Anastrozole 1 mg/1
Anastrozole · TABLET · NuCare Pharmaceuticals,Inc.
Anastrozole is a prescription tablet taken by mouth to treat certain types of breast cancer in women. It works by blocking the production of estrogen in the body, which helps slow or stop the growth of estrogen-dependent breast cancer cells.
Key Facts
- Brand Name
- Anastrozole
- Generic Name
- Anastrozole
- NDC Code (Product)
68071-1543- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 1 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090568
- Drug Class
- Aromatase Inhibitor [EPC]
- Marketing Start
- 06/22/2010
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Anastrozole is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2 ) 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 anastrozole ( 1.3 ) 1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment Anastrozole 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. 1.3 Second-Line Treatment Anastrozole 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…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION One 1 mg tablet taken once daily ( 2.1 ) 2.1 Recommended Dose The dose of anastrozole tablet is one 1 mg tablet taken once a day. For patients with advanced breast cancer, anastrozole tablets should be continued until tumor progression. Anastrozole tablets 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 was administered for five years [see Clinical Studies ( 14.1 )]. No dosage adjustment is necessary for patients with renal impairment or for elderly patients [see Use in Specific Populations ( 8.6 )]. 2.2 Patients with Hepatic Impairment No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Anastrozole has not been studied in patients with severe hepatic impairment [see Use in Specific Populations ( 8.7 )].
Contraindications
4 CONTRAINDICATIONS Hypersensitivity Anastrozole is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions ( 6.2 )]. Patients with demonstrated hypersensitivity to anastrozole or any excipient ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Tamoxifen: Do not use in combination with anastrozole. No additional benefit seen over tamoxifen monotherapy ( 7.1 , 14.1 ). Estrogen-containing products: Combination use may diminish activity of anastrozole ( 7.2 ). 7.1 Tamoxifen Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and tamoxifen did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen. At a median follow-up of 33 months, the combination of anastrozole and tamoxifen did not demonstrate any efficacy benefit when compared with tamoxifen in all patients as well as in the hormone receptor-positive subpopulation. This treatment arm was discontinued from the trial. [see Clinical Studies ( 14.1 )] . Based on clinical and pharmacokinetic results from the ATAC trial, tamoxifen should not be administered with anastrozole. 7.2 Estrogen Estrogen-containing therapies should not be used with anastrozole as they may diminish its pharmacological action. 7.3 Warfarin In a study conducted in 16 male volunteers, anastrozole did not alter the exposure (as measured by C max and AUC), and…
Adverse Reactions
6 ADVERSE REACTIONS Serious adverse reactions with anastrozole occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [see Adverse Reactions ( 6.2 )]. Common adverse reactions (occurring with an incidence of ≥10%) in women taking anastrozole included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema. In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the anastrozole group. Because clinical trials are conducted unde…
Frequently Asked Questions
What is Anastrozole used for?
Anastrozole is a prescription tablet taken by mouth to treat certain types of breast cancer in women. It works by blocking the production of estrogen in the body, which helps slow or stop the growth of estrogen-dependent breast cancer cells.
Is Anastrozole a controlled substance?
Anastrozole is not classified as a controlled substance by the DEA.
What is the generic name for Anastrozole?
The generic name for Anastrozole is Anastrozole. There are 5 other brand versions of Anastrozole.
What is the NDC code for Anastrozole 1 mg/1?
The NDC (National Drug Code) for Anastrozole 1 mg/1 is 68071-1543, listed by NuCare Pharmaceuticals,Inc..