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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Cobalefol
Generic Name
Vitamin
Active Ingredient
.alpha.-tocopherol Succinate, D-Category
Vitamin C [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 10.5 mg/1 | CAPSULE | ORAL | 72835-550 |
Detailed information about Cobalefol
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Cobalefol, you must consult a qualified healthcare professional.
.alpha.-tocopherol Succinate, D- is a potent, fat-soluble form of Vitamin E belonging to the Vitamin C [EPC] and Photoenhancer [EPC] drug classes. It is primarily utilized for its antioxidant properties and its role in protecting cellular membranes from oxidative damage.
The dosage of .alpha.-tocopherol Succinate, D- must be individualized based on the patient's nutritional status and the specific condition being treated.
Pediatric dosing is strictly based on age and weight.
In cases of pediatric malabsorption (e.g., cystic fibrosis), a pediatric gastroenterologist may prescribe doses as high as 100-400 IU per day.
Standard doses of .alpha.-tocopherol Succinate, D- do not generally require adjustment in patients with mild to moderate renal impairment. However, because water-soluble metabolites are excreted renally, patients with end-stage renal disease (ESRD) should be monitored for potential accumulation if taking high-dose supplements.
Since the liver is the primary site for the production of alpha-tocopherol transfer protein (alpha-TTP), patients with severe hepatic impairment (e.g., cirrhosis) may have altered Vitamin E metabolism and transport. Dosing should be cautious, and serum levels may need to be monitored.
No specific dosage adjustments are required for the elderly, although healthcare providers should consider the increased risk of polypharmacy (taking multiple medications) and potential interactions with anticoagulants in this population.
To ensure maximum efficacy and safety, patients should follow these administration guidelines:
If a dose is missed, it should be taken as soon as the patient remembers. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Do not double the dose to catch up, as this can increase the risk of gastrointestinal upset.
Acute overdose of .alpha.-tocopherol Succinate, D- is rarely life-threatening but can cause significant distress. Signs of excessive intake include:
In case of a massive overdose, contact a poison control center or seek emergency medical attention immediately. Treatment is generally supportive, involving the discontinuation of the supplement.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
When taken at standard nutritional doses (less than 400 IU/day), .alpha.-tocopherol Succinate, D- is generally well-tolerated. However, some patients may experience:
These symptoms are usually transient and resolve as the body acclimates to the treatment. Taking the supplement with a large meal often mitigates these effects.
At higher therapeutic doses (400 IU to 800 IU), the following side effects may be reported:
Rarely, patients may experience more significant reactions, often linked to high-dose long-term use:
> Warning: Stop taking .alpha.-tocopherol Succinate, D- and call your doctor immediately if you experience any of these.
Prolonged use of high-dose .alpha.-tocopherol Succinate, D- (exceeding 400-800 IU daily for years) has been a subject of clinical concern. Data from the SELECT (Selenium and Vitamin E Cancer Prevention Trial) suggested a potential increased risk of prostate cancer in men taking 400 IU of Vitamin E daily over several years. Additionally, some meta-analyses have suggested that very high-dose Vitamin E supplementation may be associated with a slight increase in all-cause mortality, although these findings remain controversial and are often debated among nutritionists.
No FDA black box warnings for .alpha.-tocopherol Succinate, D-. However, the FDA requires that labels for high-dose Vitamin E products include warnings regarding the risk of bleeding, especially for patients on anticoagulant therapy.
Report any unusual symptoms to your healthcare provider.
.alpha.-tocopherol Succinate, D- is a potent biological agent that can significantly influence blood coagulation and oxidative balance. It should not be viewed as a "harmless" vitamin when taken in supplemental doses. Patients with a history of bleeding disorders or those scheduled for surgery must exercise extreme caution. It is vital to maintain a consistent intake and avoid sudden, high-dose escalations without medical supervision.
No FDA black box warnings for .alpha.-tocopherol Succinate, D-.
