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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Aloe Socotrina, Bone Marrow Suis, Bos Taurus Placenta, Bos Taurus Skin, Dna, Echinacea Angustifolia, Echinacea Purpurea, Ferrum Metallicum, Fucus Vesiculosus, Iodium, Kali Phosphoricum, Phosphorus, Ribes Nigrum Flower Bud, Soy Lecithin, Vitamin A Acetate, Vitamin E Acetate
Brand Name
N04
Generic Name
Aloe Socotrina, Bone Marrow Suis, Bos Taurus Placenta, Bos Taurus Skin, Dna, Echinacea Angustifolia, Echinacea Purpurea, Ferrum Metallicum, Fucus Vesiculosus, Iodium, Kali Phosphoricum, Phosphorus, Ribes Nigrum Flower Bud, Soy Lecithin, Vitamin A Acetate, Vitamin E Acetate
Active Ingredient
.alpha.-tocopherolCategory
Vitamin C [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 9 [hp_X]/mL | SOLUTION/ DROPS | SUBLINGUAL | 63479-1404 |
Detailed information about N04
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for N04, you must consult a qualified healthcare professional.
.alpha.-tocopherol is the most biologically active form of Vitamin E, functioning as a potent fat-soluble antioxidant. It is classified under several EPCs including Vitamin C [EPC] and Platelet Aggregation Inhibitor [EPC] due to its diverse metabolic and hematologic effects.
The dosage of .alpha.-tocopherol varies significantly depending on whether it is being used for general nutritional support or for the treatment of a specific medical condition. Dosage is often expressed in either International Units (IU) or milligrams (mg). Note that 1 mg of d-alpha-tocopherol (natural) is equivalent to 1.49 IU, while 1 mg of dl-alpha-tocopherol (synthetic) is equivalent to 1.1 IU.
Pediatric dosing must be strictly supervised by a pediatrician, as excessive intake can be toxic to developing systems.
For children with malabsorption, doses are significantly higher and are calculated based on weight and serum vitamin levels.
Standard doses of .alpha.-tocopherol are generally considered safe for patients with kidney disease. However, patients on hemodialysis should be monitored, as water-soluble metabolites may accumulate. High-dose therapy should be used with caution.
Since the liver is the primary site for .alpha.-tocopherol processing and the production of the tocopherol transfer protein, patients with severe hepatic impairment (Child-Pugh Class C) may require dosage adjustments. Serum levels should be monitored to ensure efficacy and avoid toxicity.
No specific dosage adjustments are required for the elderly based solely on age. However, because older adults are more likely to be taking anticoagulants (blood thinners), the risk of bleeding must be carefully evaluated before starting high-dose .alpha.-tocopherol.
To ensure maximum effectiveness and safety, follow these administration guidelines:
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the dose to "catch up," as this increases the risk of side effects.
Acute overdose of .alpha.-tocopherol is rare, but chronic overconsumption (megadosing) can lead to significant toxicity. Signs of overdose include:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment is primarily supportive, focusing on the discontinuation of the supplement and management of bleeding complications.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
When taken at recommended nutritional doses (under 400 IU/day), .alpha.-tocopherol is generally well-tolerated. However, some patients may experience:
As the dose increases (especially above 800 IU/day), the following side effects become more prevalent:
> Warning: Stop taking .alpha.-tocopherol and call your doctor immediately if you experience any of these.
Prolonged use of high-dose .alpha.-tocopherol (above 400 IU daily) has been the subject of significant clinical scrutiny. Long-term risks include:
No FDA black box warnings for .alpha.-tocopherol currently exist. However, the FDA requires specific labeling for parenteral (injectable) Vitamin E regarding the risk of pulmonary edema and liver/kidney failure in premature infants, a condition historically known as E-Ferol syndrome (though that specific product was removed from the market).
Report any unusual symptoms to your healthcare provider.
.alpha.-tocopherol is a potent biological agent that can significantly alter blood chemistry and cellular signaling. It is not "just a vitamin" when taken in pharmacological doses. Patients must be aware that high doses can increase the risk of life-threatening bleeding episodes, particularly when combined with other medications that affect coagulation.
