oral solution oily 5%, 10% and 30%
Registration number: R N001153 / 01
Tradename: α-Tocopherol acetate.
International non-proprietary name: alpha-tocopherol acetate
Dosage form: oral solution [oily]
Description
Transparent oily liquid from light yellow to dark yellow in color without rancid odor. A greenish tint is allowed.
Structure
Active substance: Vitamin E (α-Tocopherol acetate) - 50 g, 100 g and 300 g;
Excipients - sunflower oil (refined deodorized sunflower oil) - up to 1 liter.
Pharmacotherapeutic group: vitamin
ATX CODE: [А11НА03]
Pharmacological properties
Vitamin E is a natural antioxidant. Protects the cell membranes of body tissues from oxidative changes; stimulates the synthesis of heme and heme-containing enzymes - hemoglobin, myoglobin, cytochromes, catalase, peroxidase. It inhibits the oxidation of unsaturated fatty acids and selenium. Inhibits cholesterol synthesis. Prevents hemolysis of erythrocytes, increased permeability and fragility of capillaries, dysfunction of seminiferous tubules and testicles, placenta, normalizes reproductive function; prevents the development of atherosclerosis, degenerative-dystrophic changes in the heart muscle and skeletal muscles.
Indications for use
Hypovitaminosis E; complex therapy of conditions accompanied by an increased need of the body for vitamin E:
with muscular dystrophies, dermatomycosis, amyotrophic lateral sclerosis, asthenic and neurasthenic syndromes, fatigue, paresis, myasthenia gravis, myopathies, with menstrual irregularities, threatened abortion, menopause, dysfunction of the gonads in men and women;
with dermatoses, psoriasis;
with atrophy of the mucous membrane of the respiratory tract, periodontal disease;
with rheumatic diseases: fibrositis, tendopathies, diseases of the joints and spine;
with endocrine diseases: thyrotoxicosis, diabetes mellitus, especially with ketoacidosis, diabetic polyneuropathies;
with malabsorption syndrome, chronic liver diseases;
with myocardial dystrophy, peripheral vascular spasms.
In a state of convalescence after illnesses with a febrile syndrome.
Contraindications
Increased individual sensitivity to the drug.
With caution: hypoprothrombinemia (against the background of vitamin K deficiency - it can increase with a dose of vitamin E more than 400 IU), severe atherosclerosis of the coronary arteries, myocardial infarction, increased risk of thromboembolism.
Method of administration and dosage
For oral administration, the drug is prescribed in the following doses:
For diseases of the neuromuscular system (myodystrophy, amyotrophic lateral sclerosis, etc.), 50-100 mg per day (50-100 drops of 5% solution, 25-30 drops of 10% solution or 7-15 drops of 30% solution) for 1- 2 months. Repeated courses in 2-3 months.
For men with impaired spermatogenesis and potency, 100-300 mg per day (100-300 drops of a 5% solution, 50-150 drops of a 10% solution or 15-46 drops of a 30% solution) in combination with hormonal therapy for a month.
With a threatening abortion, 100-150 mg per day (100-150 drops of a 5% solution, 50-75 drops of a 10% solution or 15-23 drops of a 30% solution).
With the usual abortion and deterioration in the intrauterine development of the fetus, 100-150 mg per day (100-150 drops of a 5% solution, 50-75 drops of a 10% solution or 15-23 drops of a 30% solution) in the first 2-3 months of pregnancy, daily or every other day.
For peripheral vascular diseases, myocardial dystrophy, atherosclerosis, 100 mg per day (100 drops of 5% solution, 50 drops of 10% solution or 15 drops of 30% solution) in combination with vitamin A. Course duration 20-40 days, after 3-6 months the course of treatment can be repeated.
For skin diseases from 15 to 100 mg per day (15-100 drops of 5% solution, 7-50 drops of 10% solution or 2-5 drops of 30% solution) for 20-40 days.
1 drop from an eye pipette contains: α - Tocopherol acetate in 5% solution - 1 mg, in 10% solution - 2 mg; in a 30% solution - 6.5 mg.
Side effect
Allergic reactions. The use of large doses of the drug can cause dyspeptic disorders, decreased performance, weakness, thrombophlebitis, pulmonary embolism, thrombosis, increased creatine kinase activity, creatinuria, hypercholesterolemia, white hair growth in areas of alopecia with epidermolysis blister.
