Letrozole

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Uses

1.1 Adjuvant Treatment of Early Breast Cancer

Letrozole tablets 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 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 tablets 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 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)].

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History

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Other Information

Letrozole tablets USP for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural formula is

C17H11N5 M.W. 285.31

Letrozole is a white to yellowish crystalline powder, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a melting range of 184° to 185°C.

Letrozole tablets USP are available as 2.5 mg tablets for oral administration.

Inactive Ingredients: colloidal silicon dioxide, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, starch, talc, and titanium dioxide.

Sources

Letrozole Manufacturers

Avkare, Inc.

Letrozole | Avkare, Inc.

2.1 Recommended Dose
The recommended dose of letrozole tablets USP 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 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 USP 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 [seeClinical 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 USP 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 tablets USP 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 USP for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole 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)].

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Physicians Total Care, Inc.

Letrozole | Physicians Total Care, Inc.

Enter section text here
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)]

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Dr. Reddy’s Laboratories Limited

Letrozole | Dr. Reddy's Laboratories Limited

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 tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets 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 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)].

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App Pharmaceuticals, Llc

Letrozole | App Pharmaceuticals, Llc

2.1 Recommended Dose
The recommended dose of letrozole tablets, USP 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 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, USP 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, USP 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 tablets, USP blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets, USP 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, USP for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole tablets, USP 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 )].

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Roxane Laboratories, Inc.

Letrozole | Cardinal Health

• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age
age

dose

adults and children 12 years and over

10 mL every 4 hours

children under 12 years

do not use

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Kremers Urban Pharmaceuticals Inc.

Letrozole | Kremers Urban Pharmaceuticals Inc.

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 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 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 at 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 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 for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Letrozole 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)].

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Breckenridge Pharmaceutical, Inc.

Letrozole | Breckenridge Pharmaceutical, Inc.

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 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 at 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 tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets 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)].

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Indicus Pharma Llc

Letrozole | Indicus Pharma Llc

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 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 are not known. The planned duration of treatment in the study was 5 years. In the final updated analysis 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 at 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 tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets 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)].

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Qualitest Pharmaceuticals

Letrozole | Qualitest Pharmaceuticals

2.1 Recommended Dose
The recommended dose of Letrozole Tablets, USP 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 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 tablet 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 at 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 tablet 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 tablet blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablet in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)]. The recommended dose of letrozole tablet for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Letrozole tablet 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)].

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Rebel Distributors Corp

Letrozole | Rebel Distributors Corp

2.1 Recommended Dose
The recommended dose of letrozole tablets USP 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 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 USP 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 [seeClinical 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 USP 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 tablets USP 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 USP for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole 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)].

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Apotex Corp.

Letrozole | Direct Rx

2.1 Adult Patients

[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]

Infection*

Recommended Dose/Duration of Therapy

Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5

Acute bacterial exacerbations of chronic obstructive pulmonary disease

500 mg once daily for 3 days

OR

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5

Acute bacterial sinusitis

500 mg-once daily for 3 days

Genital ulcer disease (chancroid)

One single 1 gram dose

Non-gonococcal urethritis and cervicitis

One single 1 gram dose

Gonococcal urethritis and cervicitis

One single 2 gram dose

*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]

Azithromycin tablets can be taken with or without food.

2.2 Pediatric Patients1

Infection*

Recommended Dose/Duration of Therapy

Acute otitis media

30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis

10 mg/kg once daily for 3 days.

Community-acquired pneumonia

10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Pharyngitis/tonsillitis

12 mg/kg once daily for 5 days.

*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]

1 see dosing tables below for maximum doses evaluated by indication

Azithromycin for oral suspension can be taken with or without food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA

(Age 6 months and above, [see Use in Specific Populations (8.4)])

Based on Body Weight

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*

Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.

Weight

100 mg/5 mL

200 mg/5 mL

Total mL perTreatmentCourse

Total mg perTreatmentCourse

Kg

Lbs.

Day 1

Days 2 to 5

Day 1

Days 2 to 5

5

11

2.5 mL (½ tsp)

1.25 mL (¼ tsp)

7.5 mL

150 mg

10

22

5 mL (1 tsp)

2.5 mL (½ tsp)

15 mL

300 mg

20

44

5 mL (1 tsp)

2.5 mL
(½ tsp)

15 mL

600 mg

30

66

7.5 mL (1½ tsp)

3.75 mL
(¾ tsp)

22.5 mL

900 mg

40

88

10 mL
(2 tsp)

5 mL
(1 tsp)

30 mL

1200 mg

50 and above

110 and above

12.5 mL (2½ tsp)

6.25 mL (1¼ tsp)

37.5 mL

1500 mg

* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.

OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*

Dosing Calculated on 10 mg/kg/day

Weight

100 mg/5 mL

200 mg/5 mL

Total mL perTreatmentCourse

Total mg perTreatmentCourse

Kg

Lbs.

Days 1 to 3

Days 1 to 3

5

11

2.5 mL
(½ tsp)

7.5 mL

150 mg

10

22

5 mL
(1 tsp)

15 mL

300 mg

20

44

5 mL

(1 tsp)

15 mL

600 mg

30

66

7.5 mL

(1 ½ tsp)

22.5 mL

900 mg

40

88

10 mL

(2 tsp)

30 mL

1200 mg

50 and above

110 and above

12.5 mL

(2 ½ tsp)

37.5 mL

1500 mg

*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.

