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Hypothyroidism – Proving Thyroxine

Hypothyroidism  – Proving Thyroxine

If hypothyroidism was your diagnosis then you’ll know that the first line of treatment is probably going to be a brand of thyroxine sodium or T4 . For us in Australia that is Oroxine – if you need help “translating” to similar treatments in different countries see Equivalent Thyroid Hormone Brand For Australia.

So when the high TSH hypothyroid diagnosis came through soon after the blood test Dr R called me in immediately and prescribed 100mg Oroxine daily. I was also to take 8 drops of Lugal solution (iodine) in water each day for the time being. This was a quick visit to get me started on the hypothyroidism treatment and then I saw Dr R again a week later when the rest of the blood test results arrived.

A Homeopathic Aside To Explain “Proving”

Dioscorides_De_Materia_Medica_Spain_12th_13th_...
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I should say here that earlier in my life while looking for a cure for my migraines, I spent quite a bit of time studying homoeopathy. My kids were small then, and I had much success with teething (chamomilla) and fever (belladonna) remedies. I magically removed warts from 4 different boys with Thuja and had other small miracles occur at different times.

So even though homoeopathic remedies had no effect whatsoever on my migraines, or herpes, I still learned a great deal about remedies in general and strongly believe in homoeopathy as a stimulus to the body to heal itself.

Homeopathic remedy Rhus toxicodendron, derived...
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The history of a homoeopathic remedy is compiled by individuals who relate their symptoms after overdosing on the substance. This is called “proving”. The proving  or overdose symptoms are collected and compiled in the Materia Medica and homoeopathic practitioners use this to find the right remedy to heal.

For example coffee in overdose keeps people awake and “wired”. Someone who is having difficulty sleeping and is wired and tired may well be given homeopathic coffea as a treatment. Rhus Tox is a homoeopathic remedy derived from poison ivy. It is used to treat red raised itchy skin outbreaks, among other things.

Homoeopathic remedies take the substance and progressively dilute it to get their remedies. Generally speaking if we take medication and it doesn’t work sufficiently well, we increase the dose. The overdose provides the proving – the homoeopathic remedy goes in the opposite direction by “coding” the remedy, and it’s highest potencies are the most dilute.

I Appeared to Gain Hypothyroid Symptoms on Oroxine

See Symptoms of Hypothyroidism  for a full list of thyroid disorder symptoms

This is from the Oroxine® Consumer medicine Information

Symptoms of  hypothyroidism include tiredness, muscle weakness and cramps, feeling the cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice and weight gain.

These are the symptoms I presented to Dr R on the first consultation before the hypothyroid diagnosis

  1. Candida vaginal also itching / soreness external groin skin, no rash or discharge
  2. Severe eye strain, sore eyes, (they cringe)
  3. Strongly breathless walking up steep hill and after mild exertion
  4. Poor memory, struggling to concentrate or focus on tasks
  5. Muscle weakness, joint and muscle pain, stiffness, especially knee and finger joints
  6. Severe pain lower back middle to (my) right side, occasional pain in big toe right
  7. Often feel fever (?) or strange temperature changes
  8. Severe tiredness and fatigue symptoms occur half way through the day, NOT just at its end, or after moderate physical exertion, and sick headaches when over tired

Only two things here really overlap – tiredness and muscle weakness.

My situation is also slightly complicated by the candidiasis symptoms, which probably accounts for no 4 – struggling to concentrate and poor memory – as well as no 1.

The main debilitating symptoms were the eye strain and extreme tiredness. I was finding it hard to focus my eyes and they seemed to be permanently squinting or “cringing” in an attempt to deal with bright light and attempts to focus. My eyes looked sunken and the bags under my eyes were in triplicate. Not an attractive look – trust me!  I looked in the mirror, tried to focus, and told myself to go to bed. But sleep made little difference. For perhaps an hour in the mornings after waking I was good and then I started to slide into the black hole again. I fell asleep after lunch whether I wanted to or not.

