Croscarmellose Sodium [What Is It? Why Avoid It?] – Remedy’s Nutrition

Finding the right pharmaceutical and supplement solutions to your needs requires knowing the right ingredients. Here is a guide on croscarmellose sodium in our Additives to Avoid Series.

• Know Your Ingredients
• What Is Croscarmellose Sodium?
• Why Is It Added to Some Supplements?
• Is Croscarmellose Sodium Safe?
• Does It Have Any Side Effects?
• Could I Be Allergic To Croscarmellose Sodium?
• Does Croscarmellose Sodium Raise Blood Pressure?
• Why You Should Avoid Supplements With Croscarmellose Sodium?
• Why Remedy’s Nutrition® Never Uses Croscarmellose Sodium?
• What Make Remedy’s Nutrition® Different?
• Learn More About High-Quality (Additive-Free) Dietary Supplements

Know Your Ingredients

Nothing is worse than starting on a new supplement routine, then finding out that it contains harmful ingredients. Unfortunately, this is more common than you would think. Many medications and supplements contain hidden ingredients such as croscarmellose sodium, which can do more harm than good.

According to a recent study, croscarmellose sodium has caused many allergic reactions, and the Food and Drug Administration still has it approved as an “inactive ingredient.” These reactions may include high blood pressure, swollen intestines, heart failure, and pulmonary edema. 

The problem is…

• How can we be safe from the croscarmellose side effects?
• How do we know if croscarmellose is inside our medications and supplements?
• How does croscarmellose sodium work, exactly?

Keep reading to learn more. This article can help you avoid croscarmellose sodium, stay safe & healthy, and make the most out of your supplement routine. 

Thankfully, we know how crucial it is having clean and unambiguous answers, so we have created this guide to teach you everything you need to know about croscarmellose sodium and how to avoid it.

What is Croscarmellose Sodium?

Croscarmellose sodium, or sodium croscarmellose, is a cross-linked polymer of carboxymethylcellulose sodium. It is a white, fibrous powder and is an ingredient used as a super disintegrant in pharmaceutical formulas.

It comes from wood pulp or cotton fibers and contains no sugar or starch content. 

A super disintegrating agent is a unique formula designed to help the body break down complex substances such as tablets or capsules.

WOW! This stuff sounds amazing…

They are used for low levels in the solid dosage, usually between 1-10% solid, much lower than regular disintegrating agents.

Typically, these disintegrating agents are created to break up the tablet in the intestinal tract after oral dosing.

This helps the drug or supplement to be delivered effectively; however, the formulations are still relatively new and understudied for safety.

Croscarmellose sodium has been used widely in multiple pharmaceuticals and supplements because of its ability to expand up to 20 times its original size. 

Because Croscarmellose sodium is hydrophilic, which means “water-loving”, its intent is to extract fluids from the environment and pull it into the structure. 

Croscarmellose sodium is also widely used in cosmetic and beauty products as well as food products.

Sounds great, right? Then why is there so much confusion around this additive?

Why is Croscarmellose Sodium Added to Some Supplements?

Our bodies are designed to break down molecules and eliminate foreign compounds. This means that it can be hard to absorb certain medications. Therefore, pharmaceutical companies created a compound to help your body absorb the benefits of the medications. 

Unfortunately, this is not the whole truth. Croscarmellose Sodium as an ingredient is also used as a filler, to reduce costs for big pharma, which is an unintegral decision to preserve the bottom line. 

Companies can choose how much Croscarmellose sodium they want to add to their products. Depending on where in the intestinal tract the manufacturer wants the formula to be absorbed, it will determine how much Croscarmellose sodium they use.

Additionally, Croscarmellose sodium and other disintegrant agents are used to help the tablet break down effectively. Without them, the active ingredients may not be absorbed effectively which would lower the effectiveness.

In certain circumstances where the tablet is an essential medication, the inclusion of disintegrants could make a difference in someone’s health and well-being. 

Some of the most common medications and types of drugs and supplements with croscarmellose sodium are:

• Acetaminophen 
• Acetaminophen and Oxycodone
• Acetaminophen and Hydrocodone
• Acetaminophen and Codeine Phosphate 
• Cyclobenzaprine Hydrochloride
• Clonazepam
• Naproxen
• Ibuprofen
• Percocet
• Mass Produced Supplements

This is not a medical disclaimer; however, we highly suggest that you become more aware of the ingredients in your medications.

