Atrocela 1 mg Uses

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What is Atrocela 1 mg?

Atrocela 1 mg 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. Atrocela 1 mg 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.

Atrocela 1 mg 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, Atrocela 1 mg is used in certain patients with the following medical conditions:

Atrocela 1 mg indications

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Adjuvant Treatment

Atrocela 1 mg tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

First-Line Treatment

Atrocela 1 mg 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

Atrocela 1 mg 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 Atrocela 1 mg tablets.

How should I use Atrocela 1 mg?

Use Atrocela 1 mg 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 Atrocela 1 mg.

Uses of Atrocela 1 mg 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 Atrocela 1 mg, may be considered. A small phase II trial evaluated Atrocela 1 mg in a group of unselected patients with advanced recurrent or persistent endometrial cancer; the results showed minimal activity of Atrocela 1 mg.

Atrocela 1 mg description

Atrocela 1 mg 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. Atrocela 1 mg 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.

Atrocela 1 mg dosage

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Atrocela 1 mg Dosage

Generic name: Atrocela 1 mg 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 Atrocela 1 mg is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Atrocela 1 mg should be continued until tumor progression. Atrocela 1 mg 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, Atrocela 1 mg 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. Atrocela 1 mg has not been studied in patients with severe hepatic impairment.

More about Atrocela 1 mg (Atrocela 1 mg)

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Atrocela 1 mg interactions

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What other drugs will affect Atrocela 1 mg?

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

The enzymes mediating metabolism of Atrocela 1 mg have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of Atrocela 1 mg. 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 Atrocela 1 mg 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 Atrocela 1 mg should be avoided as this may diminish its pharmacological action.

Atrocela 1 mg side effects

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What are the possible side effects of Atrocela 1 mg?

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 Atrocela 1 mg had an increase in joint disorders (including arthritis, arthrosis, and arthralgia) compared with patients receiving tamoxifen. Patients receiving Atrocela 1 mg 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 Atrocela 1 mg and tamoxifen groups, respectively, after a median follow up of 68 months. The observed fracture rate for Atrocela 1 mg 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 Atrocela 1 mg treatment reflect a protective effect of tamoxifen, a specific effect of Atrocela 1 mg, or both.

The incidence of osteoporosis was 10.5% in patients treated with Atrocela 1 mg and 7.3% in patients treated with tamoxifen.

Patients receiving Atrocela 1 mg 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 Atrocela 1 mg 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 Atrocela 1 mg, although the clinical significance has not been determined.

Atrocela 1 mg contraindications

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What is the most important information I should know about Atrocela 1 mg?

Do not use Atrocela 1 mg if you are pregnant. It could harm the unborn baby.

You may need to take a pregnancy test before using Atrocela 1 mg, to make sure you are not pregnant.

You should not use this medication if you are allergic to Atrocela 1 mg, if you are breast-feeding a baby, or if you have not yet completed menopause. Atrocela 1 mg is not for use in men or children.

Before using Atrocela 1 mg, 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.

Atrocela 1 mg 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 Atrocela 1 mg, tell your doctor if you also take tamoxifen or estrogen.

You may need to keep taking Atrocela 1 mg for up to 5 years. Follow your doctor's instructions.



Active ingredient matches for Atrocela 1 mg:

Anastrozole in Hungary.


List of Atrocela 1 mg 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

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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