizziness, headaches as well as vaginal dryness and burning
in peri- and postmenopausal women. This medicine is also
used for prevention of postmenopausal osteoporosis in
cases wher other medicines are not suitable for the patient
and are at risk of of fractures due to osteoporosis.

Progynova Tablets
Progynova Tablets are manufactured
by Zydus Healthcare and Marketed by
Bayer Pharmaceuticals Pvt. Ltd. (Bayer
Zydus Pharma)
(Website: www.bayer.in)

Estradiol Valerate Tablets – Brand Names
Estradiol Valerate tablets are
available as Progynova, Estrace,
Bestradiol, Conjugase, Ed Val,
Espauz, Estogen, Estrofem, Evafem,
Evalon, Evalon Forte, Evaride,
Oestrogel and Premarin.

Active Ingredient
The active ingredient contained in Progynova
is Estradiol Valerate, also known as Oestradiol
Valerate. Each Progynova tablet contains 1
mg or 2 mg of is Estradiol Valerate.

Chemical Structure
The structure of Estradiol Valerate is given
below:

Uses of Progynova Tablets
Progynova tablets are used for the
treatment of moderate to severe
vasomotor symptoms and moderate to
severe symptoms of vulvar and vaginal
atrophy associated with the
menopause.
Topical vaginal products should be
considered first in case this medication
is solely for relief of symptoms of vulvar
and vaginal atrophy.

Uses of Progynova Tablets
This medicine is also used for treatment of
hypoestrogenism due to hypogonadism,
castration or primary ovarian failure,
treatment of breast cancer (for palliation
only) in appropriately selected women and
men with metastatic disease, treatment of
advanced androgen-dependent carcinoma of
the prostate (for palliation only) and also for
prevention of osteoporosis in women at
significant risk of osteoporosis and for whom
non-estrogen medications are not
considered to be appropriate.

Progynova Tablets Dosage
➢Hysterectomised patients may start at any
time. In case the patient is still menstruating
and has an intact uterus, a combination
regimen of Progynova tablets and a
progestogen should start within the first 5 days
of menstruation. Patients whose periods are
very infrequent or with amenorrhoea or who
are postmenopausal may start at any time,
provided pregnancy has been excluded.
The dosage of Progynova tablets (Estradiol
Valerate) is given below:

Estradiol Valerate Dosage
➢It does not matter at what time of day the patient takes her
tablet(s), but once she has selected a particular time, she
should keep to it every day. In case she forgets to take a
tablet at the usual time, she may take it within the following
12 to 24 hours. If the treatment is discontinued for longer,
irregular bleeding may occur. One tablet is taken daily. The
tablets are to be swallowed whole with some liquid.
➢Each pack covers 28 days of treatment. Treatment is
continuous, which means that the next pack follows
immediately without a break. Combination Regimen In
women with an intact uterus, the concomitant use of an
appropriate progestogen is advised for 10 to 14 days every 4
weeks (sequentially combined HRT) or with each tablet of
oestrogen (continuous combined HRT).
The dosage of Progynova (Estradiol Valerate
Tablets) is given below:

Storage Instructions
Progynova (Estradiol Valerate tablets )
has to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F
to 77°F). Keep your tablets in a cool dry
place. Store your tablets as per directions
on the carton. Do not store it or any other
medicine in the bathroom, near a sink, or
on a window-sill. Do not leave it in the car.
Heat and dampness can destroy some
medicines.
Keep this as well as all other medicines
away from children and pets.

Progynova Tablets
Contraindications
Progynova is contraindicated in patients with
a hypersensitivity to Estradiol Valerate or any
other component of this medication.
It is also contraindicated in Pregnancy and
Lactation, Undiagnosed vaginal bleeding,
Known or suspected cancer of the breast,
Known or suspected premalignant conditions
or malignancies, if sex steroid influenced,
Presence or history of liver tumours (benign or
malignant).

Progynova Tablets
Contraindications
Other contraindications include Severe hepatic
disease, Acute arterial thromboembolism (e.g.
myocardial infarction, stroke), Active deep vein
thrombosis, thromboembolic disorders, or a
documented history of these conditions, A high
risk of venous or arterial thrombosis, Severe
hypertriglyceridemia, Idiopathic cholestatic
jaundice of pregnancy or jaundice with prior
combined oral contraceptive use or combined
HRT use, Otosclerosis with deterioration during
pregnancy or Severe diabetes with vascular
changes.

Warnings
Oestrogen and oestrogen/progestogen therapy have
been associated with an increased risk of
cardiovascular events such as myocardial infarction
and stroke, as well as venous thrombosis and
pulmonary embolism. In case any of these occur or
be suspected, oestrogens should be discontinued
immediately.
The use of unopposed oestrogens in women with
intact uteri has been associated with an increased
risk of endometrial cancer. The reported endometrial
cancer risk among unopposed oestrogen users with
an intact uterus is about 2- to 12-fold greater than in
nonusers, and appears dependent on duration of
treatment and on oestrogen dose.

Warnings
Addition of a progestogen when a woman has not had a
hysterectomy Studies of the addition of a progestogen for 10
or more days of a cycle of oestrogen administration, or daily
with oestrogen in a continuous regimen, have reported a
lowered incidence of endometrial hyperplasia than would be
induced by oestrogen treatment alone. Endometrial
hyperplasia may be a precursor to endometrial cancer.
In some studies, the use of oestrogens and progestogens by
postmenopausal women has been reported to increase the
risk of breast cancer.
In rare cases benign and in even rarer cases malignant liver
tumours leading in isolated cases to life-threatening intra-
abdominal haemorrhage have been observed after the use
of hormonal substances such as the one contained in
Progynova tablets.