Some drug and supplement manufacturers may focus more on production and add disintegrants like croscarmellose sodium to help with the timely breakdown in a cheap manner, ignoring any potential side effects of the end user.

So now down to the question you have been wanting to know…

Is Croscarmellose Sodium Safe?

Because croscarmellose sodium is a commonly used disintegrating agent, it means that it should be safe, right?

Wrong!

The Food and Drug Administration has only approved croscarmellose sodium in small amounts for medication and supplement usage.

If used in too high of quantities, it can cause harmful side effects.

In 2010, one woman was taken to the hospital for pulmonary edema, congestive heart failure, and extremely high blood pressure. Upon investigation, doctors discovered that she was experiencing an allergic reaction to croscarmellose sodium. She also experienced an enlarged left ventricle, rashes all over the body, and multiple other health concerns.   

Does Croscarmellose Sodium Have Any Side Effects?

Croscarmellose sodium does not have any official “side effects” unless you react to the additive directly. 

It is also suggested that anyone with any intestinal conditions should avoid croscarmellose sodium altogether.

This additive may make it risky for those who are on the verge of a relapse of Crohn’s and other conditions.

Could I Be allergic to Croscarmellose Sodium?

There is a very slight chance that you could be allergic to croscarmellose sodium, and unfortunately, when you notice symptoms, you could already be suffering from severe complications.

Anaphylactic Reactions

Patients who have a slight sensitivity to croscarmellose sodium can go into anaphylactic shock if they receive an injection with the additive.

The problem is, not many people know that they have a sensitivity until it is too late.

One study found that two patients who received a cortisone injection with croscarmellose sodium as the additive immediately went into anaphylactic shock.

The best way to avoid any allergic reactions is to pay attention to how your body is responding to medications with the croscarmellose sodium additive in them. If you are noticing any abdominal or intestinal pain, notify your doctor immediately.

Intestinal Obstructions

Because of its ability to absorb surrounding fluids and expand up to 20 times its size for better drug solubility, croscarmellose sodium can put you at risk for intestinal blockages. If you experience abdominal pain while taking any medications with croscarmellose sodium, speak to your doctor immediately. 

Overgrowth of Intestinal Flora

While we may be taught to fear all bacteria, this is not entirely true, as intestinal bacteria is a crucial element of good health.

Intestinal, or gut microflora, are microorganisms and good bacteria that grow in your gut. 

Our gut is like an ecosystem; it needs a proper balance of good and bad bacteria to function efficiently.

Therefore taking probiotics are an essential part of any health routine.  

Unfortunately, some things can send our gut bacteria out of balance, causing a significant overgrowth and unbalance of harmful bacteria.

This overgrowth causes Crohn’s disease, celiac disease, and irritable bowel syndrome.

Many health researchers have found a correlation between croscarmellose sodium and intestinal flora overgrowth.

Inefficient Supplement Delivery

Croscarmellose sodium is popularly used among pharmaceutical manufacturers because of its ability to extract water from its environment. However, this same benefit can also make it dangerous.

If someone leaves the medication out without the lid, this additive will absorb moisture out of the air.

This premature absorption causes the medication to be broken down and released into the stomach instead of the intestines. This could either make the drug stronger or weaker, depending on the drug or rate of absorption.

If this drug is essential for your health, this could lead to severe implications.

Does Croscarmellose Sodium Raise Blood Pressure?

Sodium is an essential mineral for proper nerve and muscle function. Yet, too much sodium (also known as hypernatremia) can negatively impact blood pressure levels.

Because croscarmellose sodium does not contain much sodium, it does not officially raise blood pressure levels.

That being said, if you react to it, your blood pressure will elevate to help pump more blood to remove the compounds, which inadvertently raises your blood pressure. 

Why Should I Avoid Supplements With Croscarmellose Sodium?

Many low-grade, mass-produced supplements contain croscarmellose sodium in their synthetic vitamins and minerals.

These synthetic compounds can prevent the body from absorbing any of the ingredients.

This is because every cell within our bodies has receptor sites that detect which combination it recognizes and approves or rejects accordingly.

If it does not recognize it, you may be putting your health at risk, especially if you are deficient in that vitamin or mineral.

This also leads to a waste of money because you are purchasing low-grade supplements that are not doing their job.

