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LEVOTHYROXINE SODIUM tablet 125mcg (0.125mg) 1000 Tablets

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Description

Indications and Usage:

Hypothyroidism

Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression

Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

  • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)].
  • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Product Properties:

Description -
Description N
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind A1
Drug Category -
Drug Category USES: Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.
Drug Type Code COMMON BRAND NAME(S): Levothroid, Levoxyl, Synthroid, Unithroid
Drug Type Code N
FDA Approval Date 03/20/2019
FDA Therap Equiv TAB
HCPCS -
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date (lee-voe-thye-ROX-een)
Unit 1000
Units Per Pkg 01/18/2019
Active Ingredients 2132 levothyroxine sodium 55038
Active Ingredients 2132 levothyroxine sodium 55038
AHFS Class 68360400 THYROID AGENTS
AHFS Class 68360400 THYROID AGENTS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 6653 levothyroxine sodium ORAL TABLET 125 MCG
Gen Code and Des 6653 levothyroxine sodium ORAL TABLET 125 MCG
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye; 11039 sodium bicarbonate 144558; 2272 mannitol 69658
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye; 11039 sodium bicarbonate 144558; 2272 mannitol 69658
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 125MCG
Strength 125MCG
Common Brand Name COMMON BRAND NAME(S): Levothroid, Levoxyl, Synthroid, Unithroid
Common Brand Name -
Drug Interaction DRUG INTERACTIONS: See also How to Use Section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 48
Case Quantity 48
Drug Form Pack Size 1000
Drug Form Pack Size 1000
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 1000
Unit Size 1000
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking levothyroxine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily on an empty stomach, 30 minutes to 1 hour before breakfast. Take this medication with a full glass of water unless your doctor directs you otherwise. If you are taking the capsule form of this medication, swallow it whole. Do not split, crush, or chew. People who cannot swallow the capsule whole (such as infants or small children) should use the tablet form of the medication. For infants or children who cannot swallow whole tablets, crush the tablet and mix in 1 to 2 teaspoons (5 to 10 milliliters) of water, and give using a spoon or dropper right away. Do not prepare a supply in advance or mix the tablet in soy infant formula. Consult your pharmacist for more information. The dosage is based on your age, weight, medical condition, lab test results, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop taking this medication without first consulting with your doctor. Thyroid replacement treatment is usually taken for life. There are different brands of levothyroxine available. Do not change brands without first consulting your doctor or pharmacist. Certain medications (such as cholestyramine, colestipol, colesevelam, antacids, sucralfate, simethicone, iron, sodium polystyrene sulfonate, calcium supplements, orlistat, sucroferric oxyhydroxide, lanthanum, sevelamer, among others) can decrease the amount of thyroid hormone that is absorbed by your body. If you are taking any of these drugs, separate them from this medication by at least 4 hours. Symptoms of low thyroid hormone levels include tiredness, muscle aches, constipation, dry skin, weight gain, slow heartbeat, or sensitivity to cold. Tell your doctor if your condition gets worse or lasts after several weeks of taking this medication.
How to Use -
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up unless your doctor tells you to do so. Call your doctor if you miss 2 or more doses in a row. Ask your doctor ahead of time what to do about a missed dose and follow your doctor's specific directions.
Missed Dose 1000
Notes TAB
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as thyroid function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/pounding/irregular heartbeat, loss of consciousness, confusion, seizures.
Overdose A1
Phonetic Pronunciation (lee-voe-thye-ROX-een)
Phonetic Pronunciation -
Precautions PRECAUTIONS: 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. If you have diabetes, this drug may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms such as increased thirst/urination, shakiness, unusual sweating, dizziness, or hunger. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to certain side effects of this drug, especially headache, vision changes, and hip/leg pain. High thyroid hormone levels may lead to decreased bone development/growth and reduced full adult height. Keep all lab/medical appointments so the doctor can monitor treatment. Older adults may be more sensitive to the side effects of this drug, especially fast/pounding/irregular heartbeat. This drug may be used during pregnancy. Tell your doctor if you are pregnant because your doctor may need to change your dose. Levothyroxine passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: See also Precautions section. Hair loss may occur during the first few months of treatment. This effect is usually temporary as your body adjusts to this medication. If this effect lasts or gets worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious effects of high thyroid hormone levels, including: increased sweating, sensitivity to heat, mental/mood changes (such as nervousness, mood swings), tiredness, diarrhea, shaking (tremor), headache, shortness of breath, bone pain, easily broken bones. Get medical help right away if you have any very serious effects of high thyroid hormone levels, including: chest pain, fast/pounding/irregular heartbeat, swelling hands/ankles/feet, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage 01/18/2019
Uses -
Uses USES: Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.

Frequently Asked Questions(FAQs)

The cost of LEVOTHYROXINE SODIUM tablet 125mcg (0.125mg) 1000 Tablets is available for registerd members only .
LEVOTHYROXINE SODIUM tablet 125mcg (0.125mg) 1000 Tablets is manufactured by Lupin Pharmaceuticals, Inc..
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