The Positive Results of Taking Oroxine

I don’t remember now exactly how long it took, but in only a few weeks, my eyes returned to normal (ie still needing no3 magnifying glasses to read) but not sore and not constantly tired and no longer cringing or squinting in attempts to focus at a normal distance. The tiredness receded to a normal level as well. I might still have a nap after lunch, but if there was a better offer on the table I had no problem forgoing my nap for it and still feeling ok until bedtime. 8 hours sleep at night was enough to feel normal all day. It was bliss!

Additional Symptoms From Taking Oroxine

The Oroxine pamphlet says the usual starting dose is 25 to 50 micrograms daily. Dr R started me on 100mg so perhaps this is why I “proved” it. I’m not complaining by the way just explaining, it was good to get “kick started” quickly. As people who have been taking thyroid meds for a while will know, the dosage of them is the hardest thing to get stable, as the thyroid system adjusts to the treatment.

These are my notes from the first two weeks of treatment…

Motivation shrank even further towards “too lethargic – cant be bothered to move “ so I’ve done very little real work on the computer, apart from researching this.  I have done work that I pre arranged to get done. Have felt more sleepy and hibernated, sleeping several hours more than before.

Whereas before I felt the cold outside in a normal way, now I feel cold “inside” my skin, and I’m constantly just a bit cold inside even when bundled up and warm in bed. Cold drinks and food are now unpleasantly cold and when I touch things, some feel hard or sharp like cold metal on my skin.

Week 1: Initially sticky stool, constipated and holding fluid. When I urinate sensation is acute and urgent. Increased thirst, cold drinks are unpleasant.  Week 2: Taking Coconut oil eat 2 tablespoons a day fixed constipation.

Week 1: My (external) eyes got puffy (rather than sunken).Week 2: Eyes (internal) are still feeling a bit blurry and strained but don’t feel as bad as before. (external ) Puffiness has gone down and under the eye the sunken look has improved to almost normal. (The eye bags are genetic as a family we all have them.)

I have felt mild cramping (new) in muscles when working that needs rubbing to relieve it. Only first few days when working physically. Also  I feel very tense as if my muscles are poised for flight and I have to consciously loosen up to stop the tenseness.

Week 1: After lugals feel both better and worse, Maybe I feel a bit brighter for half an hour or so, then perhaps a bit nauseous and I’m aware of my heart beating, my temperature rises and then after an hour or so returns to normal. Overall just feel a bit off through the day especially around food times after I’ve eaten or if I’m hungry. Week 2: Had an outbreak of herpes,so feeling sciatica and lymph pain.

6 weeks is normal to let thyroxine “settle” and normalise

There is a reason doctors ask to see you and retest you in periods of around 6 weeks. It is because the body needs to adjust to the medication and decide if it is enough or if it needs more or less. The symptoms you have after this period indicate what dosage change – if any – may be needed.

I found that the symptoms above that I call proving, mostly settled and disappeared around week four or five and I felt pretty good. Then the week after I started to get sore eyes and feel tired again. The cramping, especially in my hands and the joint pain in my fingers and wrists increased. This never settled, it increased. The constipation or different bowel reaction to oroxine also stayed. It was not major but it was uncomfortable, and I had not had this before taking the oroxine.

The back pain and the sensations of breathlessness were unchanged by oroxine. In the forums I had found threads that confirmed that both these are hypothyroid symptoms and that the correct dose and combination of thyroid meds had resolved them for the patients who were writing these posts. In these cases natural thyroid or dessicated thyroid was the treatment they had used. I figured that was going to be the next step for me as well, but for now I was ok with whatever Dr R thought was appropriate.

I really didn’t expect what happened next – it threw me into a loop for just over a month…

Equivalent Thyroid Hormone Brand For Australia

Thyroid Hormone Brands

(Article republished from the Australian Thyroid Website – see credit below)

Every day millions of Americans take a small pill to compensate for a lack of thyroid hormone in their bloodstream. The drug of choice for the treatment of this and other thyroid disorders is synthetic levothyroxine sodium. The American Druggist listed two brand-name preparations as the 3rd and 51st most prescribed drugs in the United States during 1996, accounting for over 36,000,000 prescriptions of synthetic levothyroxine last year. Physicians and scientists may use different scientific names for levothyroxine, such as L-thyroxine, thyroxine, and T4 ; however, all of these terms refer to the same chemical. Thyroid hormone replacement with synthetic levothyroxine is safe, simple, effective, and relatively inexpensive.