Overdose
Symptoms: when taken for a long period at doses of 400-800 U / day (1 mg \u003d 1.21 IU) - blurred vision, dizziness, headache, nausea, unusual fatigue, diarrhea, gastralgia, asthenia, when taken more than 800 U / day for a long period - increased risk of bleeding in patients with hypovitaminosis K, impaired metabolism of thyroid hormones, disorders of sexual function, thrombophlebitis, thromboembolism, necrotizing colitis, sepsis, hepatomegaly, hyperbilirubinemia, renal failure, hemorrhage in the retinal membrane of the eye stroke, ascites.
Treatment: symptomatic, drug withdrawal, prescription of glucocorticosteroid drugs.
Interaction with other medicinal products
Strengthens the effect of glucocorticosteroid drugs, non-steroidal anti-inflammatory drugs, antioxidants.
Increases the effectiveness and reduces the toxicity of vitamins A, D, cardiac glycosides.
High doses of vitamin E can cause vitamin A deficiency in the body.
Increases the effectiveness of antiepileptic drugs in patients with epilepsy (in whom the content of lipid peroxidation products in the blood is increased).
The simultaneous use of vitamin E at a dose of more than 400 U / day with anticoagulants (coumarin and indandione derivatives) increases the risk of hypoprothrombinemia and bleeding.
Cholestyramine, colestipol, mineral oils reduce absorption.
High doses of iron increase oxidative processes in the body, which increases the need for vitamin E.
special instructions
There are a lot of products on the packaging that say "vitamin E" on iherb. Some of them cost mere pennies, while others will have to pay a tidy sum. How to make the best choice for your health and wallet? How not to run into synthetic vitamin E and not overpay for the brand? How is Now Foods different from Solgar? I talk about all this in this article. Would you like to become a vitamin E expert - welcome!
What is Vitamin E?
E vitamins act as antioxidants in the body, protecting cells from free radical damage.
Let's start with a small educational program and consider what substances belong to the vitamins of group E. I have prepared this small diagram for you so that everything is clear.
Here it is important for us to understand that vitamin E is not a lonely “homeless” molecule, but a whole group of natural compounds, the most important of which are tocopherols and tocotrienols. They both have 4 isomers - alpha, beta, delta and gamma.
Forms of vitamin E
Alpha-tocopherol
To date, in the medical community, the only active form of tocopherol that is designed to meet human needs is recognized alpha- (or α-) tocopherol. In various sources, vitamin E most often refers to alpha-tocopherol.
The problem is that scientists for a long time did not study vitamin E at all, their goal was only to study alpha-tocopherol, one of the components of vitamin E. For example, a sensational 2005 study published in the journal Annals of Internal Medicine, which disputed the use of vitamin E, reported a small increase in the risk of death associated with vitamin E supplementation. In this development, as in many others, only one component was considered - alpha-tocopherol.
Numerous dietary supplements with the name "Vitamin E" produced by commercial companies are in fact just alpha-tocopherol. The more preferred forms of vitamin E will be discussed later in this article.
In many vitamin and mineral complexes, only alpha-tocopherol is present in the composition of vitamin E, and only in some - all 4 isomers of tocopherol. Tocotrienols are practically not found in vitamin and mineral complexes.
In the United States, only an organization called the FNB (Food and Nutrition Board), which is part of the National Academy Institute of Medicine, can officially recommend to mere mortals how much vitamin E they need to take to meet our needs. It is the strict uncles and aunts in white coats from the FNB who install such a thing as the RDA. Even the DV (Daily Value) standards developed by the FDA are closer to RDA values.
Children:
- 1 - 3 years: 6 mg / day (9 IU)
- 4-8 years: 7 mg / day (10.4 IU)
- 9-13 years: 11 mg / day (16.4 IU)
Women:
- Pregnant women: 15 mg / day (22.4 IU)
- Breastfeeding: 19 mg / day (28.5 IU)
Men:
- 14 years and older: 15 mg / day (22.4 IU)
How did they calculate the RDA for vitamin E? By the level of alpha-tocopherol in the serum, which was sufficient to protect red blood cells from damage by hydrogen peroxide (free radical).