Why Remedy’s Nutrition® Never Uses Croscarmellose Sodium in our Supplements

Remedy’s Nutrition® will never use additives such as croscarmellose sodium because we use only the purest ingredients in our supplement formulations.

Other supplement brands may source from low-grade or inferior ingredients because it is cheaper and easier to produce. However, there is always the possibility of risk when choosing this production method. Not our M.O.

Please remember this simple fact: Keeping your digestive system in balance can help you better utilize the nutrients you take in from food and supplements.

This can help maintain your health and improve your life.

Avoiding additives like croscarmellose sodium can only help to improve your overall health. That is why we never use these cheap fillers and additives in our amazing supplements and personal care products.

To help maintain your gut health, we recommend you take Superzymes™ and 35 Billion Probiotic for one month at least once a year.

What Make Remedy’s Nutrition® Different?

What separates Remedy’s Nutrition® from other supplement brands is our integrity behind our products. Quality, Purity, Pride is not just our slogan, it’s our way of life.

There is much investigation behind each source of our supplements and personal care products. Our goal is for your body to recognize and and utilize our supplements to make you feel better and live and stronger, healthier life. 

All our products have been tested by a third party for Lead, Cadmium, Mercury, and Arsenic to ensure they are safe for consumption.

One more added step for your safety and protection.

Some of our top sellers include:

• Superzymes™ Capsules
• 35 Billion Probiotic Capsules
• Ultimate Detox™ Capsules
• Super Diabe Caps™
• Calm Surfer™ Capsules and Tincture
• Happy Surfer™ Capsules and Tincture
• Mega Sleep™ Capsules
• Mega VMT™ | High Dose Daily Multivitamin
• Deeper Sleep™ Capsules, Tincture and Tea

We also have Premium CBD, essential oils, daily essential vitamins, and herbal blends.

Learn More About High-Quality (Additive-Free) Dietary Supplements

Now that you know more about sneaky additives in most supplements and medications, you probably wonder where to find supplements that are safe and free of croscarmellose sodium and other additives.

Thankfully, Remedy’s Nutrition® produces the highest-quality supplements on the market at surprisingly affordable prices.

All of our all-natural products are third-party tested for the purity and integrity of each ingredient.

You can feel good, shopping at Remedy’s Nutrition®, Guaranteed thanks to our 100% Risk-Free, Satisfaction Guarantee and our commitment to Quality, Purity, and Pride.

About Gene C.

Lentz

He is the president of Remedy’s Nutrition®. He has helped 100’s of clients improve their health through nutrition and supplements. He loves spending time with his lovely wife, Maria and once supported himself as a tennis pro.

LEARN MORE

Croscarmellose Sodium Side Effects | Healthfully

Croscarmellose sodium is a commonly used matrix to deliver drugs to the intestines. Stabilizing sodium carboxymethylcellulose produces croscarmellose sodium. The Food and Drug Administration has approved croscarmellose sodium for use as an inactive ingredient in any pharmaceutical. The amount of croscarmellose sodium added to the drug or supplement is dependent on where the manufacturer wants the material to disintegrate in the intestinal tract. Since croscarmellose sodium is typically used in small doses, not many side effects are reported.

Intestinal Blockage

Croscarmellose sodium is valued based on its sponge-like ability. Even when used in hard-tablet form, croscarmellose sodium can expand up to 20 times its original size by soaking up fluids in the body, according to a report in “AAPS PharmSciTech. ” This allows the drugs or supplements greater access to fluids to aid drug solubility. Large doses of croscarmellose sodium may have the ability to create an intestinal blockage if consumed at roughly the same. Industrial workers producing croscarmellose sodium may be the most likely people to come into contact with large enough samples to cause this symptom. If you experience any abdominal pain, talk to your doctor.

• Croscarmellose sodium is valued based on its sponge-like ability.
• Large doses of croscarmellose sodium may have the ability to create an intestinal blockage if consumed at roughly the same.

Ineffective Drug or Supplement Delivery

Is Potassium Chloride a Poison?

Learn More

Croscarmellose sodium’s ability to expand and absorb fluids makes it an ideal vehicle for drug and supplement delivery. However, if medicines and supplements with croscarmellose sodium are left out of their containers, they will also absorb moisture from the air, states “AAPS PharmSciTech. ” This could cause the drug to be released in your stomach instead of your intestines. If the drug is released prematurely, you may not absorb the correct dose. If your medicine has become exposed to moisture, talk to your doctor about getting a replacement prescription.

