Anazole Tablets (Generic Anastrozole Tablets)

Anazole Tablets (Generic Anastrozole Tablets)
© The Swiss Pharmacy

Anazole (Generic Anastrozole Tablets) is an aromatase
inhibitor indicated for adjuvant treatment of
postmenopausal women with hormone receptor-positive
early breast cancer.
They are also used for first-line treatment of
postmenopausal women with hormone receptor-positive or
hormone receptor unknown locally advanced or metastatic
breast cancer and for the treatment of advanced breast
cancer in postmenopausal women with disease progression
following Tamoxifen therapy.

Anazole Tablets are manufactured by Alpha Pharma
Healthcare Private limited, India in the strength of 1 mg.

Chemical Structure

The active ingredient contained in Anazole tablets
is Anastrozole.
Each Anazole tablet contains 1 mg of Anastrozole.

Uses of Anazole 1 mg Tablets:
Anazole Tablets (Generic Anastrozole Tablets) are used to treat early
hormone receptor-positive breast cancer. It is also used for first-line
treatment of hormone receptor-positive or hormone receptor-
unknown advanced or metastatic (cancer that has spread) breast
cancer. Anastrozole is also used to treat advanced breast cancer that
has grown or spread after Tamoxifen treatment. This medicine is used
only in women who have already stopped menstruating
(postmenopausal).
Many breast cancer tumors grow in response to estrogen. This
medicine interferes with the production of estrogen in the body. As a
result, the amount of estrogen that the tumor is exposed to is
reduced, limiting the growth of the tumor.

Recommended Adult Dosage
The dose of Anazole tablets (Anastrozole tablets) is one 1 mg
tablet taken once a day. For patients with advanced breast
cancer, Anazole should be continued until tumor progression.
Anazole can be taken with or without food.
For adjuvant treatment of early breast cancer in
postmenopausal women, the optimal duration of therapy is
unknown. In the ATAC trial, Anastrozole tablets were
administered for five years. No dosage adjustment is
necessary for patients with renal impairment or for elderly
patients.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html

Contraindications
➔
Anazole tablets are contraindicated in patients with a
known hypersensitivity to Anastrozole or any component
of the tablet.
➔
Administration of Anazole is contrindicated in women of
premenopausal endocrine status, including pregnant
women.

Storage Instructions
Anazole Tablets (Generic Anastrozole 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
In women with pre-existing ischemic heart disease, an increased
incidence of ischemic cardiovascular events occurred with Anastrozole
Tablets (Anazole) use compared to Tamoxifen use. Consider risks and
benefits.
Decreases in bone mineral density may occur. As Anastrozole lowers
circulating estrogen levels it may cause a reduction in bone mineral
density with a possible consequent increased risk of fracture. Consider
bone mineral density monitoring.
Increases in total cholesterol may occur. Consider cholesterol
monitoring.
Anastrozole should not be used in premenopausal women.

Warnings
Anastrozole has not been investigated in breast cancer patients with
moderate or severe hepatic impairment. Exposure to Anastrozole can be
increased in subjects with hepatic impairment. Administration of Anazole
in patients with moderate and severe hepatic impairment should be
performed with caution.
Anastrozole has not been investigated in breast cancer patients with
severe renal impairment. In patients with severe renal impairment,
administration of Anazole should be performed with caution.
Based on findings from animal studies and its mechanism of action,
Anastrozole can cause fetal harm when administered to a pregnant
woman. Anastrozole caused embryo-fetal toxicities in rats at maternal
exposure that were 9 times the human clinical exposure, based on area
under the curve (AUC).

Warnings
Anazole is not recommended for use in children and
adolescents as safety and efficacy have not been established in
this group of patients.
This product contains lactose. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption should not take this
medicine.

Possible Side Effects
In the early breast cancer (ATAC) study, the most common side
effects occurring with an incidence of more than 10% in women
taking Anastrozole tablets (Anazole) included: hot flashes, asthenia,
arthritis, pain, arthralgia, pharyngitis, hypertension, depression,
nausea and vomiting, rash, osteoporosis, fractures, back pain,
insomnia, headache, peripheral edema and lymphedema,
regardless of causality.
In the advanced breast cancer studies, the most common side
effects occurring with an incidence of more than 10% in women
taking Anastrozole tablets (Anazole) included: hot flashes, nausea,
asthenia, pain, headache, back pain, bone pain, increased cough,
dyspnea, pharyngitis and peripheral edema.

Overdosage
Clinical trials have been conducted with Anastrozole tablets, up to 60 mg
in a single dose given to healthy male volunteers and up to 10 mg
daily given to postmenopausal women with advanced breast cancer;
these dosages were tolerated. A single dose of Anastrozole that
results in life-threatening symptoms has not been established.
There is no specific antidote to Anazole overdosage and treatment must
be symptomatic. In the management of an overdose, consider that
multiple agents may have been taken. Vomiting may be induced if
the patient is alert.
Dialysis may be helpful because Anastrozole is not highly protein bound.
General supportive care, including frequent monitoring of vital signs
and close observation of the patient, is indicated.

Anazole Tablets During Pregnancy
Anastrozole (Anazole tablets) has been classified by the US
FDA as Pregnancy Category X.
Anastrozole (Anazole tablets) may cause fetal harm when
administered to a pregnant woman and offers no clinical benefit
to premenopausal women with breast cancer. Anastrozole is
contraindicated in women who are or may become pregnant.
In animal studies, Anastrozole caused pregnancy failure,
increased pregnancy loss, and signs of delayed fetal
development. There are no studies of Anastrozole use in
pregnant women.

Anazole Tablets During Pregnancy
Anastrozole (Anazole tablets) has been classified by the US FDA as
Pregnancy Category X.
In case Anastrozole (Anazole tablets) is used during pregnancy, or if
the patient becomes pregnant while receiving this drug, the patient
should be apprised of the potential hazard to the fetus and potential
risk for pregnancy loss.
In animal reproduction studies, pregnant rats and rabbits received
Anastrozole during organogenesis at doses equal to or greater
than 1 (rats) and 1/3 (rabbits) the recommended human dose on
a mg/m2 basis. In both species, Anastrozole crossed the
placenta, and there was increased pregnancy loss.

Anazole Tablets (Anastrozole 1 mg Tablets) are
manufactured by Alpha Pharma Healthcare Private
limited, India.

Anazole Tablets (Generic Anastrozole Tablets)

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