Warnings
If severe upper abdominal complaints, liver
enlargement or signs of intra-abdominal
haemorrhage occur, a liver tumour should be
included in the differential-diagnostic
considerations.
The relative risk of probable dementia for 0.625
mg conjugated oestrogens alone versus placebo
was 1.49 (95% CI 0.83-2.66). The absolute risk of
probable dementia for 0.625 mg conjugated
oestrogens alone versus placebo was 37 versus
25 cases per 10,000 Women-years.
A 2- to 4-fold increase in the risk of gallbladder
disease requiring surgery in postmenopausal
women receiving oestrogens has been reported.

Warnings
Oestrogen administration may lead to severe
hypercalcemia in patients with breast cancer and bone
metastases. In case hypercalcemia occurs, use of the
drug should be stopped and appropriate measures taken
to reduce the serum calcium level.
Retinal vascular thrombosis has been reported in
patients receiving oestrogens. 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
papilloedema or retinal vascular lesions, oestrogens
should be stopped.
In a small number of case reports, substantial increases
in blood pressure have been attributed to idiosyncratic
reactions to oestrogens.

Warnings
In patients with pre-existing hypertriglyceridemia,
oestrogen therapy may be associated with elevations of
plasma triglycerides leading to pancreatitis and other
complications.
Oestrogens may be poorly metabolised in patients with
impaired liver function. For patients with a history of
cholestatic jaundice associated with past oestrogen use
or with pregnancy, caution should be exercised and in
the case of recurrence, medication should be
discontinued.
Oestrogen administration leads to increased thyroid-
binding globulin (TBG) levels. Patients dependent on
thyroid hormone replacement therapy who are also
receiving oestrogens may require increased doses of
their thyroid replacement therapy.

Warnings
Since oestrogens may cause some degree of fluid
retention, patients with medical conditions that could be
influenced by this factor, such as cardiac or renal
dysfunction, require careful observation when
oestrogens are prescribed.
Oestrogens must be used with caution in individuals
with severe hypocalcemia.
A meta-analysis from 52 epidemiological studies
reported that the overall risk of being diagnosed with
ovarian cancer is slightly increased for users of
oestrogen-only and combined HRT compared to
women who have never used HRT.
Endometriosis may be exacerbated with administration
of oestrogen therapy.

Warnings
Oestrogen 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
patients with these conditions.
Progynova therapy must be stopped at once if
migrainous or frequent unusually severe headaches
occur for the first time, or if there are other symptoms
that are possible premonitory signs of cerebrovascular
occlusion.
Non-severe disturbances of liver function, including
hyperbilirubinemias such as Dubin Johnson syndrome
or Rotor syndrome, need closer supervision and liver
function should be checked periodically.

Progynova Side Effects
➢During the first few months of treatment you may experience some
breast tenderness or enlargement. These symptoms are usually
temporary and normally disappear with continued treatment. If they
do not, contact your doctor.
➢The other Progynova side effects can include signs of allergy such
as rash, swelling of the face, lips, mouth, throat or other parts of the
body, shortness of breath, wheezing or trouble breathing, changes in
body weight, feeling depressed and/or anxious, changes in sexual
drive, visual disturbances such as partial or complete loss of vision,
bulging eyes, double vision, intolerance to contact lenses, irregular
heartbeat, muscle cramps, changes in vaginal bleeding pattern
including spotting, painful menstrual periods, vaginal secretion,
premenstrual-like syndrome such as mood swings, bloating, breast
swelling and tenderness, breast pain, indigestion, nausea, vomiting,
stomach pain, increased appetite, rash, various skin disorders such
as itching, hives, acne, excessive hairiness, hair loss or red, painful
lumps, headache, migraine, dizziness, swelling of the hands, ankles
or feet, feeling tired

Estradiol Valerate Tablets Side Effects
➢Stop taking Progynova (Estradiol Valerate Tablets) immediately and
consult your doctor if you have any of the following conditions
➢Your very first attack of migraine (typically a throbbing headache and
nausea preceded by visual disturbances)
➢Worsening of pre-existing migraine, any unusually frequent or
unusually severe headaches
➢Sudden disturbances of vision or hearing
➢Swollen veins (phlebitis)
➢Itching of the whole body
➢Unusual upper abdominal pain that do not disappear within a short
period of time
➢If you get a blood clot while you are taking Progynova or there is a
suspicion of this you should stop taking it immediately and contact your
doctor. The warning signs to look out for are: coughing blood, unusual
pains or swelling of your arms or legs, sudden shortness of breath and
fainting.
➢Progynova must also be stopped at once if you develop jaundice
(yellowing of the skin and/or eyes). Tell your doctor immediately if either
occurs.

Progynova (Estradiol Valerate Tablets) Overdose
Serious adverse effects have not been
reported following acute ingestion of large
doses of estrogen-containing oral
contraceptives by young children.
Overdosage of estrogen may cause
nausea and vomiting, and withdrawal
bleeding could occur in females.

Estradiol Valerate During Pregnancy
Estradiol Valerate (Progynova tablets) has
been classified by the US FDA as Pregnancy
Category X.
Estradiol Valerate must not be administered
during pregnancy.
There appears to be little or no increased
risk of birth defects in children born to
women who inadvertently used estrogens
during early pregnancy.

Progynova Tablets
For more details on
Progynova Tablets click here
Progynova (Estradiol Valerate Tablets) by Zydus
Healthcare Limited, India. Marketed by Bayer
Pharmaceuticals Pvt. Ltd. (Bayer Zydus Pharma)

Progynova (Estradiol Valerate Tablets)

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