OTITIS MEDIA: (1 Day Regimen)

Dosing Calculated on 30 mg/kg as a single dose

Weight

200 mg/5 mL

Total mL perTreatment Course

Total mg perTreatment Course

Kg

Lbs.

1 Day Regimen

5

11

3.75 mL

(3/4 tsp)

3.75 mL

150 mg

10

22

7.5 mL

(1 ½ tsp)

7.5 mL

300 mg

20

44

15 mL

(3 tsp)

15 mL

600 mg

30

66

22.5 mL

(4 ½ tsp)

22.5 mL

900 mg

40

88

30 mL

(6 tsp)

30 mL

1200 mg

50 and above

110 and above

37.5 mL

(7 ½ tsp)

37.5 mL

1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS

(Age 2 years and above, [see Use in Specific Populations (8.4)])

Based on Body Weight

PHARYNGITIS/TONSILLITIS: (5 Day Regimen)

Dosing Calculated on 12 mg/kg/day for 5 days.

Weight

200 mg/5 mL

Total mL per TreatmentCourse

Total mg per TreatmentCourse

Kg

Lbs.

Day 1 to 5

8

18

2.5 mL

(½ tsp)

12.5 mL

500 mg

17

37

5 mL

(1 tsp)

25 mL

1000 mg

25

55

7.5 mL

(1½ tsp)

37.5 mL

1500 mg

33

73

10 mL

(2 tsp)

50 mL

2000 mg

40

88

12.5 mL

(2½ tsp)

62.5 mL

2500 mg

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Teva Pharmaceuticals Usa Inc

Letrozole | Teva Pharmaceuticals Usa Inc

2.1 Recommended Dose
The recommended dose of letrozole tablets USP 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 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 USP 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 [seeClinical 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 USP 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 tablets USP 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 USP for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole 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)].

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Accord Healthcare, Inc.

Letrozole | Accord Healthcare, Inc.

2.1 Recommended Dose
The recommended dose of letrozole tablet 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 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 tablet 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) ].
2.4Use 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 tablets blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [seeWarnings 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) ].

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Mylan Pharmaceuticals Inc.

Letrozole | Mylan Pharmaceuticals Inc.

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)].

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Sun Pharmaceutical Industries Limited

Letrozole | American Health Packaging

Initial Treatment
The recommended starting dose for venlafaxine tablets is 75 mg/day, administered in two or three divided doses, taken with food. Depending on tolerability and the need for further clinical effect, the dose may be increased to 150 mg/day. If needed, the dose should be further increased up to 225 mg/day. When increasing the dose, increments of up to 75 mg/day should be made at intervals of no less than 4 days. In outpatient settings there was no evidence of usefulness of doses greater than 225 mg/day for moderately depressed patients, but more severely depressed inpatients responded to a mean dose of 350 mg/day. Certain patients, including more severely depressed patients, may therefore respond more to higher doses, up to a maximum of 375 mg/day, generally in three divided doses (see PRECAUTIONS, General, Use in Patients with Concomitant Illness).
Special Populations Treatment of Pregnant Women During the Third Trimester
Neonates exposed to venlafaxine tablets, other SNRIs, or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with venlafaxine tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Dosage for Patients with Hepatic Impairment
Given the decrease in clearance and increase in elimination half-life for both venlafaxine and ODV that is observed in patients with hepatic cirrhosis and mild and moderate hepatic impairment compared to normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 50% in patients with mild to moderate hepatic impairment. Since there was much individual variability in clearance between subjects with cirrhosis, it may be necessary to reduce the dose even more than 50%, and individualization of dosing may be desirable in some patients.
Dosage for Patients with Renal Impairment
Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min) compared to normals (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 25% in patients with mild to moderate renal impairment. It is recommended that the total daily dose be reduced by 50% in patients undergoing hemodialysis. Since there was much individual variability in clearance between patients with renal impairment, individualization of dosing may be desirable in some patients.
Dosage for Elderly Patients
No dose adjustment is recommended for elderly patients on the basis of age. As with any antidepressant, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose.
Maintenance Treatment
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In one study, in which patients responding during 8 weeks of acute treatment with venlafaxine hydrochloride extended-release capsules were assigned randomly to placebo or to the same dose of venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg/day, qAM) during 26 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated. A second longer-term study has demonstrated the efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then randomly assigned to placebo or venlafaxine tablets for periods of up to 52 weeks on the same dose (100 to 200 mg/day, on a b.i.d. schedule) (see CLINICAL TRIALS). Based on these limited data, it is not known whether or not the dose of venlafaxine tablets/venlafaxine hydrochloride extended-release capsules needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Discontinuing Venlafaxine Tablets
Symptoms associated with discontinuation of venlafaxine tablets, other SNRIs, and SSRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with venlafaxine tablets. Conversely, at least 7 days should be allowed after stopping venlafaxine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Venlafaxine Tablets With Other MAOls, Such as Linezolid or Methylene Blue
Do not start venlafaxine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with venlafaxine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, venlafaxine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with venlafaxine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with venlafaxine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

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Jiangsu Hengrui Medicine Co., Ltd.

Letrozole | H E B

• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:
Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours
• nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

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American Health Packaging

Letrozole | American Health Packaging

2.1 Recommended Dose
The recommended dose of letrozole tablet 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 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 tablets 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 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)].

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