Atrozol Uses

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What is Atrozol?

Atrozol is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). It is also used for women who have already had other cancer treatments (e.g., tamoxifen).

Many breast cancer tumors grow in response to estrogen. Atrozol 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.

Atrozol is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Atrozol is used in certain patients with the following medical conditions:

Atrozol indications

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Adjuvant Treatment

Atrozol tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

First-Line Treatment

Atrozol tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

Second-Line Treatment

Atrozol tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Atrozol tablets.

How should I use Atrozol?

Use Atrozol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Atrozol.

Uses of Atrozol in details

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Use: Labeled Indications

Breast cancer:

First-line treatment of locally-advanced or metastatic breast cancer (hormone receptor-positive or unknown) in postmenopausal women

Adjuvant treatment of early hormone receptor-positive breast cancer in postmenopausal women

Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Off Label Uses

Endometrial or uterine cancers (recurrent or metastatic)

Hormonal agents such as progestational agents or tamoxifen may be used in the management of recurrent or metastatic endometrial cancer; in select patients, aromatase inhibitors, including Atrozol, may be considered. A small phase II trial evaluated Atrozol in a group of unselected patients with advanced recurrent or persistent endometrial cancer; the results showed minimal activity of Atrozol.

Atrozol description

Atrozol is a drug indicated in the treatment of breast cancer in post-menopausal women. It is used both in adjuvant therapy (i.e. following surgery) and in metastatic breast cancer. It decreases the amount of estrogens that the body makes. Atrozol belongs in the class of drugs known as aromatase inhibitors. It inhibits the enzyme aromatase, which is responsible for converting androgens (produced by women in the adrenal glands) to estrogens.

Atrozol dosage

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Atrozol Dosage

Generic name: Atrozol 1mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dose

The dose of Atrozol is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Atrozol should be continued until tumor progression. Atrozol 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, Atrozol was administered for five years.

No dosage adjustment is necessary for patients with renal impairment or for elderly patients.

Patients with Hepatic Impairment

No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Atrozol has not been studied in patients with severe hepatic impairment.

More about Atrozol (Atrozol)

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Atrozol interactions

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What other drugs will affect Atrozol?

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Atrozol inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that Atrozol at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Atrozol with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.

The enzymes mediating metabolism of Atrozol have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of Atrozol. The effect of potent CYP inhibitors is unknown.

A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Atrozol who also received other commonly prescribed medicinal products. There were no clinically significant interactions with bisphosphonates.

Co-administration of tamoxifen or estrogen-containing therapies with Atrozol should be avoided as this may diminish its pharmacological action.

Atrozol side effects

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What are the possible side effects of Atrozol?

Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (ATAC Study).

The table below presents the frequency of pre-specified adverse events in the ATAC study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.

The ATAC trial data showed that patients receiving Atrozol had an increase in joint disorders (including arthritis, arthrosis, and arthralgia) compared with patients receiving tamoxifen. Patients receiving Atrozol had an increase in the incidence of fractures (including fractures of spine, hip and wrist) compared with patients receiving tamoxifen. These differences were statistically significant. Fracture rates of 22 per 1,000 patient-years and 15 per 1000 patient-years were observed for the Atrozol and tamoxifen groups, respectively, after a median follow up of 68 months. The observed fracture rate for Atrozol is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Atrozol treatment reflect a protective effect of tamoxifen, a specific effect of Atrozol, or both.

The incidence of osteoporosis was 10.5% in patients treated with Atrozol and 7.3% in patients treated with tamoxifen.

Patients receiving Atrozol had a decrease in hot flushes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events (including deep venous thrombosis) and ischaemic cerebrovascular events compared with patients receiving tamoxifen. These differences were statistically significant.

Results from the ATAC trial bone substudy, at 12 and 24 months demonstrated that patients receiving Atrozol had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline.

Slight increases in total cholesterol have also been observed in clinical trials with Atrozol, although the clinical significance has not been determined.

Atrozol contraindications

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What is the most important information I should know about Atrozol?

Do not use Atrozol if you are pregnant. It could harm the unborn baby.

You may need to take a pregnancy test before using Atrozol, to make sure you are not pregnant.

You should not use this medication if you are allergic to Atrozol, if you are breast-feeding a baby, or if you have not yet completed menopause. Atrozol is not for use in men or children.

Before using Atrozol, tell your doctor if you have heart disease, circulation problems, a history of stroke or blood clot, severe liver disease, high cholesterol, osteoporosis, or low bone mineral density.

Atrozol may not work as well if you take it together with tamoxifen or an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings). Before you start taking Atrozol, tell your doctor if you also take tamoxifen or estrogen.

You may need to keep taking Atrozol for up to 5 years. Follow your doctor's instructions.



Active ingredient matches for Atrozol:

Anastrozole in Poland.


List of Atrozol substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Azoleres 1mg TAB / 10$ 0.60
Bio-anastrozole tablet 1 mg (Biomed Pharma (Canada))
Biomedis Anastrozole 1 mg x 28's$ 102.67
ELINAL 1 MG TABLET 1 strip / 10 tablets each (Emcure Pharmaceuticals Ltd)$ 5.35
Elinal 1mg Tablet (Emcure Pharmaceuticals Ltd)$ 0.54
Femistra 1 mg Tablet (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 0.47
FEMISTRA 1 MG TABLET 1 strip / 10 tablets each (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 4.42
FEMISTRA 1 MG TABLET 1 strip / 5 tablets each (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 2.21
FEMISTRA film-coated tab 1 mg x 10's (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 4.42
Femistra 1mg Tablet (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 0.44
Femitraz 1 mg Tablet (Lupin Laboratories Ltd.)$ 0.56
FEMITRAZ 1 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.)$ 6.11
FEMITRAZ tab 1 mg x 10's (Lupin Laboratories Ltd.)$ 5.54
Femitraz 1mg Tablet (Lupin Laboratories Ltd.)$ 0.61
Femizet 1 mg x 28's
Femizet 1 mg x 2 Blister x 14 Tablet

References

  1. DailyMed. "ANASTROZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "anastrozole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "anastrozole". http://www.drugbank.ca/drugs/DB01217 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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