• Croscarmellose sodium’s ability to expand and absorb fluids makes it an ideal vehicle for drug and supplement delivery.
• If the drug is released prematurely, you may not absorb the correct dose.

Overgrowth of Flora

Dr. Sidney Haas created the Specific Carbohydrate Diet to avoid harmful bacterial flora growth in the intestines. This diet limited complex carbohydrates and refined sugar in the attempt to stop symptoms of Crohn’s disease, irritable bowel syndrome and celiac disease. Under the guidelines of this diet, croscarmellose sodium should be specifically avoided because of its ability to promote overgrowth of flora, both good and bad. If you have any symptoms of gastrointestinal trouble, you may want to avoid this additive when possible. You can talk to your doctor about alternative medications that don’t utilize this additive, and supplements made by different manufacturers may not rely on the same additives.

• Dr. Sidney Haas created the Specific Carbohydrate Diet to avoid harmful bacterial flora growth in the intestines.
• Under the guidelines of this diet, croscarmellose sodium should be specifically avoided because of its ability to promote overgrowth of flora, both good and bad.

Pharmacy on Gagarina, 7

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MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

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INSTRUCTIONS

for the use of a medicinal product for medical use

Euthyrox ^®

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Registration number:

P N015039/01 – tablets 25 mcg, 50 mcg, 75 mcg, 100 mcg, 125 mcg, 150 mcg.

LP-000910 – tablets 88 mcg, 112 mcg, 137 mcg.

Trade name :&nbsp, Euthyrox ^®

International non-proprietary name: levothyroxine sodium

Dosage form : tablets

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Composition

Each tablet contains:

Active ingredient: levothyroxine sodium – 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg or 150 mcg.

Excipients: corn starch – 25.00 mg, gelatin – 5.00 mg, croscarmellose sodium – 3.50 mg, magnesium stearate – 0.50 mg, lactose monohydrate – 65.975 / 65.95 / 65.925 /65.912/65.90/65.888/65.875/65.863/65.85 mg.

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Description

White, round tablets, flat on both sides, beveled. On both sides of the tablet there is a dividing line, on one side of the tablet there is an engraving “I eat + dosage”.

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Pharmacotherapeutic group: thyroid agent.

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05 Pharmacotherapeutic properties

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Pharmacodynamics

its action is identical to thyroxin, synthesized by the human thyroid gland. After partial transformation into triiodothyronine (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases the need for oxygen in tissues, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system.

In high doses, it inhibits the production of thyrotropin-releasing hormone of the hypothalamus and thyroid-stimulating hormone (TSH) of the pituitary gland.

The therapeutic effect is observed after 7-12 days, during the same time the effect persists after discontinuation of the drug. The clinical effect in hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

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Pharmacokinetics

Suction. When administered orally, levothyroxine sodium is absorbed primarily in the upper small intestine. Up to 80% of the accepted dose of levothyroxine sodium is absorbed. & nbsp, Eating reduces the absorption of levothyroxine sodium. The maximum serum concentration is reached approximately 5-6 hours after ingestion.

Distribution. After absorption, more than 99% of the drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, monodeiodination of approximately 80% of levothyroxine sodium occurs with the formation of triiodothyronine (T ₃ ) and inactive products.

Metabolism. Thyroid hormones are metabolized primarily in the liver, kidneys, brain, brain and muscles. A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). The half-life of the drug is 6-7 days. With thyrotoxicosis, the half-life is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days. The estimated volume of distribution is 10-12 liters. Metabolic clearance is about 1.2 liters of blood plasma per day.

Removal. Metabolites are excreted by the kidneys and through the intestines.

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Indications

-&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, hypothyroidism,

-& nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, euthyroid goiter,

-&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp]0007

– &nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, as a suppressive and replacement therapy for malignant neoplasms of the thyroid gland, mainly after surgical treatment,

-&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, &nbsp,&nbsp,&nbsp, diffuse toxic goiter: after reaching the euthyroid state with antithyroid drugs (as a combination or monotherapy),

-&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, as a diagnostic tool during the test thyroid suppression.