No FDA black box warnings for .alpha.-tocopherol.
If you are taking high-dose .alpha.-tocopherol for a medical condition, your healthcare provider may require the following tests:
.alpha.-tocopherol generally does not interfere with the ability to drive or operate heavy machinery. However, if you experience side effects such as blurred vision or dizziness, you should avoid these activities until the symptoms resolve.
Alcohol should be consumed with caution while taking .alpha.-tocopherol. Chronic alcohol use can deplete the liver's stores of Vitamin E, but acute alcohol consumption may also increase the risk of gastrointestinal irritation and bleeding when combined with high-dose tocopherol.
For most patients taking standard doses, .alpha.-tocopherol can be stopped without a tapering period. However, patients taking very high doses for malabsorption or genetic disorders must not stop the medication suddenly, as this could lead to a rapid return of neurological or retinal symptoms. Always consult your doctor before stopping a prescribed regimen.
> Important: Discuss all your medical conditions with your healthcare provider before starting .alpha.-tocopherol.
While few drugs are strictly contraindicated, the following combinations pose extreme risks:
.alpha.-tocopherol may interfere with certain laboratory tests:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
.alpha.-tocopherol must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a physician:
Patients who are sensitive to other tocopherols (beta, gamma, delta) are highly likely to be sensitive to .alpha.-tocopherol. Additionally, patients with known allergies to legumes should exercise caution if the .alpha.-tocopherol is derived from soybean sources.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing .alpha.-tocopherol.
.alpha.-tocopherol is classified as Pregnancy Category A when used in doses meeting the RDA (15 mg). It is essential for fetal development, particularly for the nervous system and lungs. However, when used in high doses (Category C), there is insufficient data to guarantee safety. Some studies have suggested that high-dose Vitamin E supplementation during pregnancy may increase the risk of premature rupture of membranes or congenital heart defects. Pregnant women should never exceed the Upper Limit (UL) of 1000 mg daily unless specifically directed by a maternal-fetal medicine specialist.
.alpha.-tocopherol is naturally present in breast milk and is vital for the nursing infant. Standard maternal supplementation is considered safe and does not appear to cause adverse effects in the infant. However, supra-nutritional doses taken by the mother can significantly increase the concentration in breast milk. The effects of such high levels on a nursing infant's developing coagulation system are not well-studied; therefore, caution is advised with high-dose therapy.
.alpha.-tocopherol is approved for use in children for the treatment of deficiency and malabsorption. It is especially critical in premature infants to prevent hemolytic anemia and retinopathy. However, extreme caution is required; high-dose intravenous Vitamin E has been linked to a fatal syndrome in neonates characterized by liver and kidney failure. Oral dosing is the preferred route for pediatric patients.
Older adults are at an increased risk for .alpha.-tocopherol-related complications. This is primarily due to the high prevalence of polypharmacy in this age group, particularly the use of anticoagulants (warfarin) and antiplatelets (aspirin). Furthermore, the age-related decline in renal and hepatic clearance can lead to higher systemic exposure. Geriatric patients should be started on the lowest effective dose and monitored closely for signs of easy bruising or bleeding.
In patients with chronic kidney disease (CKD), the metabolism of .alpha.-tocopherol metabolites (CEHCs) is reduced. While the parent compound is primarily excreted in feces, the accumulation of these metabolites in patients with a GFR below 30 mL/min is a concern. Routine supplementation is generally safe, but high-dose therapy should be avoided in stage 4 or 5 CKD unless serum levels are monitored.
Patients with cholestatic liver disease have impaired bile flow, which is necessary for .alpha.-tocopherol absorption. These patients often require water-soluble forms of the vitamin (TPGS). In patients with cirrhosis, the liver's ability to produce the tocopherol transfer protein is diminished, which can lead to low serum levels despite adequate intake. Dose adjustments must be based on serum alpha-tocopherol-to-lipid ratios.
