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Levothyroxine The Same As Synthroid

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Last Updated: 22 October 2020

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General | Latest Info

Home PATIENTS Portal CLINICAL THYROIDOLOGY FOR Public Vol 6 Issue 4 Vol 6 Issue 4 P. 4 - 5 CLINICAL THYROIDOLOGY FOR PATIENTS publication OF American Thyroid Association summaries FOR PATIENTS from CLINICAL THYROIDOLOGY table OF Contents | PDF File FOR Saving and Printing HYPOTHYROIDISM GENERIC and brand Levothyroxine preparations ARE not same in children with congenital HYPOTHYROIDISM BACKGROUND HYPOTHYROIDISM is treat by Thyroid hormone replacement therapy, usually in form OF levothyoxine. There ARE brand Levothyroxine preparations as well as GENERIC preparations. While FDA has deemed GENERIC and branded preparations equal, this has been based on short - term studies in healthy adult volunteers and not long - term treatment OF hypothyroid PATIENTS. In infants with severe congenital HYPOTHYROIDISM, even small changes in Thyroid hormone levels may have negative effects on their development. Few CLINICAL studies have been performed to date to determine whether GENERIC and brand Levothyroxine preparations ARE truly equal in PATIENTS with HYPOTHYROIDISM. In this STUDY, GENERIC and branded Levothyroxine preparations ARE compared as treatment in a group of hypothyroid children. Full ARTICLE TITLE: Carswell JM et al. Generic and brand - name L - thyroxine ARE not bioequivalent FOR children with severe congenital HYPOTHYROIDISM. J Clin Endocrinol Metab. December 21, 2012. Summary OF STUDY This STUDY evaluated 31 children and adolescents 3 to 18 years of age with known HYPOTHYROIDISM. A total OF 20 children had congenital HYPOTHYROIDISM, while the rest had Hashimotos thyroiditis as cause of their HYPOTHYROIDISM. Children were assigned to receive their usual Levothyroxine dose as either Synthroid TM or GENERIC Levothyroxine FOR 8 weeks and then were switched to other preparation FOR 8 weeks. Serum TSH, free T 4, and total T 3 were measured at the end of each 8 week treatment period and were compared FOR each subject. Serum TSH was significantly lower after 8 weeks OF SynthroidTM than after 8 weeks OF GENERIC Levothyroxine. This difference does not depend on age and was seen only in children with congenital HYPOTHYROIDISM. In children with Hashimotos disease, TSH does not differ between brand and GENERIC Levothyroxine. There were no differences in free T 4 or total T 3 following each treatment period. What ARE the IMPLICATIONS OF this STUDY? This STUDY demonstrates that Synthroid and GENERIC Levothyroxine ARE not equal in children with congenital HYPOTHYROIDISM, even though the FDA States they ARE interchangeable. This difference was not observed in PATIENTS with Hashimotos thyroiditis, possibly because they have intact thyroid although it is not working. Results in children with congenital HYPOTHYROIDISM may possibly be seen in other PATIENTS who have had thyroidectomy. In any event, this STUDY reinforces the need FOR check thyroid tests to adjust dose when Levothyroxine preparations ARE being change. Further studies with a larger number of PATIENTS would be helpful to confirm these results. Table OF Contents | PDF File FOR Saving and Printing Hashimotos thyroiditis: most common cause OF HYPOTHYROIDISM in the United States. It is caused by antibodies that attack thyroids and destroy gland.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levothyroxine Preparations

