Octreotide Acetate (Page 4 of 4)

Acromegaly

Dosage may be initiated at 50 mcg t.i.d. Beginning with this low dose may permit adaptation to adverse gastrointestinal effects for patients who will require higher doses. IGF-I (somatomedin C) levels every 2 weeks can be used to guide titration. Alternatively, multiple growth hormone levels at 0-8 hours after octreotide acetate injection administration permit more rapid titration of dose. The goal is to achieve growth hormone levels less than 5 ng/mL or IGF-I (somatomedin C) levels less than 1.9 U/mL in males and less than 2.2 U/mL in females. The dose most commonly found to be effective is 100 mcg t.i.d., but some patients require up to 500 mcg t.i.d. for maximum effectiveness. Doses greater than 300 mcg/day seldom result in additional biochemical benefit, and if an increase in dose fails to provide additional benefit, the dose should be reduced. IGF-I (somatomedin C) or growth hormone levels should be re-evaluated at 6-month intervals.

Octreotide acetate should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If growth hormone or IGF-I (somatomedin C) levels increase and signs and symptoms recur, octreotide acetate therapy may be resumed.

Carcinoid Tumors

The suggested daily dosage of octreotide acetate during the first 2 weeks of therapy ranges from 100-600 mcg/day in 2-4 divided doses (mean daily dosage is 300 mcg). In the clinical studies, the median daily maintenance dosage was approximately 450 mcg, but clinical and biochemical benefits were obtained in some patients with as little as 50 mcg, while others required doses up to 1500 mcg/day. However, experience with doses above 750 mcg/day is limited.

VIPomas

Daily dosages of 200-300 mcg in 2-4 divided doses are recommended during the initial 2 weeks of therapy (range 150-750 mcg) to control symptoms of the disease. On an individual basis, dosage may be adjusted to achieve a therapeutic response, but usually doses above 450 mcg/day are not required.

HOW SUPPLIED

Octreotide acetate injection, containing octreotide (as acetate) 50 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-636-01 (package of 1 Single Dose Vial), NDC 64679-636-02 (package of 10 Single Dose Vials)

Octreotide acetate injection, containing octreotide (as acetate) 100 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-633-01 (package of 1 Single Dose Vial), NDC 64679-633-02 (package of 10 Single Dose Vials)

Octreotide acetate injection, containing octreotide (as acetate) 500 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-635-01 (package of 1 Single Dose Vial), NDC 64679-635-02 (package of 10 Single Dose Vials)

Octreotide acetate injection, containing octreotide (as acetate) 200 mcg per mL, is supplied in 5 ml Multi Dose Vials; NDC 64679-634-01 (package of 1 Multi Dose Vial)

Octreotide acetate injection, containing octreotide (as acetate) 1000 mcg per mL, is supplied in 5 ml Multi Dose Vials; NDC 64679-632-01 (package of 1 Multi Dose Vial)

Storage

For prolonged storage, octreotide acetate single-dose and multi-dose vials should be stored at refrigerated temperatures 2°C-8°C (36°F-46°F) and store in outer carton in order to protect from light. At room temperature, (20°C-30°C or 70°F-86°F), octreotide acetate single dose and multi-dose vials are stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Single-dose vials should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.101012

Label
(click image for full-size original)
Carton
(click image for full-size original)
Label
(click image for full-size original)
Carton
(click image for full-size original)
OCTREOTIDE ACETATE
octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-636
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 50 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-636-01 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (55648-636-01)
2 NDC:55648-636-02 10 VIAL (10 VIAL) in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (55648-636-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090985 05/11/2011
OCTREOTIDE ACETATE
octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-633
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-633-01 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (55648-633-01)
2 NDC:55648-633-02 10 VIAL (10 VIAL) in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (55648-633-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090985 05/11/2011
OCTREOTIDE ACETATE
octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-635
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-635-01 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (55648-635-01)
2 NDC:55648-635-02 10 VIAL (10 VIAL) in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (55648-635-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090985 05/11/2011
OCTREOTIDE ACETATE
octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-634
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 200 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
PHENOL
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-634-01 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (55648-634-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090986 05/11/2011
OCTREOTIDE ACETATE
octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-632
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
PHENOL
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-632-01 1 VIAL (1 VIAL) in 1 VIAL contains a VIAL
1 5 mL in 1 VIAL This package is contained within the VIAL (55648-632-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090986 05/11/2011
Labeler — Wockhardt Limited (650069115)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (55648-636), MANUFACTURE (55648-636), PACK (55648-636), LABEL (55648-636), ANALYSIS (55648-633), MANUFACTURE (55648-633), PACK (55648-633), LABEL (55648-633), ANALYSIS (55648-635), MANUFACTURE (55648-635), PACK (55648-635), LABEL (55648-635), ANALYSIS (55648-634), MANUFACTURE (55648-634), PACK (55648-634), LABEL (55648-634), ANALYSIS (55648-632), MANUFACTURE (55648-632), PACK (55648-632), LABEL (55648-632)

Revised: 10/2012 Wockhardt Limited

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