Stay on top of your health. Get up to speed on Levoxyl

If you've got questions about your treatment for hypothroidism, rest easy. It's natural and healthy to want to know more about your Levoxyl® prescription and why it's important that you take what your doctor intended. Below are answers to some commonly asked questions that may provide the health information, how-to-tips—and peace-of-mind—you need.

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Q. Why has my doctor prescribed Levoxyl®?
A. Levoxyl® is a synthetic form of the hormone produced by a normal functioning thyroid. If you have hypothyroidism (under active thyroid), thyroid deficiency, or absence of the thyroid, your doctor may prescribe Levoxyl® as a thyroid hormone replacement therapy. It may be used in the treatment or prevention of various types of goiters, including thyroid nodules, by suppressing pituitary thyroid stimulating hormone (TSH). Levoxyl® may also be used, along with surgery or radioactive iodine, to manage certain types of thyroid cancer.


Q. When should I take Levoxyl®?
A. Levoxyl® should be taken in the morning, on an empty stomach, at least 30 minutes before eating. Levoxyl® should be taken at least 4 hours apart from drugs that are known to interfere with its absorption. Drugs that may decrease absorption of Levoxyl® and should be administered at least 4 hours apart from these agents: Antacids (Aluminum and magnesium hydroxides, simethicone), Bile Acid Sequestrants (Cholestyramine and Colestipol), Calcium Carbonate, Cation Exchange Resins (kayexalate), Ferrous Sulfate, and Sucralfate. It is very important that you take Levoxyl® with a full glass of water. Be consistent in taking your Levoxyl® so that your physician can accurately evaluate how you are responding to therapy.


Q. What happens if I miss a dose of Levoxyl®?
A.If you miss a dose of this medicine, take it as soon as possible, following the instructions under the "When should I take Levoxyl®" question above. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Q. Are Levoxyl®tablets designed to dissolve rapidly?
A. Levoxyl® has a patented formulation that may rapidly swell and disintegrate resulting in choking, gagging, the tablet getting stuck in your throat or difficulty swallowing. It is very important that you take Levoxyl® with a full glass of water. For patients who have difficulty swallowing tablets, or for infants and children, the tablet may be crushed and added to 1-2 teaspoons of water. This should be taken right away and not stored. Do not double your dose. If you miss two or more doses in a row or if you have questions about this, consult with your doctor.


Q. What food interactions should I be aware of while on Levoxyl®?
A. Consumption of certain foods may affect levothyroxine absorption thereby necessitating adjustments to your Levoxyl® dose. Soybean flour (infant formula), cottonseed meal, walnuts and dietary fiber may bind and decrease the absorption of levothyroxine sodium from the gastrointestinal tract.


Q. If starting Levoxyl®, when should I see improvements in my hypothyroid symptoms?
A. Levothyroxine is a slow-acting thyroid hormone and it may take several weeks before you notice an improvement in your symptoms. Generally, when starting Levoxyl therapy, your physician will repeat blood tests to evaluate how you are responding to therapy and whether a dosage adjustment is needed.

Q. Is weight gain a side effect of Levoxyl®?
A. . No, weight gain is not a side effect associated with Levoxyl® therapy. Weight gain or increased difficulty in losing weight is a common symptom associated with hypothyroidism. Thyroid hormones are noted to influence metabolism.


Q. Will Levoxyl® help me lose weight?
A. Levoxyl® is not indicated for weight loss. In fact, warnings against using Levoxyl® in this manner are identified with a "black box" in the complete prescribing information for Levoxyl®.


Q. Is hair loss a side effect of Levoxyl®?
A. Hair loss can be associated with thyroid disorders. Diseases of the thyroid gland are associated with changes in hair texture and alterations in hair patterns. Hyperthyroidism induces a fine, silky textured hair, occasionally associated with diffuse hair loss, while lack of levothyroxine in hypothyroidism causes the hair to be coarse, dry and brittle. There may also be diffuse and occasionally marked loss of scalp hair. Therefore, it is often difficult to assess whether the hair loss is a result of the thyroid therapy or possibly stems from the thyroid disorder.

Partial loss of hair may occur rarely during the first few months of thyroid therapy, but this is usually temporary. Additionally, adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. Hair loss is a potential condition of hyperthyroidism as well as hypothyroidism.


Q. What are the side effects associated with Levoxyl® therapy?
A. Side effects are primarily related to symptoms of hyperthyroidism due to therapeutic over dosage. If you take too much medication, you may experience hyperthyroid symptoms (overactive thyroid) and if you do not take enough medication you may experience hypothyroid symptoms (under active thyroid).

Common symptoms and signs of hyperthyroidism: sensation of irregular or forced beating of the heart, heat intolerance, nervousness, trouble sleeping, breathlessness, increased bowel movements, vomiting, stomach cramps, light or absent menstrual periods, fatigue, headache, chest pain, irritability, fast heart rate, increased blood pressure, trembling hands, weight loss, muscle weakness, warm moist skin, hair loss, staring gaze, increased appetite.

Common symptoms and signs of hypothyroidism: fatigue, weakness, weight gain, increased difficulty in losing weight, intolerance to cold, muscle aching and cramps, constipation, depression, memory loss, abnormal menstrual cycles.