The most significant clinical precaution for .alpha.-tocopherol Succinate, D- is its effect on Vitamin K metabolism. High doses of alpha-tocopherol can inhibit the activity of Vitamin K-dependent carboxylase, effectively acting as a mild anticoagulant. This increases the risk of bleeding, particularly in patients who are already Vitamin K deficient or taking blood thinners.
Due to the risk of increased perioperative bleeding, healthcare providers typically recommend discontinuing .alpha.-tocopherol Succinate, D- supplements at least two weeks before any elective surgical or dental procedure.
While Vitamin E was once thought to protect the heart, the HOPE-TOO (Heart Outcomes Prevention Evaluation The Ongoing Outcomes) trial indicated that long-term supplementation with 400 IU of Vitamin E might actually increase the risk of heart failure in patients with vascular disease or diabetes.
Patients with retinitis pigmentosa (a genetic eye disorder) should consult an ophthalmologist before taking Vitamin E, as some evidence suggests it may accelerate the progression of the disease in specific populations.
For patients on long-term or high-dose therapy, healthcare providers may require the following monitoring:
.alpha.-tocopherol Succinate, D- typically does not interfere with the ability to drive or operate heavy machinery. However, if a patient experiences blurred vision or dizziness as a side effect, they should avoid these activities until the symptoms resolve.
There is no direct contraindication between moderate alcohol consumption and .alpha.-tocopherol Succinate, D-. However, chronic heavy alcohol use can impair the liver's ability to store and transport Vitamin E, potentially leading to deficiency or altered drug metabolism.
There is no known withdrawal syndrome associated with the discontinuation of .alpha.-tocopherol Succinate, D-. However, patients taking it for a specific medical deficiency should not stop treatment without consulting their doctor, as the underlying deficiency symptoms may return.
> Important: Discuss all your medical conditions with your healthcare provider before starting .alpha.-tocopherol Succinate, D-.
While there are few absolute contraindications, .alpha.-tocopherol Succinate, D- should not be used in combination with:
.alpha.-tocopherol Succinate, D- does not typically interfere with common laboratory blood tests, but it can affect the results of specialized assays for oxidative stress markers or lipid peroxidation levels.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
.alpha.-tocopherol Succinate, D- must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a healthcare provider include:
Patients who are allergic to soy or vegetable oils should check the source of their .alpha.-tocopherol Succinate, D-. Many natural Vitamin E supplements are derived from soybean oil, which may contain trace proteins that trigger reactions in highly sensitive individuals. Synthetic versions (dl-alpha-tocopherol) may be a safer alternative for these specific patients, though they are less biologically active.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing .alpha.-tocopherol Succinate, D-.
.alpha.-tocopherol Succinate, D- is generally considered safe during pregnancy when taken in amounts that meet the RDA (15 mg or 22.4 IU). It is classified as Pregnancy Category A at these levels. However, when taken in high supplemental doses, it is classified as Category C. There is limited data on the effects of high-dose Vitamin E on the developing fetus. Some studies have suggested that excessive Vitamin E intake during the first trimester might be associated with a slightly increased risk of congenital heart defects, though the evidence is not conclusive. Pregnant women should never exceed the RDA unless specifically directed by their obstetrician.
Vitamin E is a natural component of breast milk and is essential for infant health. Supplemental .alpha.-tocopherol Succinate, D- is considered compatible with breastfeeding at RDA levels. The vitamin does pass into breast milk, and maternal supplementation can increase the Vitamin E content of the milk. There are no known adverse effects on nursing infants when the mother consumes standard doses. High-dose maternal supplementation should be avoided unless medically necessary.
Vitamin E is vital for the development of the nervous system and muscles in children. It is approved for use in children to treat deficiency and certain genetic disorders. However, pediatric patients are more sensitive to the effects of overdose. In premature infants, high-dose Vitamin E has been linked to an increased risk of necrotizing enterocolitis (a serious intestinal disease) and sepsis. Supplementation in infants must be managed by a pediatrician.
