Anastrozole 1 mg/1
Anastrozole · TABLET · A-S Medication Solutions
Anastrozole is a tablet containing anastrozole at 1 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Anastrozole
- Generic Name
- Anastrozole
- NDC Code (Product)
50090-2453- Manufacturer
- A-S Medication Solutions
- 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
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Wells Pharmacy Network, LLC
Superpotent and Subpotent drugs
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
JD & SN Inc., dba Moses Lake Professional Pharmacy
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
JD & SN Inc., dba Moses Lake Professional Pharmacy
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
American Health Packaging
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Full 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 contains Anastrozole. It is a tablet taken oral. Consult your doctor for specific uses.
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 50090-2453, listed by A-S Medication Solutions.