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Contraindications ,&nbsp,&nbsp, untreated thyrotoxicosis,

-&nbsp,&nbsp ,&nbsp, untreated pituitary insufficiency,

-&nbsp,&nbsp,&nbsp,&nbsp,&nbsp, untreated adrenal insufficiency,

-&nbsp, use during pregnancy in combination with antithyroid drugs,

Do not start treatment with the drug in the presence of acute myocardial infarction, acute myocarditis, acute pancarditis.

This product contains lactose and is therefore not recommended in patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption syndrome.

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With caution & nbsp, the drug should be prescribed for diseases of the cardiovascular system: ischemic heart disease (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term existence developing hypothyroidism, syndrome malabsorption (dose adjustment may be required), in patients with a predisposition to psychotic reactions.

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Use during pregnancy and breastfeeding

During pregnancy and breastfeeding, treatment of hypothyroidism with Euthyrox 9002 3 ® must continue. During pregnancy, an increase in the dose of the drug may be required due to an increase in the content of thyroxine-binding globulin. During breastfeeding, the drug should be taken strictly in recommended doses, under the supervision of a physician. When using levothyroxine sodium at the recommended therapeutic doses, the concentration of thyroid hormones in breast milk does not reach a level that can cause hyperthyroidism and suppress TSH secretion in a child. There is no evidence of the occurrence of teratogenic and fetotoxic effects when taking the drug at recommended therapeutic doses. Taking the drug during pregnancy in excessively high doses &nbsp, can &nbsp, negatively affect the fetus and postnatal development.

The use of the drug during pregnancy in combination with antithyroid drugs is contraindicated, since taking levothyroxine sodium may require an increase in the doses of antithyroid drugs. Since antithyroid drugs, unlike levothyroxine sodium, can cross the placenta, the fetus may develop hypothyroidism.

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Method of administration and dosage

The daily dose of Euthyrox ^® is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) and without chewing.

When performing replacement therapy for hypothyroidism in patients younger than 55 years of age in the absence of cardiovascular diseases, Euthyrox ^® is prescribed in a daily dose of 1.6-1.8 mcg per 1 kg of body weight, in patients older than 55 years or with cardiovascular diseases – 0.9mcg per 1 kg of body weight.

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90 002

0007

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  for children under 3 years old, the daily dose of Euthyrox ^® is given in one dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.

In patients with severe long-term hypothyroidism, treatment should be initiated with extreme caution, starting at low doses at 12.5 mcg/day, increasing to maintenance at longer intervals by 12.5 mcg/day every 2 weeks or more frequently determine the concentration of TSH in the blood.

In hypothyroidism, Euthyrox ^® is usually taken throughout life. In thyrotoxicosis, Euthyrox ^® is used in complex therapy with antithyroid drugs after reaching the euthyroid state. In all cases, the duration of treatment with the drug is determined by the doctor.

For accurate dosing, the most suitable dosage of Euthyrox ^® must be used.

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Side effect

When Euthyrox ^® is used correctly under the supervision of a physician, side effects are not observed. Cases of allergic reactions in the form of angioedema have been reported.

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Overdose

In overdose of the drug, a significant increase in the metabolic rate is observed. Clinical signs of hyperthyroidism may occur in case of overdose, if the individual tolerance threshold for levothyroxine sodium is exceeded, or if the dose of the drug increases too quickly from the start of therapy. Symptoms characteristic of hyperthyroidism: cardiac arrhythmias, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle twitches, flushing (especially of the face), fever, vomiting, menstrual irregularities, benign intracranial hypertension, tremor, anxiety, insomnia, hyperhidrosis, weight loss, diarrhea.

Depending on the severity of symptoms, the doctor may recommend a reduction in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers. When taking extremely high doses, plasmapheresis can be prescribed. After the disappearance of side effects, treatment should be started with caution at a lower dose.

Overdose of levothyroxine sodium may lead to symptoms of acute psychosis, especially in patients with a predisposition to psychotic disorders.

Cases of sudden cardiac arrest have been reported in patients who have taken excessively high doses of levothyroxine sodium for many years. In predisposed patients, isolated cases of seizures have been noted when the individual tolerance threshold is exceeded.

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Interaction with other drugs

effect of antidepressants.

Levothyroxine sodium reduces the effect of cardiac glycosides.

With the simultaneous use of cholestyramine and colestipol (ion exchange resins), as well as aluminum hydroxide, the plasma concentration of levothyroxine sodium is reduced by inhibiting its absorption in the intestine. In this regard, levothyroxine sodium should be used 4-5 hours before taking these drugs.