Elderly patients are often at a higher risk for Vitamin E deficiency due to decreased dietary intake or malabsorption. However, they are also more likely to be taking medications like aspirin or warfarin, which increases the risk of bleeding complications from .alpha.-tocopherol Succinate, D-. Geriatric patients should be monitored for signs of easy bruising or cognitive changes, and healthcare providers should prioritize dietary sources over high-dose supplements whenever possible.
In patients with significant renal impairment, the water-soluble metabolites of Vitamin E (CEHCs) may accumulate. While these metabolites are not known to be highly toxic, the long-term effects of their accumulation are not well-studied. Dosing should be conservative, and high-dose therapy should be avoided in patients on dialysis unless supervised.
Because the liver produces the transport proteins necessary for Vitamin E distribution, patients with liver disease may have low serum Vitamin E levels despite adequate intake. Conversely, severe liver dysfunction can impair the metabolism of the vitamin. Dosage adjustments should be based on serum level monitoring rather than standardized formulas.
> Important: Special populations require individualized medical assessment.
.alpha.-tocopherol Succinate, D- acts primarily as a lipid-soluble antioxidant. Its molecular structure contains a chromanol ring with a hydroxyl group that can donate a hydrogen atom to reduce free radicals. Specifically, it targets the peroxyl radicals that initiate the chain reaction of lipid peroxidation in cell membranes. By neutralizing these radicals, it maintains the structural integrity of the phospholipid bilayer. The "succinate" moiety is an ester that is cleaved by esterases in the gut, but research into the un-cleaved succinate form suggests it may have pro-apoptotic (cell-death inducing) effects in certain cancer cell lines by targeting the mitochondria, though this remains an area of active investigation and is not an approved clinical use.
The pharmacodynamic effect of .alpha.-tocopherol Succinate, D- is not immediate. It takes several days of consistent dosing to significantly increase the concentration of Vitamin E in cell membranes. The duration of effect is long, as the vitamin is stored in adipose tissue and the liver, providing a reservoir that can last for weeks after discontinuation. There is no evidence of tolerance development; however, the body has a limited capacity to transport Vitamin E, meaning that increasing the dose beyond a certain point does not result in a proportional increase in tissue levels.
| Parameter | Value |
|---|---|
| Bioavailability | 20% - 50% (highly fat-dependent) |
| Protein Binding | Bound to Lipoproteins (VLDL, LDL, HDL) |
| Half-life | ~48 hours (plasma) |
| Tmax | 4 - 6 hours |
| Metabolism | Hepatic (CYP4F2) to CEHC metabolites |
| Excretion | Fecal (unabsorbed), Renal (metabolites) |
.alpha.-tocopherol Succinate, D- is classified within the Vitamin C [EPC] and Vitamin D [EPC] pharmacological groups in certain databases to represent its role as an essential micronutrient and antioxidant. It is the primary member of the tocopherol family used in clinical medicine.
Common questions about Cobalefol
.alpha.-tocopherol Succinate, D- is primarily used as a supplemental source of Vitamin E to treat or prevent deficiency, especially in individuals with fat malabsorption issues like cystic fibrosis. It acts as a powerful antioxidant that protects cells from oxidative damage caused by free radicals. Healthcare providers may also recommend it for specific genetic conditions like abetalipoproteinemia or as an off-label treatment for certain liver diseases. Additionally, it is used in dermatological products to support skin health and protect against UV-induced damage. Always consult your doctor to see if this specific form of Vitamin E is appropriate for your health needs.
Most people taking .alpha.-tocopherol Succinate, D- at standard doses do not experience significant side effects. When side effects do occur, they are typically gastrointestinal in nature, such as mild nausea, diarrhea, or stomach cramps. Some individuals may also report feeling unusually tired or experiencing mild headaches or blurred vision, particularly at higher dosages. These symptoms often resolve on their own or can be minimized by taking the supplement with a meal. If you experience persistent or worsening symptoms, it is important to contact your healthcare provider for guidance.
