Synthroid, Drug Profile
SYNTHROID® (levothyroxine sodium tablets, USP) is an important drug, used to treat hypothyroidism. Synthroid has been extensively studied for over 42 years. It is the most widely prescribed thyroid medicine in the United States. Currently, over eight million people are using Synthroid for thyroid replacement therapy. [Abbott, 2001]
Synthetic Levothyroxine (T4 ) is identical in chemical composition and molecular weight to naturally secreted T4. Synthroid tablets contain the following inactive ingredients: acacia, confectioner's sugar, lactose, magnesium stearate, povidone, talc, and color additives.[Abbott, 2001].
Synthroid is pregnancy category A. Studies have shown that Synthroid increases the risk of fetal abnormalities if given during pregnancy. The possibility of fetal harm does appear to be remote, however, Synthroid should only given during pregnancy if it is clearly needed [Abbott, 2001]. In addition Abbot Laboratories reports that thyroid hormones do cross the placental barrier to some extent. T4 levels in the cord blood of a thyroid fetuses have been shown to be about one-third of maternal levels. This could cause hypothyroidism in the developing fetus.
Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion and preeclampsia. It has been reported to have an adverse effect on fetal and childhood development. On the basis of current knowledge, Synthroid should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be treated. [Abbott, 2001].
Minimal amounts of thyroid hormones are excreted in human milk. Thyroid hormones are not associated with serious adverse reactions and do not have known tumor-producing potential. While caution should be exercised when Synthroid is administered to a nursing woman, adequate replacement doses of levothyroxine sodium are generally needed to maintain normal lactation. .[Abbott, 2001]
The starting dose of Synthroid, the frequency of the dose, and the optimal dosage must be determined on an individual basis. The proper dosage will be influenced by such factors as age, weight, cardiovascular status, presence of other illness, and the severity and duration of hypothyroid symptoms. The usual full replacement dose of Synthroid for younger, healthy adults is approximately 1.6 mug/kg/day administered once daily....
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