All daily recommended dosages of vitamin E are calculated specifically for alpha-tocopherol. The existence of other forms of vitamin E appears to be ignored by both the FDA and the Institute of Medicine. How much and what kind of vitamin E do we really need? About all this further and in order.
How to distinguish natural alpha-tocopherol from synthetic?
Natural alpha-tocopherol, derived from natural sources, is commonly shown on product labels as “ d-alpha-tocopherol ". Synthetic (laboratory-derived) alpha-tocopherol, referred to as " dl-alpha-tocopherol ". In general, the prefix "DL" or "dl" in the name of an active substance should suggest a synthetic form. The natural form of alpha-tocopherol is more bioavailable. For example, 100 IU of natural vitamin E corresponds to about 150 IU in synthetic form.
D-alpha tocopheryl acetate and d-alpha tocopheryl succinate are also considered natural forms of alpha-tocopherol that have undergone an esterification process to preserve the antioxidant properties of vitamin E (in order to produce vitamin E in dry form: tablets, powder). As part of vitamin and mineral complexes, d-alpha tocopheryl succinate is most often found.
Gamma-tocopherol
While alpha-tocopherol rested on its laurels and was highly regarded for its antioxidant properties, its younger, little-known cousin, gamma-tocopherol, remained underestimated, although it was equal if not superior to alpha-tocopherol in its properties. Present in nuts, seeds, and vegetable oils, gamma-tocopherol accounts for 70% of all vitamin E in the North American diet.
In April 2006, Life Extension Magazine published an article entitled "Why is gamma-tocopherol preferred over alpha-tocopherol?" which raised the issue that gamma-tocopherol should be included in the nutritional guidelines set by the US Food and Nutrition Board.
Tocotrienols
Tocotrienols are the least researched half of the entire vitamin E group. Tocotrienols differ from tocopherols structurally and have important biological functions that tocopherols lack.
Tocotrienols are considered to be more effective antioxidants than tocopherols, because due to the presence of a double bond, tocotrienols penetrate significantly more efficiently into the saturated fat layers of the brain and liver.
The richest source of tocotrienols is annatto (fondant tree), red palm oil and wheat germ.
Natural vegetable oils
Natural unrefined oils is the best and most delicious source of natural vitamin E. What oils do I prefer?
Red Palm Oil by Nutiva is an aromatic, unrefined, bright orange palm oil saturated with natural antioxidants - beta-carotene, tocotrienols and tocopherols. In a cool room, it freezes, if it is hot in the room, it becomes liquid. The manufacturer suggests using it for soups, sauces and stews. But I prefer to add it to porridge, instead of creamy, spread on slices of apple or pear, or just eat with a spoon from a can.
Wheat Germ Oil from Now Foods - natural aromatic oil, not deodorized or hydrogenated. Each tablespoon of NOW Wheat Germ Oil can contain over 1000 mcg of naturally occurring octacosanol. Octaconazole is considered one of the best sources of vitamin E. This oil is delicious - it is pleasant to take it just like that or dress it in a salad.
Vitamin E supplements on iherb
Vitamin E products on iherb can contain either one isomer (alpha-tocopherol only) or all eight. To find out which of the 8 isomers a product contains, look at the Supplement Facts table.
Let's look at and analyze together a few foods that contain a full vitamin E complex.
A complete vitamin E complex containing all 8 isomers, including 35 g of tocotrienols per serving, coenzyme Q10, alpha lipoic acid and vitamin C. Price - $ 11 for 30 servings / 400 IU of vitamin E per serving. This is the most affordable and most tocotrienol-rich complex on iHerb.
Olympian Labs Inc., Tocomin Tocotrienol Vitamin E Complete, 60 Softgels is also a complete vitamin E complex, but contains 20 mg of tocotrienols per serving. Price - $ 30 for 60 servings / 200 IU of alpha-tocopherol per serving.
INSTRUCTION
on the medical use of the drug
Registration number:
P N001777 / 01-070610Tradename: Alpha-Tocopherol Acetate (Vitamin E)
INN or grouping name: vitamin E
Dosage form:
capsulesStructure:
Active substance: Alpha-Tocopherol Acetate (Vitamin E) -100 mgExcipient: Soybean oil -100 mg.
