Levoxyl

Levoxyl

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Questions & Answers

Side Effects & Adverse Reactions

WARNING: Thyroid hormones, including LEVOXYL®, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Levothyroxine sodium is used for the following indications:

Hypothyroidism — As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.

Pituitary TSH Suppression — In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

History

There is currently no drug history available for this drug.

Other Information

–LEVOXYL® (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 • H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

Molecular formula
Inactive Ingredients

Microcrystalline cellulose, croscarmellose sodium and magnesium stearate. The following are the coloring additives per tablet strength:

Strength (mcg)

Color additive(s)

25

FD&C Yellow No. 6 Aluminum Lake

50

None

75

FD&C Blue No. 1 Aluminum Lake, D&C Red No. 30 Aluminum Lake

88

FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

100

FD&C Yellow No. 6 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

112

FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Red No. 30 Aluminum Lake

125

FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

137

FD&C Blue No. 1 Aluminum Lake

150

FD&C Blue No. 1 Aluminum Lake, D&C Red No. 30 Aluminum Lake

175

FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

200

D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

 

Levoxyl Manufacturers


  • Cardinal Health
    Levoxyl (Levothyroxine Sodium) Tablet [Cardinal Health]
  • Physicians Total Care, Inc.
    Levoxyl (Levothyroxine Sodium) Tablet [Physicians Total Care, Inc.]
  • Dispensing Solutions, Inc.
    Levoxyl (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Pfizer Laboratories Div Pfizer Inc
    Levoxyl (Levothyroxine Sodium) Tablet [Pfizer Laboratories Div Pfizer Inc]

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