When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interactions at the level of plasma protein binding are possible.

Protease inhibitors (eg ritonavir, indinavir, lopinavir) may interfere with the efficacy of levothyroxine sodium. Careful monitoring of thyroid hormone levels is recommended. If necessary, the dose of levothyroxine sodium should be adjusted. Phenytoin may interfere with the efficacy of levothyroxine sodium due to displacement of levothyroxine sodium from plasma protein binding, which may lead to an increase in free T4 and T3 concentrations. On the other hand, phenytoin increases the intensity of the metabolism of levothyroxine sodium in the liver. Careful monitoring of thyroid hormone levels is recommended.

Levothyroxine sodium may reduce the effectiveness of hypoglycemic drugs. Therefore, frequent monitoring of blood glucose levels is necessary from the start of thyroid hormone replacement therapy. If necessary, the dose of the hypoglycemic drug should be adjusted.

Levothyroxine sodium may enhance the effect of anticoagulants (coumarin derivatives) by displacing them from plasma proteins, which may increase the risk of bleeding, such as CNS or gastrointestinal bleeding, especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary both at the beginning and during combined therapy with these drugs. If necessary, the dose of the anticoagulant should be adjusted. Salicylates, dicoumarol, high-dose furosemide (250 mg), clofibrate and other drugs can displace levothyroxine sodium from plasma protein binding, leading to an increase in the concentration of the free T4 fraction.

Orlistat: Concomitant use of orlistat and levothyroxine sodium may result in hypothyroidism and/or decreased control of hypothyroidism. The reason for this may be a decrease in the absorption of iodine salts and / or sodium levothyroxine.

Sevelamer may reduce the absorption of levothyroxine sodium. Tyrosine kinase inhibitors (eg, imatinib, sunitinib) may reduce the effectiveness of levothyroxine sodium. Therefore, at the beginning or at the end of the course of concomitant therapy with these drugs, it is recommended to monitor changes in thyroid function in patients. If necessary, the dose of levothyroxine sodium is adjusted.

Aluminum-containing drugs (antacids, sucralfate), iron-containing drugs, calcium carbonate have been described in the literature as potentially reducing the effectiveness of levothyroxine sodium. Therefore, it is recommended to take levothyroxine sodium at least 2 hours before the use of such drugs.

Somatropin, when used simultaneously with levothyroxine sodium, may accelerate the closure of the epiphyseal growth zones.

Propylthiouracil, glucocorticosteroids, beta-sympatholytics, iodine-containing contrast agents and amiodarone inhibit the peripheral conversion of T4 to T3. Due to the high content of iodine, the use of amiodarone may be accompanied by the development of both hyperthyroidism and hypothyroidism. Particular attention should be paid to nodular goiter with the possible development of unrecognized functional autonomy.

Sertraline, chloroquine/proguanil decrease the efficacy of levothyroxine sodium and increase serum TSH levels.

Drugs that induce hepatic enzymes (eg, barbiturates, carbamazepine) may increase hepatic clearance of levothyroxine sodium.

In women using estrogen-containing contraceptives, or in postmenopausal women receiving hormone replacement therapy, the need for levothyroxine sodium may increase.

Consumption of soy-containing foods may reduce intestinal absorption of levothyroxine sodium. Therefore, dose adjustment may be required, especially at the beginning or after the cessation of the use of products containing soy.

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With the simultaneous use of orlistat and levothyroxine sodium, hypothyroidism and / or a decrease in the control of hypothyroidism may occur (see section “Interaction with other drugs”). Patients taking levothyroxine sodium should consult a physician before starting orlistat, as it may be necessary to take orlistat and levothyroxine sodium at different times of the day and adjust the dose of levothyroxine sodium. Further monitoring of thyroid function is recommended.

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Influence on the ability to drive vehicles and mechanisms

Studies of the drug on the effect on the ability to drive vehicles and mechanisms have not been conducted. However, since levothyroxine sodium is identical to natural thyroid hormone, no effect on the ability to drive vehicles and mechanisms is expected.

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Release form

Tablets 25, 50, 75, 88, 100, 112, 125, 137 or 150 mcg. 25 tablets in a PVC / AL or Polypropylene / AL blister, 2 or 4 blisters, together with instructions for use, are placed in a cardboard box.