The composition of the shell in terms of absolutely dry substance: gelatin - 52.75 mg; glycerol - 16.80 mg; methyl parahydroxybenzoate - 0.45 mg.
Description
Spherical capsules of red color, filled with oily liquid from light yellow to dark yellow, without rancid odor.
Pharmacotherapeutic group:
Vitamin.ATX code: A11NA03.
pharmachologic effect
Vitamin E is an antioxidant. Protects the cell membranes of body tissues from oxidative changes; stimulates the synthesis of heme and heme-containing enzymes - hemoglobin, myoglobin, cytochromes, catalase, peroxidase. It inhibits the oxidation of unsaturated fatty acids and selenium. Inhibits cholesterol synthesis. Prevents hemolysis of erythrocytes, increased permeability and fragility of capillaries, dysfunction of the seminiferous tubules and testicles, placenta, and normalizes reproductive function.
Pharmacokinetics
Absorption from the duodenum (requires the presence of bile salts, fats, normal function of the pancreas) - 50 - 80%. Binds to blood beta-lipoproteins. When protein metabolism is disturbed, transport is hampered. TC max -4 hours. It is deposited in all organs and tissues, especially in adipose tissue. It penetrates through the placenta in insufficient quantities: 20-30% of the concentration in the mother's blood penetrates into the fetal blood. Penetrates into breast milk. It is metabolized in the liver to derivatives with a quinone structure (some of them have vitamin activity). It is excreted in the bile - more than 90% (a certain amount is reabsorbed and undergoes enterohepatic circulation), by the kidneys - 6% (in the form of glucuronides of tocopheronic acid and its gamma - lactone).
Indications for use
Hypovitaminosis E.
In complex therapy: muscular dystrophies; dermatomyositis; atherosclerosis, myocardial dystrophy; menstrual irregularities; threats of termination of pregnancy, dysfunction of the sex glands in men; dermatoses, psoriasis.
Contraindications
Individual hypersensitivity to the components of the drug, acute myocardial infarction, childhood.
Carefully: hypoprothrombinemia, severe cardiosclerosis, previous myocardial infarction, increased risk of thromboembolism.
Pregnancy and breastfeeding period
The drug in this dosage is not recommended for use in the normal course of pregnancy. For pregnant and lactating mothers, the recommended dose of vitamin E is 10-14 mg.
Method of administration and dosage
Inside, 100-300 mg / day, if necessary, up to 1 g / day.
For diseases of the neuromuscular system - 100 mg per day for 1-2 months. Repeated courses in 2-3 months.
With violations of spermatogenesis and potency - 100 - 300 mg per day in combination with hormonal therapy for a month.
With a threatened abortion - 100 mg per day for 7-14 days, with the usual abortion and deterioration of intrauterine development of the fetus - 100 mg per day for the first 2-3 months of pregnancy every day or every other day.
With diseases of peripheral vessels, myocardial dystrophy, atherosclerosis - 100 mg per day (with vitamin A) for 20 - 40 days, after 3-6 months the course of treatment can be repeated.
In dermatology - 100 mg per day for 20 - 40 days.
Side effect
Allergic reactions, dyspepsia are possible.
Overdose
Symptoms: when taking vitamin E for a long period at doses of 400-800 mg / day: - blurred vision, dizziness, headache, nausea, fatigue, diarrhea, gastralgia, asthenia.
When taking more than 800 mg / day for a long period - an increase in the risk of bleeding in patients with hypovitaminosis K, impaired metabolism of thyroid hormones, disorders of sexual function, thrombophlebitis, thromboembolism, necrotizing colitis, sepsis, hyperbilirubinemia, renal failure, hemorrhage in the retina , hemorrhagic stroke, ascites.
Treatment: symptomatic. Cancellation of the drug, the appointment of glucocorticosteroid drugs.
Interaction with other medicinal products
Vitamin E enhances the effect of glucocorticosteroid drugs, non-steroidal anti-inflammatory drugs, cardiac glycosides.
Reduces the effectiveness and toxicity of vitamins A and D. Increases the effectiveness of antiepileptic drugs in patients with epilepsy.
The simultaneous use of other multivitamin complexes containing vitamin E is not recommended in order to avoid overdose.
The simultaneous intake of large doses of vitamin E with iron, vitamin K, or anticoagulants (drugs that prevent blood clotting), increases the time of blood clotting.
special instructions
Do not exceed the recommended dosage. Do not take a double dose if you missed a previous dose.