Home Patients Portal Thyroid Q & Q and: Thyroxine Preparations Most Endocrinologists believe that FDA methods for testing equivalence of Thyroxine Preparations are seriously flaw. One of the problems with FDA methods is that they do not use TSH blood tests, cornerstone of Thyroxine monitoring, to compare different Thyroxine preparations in study participants. Another concern is many factors that can influence thyroxine absorption and availability to your body. There is variation in thyroxine content among various approved preparations with same state dose on tablet, in some cases greater than 10%. This is a potential problem if patients switch to Thyroxine Preparations. Thyroid disease often requires lifelong therapy and is best managed with consistent and precise treatment with the same brand of Thyroid hormone. Your doctor may change your dose of Thyroid hormone, but the brand of your Thyroid hormone medication should be constant. When you go to the pharmacy, do not change the brand of your thyroid medication without checking with your doctor. You should not change from one brand of Thyroid medication to another, from your brand of Thyroid medication to a generic product, or from one generic product to another without first checking with your doctor. Your insurance company or state aid program, however, may not pay for the cost of a brand name drug or charge higher co - payment if you want a specific brand name drug. Repeat blood tests and visits to your doctor may be required if your Thyroxine preparation is change, and your dose may need to be readjust. Finally, be familiar with the shape and markings on your branded levothyroxine product. Generic levothyroxine products may contain brand names as part of labeling, so be sure to inspect your tablets when you receive refill. Take a look at our Patient Web Brochure Hypothyroidism to learn more about Hypothyroidism and how it is treat. Medical Disclaimer Information contained in or made available through the American Thyroid Association Website is not intended to replace services of trained health professionals or to be a substitute for medical advice of physicians. A user should consult a physician on all matters relating to his or her health, and particularly in respect to any symptoms that may require diagnosis or medical attention. The American Thyroid Association makes no representations or warranties with respect to any information offered or provided within or through the American Thyroid Association Website regarding treatment, action, or application of medication. Terms of Use Privacy Policy

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Special Considerations

Thyroid Hormone replacement therapy with oral levothyroxine is standard treatment for patients with hypothyroidism. Goals of treatment include resolution of symptoms and signs of hypothyroidism and normalization of circulating Thyroid - Stimulating Hormone levels. Orally administered LT4 is available in several formulations, and LT4 tablets are available in multiple brand and generic forms. Traditional tablet formulations contain LT4 sodium, stable salt, and a variety of inactive excipients, composition of which may affect tablet stability and pharmacokinetics. The US Food and Drug Administration defines generic drug as medication that has the same dosage form, safety, strength, route of Administration, quality, performance characteristics and intended use as already marketed brand - name medication. The European Medicines Agency defines generic drugs as those that have the same qualitative and quantitative composition of active substances and same pharmaceutical form as reference drug and whose bioequivalence with reference drug has been demonstrated by appropriate bioavailability studies. With regard to generic and brand LT4 preparations, endocrinologists around the world differ in their preferences. According to a survey of 880 members of the Endocrine Society, American Thyroid Association and American Association of Clinical Endocrinologists, 49. 9% of respondents prefer the brand - name LT4, while 49. 3% preferred generic LT4. However, among European members, who represent 9. 2% of respondents, proportion of those who prefer brand - name drugs was 58. 8%. At present, FDA uses serum thyroxine levels to establish Bioequivalence of LT4 products. Base on FDA criteria for Bioequivalence, substitution between bioequivalent generic and brand - name LT4 can be automatically performed with no need for dose adjustment. There is ongoing debate around concerns that currently use pharmacokinetic approach for assessing bioequivalence of LT4 products could allow products with clinically significant differences in bioavailability to be declared therapeutically equivalent and interchangeable. Therefore, ATA, ES and AACE have issued joint statement encouraging consistent use of the same brand or generic LT4 formulation in individual patients. These recommendations have since been reinforced by guidelines from the Endocrine Society of Australia, European Thyroid Association and Thyroid Federation International, and are summarized in Table 1. If switch to another LT4 formulation is make, repeat Thyroid function testing is recommend. Switching is considered to be a particular concern in vulnerable populations, including elderly, pregnant and pediatric patients, especially since these patients are often excluded from studies undertaken to establish Bioequivalence. This review describes problems that can be encountered when switching between formulations or when original products are reformulate.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Thyroid Hormone Replacement

