Synthroid

Synthroid

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Questions & Answers

Side Effects & Adverse Reactions

Boxed Warning

WARNING: Thyroid hormones, including SYNTHROID, 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.

Levothyroxine sodium should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.

In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS). If the serum TSH level is not suppressed, SYNTHROID should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for potential associated adverse cardiovascular signs and symptoms of hyperthyroidism.

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

SYNTHROID (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:

Chemical structure for Levothyroxine.

Inactive Ingredients

Acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. The following are the color additives by tablet strength:

Strength (mcg)Color additive(s)
25FD&C Yellow No. 6 Aluminum  Lake*
50None
75FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum  Lake
88FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, D&C Yellow No. 10 Aluminum  Lake
100D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum  Lake*
112D&C Red No. 27 & 30 Aluminum  Lake
125FD&C Yellow No. 6 Aluminum Lake*, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum  Lake
137FD&C Blue No. 1 Aluminum  Lake
150FD&C Blue No. 2 Aluminum  Lake
175FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 & 30 Aluminum  Lake
200FD&C Red No. 40 Aluminum  Lake
300D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum  Lake

*Note – FD&C Yellow No. 6 is orange in color.

Meets USP Dissolution Test 3

Synthroid Manufacturers


  • State Of Florida Doh Central Pharmacy
    Synthroid (Levothyroxine Sodium) Tablet [State Of Florida Doh Central Pharmacy]
  • Pd-rx Pharmaceuticals, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Dispensing Solutions, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Synthroid (Levothyroxine Sodium Tablets) Tablet [Cardinal Health]
  • A-s Medication Solutions Llc
    Synthroid (Levothyroxine Sodium) Tablet [A-s Medication Solutions Llc]
  • Dispensing Solutions, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Dispensing Solutions, Inc.]
  • Abbvie Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Abbvie Inc.]
  • Physicians Total Care, Inc.
    Synthroid (Levothyroxine Sodium) Tablet [Physicians Total Care, Inc.]
  • State Of Florida Doh Central Pharmacy
    Synthroid (Levothyroxine Sodium) Tablet [State Of Florida Doh Central Pharmacy]

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