Release form
Capsules 100 mg.
10 capsules in a blister strip made of polyvinyl chloride film and polymer-coated paper or lacquered aluminum foil.
2, 3, 4 blister packs, together with instructions for use, are placed in a pack of chrome-ersatz cardboard or boxboard.
1, 2, 3, 5, 10, 20, 50 blister packs, together with an equal number of instructions for use, are placed in a hermetically sealed polyethylene bag made of opaque polyethylene film, or of a combined material on a paper and cardboard basis, or of a combined material " Buflen ", or from a two-layer combined material.
50, 100, 200, 400, 600 blister strip packs together with an equal number of instructions for use are placed in a hermetically sealed polyethylene bag made of opaque polyethylene film.
Plastic packaging is placed in a cardboard box.
For hospitals 50, 100, 200, 400, 600 blister strip packs together with instructions for use are placed in a cardboard box.
Vitamin E (alpha-tocopherol) is a compound of fat-soluble molecules. The most biologically active is alpha-tocopherol, or TE for short. It is this equivalent that measures the activity of vitamin E and is the standard for measuring the activity of other forms.
The name tocopherol was derived from the Latin tocos phero, which means "bearing offspring". And this name, accordingly, reflects its role in reproduction.
The assimilation of vitamin E (TE) is due to its fat-soluble nature and requires its intake with fats and bile.
Tocopherol does not withstand high temperatures, exposure to light, freezing and long-term storage. Frying destroys almost all of the vitamin in the oil.
Action of vitamin E (alpha-tocopherol)
Vitamin E (TE) is not limited to reproductive function. It is also able to have a beneficial effect on such body processes as:
Due to its antioxidant properties, it can be used to prevent Alzheimer's disease and diabetes complications. In addition, this vitamin can be used in the treatment of inflammatory diseases, Parkinson's disease. It also lives up to its name, helping restore potency disorders in men, acting in combination with vitamin A.
Tocopherol has a strong diuretic effect, due to which it can normalize blood pressure.
Unfortunately, tocopherol is capable of providing only a preventive effect, but not a curative one for many diseases, and therefore it is worthwhile to think about the right lifestyle as soon as possible.
Daily rate
The daily intake of vitamin E (TE) varies by age, gender, and in different countries. It has already been proven that most of the population in Europe and the United States suffers from vitamin deficiency due to unbalanced diet and lifestyle. Especially considering the fact that more than half of the vitamin consumed is not absorbed and washed out of the body.
The daily requirement ranges from 140-210 IU per day for an adult. With increased loads, for example, among athletes, it is necessary to increase the consumption rate. Dosage increases are also required in conditions of living in high mountain areas, in industrial polluted areas, under stress, during puberty and with hormonal treatment.
Interestingly, in Europe, the upper limit is considered consumption of 300 mg per day, in the UK - 540 mg, and in the United States, this dose reaches 1000 mg per day for any form of E (alpha-tocopherol). It has been proven that such a dose can be used for a long period and does not cause hypervitaminosis.
Lack of vitamin E (alpha-tocopherol)
Vitamin E (alpha-tocopherol) deficiency is most commonly seen in people with fat digestion problems, liver disease, and in newborn babies.
In the modern world, people have practically stopped consuming wheat germ and switched to fine flour, which does not carry any useful properties. This largely determines the lack of tocopherol, which is found in large quantities in wheat.
The manifestations of hypovitaminosis are primarily a decrease in muscle mass, vision problems, especially in children. Externally, hypovitaminosis is expressed in the appearance of age spots on the skin and lime deposits on the teeth. Dry skin and brittle nails also begin to appear. There are problems with being overweight, because lack of oxygen affects the metabolic rate.
With persistent failure, kidney and liver problems may occur.
In addition, in pregnant women, acute failure can be expressed in premature birth or in general to problems with gestation, and in general there are problems with sexual dysfunction in women and men.
Excess vitamin E (alpha-tocopherol)
Excess vitamin E (TE) for a long time can cause profuse bleeding. Therefore, in cases of planned surgery, it is recommended to reduce the intake of tocopherol in advance.