Seizures have been reported rarely with the institution of levothyroxine therapy.

Allergic reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include: hives, itching, skin rash, redness of the face and neck, stomach pain, nausea, vomiting and increased bowel movements, fever, joint pain, wheezing or swelling of the face, eyes, lips or tongue or difficulty breathing.

In addition to the above events, the following have been reported, predominately when Levoxyl tablets were not taken with water: choking, gagging, tablet stuck in throat and difficulty in swallowing.

Other side effects not listed above may also occur in some patients. Notify your physician or healthcare provider if you are experiencing any of the symptoms listed or any other abnormal effects.


Q. What drug interactions should I be aware of while on Levoxyl®?
A. There are medications, vitamins, supplements and herbs that may affect the absorption of or have an interaction with Levoxyl®. See full Prescribing Information for interaction information. Inform your physician of other medications, vitamins, supplements or herbal products that you may be taking in combination with Levoxyl®®


Q. Can I take Levoxyl® if I am pregnant or if I am trying to get pregnant?
A. Levoxyl® is safe to take during pregnancy. Studies in women taking levothyroxine sodium during pregnancy have not shown an increased risk of birth defects. Notify your physician if you are pregnant or intend to become pregnant.


Q. Can infertility be associated with thyroid disease?
A. Impaired fertility is listed as an adverse reaction associated with levothyroxine therapy due to hyperthyroidism, secondary to therapeutic over dosage. Additionally, levothyroxine sodium should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.


Q. What is TSH? How does my physician use TSH to determine my dose of Levoxyl®?
A. TSH stands for thyroid-stimulating hormone and is the name of a simple blood test often utilized as one of the thyroid function tests to diagnose thyroid dysfunction. TSH is a natural occurring hormone that signals the thyroid gland to make levothyroxine. If you have hypothyroidism, your TSH will be high because your thyroid gland needs to be told to make more levothyroxine. If you have hyperthyroidism, your TSH will be low because your thyroid gland is producing too much levothyroxine.

The goal is to achieve a TSH level within a normal range. The goal is to achieve a TSH level within a normal range. An example of a normal range for TSH is 0.4 mu/L to 4.0 mU/L; however, this can vary depending on the lab evaluating your blood test. Your physician may titrate your dose of Levoxyl® until your TSH level is within normal range. Do not be concerned if your TSH levels fluctuate within the normal range.


Q. Can I take Levoxyl® with a liothyronine sodium (T3) preparation?
A. Although some physicians may prescribe these drugs in combination, the FDA has not approved the use of Levoxyl® in this manner and dose and administration recommendations are not provided in the full Prescribing Information. Please consult your physician for information regarding combination therapy.


Q. Why should I start and stay with the same levothyrine?
A. All Levothyroxine sodium products contain the same active ingredient but are formulated differently. The American Thyroid Association (ATA), The Endocrine Society (TES) and The American Association of Clinical Endocrinologists (AACE) advise that patients start on and stay on the same levothyroxine. However if patients switch between levothyroxine products, repeat thyroid function testing is recommended. This is to allow for dose retitration if the therapeutic target is not being achieved with the new preparation.


Q. Can my pharmacist substitute another levothyroxine product for my Levoxyl® prescription?
A. Certain manufacturers of levothyroxine sodium products have received approval from the FDA, which would allow their levothyroxine product to be substituted for Levoxyl®.Please consult with your pharmacist for additional information. However, The American Thyroid Association (ATA), The Endocrine Society (TES) and The American Association of Clinical Endocrinologists (AACE) have advised physicians caring for patients on levothyroxine therapy to:
  • Alert their patients that their levothyroxine preparation may be switched at the pharmacy.
  • Encourage their patients to ask to remain on their current levothyroxine product.
  • Make sure their patients understand that if they receive a new or different levothyroxine product that they will need to be retested with a serum TSH to determine if they are receiving the correct dose.


Q. How many strengths of Levoxyl® are there?
A. There are 12 color-coded dosage strengths of Levoxyl®, which provide broad dosing flexibility. The dosage strengths available are 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 micrograms.


Q. Is Levoxyl® FDA approved?
A. Yes. Levoxyl® was FDA approved on May 25, 2001.


Q. Who manufactures Levoxyl®?
A. . Levoxyl® is manufactured by Jones Pharma, a wholly owned subsidiary of King Pharmaceuticals,® Inc.


Q. Should I have my TSH retested if switching to Levoxyl®?
A. All Levothyroxine sodium products contain the same active ingredient but are formulated differently. The American Thyroid Association (ATA), The Endocrine Society (TES) and The American Association of Clinical Endocrinologists (AACE) advise that patients start on and stay on the same levothyroxine. However if patients switch between levothyroxine products, repeat thyroid function testing is recommended. This is to allow for dose retitration if the therapeutic target is not being achieved with the new preparation.


Q. What are the three most important things I should remember to get the most out of my Levoxyl® treatment?
A.
  1. Use your medication exactly as your physician has prescribed it.
  2. Contact your physician if you think you are experiencing symptoms of thyroid hormone excess or deficiency.
  3. Maintain follow-up appointments with your physician to be sure that your hypothyroidism remains well controlled.