Liothyronine Sodium: Package Insert and Label Information (Page 3 of 3)

12.1 Mechanism of Action

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

12.2 Pharmacodynamics

The onset of activity of liothyronine sodium occurs within a few hours. Maximum pharmacologic response occurs within 2 or 3 days.

12.3 Pharmacokinetics

Absorption

T3 is almost totally absorbed, 95 percent in 4 hours. The hormones contained in the natural preparations are absorbed in a manner similar to the synthetic hormones.

Distribution

Liothyronine sodium (T3) is not firmly bound to serum protein. The higher affinity of levothyroxine (T4) for both thyroid-binding globulin and thyroid-binding prealbumin as compared to triiodothyronine (T3) partially explains the higher serum levels and longer half-life of the former hormone. Both protein-bound hormones exist in reverse equilibrium with minute amounts of free hormone, the latter accounting for the metabolic activity.

Elimination

Metabolism

The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately 80% of circulating T3 is derived from peripheral T4 by monodeiodination. The liver is the major site of degradation for both T4 and T3. T3 is further deiodinated to diiodothyronine. Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.

Excretion

Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces. The biological half-life is about 2-1/2 days.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of liothyronine sodium.

16 HOW SUPPLIED/STORAGE AND HANDLING

Liothyronine sodium tablets (round, white to off-white) are supplied as follows:

Strength Tablet Markings NDC – bottles of 100
5 mcg Debossed with KPI on one side and 115 on the other side 59762-1206-1
25 mcg Scored on one side and debossed with KPI and 116 on the other side 59762-1207-1
50 mcg Scored on one side and debossed with KPI and 117 on the other side 59762-1208-1

Store between 15°C and 30°C (59°F and 86°F).

17 PATIENT COUNSELING INFORMATION

Dosing and Administration

  • Instruct patients that liothyronine sodium should only be taken as directed by their healthcare provider.
  • Instruct patients to notify their healthcare provider should they become pregnant or breastfeeding or are thinking of becoming pregnant, while taking liothyronine sodium.

Important Information

  • Inform patients that the liothyronine in liothyronine 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 liothyronine sodium 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 healthcare provider of any other medical conditions, 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 taking liothyronine sodium. If patents are taking anticoagulants (blood thinners), their clotting status should be checked frequently.
  • Instruct patients to notify their physician or dentist if they are taking liothyronine sodium 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 [see Adverse Reactions (6)].
  • Inform patients that partial hair loss may occur rarely during the first few months of liothyronine sodium therapy; this is usually temporary [see Adverse Reactions (6)].

This product’s label may have been updated. For current full prescribing information, please visit www.greenstonellc.com

Logo

LAB-0960-4.0

PRINCIPAL DISPLAY PANEL — 5 mcg Tablet Bottle Label

NDC 59762-1206-1
100 Tablets

GREENSTONE® BRAND

liothyroninesodium tablets

5 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 5 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mcg Tablet Bottle Label

NDC 59762-1207-1
100 Tablets

GREENSTONE® BRAND

liothyroninesodium tablets

25 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 25 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mcg Tablet Bottle Label

NDC 59762-1208-1
100 Tablets

GREENSTONE® BRAND

liothyroninesodium tablets

50 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 50 mcg Tablet Bottle Label
(click image for full-size original)
LIOTHYRONINE SODIUM liothyronine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-1206
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM (LIOTHYRONINE) LIOTHYRONINE 5 ug
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code KPI;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-1206-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA010379 02/06/2019
LIOTHYRONINE SODIUM liothyronine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-1207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM (LIOTHYRONINE) LIOTHYRONINE 25 ug
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code KPI;116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-1207-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA010379 06/24/2019
LIOTHYRONINE SODIUM liothyronine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-1208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM (LIOTHYRONINE) LIOTHYRONINE 50 ug
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code KPI;117
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-1208-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA010379 06/24/2019
Labeler — Greenstone LLC (825560733)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Peptido GmbH 327335410 API MANUFACTURE (59762-1206), API MANUFACTURE (59762-1207), API MANUFACTURE (59762-1208)

Revised: 11/2020 Greenstone LLC

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