> Important: Special populations require individualized medical assessment.
At the molecular level, .alpha.-tocopherol acts as a lipid-soluble antioxidant that protects polyunsaturated fatty acids (PUFAs) in cell membranes from oxidation. When a peroxyl radical (LOO•) attacks a membrane lipid, .alpha.-tocopherol reacts with the radical faster than the radical can react with an adjacent lipid chain. The .alpha.-tocopherol molecule donates a phenolic hydrogen to the radical, forming a stable lipid hydroperoxide and an alpha-tocopheroxyl radical. This tocopheroxyl radical is then "recycled" back into .alpha.-tocopherol by other antioxidants like Vitamin C (ascorbic acid) or glutathione. This explains why .alpha.-tocopherol is classified under Vitamin C [EPC] in some systems—the two vitamins work in a synergistic redox cycle.
Additionally, .alpha.-tocopherol inhibits the enzyme Protein Kinase C (PKC). PKC is a key signaling molecule in vascular smooth muscle cells and platelets. By inhibiting PKC, .alpha.-tocopherol reduces cell proliferation and inhibits platelet aggregation, providing a secondary mechanism for its cardiovascular and anti-inflammatory effects.
The pharmacodynamic effect of .alpha.-tocopherol is not immediate. For antioxidant protection, steady-state levels in the cell membranes must be reached, which can take several weeks of consistent dosing. The anti-platelet effect is dose-dependent, typically becoming clinically significant at doses exceeding 400 IU per day. Tolerance to the antioxidant effects does not typically develop, but the body has a finite capacity to store and transport the vitamin via α-TTP.
| Parameter | Value |
|---|---|
| Bioavailability | 20% - 80% (requires dietary fat) |
| Protein Binding | Bound to Lipoproteins (VLDL, LDL, HDL) |
| Half-life | ~48 hours |
| Tmax | 3 - 6 hours |
| Metabolism | Hepatic (CYP4F2 mediated ω-oxidation) |
| Excretion | Fecal (>75%), Renal (<25% as metabolites) |
.alpha.-tocopherol is a fat-soluble vitamin. Within the Electronic Orange Book and other regulatory databases, it is associated with the Vitamin C [EPC] and Vitamin D [EPC] classes, as well as the Platelet Aggregation Inhibitor [EPC] and Nonsteroidal Anti-inflammatory Drug [EPC] classes due to its multi-faceted physiological roles.
Common questions about N04
.alpha.-tocopherol, commonly known as Vitamin E, is primarily used to treat or prevent Vitamin E deficiency, especially in individuals with fat malabsorption disorders like cystic fibrosis or Crohn's disease. It acts as a powerful antioxidant, protecting your body's cells from damage caused by free radicals. Doctors may also prescribe it for specific conditions like non-alcoholic steatohepatitis (NASH) or to prevent neurological damage in rare genetic disorders. Beyond its nutritional role, it is sometimes used to support skin health and eye function. Always consult your healthcare provider to see if a supplement is necessary for your specific health needs.
Most people taking .alpha.-tocopherol at standard doses do not experience significant side effects. However, some may notice mild gastrointestinal issues such as nausea, stomach cramps, or diarrhea, particularly if the supplement is taken without food. At higher doses, users have reported symptoms like fatigue, headache, and blurred vision. Because it has mild blood-thinning properties, easy bruising or slightly prolonged bleeding from small cuts can also occur. If you experience any severe symptoms like a sudden, intense headache or signs of internal bleeding, seek medical attention immediately. Most minor side effects resolve quickly once the body adjusts or the dose is lowered.
While there is no direct contraindication, you should be cautious when consuming alcohol while taking .alpha.-tocopherol. Chronic alcohol consumption can interfere with the liver's ability to store and process Vitamin E, potentially leading to lower levels in the body. Additionally, both alcohol and high-dose Vitamin E can irritate the stomach lining and increase the risk of bleeding. If you are taking high doses of .alpha.-tocopherol for a medical condition, alcohol may complicate your treatment or increase the risk of side effects. It is best to discuss your alcohol intake with your doctor to ensure it does not interfere with your health goals. Moderation is generally advised.
