Sotradecol (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored.

Sotradecol (sodium tetradecyl sulfate injection) is for intravenous use only. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small, using 0.5 mL to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

HOW SUPPLIED

Sotradecol® (sodium tetradecyl sulfate injection)

NDC 67457-162-02
carton containing 5 x 2 mL multiple-dose vials with 1% 20 mg/2 mL (10 mg/mL)

NDC 67457-163-02
carton containing 5 x 2 mL multiple-dose vials with 3% 60 mg/2 mL (30 mg/mL)

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

ANIMAL TOXICOLOGY

The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg.

In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.

Purified sodium tetradecyl sulfate was found to have an LD50 of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15 g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

Revised: 8/2021
MI:SOTRIJ:R7
0521L112

® Sotradecol is a registered trademark of Mylan Pharma Group Limited

PRINCIPAL DISPLAY PANEL — 10 mg/mL Carton Label

NDC 67457-162-02

Sotradecol® 1%
(sodium tetradecyl sulfate injection)

20 mg/2 mL (10 mg/mL)

For Intravenous Use Only

Rx only 5 x 2 mL Multiple-Dose Vials

Each mL contains: Sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL
and dibasic sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9; monobasic
sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

WARNING: Do not use if precipitated.

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional Galway, Ireland

MI:162:5C:R7

Mylan.com

Sotradecol Injection 1% Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg/mL Carton Label

NDC 67457-163-02

Sotradecol® 3%
(sodium tetradecyl sulfate injection)

60 mg/2 mL (30 mg/mL)

For Intravenous Use Only

Rx only 5 x 2 mL Multiple-Dose Vials

Each mL contains: Sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and
dibasic sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9; monobasic
sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

WARNING: Do not use if precipitated.

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled RoomTemperature.]

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional Galway, Ireland

MI:163:5C:R7

Mylan.com

Sotradecol Injection 3% Carton Label
(click image for full-size original)
SOTRADECOL tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-162
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRADECYL HYDROGEN SULFATE (ESTER) (TETRADECYL HYDROGEN SULFATE (ESTER)) TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 4 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-162-02 5 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (67457-162-00)
1 NDC:67457-162-00 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (67457-162-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 04/29/2013
SOTRADECOL tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-163
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRADECYL HYDROGEN SULFATE (ESTER) (TETRADECYL HYDROGEN SULFATE (ESTER)) TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 9 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-163-02 5 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (67457-163-00)
1 NDC:67457-163-00 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (67457-163-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 04/29/2013
Labeler — Mylan Institutional LLC (790384502)

Revised: 08/2021 Mylan Institutional LLC

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