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Storage conditions

In a place protected from light at a temperature not exceeding 25 °C.

Keep out of reach of children.

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Shelf life

3 years. &nbsp, Do not use after the expiration date.

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Dispensing conditions

By prescription.

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MH/Manufacturer

Merck KGaA

Frankfurter Strasse 250, 64293 Darmstadt, Germany

Merc k KGaA

Frankfurter Strasse 250, 64293 Darmstadt, Germany

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Consumer claims and information about adverse events should be sent to:

Merck LLC

115054 Moscow, st. Valovaya, d. 7

Normoson

General characteristics

• Dosage form and description:

  Film-coated tablets.
  Round, biconvex, white film-coated tablets with a score line on one side.
  The tablet may be divided according to risk into 2 equal doses.

  Composition :
  Each film-coated tablet contains 15.0 mg doxylamine succinate.
  Excipients, the presence of which should be taken into account in the composition of the medicinal product: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silicon dioxide, magnesium stearate, povidone, lactose monohydrate
  Coating composition: hypromellose, titanium dioxide, macrogol 6000

  Pharmacotherapeutic group: Antihistamines for systemic use. Aminoalkyl ethers.

  ATC code: R06AA09

• Pharmacological properties

  Pharmacodynamics
  Doxylamine is an H1-histamine receptor antagonist from the group of ethanolamines. It has a hypnotic, sedative and M-anticholinergic effect. Reduces the time to fall asleep, improves the quality and duration of sleep.

  Pharmacokinetics
  Absorption:
  The maximum plasma concentration is reached on average 2 hours after oral administration.

  Metabolism and excretion:
  The plasma half-life is 10 hours on average.
  Doxylamine succinate is partially metabolized in the liver by demethylation and N-acetylation.
  The number of metabolites formed during the breakdown of the doxylamine succinate molecule is insignificant, since 60% of the administered dose is found unchanged in the urine.

• Indications for use
• Dosage and Administration

  The drug is intended for adults only
  Dosing regimen
  The recommended dose is 7. 5-15 mg (1/2 – 1 tablet) 1 time per day.
  If necessary, the dose can be increased to 30 mg (2 tablets) 1 time per day.
  Special patient groups
  The elderly and in cases of renal or hepatic insufficiency are advised to reduce the dose.
  How to use
  inside.
  It is necessary to take the drug once a day 15-30 minutes before bedtime with a small amount of water.
  Duration of treatment
  The duration of the drug Normoson® is from 2 to 5 days; if insomnia persists for more than 5 days despite ongoing doxylamine therapy, treatment should be reassessed.

• Side effect

  – Anticholinergic effects: constipation, urinary retention, dry mouth, visual impairment (accommodation disturbance, blurred vision, visual hallucinations, decreased visual acuity), palpitations, confusion.
  – Rhabdomyolysis, an increase in the level of creatine phosphokinase (CPK) in the blood.
  – Daytime drowsiness, the occurrence of which requires a dose reduction.
  Cases of doxylamine abuse and addiction have been reported.
  First generation H1 antihistamines can cause sedation, cognitive and psychomotor impairment.

  Reporting adverse reactions
  It is important to report suspected adverse reactions after a medicinal product is registered in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union. In the Republic of Belarus, it is recommended to report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of drug failure (UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, http:www.rceth. by).

• Contraindications

  – Hypersensitivity to doxylamine succinate or other components of the drug;
  – Hypersensitivity to antihistamines. ;
  – History of angle-closure glaucoma (increased intraocular pressure), incl. family.;
  –
  Diseases of the urethra and prostate with the risk of urinary retention .;
  – Age up to 15 years.

• Overdose

  Symptoms
  With an overdose of the drug, drowsiness and signs of anticholinergic effects occur: agitation, sinus tachycardia, redness of the face and neck, hyperthermia, dilated pupils, accommodation paralysis, dry mouth. Delirium, hallucinations, athetotic movements are observed more often in children and may be harbingers of convulsions that occur as complications of severe poisoning or coma. Even in the absence of convulsions in acute doxylamine poisoning, there is a possibility of rhabdomyolysis, which can be complicated by acute renal failure. In connection with the possibility of developing these disorders, it is necessary to carry out systematic monitoring by measuring the level of creatine phosphokinase.

