Drug Catalog - Product Detail
LETROZOLE TB 2.5MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-2071-05 | MYLAN | 500 | 2.5MG | TABLET |
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Description
11 DESCRIPTION Letrozole tablets, USP for oral administration contains 2.5 mg of letrozole, a non-steroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1 H -1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural formula is: Letrozole, USP is a white to off-white powder, freely soluble in dichloromethane, slightly soluble in ethanol and practically insoluble in water. It has a molecular weight of 285.31, molecular formula C 17 H 11 N 5 , and a melting range of 184°C to 185°C. Letrozole tablets, USP are available as 2.5 mg tablets for oral administration. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 27 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, sodium starch glycolate, titanium dioxide and triacetin. USP Dissolution Test Pending. Letrozole Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Letrozole Tablets, USP are available containing 2.5 mg of letrozole, USP. The 2.5 mg tablets are pink film-coated, round tablets debossed with M on one side of the tablet and L71 on the other side. They are available as follows: NDC 0378-2071-93 bottles of 30 tablets NDC 0378-2071-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Letrozole tablets, USP is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. ( 1.1 ) • Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. ( 1.2 ) • First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. ( 1.3 ) 1.1 Adjuvant Treatment of Early Breast Cancer Letrozole tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.2 Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets, USP are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies (14.2 , 14.3) ] . 1.3 First and Second-Line Treatment of Advanced Breast Cancer Letrozole tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4 , 14.5) ] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Letrozole tablets are taken orally without regard to meals ( 2 ): • Recommended dose: 2.5 mg once daily ( 2.1 ) • Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day ( 2.5 , 5.3 ) 2.1 Recommended Dose The recommended dose of letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. 2.2 Use in Adjuvant Treatment of Early Breast Cancer In the adjuvant setting, the optimal duration of treatment with letrozole tablets is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1) ] . 2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer In the extended adjuvant setting, the optimal treatment duration with letrozole tablets is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2) ] . 2.4 Use in First and Second-Line Treatment of Advanced Breast Cancer In patients with advanced disease, treatment with letrozole tablets should continue until tumor progression is evident [see Clinical Studies (14.4 , 14.5) ]. 2.5 Use in Hepatic Impairment No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3) ] . The recommended dose of letrozole tablets for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole tablets exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined. 2.6 Use in Renal Impairment No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 mL/min [see Clinical Pharmacology (12.3) ] .