THYROID HORMONE PREPARATIONS
UNITED STATES
BRAND-NAME LEVOTHYROXINE
Euthyrox®
Levothroid®
Levoxyl®
Synthroid®
GENERIC LEVOTHYROXINE
levothyroxine sodium USP
L-thyroxine
DESICCATED ANIMAL (“natural”) T4 /T3
Armour®
SYNTHETIC T4 /T3
Thyrolar®
SYNTHETIC T3
Cytomel®
AUSTRALIA
BRAND-NAME LEVOTHYROXINE
Oroxine®
Eutroxsig®
GENERIC LEVOTHYROXINE
DESICCATED ANIMAL (“natural”) T4 /T3
Dartnells Pharmacy
Stenlake Pharmacy
SYNTHETIC T4 /T3
SYNTHETIC T3
Tertroxin®

History of Thyroid Hormone Replacement

From the late 1890’s until relatively recently, physicians worldwide have treated hypothyroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Administration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were “grandfathered” into the system; consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain between 90% to 110% of the stated chemical content.

Who Needs It?

The majority of patients taking levothyroxine have a permanent form of hypothyroidism and will take one pill, every day, for the rest of their lives. The causes of permanent hypothyroidism are listed below:

  • Hashimoto’s thyroiditis (a chronic inflammation of the thyroid gland)
  • Radioactive iodine treatment for hyperthyroidism
  • Surgical removal of part or all of the thyroid gland
  • Congenital abnormalities, including an absence of the thyroid gland
  • Iodine deficiency
  • Radiation for cancers, such as Hodgkin’s disease
  • Pituitary or hypothalamic dysfunction
  • Unknown causes (idiopathic)

Levothyroxine therapy may also be indicated for patients with goiter, solitary thyroid nodule, multinodular goiter, thyroid cancer, thyroiditis, and hyperthyroidism treated with antithyroid drugs. In addition to the thyroid disorders listed here, some physicians have found that levothyroxine can enhance the effectiveness of certain antidepressants and use it temporarily to treat depressed patients.

Thyroid Hormones in the Bloodstream

Levothyroxine (T4) and triiodothyronine (T3) are the thyroid hormones that circulate throughout the bloodstream. The thyroid gland is the sole source of T4 . However, only 10% to 20% of T3 is made in the thyroid gland; the remaining 80% to 90% is produced when T4 is broken down into T3 by other organs in the body.

When a patient takes levothyroxine, the level of T4 in the blood rises and falls slowly. On the other hand, when a patient takes medications containing the much more potent T3, the blood level of T3 rises quickly to hyperthyroid levels and falls rapidly. Therefore, preparations containing T3 cause patients to become hyperthyroid several hours a day. Substituting one disease–hyperthyroidism–for another is not desirable.

Synthetic vs. “Natural” Thyroid Hormone

Nearly everyone can take synthetic levothyroxine; it is identical to the body’s own T4 . However, some patients, thinking that “natural” means better, prefer natural thyroid hormones, which are made of desiccated animal thyroid glands. Thyroid hormones derived from animals invariably contain T3 and, as previously noted, should not be used because they can cause hyperthyroidism. Another advantage of synthetic levothyroxine is that it has a longer shelf life than natural thyroid hormones.

Brand-Name vs. Generic

There are three well-tested, brand-name levothyroxine preparations available in the United States for the treatment of thyroid patients: Levothroid®, Levoxyl®, and Synthroid®. ( By the end of this year, Euthyrox®, which is marketed in twenty-nine other countries, will become the fourth brand-name levothyroxine product to be sold here.) Although there may be differences in the manufacturing, composition (dyes and fillers), and absorption rates among these prep-arations, each of these brand-name products is reliable and offers predictable results. Although changing from one brand to another does not usually cause problems, it is preferable to take the same brand consistently.

