1 Product Characteristics Color GREEN Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code Synthroid;300 l-thyroxine synthroid Packaging # NDC Package Description Multilevel Packaging 1 0074-7149-13 100 TABLET In 1 BOTTLE None 2 0074-7149-19 1000 TABLET In 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021402 07/24/2002 Synthroid levothyroxine sodium tablets tablet Product l-thyroxine synthroid Product l-thyroxine synthroid HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0074-4341 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM 25 ug Inactive Ingredients Ingredient Name Strength ACACIA l-thyroxine synthroid LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TALC FD&C YELLOW NO. 6 Aluminum Lake 112 D&C Red No. How is Synthroid Supplied Synthroid (levothyroxine sodium tablets, USP) are round, color coded, scored and debossed with "Synthroid" on one side and potency on the other side. Therefore, the possibility of fetal harm appears remote. Tell your doctor about all the prescription and over-the-counter medications you use.
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Synthroid Generic Name: levothyroxine (LEE voe thy ROX een) Brand Names: Levothroid, Levoxyl, Synthroid, Tirosint, Unithroid What is Synthroid? Synthroid is a replacement for a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. 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. You should not use this medication if you have had a heart attack, a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment. Routine clinical examination, including assessment of mental and physical growth and development, and bone maturation, should be performed at regular intervals (see PRECAUTIONS - Pediatric Use and DOSAGE AND ADMINISTRATION). Miscellaneous Anticoagulants (oral) - Coumarin Derivatives - Indandione Derivatives Thyroid hormones appear to increase the catabolism of vitamin K-dependent clotting factors, thereby increasing the l-thyroxine synthroid activity of oral anticoagulants. For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as l-thyroxine synthroid Drug Interactions Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, l-thyroxine synthroid target tissue response) and may alter the therapeutic response to Synthroid. Tell your doctor or dentist that you take Synthroid before you receive any medical or dental care, emergency care, or surgery. Therefore, Synthroid therapy should be l-thyroxine synthroid immediately upon diagnosis and is generally continued for life. Levothyroxine is also effective in the suppression of pituitary TSH secretion l-thyroxine synthroid the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, Hashimoto's thyroiditis, multinodular goiter and, as l-thyroxine synthroid therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer (see INDICATIONS AND USAGE, PRECAUTIONS, and DOSAGE AND ADMINISTRATION). The fetus, neonate, elderly and euthyroid patients with underlying thyroid disease (e.g., Hashimoto's thyroiditis or with Grave's disease previously treated with radioiodine or surgery) are among those individuals who are particularly susceptible to iodine-induced hypothyroidism. If your symptoms do not improve or if they become worse, check with your doctor. Routine clinical l-thyroxine synthroid including assessment of mental and l-thyroxine synthroid growth and development, and bone maturation, should be performed at regular intervals (see PRECAUTIONS - Pediatric Use and DOSAGE AND ADMINISTRATION). Excessive dosage or a too rapid increase in dosage may lead to overstimulation of the thyroid gland. Tell your doctor if you become pregnant during treatment. The following information includes only the l-thyroxine synthroid doses of this medicine.
Taking Synthroid l-thyroxine synthroid long periods of time may cause bone loss, which can lead to osteoporosis. Abbott Laboratories North Chicago, IL 60064, U.S.A. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Acute Massive Overdosage This may be a life-threatening emergency, therefore, symptomatic and supportive therapy should be instituted immediately. It is also safe to l-thyroxine synthroid while you are breast-feeding a baby. Thyrotropin-releasing hormone (TRH) released from the l-thyroxine synthroid stimulates secretion of thyrotropin-stimulating hormone, TSH, from the anterior pituitary. Caution should be exercised when administering Synthroid to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS ). If the results of the levothyroxine withdrawal test l-thyroxine synthroid inconclusive, careful follow-up and subsequent testing will be necessary. Drug-Food Interactions Consumption of certain foods may affect levothyroxine absorption thereby necessitating adjustments in dosing. Do not start a new medication without telling your doctor. Information for Patients Patients should be informed of the following information to aid in the safe and effective use of Synthroid: Notify your physician if you are allergic to any l-thyroxine synthroid or medicines, are pregnant or intend to become pregnant, are breast-feeding or are taking any other medications, including prescription and over-the-counter preparations. Only l-thyroxine synthroid hormone is metabolically active. 1 Aluminum Lake, D&C Red No.