Also, when taking more than 4000 IU per day for several months, the appearance of disorders of the gastrointestinal tract was observed - increased stool frequency, nausea, pain and bloating in the stomach. Bleeding increases noticeably even with minor wounds, and women experience a longer and more painful menstruation.
Sources of vitamin E (alpha-tocopherol)
The richest sources of vitamin E (TE) include all types of vegetable oils, nuts, cereals and wheat germ. Much less of it is found in meat, dairy products and plant products.
Interaction with other elements
When taking a vitamin, it should be borne in mind that it can interact with other vitamins and drugs that can have both positive and negative effects:
Indications for appointment
Indications for prescription for disease prevention:
There are also contraindications to taking tocopherol: heart failure, ischemic heart disease, hypertension, diabetes mellitus, disorders of fat metabolism, hypersensitivity to the drug.
Instructions for use:
Alpha-Tocopherol Acetate is a natural antioxidant, fat-soluble vitamin.
Release forms
Vitamin Alpha-tocopherol acetate is available in the form of lozenges, capsules, oily solution for intramuscular infusion, oily solution for oral administration. The active ingredient is vitamin E.
pharmachologic effect
Vitamin Alpha-tocopherol acetate as an antioxidant prevents the development of free radical reactions, stops the formation of peroxides that harm the full development of the human body, it is necessary for the normal functioning of the muscular and nervous systems. Vitamin E in combination with selenium inhibits erythrocyte hemolysis, prevents oxidation of unsaturated fatty acids. Serves as a cofactor in some enzyme systems.
Vitamin E plays an important role in the functioning of the body. So, for example, it was noticed that in animals with a lack of vitamin E, irreversible changes are found in the structures of tissues, in the muscle of the heart and skeletal muscles, there is increased permeability and fragility of capillaries. In embryos, due to a lack of vitamin E, hemorrhages occur, leading to intrauterine death. Lack of vitamin E leads to damage to nerve tissues and liver cells.
Vitamin E hypovitaminosis in newborns can cause hemolytic jaundice. There is also an increased content of fat in the stool (steatorrhea), malabsorption syndrome.
Indications for the use of vitamin Alpha-tocopherol acetate
Alpha-tocopherol acetate according to the instructions is prescribed for:
- muscular dystrophy (decrease in muscle strength and volume);
- amyotrophic lateral sclerosis (a disease of the central nervous system, the consequence of which is a deterioration in the motor activity of the limbs and facial muscles);
- myocardiopathy (heart muscle disease);
- spasms of peripheral vessels;
- liver diseases;
- violations of potency (sexual activity) and impaired spermatogenesis (the process of formation of germ cells);
- some types of skin diseases, including psoriasis;
- malfunctions of the menstrual cycle;
- threatened miscarriage.
In pediatrics, Alpha-tocopherol acetate is prescribed according to the instructions for:
- hypotrophy (eating disorder);
- scleroderma (a systemic skin disease);
- hypervitaminosis D (excess vitamin D in the body).
As an antioxidant, tocopherol is used in the complex therapy of eye, cardiovascular diseases, to reduce side effects in the treatment of chemotherapeutic drugs.
There is evidence that tocopherol enhances the effectiveness of anticonvulsant therapy in epilepsy, in the case of an increased content of lipid peroxidation products in the blood.
Contraindications to the use of the drug
Alpha-tocopherol acetate capsules and solution should be used with caution in myocardial infarction, severe cardiosclerosis and high risk of thromboembolism.
Method of administration according to the instructions Alpha-tocopherol acetate
For diseases of the muscular and nervous system, Alpha-tocopherol acetate capsules or solution are prescribed at a dosage of 50 to 100 mg per day.
In case of violation of potency and spermatogenesis, the daily dose of Alpha-tocopherol acetate capsules or solution ranges from 100 to 300 mg.
When the condition of the embryo worsens and the usual abortion is prescribed tocopherol in a dosage of 100 to 150 mg per day in the first trimester of pregnancy.
If the pregnancy is threatened, Alpha-tocopherol acetate is prescribed according to the instructions in a dosage of 100 to 150 mg per knock for one month.
For peripheral vascular disease and atherosclerosis, the daily dose of tocopherol is 100 mg in combination with retinol.
Side effects of the drug
When taking large doses of alpha-tocopherol acetate, performance decreases, creatinuria and diarrhea occur.