Levothyroxine liothyronine liotrix natural Thyroid Thyroid replacement is used to treat people with underactive Thyroid, whether it is caused by autoimmune disease, radioactive iodine treatment, or surgical removal. The main medication used to treat HYPOTHYROIDISM is Levothyroxine sodium, synthetic version OF thyroxine, thyroid hormone your body produces naturally. Other medications ARE also available, namely liothyronine, synthetic version OF another Thyroid hormone called triiodothronine; liotrix, synthetic combination OF T4 and T3; and desiccated natural Thyroid. Since these medications simply supplement hormone that is missing, only real safety concern is ensuring that you take the right amount. Therefore, your doctor will need to regularly check your thyroid and TSH levels to make sure you ARE receiving the correct dosage. Thyroid hormone stays in your body FOR a long time, so you will only need to take it once a day, usually in the morning. It is important to take this medication without food, because food can affect your body's absorption of hormone.Sss in addition, remember to take your thyroid medication at the same time of day, and do not stop taking your medication without first discussing decision with your doctor. Many people need to take Thyroid medication FOR the rest of their lives. Remember to tell your doctor about any other medications you may be taking, since certain drugs can interact with your Thyroid medication. These include oral contraceptives, estrogen, testosterone, certain anti - seizure medications, cholesterol - lowering medications and some antidepressants. Certain foods can also interfere with your body's absorption of thyroid hormone,s including iron, calcium, and soy. If you ARE pregnant or may become pregnant, it is perfectly safe to continue taking your Thyroid medication. It is important for pregnant women to maintain appropriate levels of Thyroid hormone in the body to provide the healthiest environment FOR fetal development. When you first learn that you ARE pregnant, you should contact your doctor so that s / he can check your thyroid hormone and TSH levels; these levels should also be checked once during each trimester.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Anti-thyroid Medications

Currently, there ARE several effective treatments available FOR hyperthyroidism depending on cause, severity, and several other factors. The most common treatments for hyperthyroidism include antithyroid medications, Radioactive iodine, and thyroid surgery. Antithyroid medication decreases Thyroid hormone production. Antithyroid medicine does not cure disease but works while patients take medication. It is not usually recommended as a long term solution, although in some PATIENTS hyperthyroidism does go into remission and medication can be discontinue. If hyperthyroidism does not go into remission after two years, more definitive treatment is often recommended. Radioactive iodine is a common treatment for hyperthyroidism. The thyroid is one OF few organs in the body that avidly takes up iodine. This allows radioactive iodine to selectively damage thyroid gland without affecting other parts of the body. The thyroid gland is eventually destroyed and disappears and the body no longer produces its own Thyroid hormone. In general, this treatment can be used in PATIENTS with Graves disease or in those PATIENTS with nodules in the thyroid gland causing hyperthyroidism. Not all cases of hyperthyroidism respond well to radioactive iodine. After radioactive iodine, most PATIENTS will require Thyroid hormone replacement with Levothyroxine. Thyroid hormone levels will be checked frequently at the beginning, and then often ARE only checked once a year after the correct dose OF Thyroid hormone FOR patient has been determine. Some PATIENTS will have their hyperthyroidism treated by having part or all OF their thyroid surgically remove. Deciding which treatment for hyperthyroidism is the right treatment is made on a case by case basis according to each individual's PATIENTS medical, social, and family history. Often, surgical thyroidectomy is recommended over RAI in the following circumstances: large thyroid causing compressive symptoms unlikely to be treated adequately with RAI. Significant compression OF adjacent structures and compressive symptoms Moderate to severe Graves eye disease fail medical therapy. Adverse reaction to antithyroid medications Need FOR rapid reversal OF hyperthyroidism Fear OF radiation exposure, inability to comply with radiation safety guidelines, Co - existent Thyroid nodules and Need to rule out possibility OF Thyroid cancer Small children at home Pregnancy, desire FOR Pregnancy within next 4 - 6 months, or lactation Patient desire