.alpha.-tocopherol is considered safe and essential during pregnancy when taken at the Recommended Dietary Allowance (RDA) of 15 mg per day. It supports the development of the baby's nervous system and immune function. However, taking high-dose supplements (megadoses) during pregnancy is not recommended and could potentially be harmful to the developing fetus. Some research suggests that excessive Vitamin E intake might be linked to heart defects or other complications in the newborn. Always talk to your obstetrician before starting any new supplement while pregnant. They can help you determine the correct amount based on your diet and prenatal vitamins.
The time it takes for .alpha.-tocopherol to work depends on the condition being treated. For someone with a severe deficiency, it may take several weeks of consistent daily dosing before blood levels normalize and symptoms like muscle weakness or vision problems begin to improve. As an antioxidant, its effects are not something you 'feel' immediately, as it works at the cellular level over time to reduce oxidative stress. If you are taking it for a condition like NASH, your doctor will likely monitor your liver enzymes over several months to assess its effectiveness. Consistency is key, as it takes time for the vitamin to build up in your cell membranes. Do not expect instant results from this supplement.
For most individuals taking .alpha.-tocopherol as a general nutritional supplement, stopping suddenly does not cause withdrawal symptoms or immediate health risks. However, if you are taking high doses to manage a specific medical condition, such as a genetic malabsorption disorder, stopping abruptly could lead to a return of serious symptoms. These might include a decline in neurological function, coordination issues, or vision changes as your body's antioxidant protection drops. It is always safest to consult your healthcare provider before discontinuing any prescribed supplement. They may want to monitor your blood levels or gradually reduce your dose. Never stop a medically necessary treatment without professional guidance.
If you miss a dose of .alpha.-tocopherol, take it as soon as you remember, provided it is not almost time for your next scheduled dose. If you are close to your next dose, simply skip the missed one and continue with your regular routine. You should never take two doses at once to make up for a missed one, as this can increase the risk of gastrointestinal upset or bleeding. Because .alpha.-tocopherol is fat-soluble and stored in the body, missing a single dose is unlikely to have a major impact on your overall health. To help you remember, try taking your supplement at the same time each day with a meal. Consistency ensures that your body maintains adequate levels of the vitamin.
There is currently no clinical evidence to suggest that .alpha.-tocopherol causes weight gain. It is a micronutrient that does not contain significant calories and does not typically affect appetite or metabolism in a way that leads to fat accumulation. In fact, some studies have explored its role in supporting metabolic health in patients with fatty liver disease. If you notice unexpected weight gain while taking this supplement, it is likely due to other factors such as diet, lifestyle changes, or other medications. Always discuss significant weight changes with your healthcare provider to identify the underlying cause. .alpha.-tocopherol is generally considered weight-neutral.
.alpha.-tocopherol can interact with several types of medications, so it is important to be cautious. The most significant interaction is with blood thinners like warfarin (Coumadin) or aspirin, as Vitamin E can increase the risk of bleeding. It may also interfere with the effectiveness of certain chemotherapy drugs or cholesterol-lowering medications like statins and niacin. Some weight-loss drugs, such as Orlistat, can prevent your body from absorbing .alpha.-tocopherol properly. Because of these potential interactions, you should always provide your doctor with a full list of all medications and supplements you are taking. They can help you schedule your doses to avoid any negative effects.
Yes, .alpha.-tocopherol is widely available as a generic supplement and is sold under many different brand names and store labels. It is available over-the-counter (OTC) in various strengths and formulations, including natural (d-alpha-tocopherol) and synthetic (dl-alpha-tocopherol) versions. Generic versions are required to meet the same quality standards as brand-name supplements, making them a cost-effective option for most patients. You can find it in most pharmacies, grocery stores, and health food shops. When choosing a generic, look for products that have been third-party tested for purity. Your pharmacist can help you select a high-quality generic version that fits your needs.
Other drugs with the same active ingredient (.alpha.-tocopherol)