Levothroid (Page 6 of 7)

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 LEVOTHROID® 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 drug products formulated for intravenous administration should be administered.

HOW SUPPLIED

‑‑‑LEVOTHROID® (levothyroxine sodium tablets, USP) are supplied as caplet-shaped, color-coded, potency marked tablets in 12 strengths:

Strength (mcg) Color NDC # for bottles of 100
25 Orange NDC 0456-1320-01
50 White NDC 0456-1321-01
75 Violet NDC 0456-1322-01
88 Mint Green NDC 0456-1329-01
100 Yellow NDC 0456-1323-01
112 Rose NDC 0456-1330-01
125 Brown NDC 0456-1324-01
137 Deep Blue NDC 0456-1331-01
150 Blue NDC 0456-1325-01
175 Lilac NDC 0456-1326-01
200 Pink NDC 0456-1327-01
300 Green NDC 0456-1328-01

STORAGE CONDITIONS

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

Protect from moisture and light.

MANUFACTURED for:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045

by:
LLOYD PHARMACEUTICAL
Division of Lloyd, Inc.
Shenandoah, IA 51601

REV: June 2011

PRINCIPAL DISPLAY PANEL — 25 mcg Tablet Bottle Label

NDC 0456-1320-01

Levothroid® (levothyroxine sodium tablets, USP)

25 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

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

PRINCIPAL DISPLAY PANEL — 50 mcg Tablet Bottle Label

NDC 0456-1321-01

Levothroid® (levothyroxine sodium tablets, USP)

50 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

PRINCIPAL DISPLAY PANEL -- 50 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mcg Tablet Bottle Label

NDC 0456-1322-01

Levothroid® (levothyroxine sodium tablets, USP)

75 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

PRINCIPAL DISPLAY PANEL -- 75 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 88 mcg Tablet Bottle Label

NDC 0456-1329-01

Levothroid® (levothyroxine sodium tablets, USP)

88 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

PRINCIPAL DISPLAY PANEL -- 88 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mcg Tablet Bottle Label

NDC 0456-1323-01

Levothroid® (levothyroxine sodium tablets, USP)

100 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

PRINCIPAL DISPLAY PANEL -- 100 mcg Tablet Bottle Label
(click image for full-size original)

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