Sotalol Hydrochloride (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “61” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1061-01).

Sotalol hydrochloride tablets USP, 120 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “1060” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1060-01).

Sotalol hydrochloride tablets USP, 160 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “62” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1062-01).

Sotalol hydrochloride tablets USP, 240 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “63” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1063-01).

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, with a child-resistant closure (as required).

Keep this and all medications out of the reach of children.

17 PATIENT COUNSELING INFORMATION

  • Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms or cardiac palpitations.
  • Advise patients that their electrolytes and ECG will be monitored during treatment [see Warnings and Precautions (5.1)].
  • Advise patients to contact their healthcare provider in the event of conditions that could lead to electrolyte changes such as severe diarrhea, unusual sweating, vomiting, less appetite than normal, or excessive thirst [see Warnings and Precautions (5.1)].
  • Advise patients not to change the sotalol hydrochloride tablets dose prescribed by their healthcare provider.
  • Advise patients that they should not miss a dose, but if they do miss a dose they should not double the next dose to compensate for the missed dose: they should take the next dose at the regularly scheduled time [see Dosage and Administration (2)].
  • Advise patients to not interrupt or discontinue sotalol hydrochloride tablets without their physician’s advice, that they should get their prescription for sotalol filled and refilled on time, so they do not interrupt treatment [see Dosage and Administration (2)].
  • Advise patients to not start taking other medications without first discussing new medications with their healthcare provider.
  • Advise patients to avoid taking sotalol hydrochloride tablets within two hours of taking antacids that contain aluminum oxide or magnesium hydroxide [see Drug Interactions (7.7)].
  • Inform patients or caregivers that there is a risk of hypoglycemia when sotalol hydrochloride tablets are given to patients who are fasting or who are vomiting. Inform patients to notify their healthcare provider if they experience symptoms of hypoglycemia [see Warnings and Precautions (5.7)].

Lactation

  • Advise women not to breastfeed while on treatment with sotalol hydrochloride tablets [see Use in Specific Populations (8.2)].

Brands listed are the trademarks of their respective owners.

Manufactured In Czech Republic By:
Teva Czech Industries s.r.o.
Opava-Komarov, Czech Republic

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. P 12/2023

Package/Label Display Panel

NDC 0093-1061 -01

Sotalol
Hydrochloride
Tablets, USP 80 mg

Rx only

100 Tablets

1
(click image for full-size original)

Package/Label Display Panel

NDC 0093-1060 -01

Sotalol
Hydrochloride
Tablets, USP 120 mg

Rx only

100 Tablets

2
(click image for full-size original)

Package/Label Display Panel

NDC 0093-1062 -01

Sotalol
Hydrochloride
Tablets, USP 160 mg

Rx only

100 Tablets

3
(click image for full-size original)

Package/Label Display Panel

NDC 0093-1063 -01

Sotalol
Hydrochloride
Tablets, USP 240 mg

Rx only

100 Tablets

4
(click image for full-size original)

SOTALOL HYDROCHLORIDE sotalol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1061
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code 93;61
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-1061-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075429 05/04/2000
SOTALOL HYDROCHLORIDE sotalol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code 93;1060
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-1060-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075429 05/05/2000
SOTALOL HYDROCHLORIDE sotalol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1062
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 160 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code 93;62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-1062-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075429 05/05/2000
SOTALOL HYDROCHLORIDE sotalol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1063
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code 93;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-1063-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075429 05/05/2000
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2023 Teva Pharmaceuticals USA, Inc.

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