There is no known direct interaction between .alpha.-tocopherol Succinate, D- and moderate alcohol consumption. However, chronic and heavy alcohol use can damage the liver and interfere with the body's ability to absorb and transport fat-soluble vitamins, including Vitamin E. This can lead to a deficiency over time or make supplementation less effective. Furthermore, both high-dose Vitamin E and heavy alcohol use can affect blood clotting and liver health. For these reasons, it is best to discuss your alcohol intake with your doctor if you are taking therapeutic doses of this supplement.
.alpha.-tocopherol Succinate, D- is considered safe and essential during pregnancy when consumed at the Recommended Dietary Allowance (RDA) levels, typically around 15 mg per day. At these levels, it is vital for the healthy development of the fetus and is classified as Pregnancy Category A. However, taking high-dose Vitamin E supplements during pregnancy is generally discouraged unless specifically prescribed by an obstetrician, as the safety of high doses has not been fully established. Some research suggests that excessive intake could potentially impact fetal heart development. Always speak with your healthcare provider before starting any new supplement while pregnant.
The time it takes for .alpha.-tocopherol Succinate, D- to work depends on the condition being treated. For someone with a Vitamin E deficiency, blood levels may begin to rise within a few days of starting supplementation, but it can take several weeks of consistent use to fully replenish tissue stores and see an improvement in symptoms. As an antioxidant, its effects are cumulative and preventive rather than immediate. You likely will not 'feel' the supplement working, as its primary role is to protect cells from long-term damage. Your doctor may perform blood tests to monitor your progress over several months.
Yes, you can generally stop taking .alpha.-tocopherol Succinate, D- suddenly without experiencing withdrawal symptoms, as it is a nutrient rather than a habit-forming drug. However, if you were prescribed this supplement to treat a specific medical condition or a diagnosed deficiency, stopping it abruptly may cause your Vitamin E levels to drop, leading to a return of deficiency symptoms over time. It is always advisable to consult with your healthcare provider before discontinuing any prescribed supplement. They can help you determine if your dietary intake is sufficient to maintain healthy levels without the supplement.
If you miss a dose of .alpha.-tocopherol Succinate, D-, take it as soon as you remember, provided it is not very close to the time for your next scheduled dose. If it is almost time for your next dose, simply skip the missed one and continue with your regular schedule. You should never take two doses at once to make up for a missed one, as this can increase the risk of stomach upset or other side effects. Missing a single dose is unlikely to have a significant impact on your overall health or the effectiveness of the treatment. Consistency is key, so try to take it at the same time each day.
There is no scientific evidence to suggest that .alpha.-tocopherol Succinate, D- 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 looked at Vitamin E's role in supporting metabolic health, though it is not a weight-loss aid. If you experience unexpected weight gain while taking this supplement, it is likely due to other factors such as changes in diet, activity levels, or other medications. Consult your doctor if you have concerns about weight changes.
.alpha.-tocopherol Succinate, D- can interact with several types of medications, so it is important to be cautious. The most significant interaction is with blood thinners like warfarin, as high doses of Vitamin E can increase the risk of bleeding. It can also interfere with the absorption of certain cholesterol-lowering drugs and weight-loss medications like orlistat. Some evidence suggests it might interfere with the effectiveness of chemotherapy or radiation therapy by protecting cancer cells from oxidative stress. Always provide your healthcare provider with a complete list of all medications and supplements you are currently taking to avoid dangerous interactions.
Yes, .alpha.-tocopherol Succinate, D- is widely available as a generic supplement and is often sold under its chemical name or as 'Natural Vitamin E Succinate.' It is also a common ingredient in many store-brand and name-brand multivitamin formulations. Because it is classified as a dietary supplement rather than a prescription drug in many regions, you can find it at most pharmacies, health food stores, and online retailers. While generic versions are generally just as effective as name brands, it is important to choose a reputable manufacturer that follows Good Manufacturing Practices (GMP) to ensure the purity and potency of the product.
Other drugs with the same active ingredient (.alpha.-tocopherol Succinate, D-)