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

Synthroid is approved to treat hypothyroidism. With this condition, you can have symptoms such as tiredness and weight gain. You may also have muscle weakness and constipation. With hypothyroidism, your body doesnt make enough thyroid hormones. Thyroid hormones are very important to your health because they regulate your metabolism. Your metabolism affects everything from your digestion to your body's growth and repair to even your temperature. The two main Thyroid hormones in your body are called T3 and T4. The Synthroid is a man - made form of T4, and it works by replacing T4 in your body. With Synthroid treatment, your T4 levels increase to a level that is closer to normal. Your body then uses T4 to make T3. Synthroid is approved to treat hypothyroidism that is congenital or acquire. And it approved to treat three main types of hypothyroidism, which are: primary hypothyroidism. With this condition, your Thyroid gland doesnt produce enough Thyroid hormones. Primary hypothyroidism is the most common type of hypothyroidism. It may be caused by an autoimmune disorder called Hashimotos thyroiditis. You may also develop primary hypothyroidism if your thyroid gland has been either treated with radiation or surgically remove. Secondary hypothyroidism. Your pituitary gland is supposed to tell your Thyroid gland to make Thyroid hormones. With secondary hypothyroidism, that doesnt happen. As a result, your Thyroid gland doesnt make enough Thyroid hormones. This condition may be caused by having surgery or radiation on pituitary gland. It may also be caused by trauma to your head that affects your pituitary gland, or pituitary cancer. Tertiary hypothyroidism. Your hypothalamus is supposed to tell your pituitary gland that your body needs more Thyroid hormones. With tertiary hypothyroidism, this doesnt happen. As a result, your pituitary gland doesnt tell your Thyroid gland to make enough Thyroid hormones. Tertiary hypothyroidism may occur if you have cancer in your hypothalamus. Condition can also occur if youve had radiation or surgery on your hypothalamus in the past. These different types of hypothyroidism have different causes. However, synthroid works the same way no matter the cause of condition. There are no statistics to show the effectiveness of Synthroids in treating hypothyroidism. This is because there haven't been any clinical trials that compared Synthroid or products containing levothyroxine to placebo. This lack of studies is due to drugs age and FDA History of Drug approval requirements. Despite this lack of clinical trials, levothyroxine is recommended as the primary treatment for hypothyroidism. In 2014, American Thyroid Association released guidelines showing best treatments for hypothyroidism. These guidelines state that products that contain levothyroxine should be used as standard treatment for hypothyroidism. These guidelines are based on levothyroxine many years of successful use. Years of use have shown that levothyroxine reduces symptoms of hypothyroidism in most people. Theyve also shown that when people with hypothyroidism stop using levothyroxine, they begin having symptoms of their condition again. In addition, levothyroxine treatment has been shown to be safe and without many serious side effects.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Synthroids can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Synthroid. These lists do include all possible side effects. It is important to note that most of the side effects of Synthroid are caused by having too much thyroid hormone in your body. Even small changes in your synthroid dose may cause large changes in your hormone levels, which may cause side effects. Be sure to talk with your doctor about any side effects youre having with Synthroid. In some cases, your doctor may need to adjust your dosage of drug.


General

Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;


What Is Synthroid?

Synthroid is prescribed in tablets that range from 25 to 300 mcg in strength and is usually taken once a day with a full glass of water 30 to 60 minutes before breakfast for best adsorption into body. Children can take medicine if a tablet is crushed and put into about 1 to 2 teaspoons of water; do not store or delay giving this crush pill suspension. Doctors often have to slowly increase the dose; patients should not increase or decrease this medication themselves. Because some preparations of drug may contain iodine or lactose, patients should tell their doctors about such allergies or reactions to these components.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Interactions