Generic levothyroxine tablets have not been widely recommended for several reasons:

  • Scientific studies have shown that, for some generics, the T4 content of each pill can be outside the FDA range of 90% to 110% of the stated chemical content. While a 20% range may not be a significant factor for some drugs, very small amounts of thyroid hormone can make quite a difference in the treatment of thyroid patients. For example, for some patients, a 12.5% variation in levothyroxine dosage can mean the difference between hypothyroidism or euthyroidism (having the proper amount of thyroid hormone in the body). Therefore, it is essential that patients with thyroid disease take the exact amount of prescribed levothyroxine to ensure successful treatment.
  • There have been additional concerns about the quality control in the production of generic levothyroxine, especially since generic manufacturers tend to come and go in the marketplace with great frequency, making them less accountable than long-standing manufacturers of levothyroxine. The 1997 Red Book, a pharmacist’s guide to prescription generic and brand-name drugs, lists twenty-five companies distributing synthetic levothyroxine. (Some of these companies manufacture and distribute levothyroxine tablets, and others just distribute them.) Since publication, many of the listed companies are not making or selling synthetic levothyroxine.
  • From prescription to prescription, patients may be given a different generic preparation each time, making it impractical, if not impossible, to determine if retesting patients’ thyroid hormone levels is necessary.
  • While brand-name levothyroxine preparations come in eleven to twelve different strengths, generics have less variety of strengths from which to choose. Of the generic levothyroxine distri-butors listed in the Red Book, 44% have one to four strengths available; the remaining offer five to eight strengths. For patients whose levothyroxine dosage must be adjusted several times due to age or other medical conditions, it would be difficult to stay with the same product if certain incremental changes are made.

THYROID FACTOIDS
  • Synthetic levothyroxine is the treatment of choice for thyroid hormone replacement; brand-name levothyroxine is preferable to generic preparations.
  • A diagnosis of permanent hypothyroidism requires lifetime treatment with levothyroxine.
  • The average dose of prescribed levothyroxine is between 100 mcg (0.1 mg) and 125 mcg (0.125 mg); one-third of the levothyroxine prescriptions filled are for 100 mcg.
  • If the type, brand, or dosage of levothyroxine is changed, patients should have their blood levels of thyroid hormones checked two to three months later.
  • Taking more levothyroxine than prescribed does not speed up recovery and may cause hyperthyroidism and osteoporosis (thinning of the bones).
  • Taking the proper dose of levothyroxine will not increase a patient’s risk of developing osteoporosis.
  • Levothyroxine treatment is not indicated for patients with fatigue, obesity, or infertility unless the patients also have a confirmed diagnosis of hypothyroidism.
  • The warning on some non-prescription cold and flu preparations to avoid taking them if the patient has thyroid disease does not apply to hypothyroid patients taking levothyroxine in the prescribed amounts.
  • Pregnant women and nursing mothers can safely take levothyroxine. In fact, patients with inadequately treated hypothyroidism have an increased risk of miscarriage

LEVOTHYROXINE PRICES – HOUSTON
Findings of a very informal, “unscientific” survey of levothyroxine prices at four Houston pharmacies in July 1997. If you are concerned about the cost of your thyroid hormone replacement, do your own “survey” by calling several of the pharmacies in your area.
Levothyroxine
100mcg/0.1 mg
100 Tablets
Chain One Chain Two Independent
One
Independent
Two
Synthroid® $22.99 $22.49 $42.50 $33.65
Levoxyl® $9.99 $11.09 $29.00 $21.70
Levothroid® $22.99 $11.09 $26.70 $35.00
generic Levoxyl® Levoxyl® $35.00 Levoxyl®
* Pharmacy uses Levoxyl® to fill generic prescriptions.
NATIONAL COMPARISONS
Levothyroxine
100mcg/0.1 mg
Average Wholesale Price
for 100 Tablets
Synthroid® $22.70
Levothroid® $18.56
Levoxyl® $12.17
generic $3.05 to $21.45
In Australia the supply of Oroxine® is covered by the Pharaceutical Benefits Scheme and patients can expect to pay $15.00 for 200 100mcg tablets

