Synthroid (Page 6 of 6)

Newborns

The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.

Infants and Children

Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see Table 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.

Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.

Table 3. Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism
AGE Daily Dose Per Kg Body Weighta
0-3 months 10-15 mcg/kg/day
3-6 months 8-10 mcg/kg/day
6-12 months 6-8 mcg/kg/day
1-5 years 5-6 mcg/kg/day
6-12 years 4-5 mcg/kg/day
> 12 years but growth and puberty incomplete 2-3 mcg/kg/day
Growth and puberty complete 1.7 mcg/kg/day
a The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTIONS — Laboratory Tests and Pediatric Use).

Pregnancy

Pregnancy may increase levothyroxine requirements (see PREGNANCY).

Subclinical Hypothyroidism

If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.

TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules

The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of SYNTHROID used for TSH suppression should be individualized based on the specific disease and the patient being treated.

In the treatment of well-differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to < 0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be < 0.01 mU/L.

In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1 to either 0.5 or 1.0 mU/L) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

Myxedema Coma

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.

HOW SUPPLIED

SYNTHROID (levothyroxine sodium tablets, USP) are round, color coded, scored and debossed with “SYNTHROID” on one side and potency on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1013-2 100 UG 60 Tablets in a Blister Pack YELLOW 0074-6624

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. SYNTHROID tablets should be protected from light and moisture.

AbbVie Inc.

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

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1013 100ug

Label Image for 100ugLabel Image for 100ug
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1013(NDC:0074-6624)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 100 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
POVIDONES
SUCROSE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1013-2 60 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1013)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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