Levothyroxine Sodium (Page 6 of 6)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50436-5181

NDC: 50436-5181-1 30 TABLET in a BOTTLE

Product: 50436-5182

NDC: 50436-5182-1 30 TABLET in a BOTTLE

Product: 50436-5183

NDC: 50436-5183-1 30 TABLET in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Inform the patient of the following information to aid in the safe and effective use of levothyroxine sodium tablets:

Dosing and Administration

• Instruct patients that levothyroxine sodium tablets should be taken with a full glass of water since the tablet may rapidly disintegrate.
• Instruct patients to take levothyroxine sodium tablets only as directed by their healthcare provider.
• Instruct patients to take levothyroxine sodium tablets as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
• Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take levothyroxine sodium tablets within 4 hours of these agents.
• Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking levothyroxine sodium tablets.

Important Information

• Inform patients that it may take several weeks before they notice an improvement in symptoms.
• Inform patients that the levothyroxine in levothyroxine sodium tablets is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
• Inform patients that levothyroxine sodium tablets should not be used as a primary or adjunctive therapy in a weight control program.
• Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.
• Instruct patients to notify their physician of any other medical conditions they may have, particularly heart disease, diabetes, clotting disorders and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while they are taking levothyroxine sodium tablets. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.
• Instruct patients to notify their physician or dentist that they are taking levothyroxine sodium tablets prior to any surgery.

Adverse Reactions

• Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash or any other unusual medical event. • Inform patients that partial hair loss may occur rarely during the first few months of levothyroxine sodium tablets therapy, but this is usually temporary.

LEVOTHYROXINE SODIUM TABLET LEVOTHYROXINE SODIUM TABLET

Label Image
(click image for full-size original)

LEVOTHYROXINE SODIUM TABLET LEVOTHYROXINE SODIUM TABLET

Label Image
(click image for full-size original)

LEVOTHYROXINE SODIUM TABLET LEVOTHYROXINE SODIUM TABLET

Label Image
(click image for full-size original)
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-5181(NDC:0781-5181)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 50 ug
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code 50;GG;332
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-5181-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021342 03/01/2002
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-5182(NDC:0781-5182)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 75 ug
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color purple (violet) Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code 75;GG;333
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-5182-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021342 03/01/2002
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-5183(NDC:0781-5183)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 88 ug
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color green (olive green) Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code 88;GG;334
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-5183-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021342 03/01/2002
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-5183), REPACK (50436-5181), RELABEL (50436-5181), REPACK (50436-5182), RELABEL (50436-5182), RELABEL (50436-5183)

Revised: 10/2018 Unit Dose Services

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