The question of brand-name versus generic levothyroxine has never been more controversial or hotly debated than in the last year. An article in the April 25, 1996 issue of The Wall Street Journal revealed that the brand-name manufacturer who controls 84% of the levothyroxine market in the United States was trying to withhold the results of a study it had commissioned. The controversial study was eventually published in the April 16, 1997 edition of The Journal of the American Medical Association. Designed to determine whether two generic levothyroxine products and two brand-name levothyroxine products were bioequivalent, the study concluded that the four drugs tested were bioequivalent and could be used interchangeably. Since that time, scientists and physicians have debated the merits, flaws, and significance of the study. Interestingly, the two generic levothyroxine preparations used in this controversial study were actually manufactured by the same company and distributed by two other companies. Since the time of the study, one company, after switching manufacturers, has discontinued distributing levothyroxine tablets. The second company has also switched to another manufacturer and is currently distributing only one strength (25 mcg) of levothyroxine.

Where does the controversy surrounding brand-name vs. generic leave thyroid patients who depend on levothyroxine? Will physicians change their guidelines for prescribing levothyroxine? Both the American Thyroid Association (ATA) and the American Association of Clinical Endocrinologists (AACE) publish guidelines for the treatment of hypothyroidism. AACE guidelines still recommend a brand-name preparation of levothyroxine over a generic; the ATA guidelines state that levothyroxine sodium is the treatment of choice, without specifying brand-name or generic. However, both the ATA and AACE recommend that patients be retested and their dosage adjusted accordingly if patients switch levothyroxine products. (Neither The Endocrine Society nor the National Institute of Diabetes and Digestive and Kidney Diseases-the division of the National Institutes of Health that studies thyroid disease-has published guidelines for the treatment of thyroid disease or has a stated position concerning the brand-name vs. generic issue.) Because the FDA regulations only concern the amount of stated chemical content and because researchers cannot seem to agree on the most reliable and relevant methods for testing and comparing levothyroxine preparations, it appears likely that the controversy of brand-name or generic will continue for some time. Until more testing, evaluation, and information become available, The Thyroid Society believes that it would be prudent to continue to follow the same course of action that has yielded reliable, consistent results with a minimum of additional laboratory tests and office visits. Brand-name synthetic levothyroxine can assure physicians and patients predictable results and is, therefore, the levothyroxine preparation of choice.

Cost Factors

Patients may be concerned about the costs involved in lifetime thyroid hormone replacement. Compared to other drugs, levothyroxine is relatively inexpensive. As can be seen in the table National Comparisons, the average wholesale price for the three leading brand-name levothyroxine products in the U.S. varies as much as 40%.The previously mentioned controversial study implied that generics could save consumers a great deal of money, and, indeed, most people expect generics to be less expensive than brand-names. In fact, generic prices can either be much less expensive or more expensive than a given brand-name product, depending upon the manufacturer, distributor, and pharmacy (see table Levothyroxine Prices – Houston). Depending on where you buy your generic levothyroxine, it might cost more than a brand-name. If cost savings is the incentive to switch to generic levothyroxine, the additional laboratory testing and office visits recommended when patients change from one levothyroxine product to another could offset or exceed any perceived cost savings. Some patients have expressed concern that their managed healthcare program will restrict the use of brand-name levothyroxine. Each managed healthcare plan has developed a list of drugs (a formulary) that they will cover for certain diseases. Typically, the patient pays a flat rate, or co-pay, for each prescription they have filled, regardless of the actual cost of a drug. Some plans only allow a 30-day supply of any medication to be filled at one time. If the average co-pay is $5, the patient will spend a total of $15 for 90 tablets of levothyroxine-generic or brand-name-and will go to the pharmacy three times. The patient might have spent less money and avoided two additional trips to the pharmacy by paying in full for a prescription of 100 tablets of a lower priced brand-name levothyroxine. Patients should discuss with their physician any financial concerns they have about levothyroxine so that the physician can take this information into consideration when prescribing the best treatment for the patient. In addition, thyroid patients with managed healthcare plans can discuss their concerns about their treatment with the plan’s administrator.

