Synthroid (Page 6 of 8)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies to evaluate mutagenic potential and animal fertility have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

SYNTHROID (levothyroxine sodium, USP) tablets are supplied as follows (Table 11):

Table 11: SYNTHROID Tablet Presentations
Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 NDC # for unit dose cartons of 100
25 Orange/Round “SYNTHROID”and “25” 0074-4341-90 0074-4341-19
50 White/Round “SYNTHROID”and “50” 0074-4552-90 0074-4552-19 0074-4552-11
75 Violet/Round “SYNTHROID”and “75” 0074-5182-90 0074-5182-19 0074-5182-11
88 Olive/Round “SYNTHROID”and “88” 0074-6594-90 0074-6594-19
100 Yellow/Round “SYNTHROID”and “100” 0074-6624-90 0074-6624-19 0074-6624-11
112 Rose/Round “SYNTHROID”and “112” 0074-9296-90 0074-9296-19
125 Brown/Round “SYNTHROID”and “125” 0074-7068-90 0074-7068-19 0074-7068-11
137 Turquoise/Round “SYNTHROID”and “137” 0074-3727-90 0074-3727-19
150 Blue/Round “SYNTHROID”and “150” 0074-7069-90 0074-7069-19 0074-7069-11
175 Lilac/Round “SYNTHROID”and “175” 0074-7070-90 0074-7070-19
200 Pink/Round “SYNTHROID”and “200” 0074-7148-90 0074-7148-19 0074-7148-11
300 Green/Round “SYNTHROID”and “300” 0074-7149-90 0074-7149-19

Storage and Handling

Store SYNTHROID at 20° to 25°C (68° to 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 discontinue biotin or any biotin-containing supplements for at least 2 days before thyroid function testing is conducted.
  • 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.

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SYNTHROID and its design are trademarks of AbbVie Inc.

AbbVie Inc.

North Chicago, IL 60064 U.S.A.

20083657

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