Synthroid (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

SYNTHROID (levothyroxine sodium, USP) tablets are supplied as follows:

125 mcg tablet

NDC 0074-7068-90 bottle of 90 tablets

NDC 0074-7068-13 bottle of 100 tablets

NDC 0074-7068-19 bottle of 1000 tablets

NDC 0074-7068-11 UD carton of 100 tablets

NDC 69189-7068-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F)

[see USP Controlled Room Temperature]. SYNTHROID tablets should be protected from light and moisture.

17 PATIENT COUNSELING INFORMATION

Inform the patient of the following information to aid in the safe and effective use of SYNTHROID:

Dosing and Administration

  • Instruct patients to take SYNTHROID only as directed by their healthcare provider.
  • Instruct patients to take SYNTHROID 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 SYNTHROID 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 SYNTHROID.

Important Information

  • Inform patients that it may take several weeks before they notice an improvement in symptoms.
  • Inform patients that the levothyroxine in SYNTHROID 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 SYNTHROID 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 SYNTHROID. 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 SYNTHROID 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 SYNTHROID therapy, but this is usually temporary.

© 2017 AbbVie Inc.

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

03-A648 February 2017

Principal Display Panel

Levothyroxine 125 mcg tablet
(click image for full-size original)

SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-7068(NDC:0074-7068)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 125 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1
POVIDONES
SUCROSE
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-7068-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 01/26/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-7068), repack (69189-7068)

Revised: 03/2017 Avera McKennan Hospital

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