Thyroid Medication levothyroxine is USE TO treat hypothyroidism, endocrine disorder resulting from thyroid homone deficiency that affects about 4. 6 percent of the US population. Medication is USE TO replace missing or deficient amount of thyroid hormone. The number of prescriptions for levothyroxine filled each yearmore than 75 million US prescriptions in 2007, making it one of mostprescribed drugs in the country. Unfortunately, USE of other medications while taking levothyroxine could have one of several kinds of unintended results: some drugs may interact with levothyroxine by thwarting absorption of this thyroid drug. This effect can be avoided by taking thyroxine considerably before or, in some cases, after other Drug. That allows levothyroxine TO get absorbed without interacting with a second drug. Antacids are often USE TO treat heartburn and other intestinal distress, including calcium products such as TUMS or ROLAIDS and other antacids, may have absorption - inhibiting effects on thyroid medications. People should take levothyroxine four TO six hours before or after taking these antacids. Iron supplements have been shown to reduce the effect of levothyroxine in some people, although the effect is highly variable from one person to another. Other iron preparations may also have similar effects. Again, we advise taking levothyroxine four TO six hours before or after iron. Sucralfate, USE TO treat ulcers and other gastrointestinal diseases, appears TO inhibit absorption of levothyroxine. Trials found that this interaction was avoided when thyroid drug was given eight hours after sucralfate. Sevelamer, which is USE TO reduce excessive blood phosphate in persons with severe chronic kidney disease, also interferes with absorption of levothyroxine. Separating doses of two types of drugs by at least four TO six hours is likely TO avert interaction. Cholestyramine lowers cholesterol by increasing conversion of cholesterol TO bile acids. But it also tends TO reduce levothyroxine absorption and effect. Similar agents such as colestipol and cholesevelam may have the same effect, although there is not as much evidence for this. We recommend separating all of these medications, known as bile acid binders, from taking levothyroxine for at least four TO six hours. The antibiotic ciprofloxacin was associated with reduced levothyroxine effect in case reports, but more information is needed TO establish whether interaction occurs. Until more information is available, it would be prudent to separate doses of ciprofloxacin from those of levothyroxine by at least four hours. The same precaution should apply to other antibiotics in the same class, such as levofloxacin, lomefloxacin, monifloxacin, norfloxacin, and ofloxacin. Raloxifene, USE TO treat osteoporosis, may reduce absorption of levothyroxine, although evidence TO date is not sufficient TO establish the extent of interaction. In one case, separating two drugs by 12 hours appears TO avert interaction. Enzyme inducers stimulate production of enzymes, which in turn increase levothyroxine in the body.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Patients and Methods

Table

HormoneRatio in ThyroglobulinBiologic Potencyt 1/2 (days)Protein Binding (%) a
Levothyroxine (T4)10 - 2016-7 b99.96
Liothyronine (T3)14299.5

This was a 16 - week, open - label, randomize, control, crossover trial in which subjects were randomly assigned to receive their usual L - T 4 replacement dose as either SYNTHROID or generic for 8 weeks sequentially. To assign treatment arms, we use permutated block randomization with random block sizes of 2, 4, or 6. Sixteen patients were randomized to receive brand - name L - T 4 first, while 18 subjects were randomized to receive generic first. All 3 excluded patients had been randomized to former group, leaving 13 subjects who received SYNTHROID first and 18 who received generic first. Patients were seen at baseline, 8 weeks, and 16 weeks in the Clinical and Translational Studies Unit at Boston Children's Hospital. Patients were instructed to take their L - T 4 with water in the morning in fasting state and to have nothing to eat for 30 minutes. If they miss dose, they were told to double their dose the next day. All other medications and supplements were to be given at different times of day with particular emphasis on avoidance of soy and iron, because these are known to affect Thyroid Hormone absorption. To minimize the potential influence of diurnal variation in serum TSH concentration, blood was obtained at same time of day 2 hours, corresponding to within 2 to 8 hours after daily dose of Hormone. All medication was dispensed through a research pharmacy in 25 - g tablets. Because of the time required to recruit an adequate sample of patients, total of 12 lots of Sandoz formulation and 7 lots of SYNTHROID were used to avoid expiration. Compliance was assessed by pill counts and patient / parent recall at each visit. In addition, parents were contacted either by phone or email between visits to review progress and answer questions. The primary endpoint was the difference in serum TSH concentration after each 8 - week treatment period with branded vs generic formulation. Secondary endpoints were serum concentration of free T 4 and total T 3.