  Treatment
  In case of overdose, symptomatic treatment is carried out. As a first aid in the early stages of treatment, it is recommended to take activated charcoal (50 g for adults, 1 g/kg of body weight for children).

• Interaction with other drugs

  Alcohol, including alcoholic beverages and products
  The sedative effect of h2-antihistamines is enhanced by alcohol. A decrease in concentration and speed of psychomotor reactions can be dangerous when driving vehicles and performing other potentially hazardous activities, therefore, during treatment with doxylamine, it is necessary to avoid drinking alcoholic beverages and taking medicines containing alcohol.
  Sodium hydroxybutyrate
  Increased depression of the central nervous system can occur with the combined use of doxylamine succinate and sodium hydroxybutyrate.
  Combinations with which caution should be exercised
  Atropine and other atropine-like medicinal products
  Doxylamine in combination with atropine and atropine-like drugs (imipramine antidepressants, other atropine-like H1 antihistamines, anticholinergic antiparkinsonian drugs, atropine antispasmodic drugs, disopyramide, phenothiazine antipsychotics, clozapine) increases the risk of adverse reactions such as urinary retention, constipation, dry mouth, etc.
  Other sedative drugs
  Morphine derivatives (used for pain relief, cough or substitution therapy), antipsychotics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative h2 antihistamines, antihypertensives central action, some other drugs (baclofen, pizotifen, thalidomide) when used together with doxylamine lead to depression of the central nervous system. Reduced attention in this case can be dangerous when driving and / or working with moving mechanisms.
  Other sleeping pills
  Increase the depression of the central nervous system.

• Fertility, pregnancy and lactation

  Pregnancy
  Doxylamine should be used with caution during pregnancy. In the case of the use of the drug by a pregnant woman in late pregnancy, the atropine-like and sedative properties of the drug should be taken into account when monitoring the newborn.
  Breastfeeding period
  Because it is not known whether doxylamine passes into breast milk, this drug is not recommended during breastfeeding because of the potential for sedation or increased arousal in the newborn.

• Effects on ability to drive and use machines

  It is necessary to inform the patient about the risk of daytime sleepiness in persons driving vehicles and working with potentially dangerous mechanisms. In particular, the patient’s attention should be paid to this effect when taking the drug together with alcohol, preparations containing ethyl alcohol, other sedatives, sodium oxybutyrate (see section 4.5). Therefore, during the period of treatment with Normoson®, it is recommended to avoid driving moving mechanisms, work that requires increased attention, and other potentially hazardous activities. It is also necessary to inform the patient that if the duration of sleep is insufficient after taking a dose of the drug, the risk of decreased attention increases.

• Special instructions

  Often, sleep disorders can be associated with a deterioration in general well-being or mental disorders and do not require drug therapy with hypnotic drugs, as they are eliminated by other means or treatment of the underlying disease. Normoson® should not be taken for a long time for the treatment of chronic sleep disorders.
  Doxylamine succinate, like all hypnotics or sedatives, may aggravate pre-existing sleep apnea.
  The risk of drug abuse and dependence is low. At the same time, cases of abuse and development of dependence on doxylamine have been reported. Monitor for signs of abuse or dependence on the drug. The recommended duration of taking the drug should not exceed 5 days. If the symptoms of insomnia persist for more than 5 days, despite the ongoing treatment, the treatment tactics should be reconsidered. If the patient has a history of disorders such as drug abuse, the use of Normoson® is not recommended.
  Accumulation risk
  Doxylamine succinate, like all drugs, remains in the body for approximately five half-lives.
  In the elderly or in the presence of renal or hepatic insufficiency, the half-life may be significantly increased. With repeated use, the drug and its metabolites reach the equilibrium concentration much later and at a much higher level, in such cases, only when the equilibrium concentration is reached can the efficacy and safety of the drug be assessed. Dose adjustment may be required.
  Features of the use of doxylamine in the elderly
  In the elderly, h2-antihistamines should be used with caution because of the possible risk of developing cognitive impairment, sedation, slow response and/or dizziness, resulting in an increased risk of falls (eg, when getting up at night) with possible consequences that are often are serious for this category of patients.
  Precautions for use in the elderly, with renal or hepatic impairment
  In the elderly and / or in the presence of renal or hepatic insufficiency, an increase in the concentration of doxylamine succinate in plasma and a decrease in plasma clearance are possible.