"DENVER â€” New data shed more light on the specific risks of congenital birth defects associated with the Graves' disease drug methimazole (MMI) and the timing of the teratogenic effects.
The results indicate that there were significant"...
(levothyroxine sodium) tablets, USP
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 manifes tations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
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:
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 )|
|25||FD&C Yellow No. 6 Aluminum Lake*|
|75||FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake|
|88||FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*,
D&C Yellow No. 10 Aluminum Lake
|100||D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*|
|112||D&C Red No. 27 & 30 Aluminum Lake|
|125||FD&C Yellow No. 6 Aluminum Lake*, FD&C Red No. 40 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake
|137||FD&C Blue No. 1 Aluminum Lake|
|150||FD&C Blue No. 2 Aluminum Lake|
|175||FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 & 30 Aluminum Lake|
|200||FD&C Red No. 40 Aluminum Lake|
|300||D&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
What are the possible side effects of levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint, Unithroid)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- sleep problems (insomnia);
- feeling nervous or irritable;
- fever, hot flashes, sweating;
- pounding heartbeats or fluttering in your chest;
- changes in your menstrual periods; or
- appetite changes, weight changes.
Less serious side...
What are the precautions when taking levothyroxine sodium (Synthroid)?
Before taking levothyroxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: increased thyroid hormones (thyrotoxicosis), decreased adrenal gland function, heart disease (such as coronary artery disease, irregular heartbeat), high blood pressure, diabetes.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Current information shows that this drug may be used during pregnancy....
Last reviewed on RxList: 8/31/2016
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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