Dosage

The exact amount of levothyroxine prescribed to correct thyroid disorders must be individualized for each patient. When determining the initial dose of levothyroxine, physicians take several factors into consideration:

  • The patient’s age
  • The patient’s weight
  • The patient’s heart status
  • The severity of hypothyroidism

The majority of patients can be started on full thyroid hormone replacement. Patients with a history of heart problems are sometimes started on an a relatively low dosage-25 mcg (0.025 mg) to 50 mcg (0.05 mg)-of levothyroxine. [EDITOR: In Australia, Sigma Pharmaceuticals, the maker of Oroxine, recommends that all patients start on a low dose. It is Thyroid Australia’s experience that petients starting on a full dose frequently experience overdose symptoms.] The amount of levothyroxine is gradually increased every four to six weeks until the patient becomes euthyroid.

Patients who have had their entire thyroid surgically removed because of thyroid cancer typically require considerably higher doses of levothyroxine than patients with Hashimoto’s thyroiditis who have some remaining thyroid function. In addition, women taking estrogens for birth control or menopause may require higher doses of levothyroxine. Patients should not expect to feel better immediately after beginning treatment with levothyroxine, even if the initial dosage is correct. It may take six weeks or more before they experience a full response to treatment. Patients are usually re- examined and have repeat thyroid function tests two to three months after they are started on levothyroxine. If dosage adjustments are necessary, patients are re-examined and tested in another two or three months. Once patients’ thyroid hormone levels are within the proper range, they are ordinarily seen no less than once a year. Physicians may change patients’ levothyroxine dosage for various reasons, including aging and changes in patients’ medical condition.

Patients who become pregnant or start taking estrogen should see their physician two months later to determine if their levothyroxine should be increased. Pregnant women should also be checked again when they are five to six months pregnant and three to four months after they deliver. Additionally, adjustments in the dosage of levothyroxine are sometimes necessary because of changes in the thyroid disease itself. For example, if a patient is being treated for hypothyroidism due to Hashimoto’s thyroiditis, over time, this inflammation could damage additional thyroid gland tissue, causing it to produce even less thyroid hormone.

When to Take Levothyroxine

Levothyroxine should be taken daily, unless otherwise directed by the physician. For patients who have trouble remembering to take their medication, inexpensive pill boxes can be helpful. If a pill is forgotten, the patient can either take it the next day or at the end of the week. (“Doubling up” on other medications is not advisable without first checking with a physician.) Since food- especially high-fiber food and soy bean products- can interfere with absorption of levothyroxine, it is best to take levothyroxine on an empty stomach, twenty to thirty minutes before breakfast. Several drugs can also cause absorption problems. For example, Feosol®, Fergon®, prenatal vitamins, and other preparations containing large amounts of iron can significantly interfere with levothy-roxine absorption. Another drug that can cause problems is sucralfate (Carafate®), which is used in the treatment of ulcers and esophagitis. Therefore, iron and sucralfate should be taken two to four hours after levothyroxine. Patients should also avoid taking levothyroxine and antacids containing aluminum hydroxide at the same time. Drugs used to treat high cholesterol, such as Questran® and Colestid® have an even more dramatic effect on levothyroxine absorption. These drugs should be taken at least four hours, and preferably twelve hours, after levothyroxine. The effects of drugs, supplements, and diet on levothyroxine absorption can be significant. Therefore, it is always advisable for patients to tell the physician treating their thyroid disease about all of the other medications or supplements they take. It is also important for thyroid patients to tell physicians treating them for other disorders that they are taking levothyroxine. The Thyroid Society strongly encourages patients to discuss their concerns about levothyroxine therapy with their physician. Each patient is unique, and the physician managing their disease is in the best position to advise them on their treatment plan. By focusing this edition of The Thyroid Connection on levothyroxine therapy, The Thyroid Society hopes that patients will better understand the importance of taking their thyroid hormone replacement and that they will find it easier to follow their physician’s instructions.

This article is reproduced in full and acknowledges the source below
(c) Copyright 2001, Thyroid Australia Limited ABN 71 094 832 023
333 Waverley Road, Mount Waverley, 3149, Australia
Thyroid Australia Home – www.thyroid.org.au

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