DESCRIPTION

The Synthroid contains synthetic crystalline L - 3 3 55 - tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in human thyroid gland. Levothyroxine sodium has an empirical formula of C 15 H 10 I 4 N NaO 4 H 2 O, molecular weight of 798. 86, and structural formula as show: SYNTHROID tablets for oral administration are supplied in following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains inactive ingredients acacia, confectioner's sugar, lactose monohydrate, magnesium stearate, povidone, and talc. Synthroid tablets contain no ingredients made from gluten - containing grain. Each tablet strength meets USP Dissolution Test 3. Table 6 provides a listing of color additives by tablet strength:

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Table 1. SYNTHROID Dosing Guidelines for Pediatric Hypothyroidism

AGEDaily Dose Per Kg Body Weight a
0-3 months10-15 mcg/kg/day
3-6 months8-10 mcg/kg/day
6-12 months6-8 mcg/kg/day
1-5 years5-6 mcg/kg/day
6-12 years4-5 mcg/kg/day
Greater than 12 years but growth and puberty incomplete2-3 mcg/kg/day
Growth and puberty complete1.6 mcg/kg/day
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Discussion

Synthroid is prescribed in tablets that range from 25 to 300 mcg in strength and is usually taken once a day with a full glass of water 30 to 60 minutes before breakfast for best adsorption into body. Children can take medicine if a tablet is crushed and put into about 1 to 2 teaspoons of water; do not store or delay giving this crush pill suspension. Doctors often have to slowly increase the dose; patients should not increase or decrease this medication themselves. Because some preparations of Drug may contain iodine or lactose, patients should tell their doctors about such allergies or reactions to these components. Many drugs can inhibit Synthroid's adsorption by body; other medications may increase or decrease its effectiveness once it is adsorb. Providing a complete list of medications to doctor will help with getting the correct dose established for each individual patient. Pregnant and lactating females need to discuss dose and use of this medication with their caregivers. The Dosage of Armour Thyroid is determined by the condition being treated and is individualized according to patient response and laboratory findings. Armour Thyroid may interact with birth control pills or hormone replacement therapy, blood thinners, insulin or oral diabetes medication, medications that contain iodine, salicylates such as aspirin and others, or steroids. Tell your doctor all the medications you use. Current information shows Armour Thyroid may be used during pregnancy. Tell your doctor if you are pregnant because your dose may need to be adjust. Thyroid hormone passes into breast milk but is unlikely to harm nursing infant. Consult your doctor before breast - feeding.


What is Synthroid?

Usually, if youre already taking Synthroid, youll continue taking it during pregnancy. Some information shows that taking Synthroid during pregnancy doesnt increase the risk of birth defects or pregnancy loss. In fact, hypothyroidism, which Synthroid is used to treat, can actually be dangerous during pregnancy. Not having enough thyroid hormone in your body, which happens in hypothyroidism, can increase certain risks. These risks include pregnancy loss, high blood pressure during pregnancy, and premature delivery. If you have a thyroid condition, it is important that your doctor monitors your thyroid while youre pregnant. In some cases, pregnancy may increase your thyroid hormone needs. In that case, you need to take more Synthroid than you did before pregnancy. If needed during your pregnancy, your doctor will increase your dosage of Synthroid. If youre pregnant or planning to become pregnant, talk to your doctor about how to manage Synthroid treatment.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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