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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Growth Supportpatch, Hautuki
Generic Name
Cholecalciferol (vitamin D3)
Active Ingredient
CholecalciferolCategory
Vitamin D [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .2 mg/100g | PATCH | TOPICAL | 83463-0002 |
Detailed information about Growth Supportpatch, Hautuki
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Growth Supportpatch, Hautuki, you must consult a qualified healthcare professional.
Cholecalciferol, also known as Vitamin D3, is a fat-soluble vitamin essential for calcium absorption and bone health. It belongs to the Vitamin D [EPC] class and is used to treat or prevent Vitamin D deficiency and related bone disorders.
The dosage of cholecalciferol is highly individualized and depends on the patient's baseline serum 25-hydroxyvitamin D [25(OH)D] levels, age, body mass index (BMI), and the specific condition being treated.
Patients with mild to moderate renal impairment may take standard doses of cholecalciferol. However, in patients with severe Chronic Kidney Disease (CKD Stage 4 or 5), the kidneys lose the ability to convert cholecalciferol into its active form (calcitriol). In these cases, cholecalciferol may still be used to maintain nutritional status, but active Vitamin D analogs (like calcitriol or paricalcitol) are usually required to manage secondary hyperparathyroidism.
Because the first step of Vitamin D activation occurs in the liver, patients with severe hepatic failure or cirrhosis may have reduced 25-hydroxylation capacity. These patients require close monitoring of serum 25(OH)D levels and may require higher doses to achieve therapeutic targets.
Older adults often have thinner skin and reduced levels of 7-dehydrocholesterol, making them less efficient at synthesizing Vitamin D from sunlight. They also have a higher risk of falls and fractures. Consequently, higher maintenance doses (800-1,000 IU daily) are frequently recommended for this population.
If you miss a daily dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up. If you miss a weekly high-dose (e.g., 50,000 IU), contact your healthcare provider for instructions on when to resume.
Vitamin D toxicity (hypervitaminosis D) is serious and usually results from prolonged intake of excessively high doses. Signs of overdose include:
In case of a suspected acute overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment typically involves stopping Vitamin D and calcium intake, intravenous hydration, and sometimes the use of corticosteroids or bisphosphonates to lower serum calcium.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or start high-dose supplementation without medical guidance, as Vitamin D is stored in the body and can reach toxic levels.
When taken at recommended doses (RDA levels), cholecalciferol rarely causes side effects. However, when starting therapeutic doses for deficiency, some patients may experience mild gastrointestinal effects:
> Warning: Stop taking Cholecalciferol and call your doctor immediately if you experience any of these symptoms, as they may indicate Vitamin D toxicity or dangerous calcium levels.
No FDA black box warnings currently exist for cholecalciferol. It is generally considered safe when used within the established Tolerable Upper Intake Level (UL) or under strict medical supervision for the treatment of deficiency.
Report any unusual symptoms to your healthcare provider. Monitoring your blood levels is the best way to prevent long-term side effects.
Cholecalciferol is a potent biological regulator. While it is available over-the-counter, it should be treated with the same caution as prescription medications. The primary safety concern with cholecalciferol is its potential to cause hypercalcemia (high blood calcium), which can lead to multi-organ damage if left untreated. Patients should never exceed the dose recommended by their healthcare provider, as Vitamin D is fat-soluble and accumulates in the body's fat stores, meaning toxicity can persist for weeks even after stopping the supplement.
There are no FDA black box warnings for Cholecalciferol. It has a high safety profile when used appropriately for its intended indications.
While rare, hypersensitivity to cholecalciferol or any of the inactive ingredients in the formulation (such as soybean oil or gelatin) can occur. Symptoms of a serious allergic reaction include rash, swelling (especially of the face/tongue/throat), severe dizziness, and trouble breathing. Patients with known allergies to Vitamin D analogs should avoid cholecalciferol.
Patients with pre-existing kidney disease are at a higher risk of developing complications from Vitamin D supplementation. High doses can lead to the formation of kidney stones or permanent kidney damage due to calcium deposits in the renal parenchyma (nephrocalcinosis). Healthcare providers must carefully weigh the benefits against the risks in patients with a history of renal calculi.
Patients with conditions such as sarcoidosis, tuberculosis, or certain lymphomas must use cholecalciferol with extreme caution. In these diseases, macrophages (immune cells) can uncontrollably convert 25(OH)D into active 1,25(OH)2D, leading to rapid and severe hypercalcemia even with relatively low doses of Vitamin D.
If you are taking therapeutic doses of cholecalciferol (e.g., >2,000 IU daily), your doctor will likely require periodic lab tests to ensure safety:
Cholecalciferol does not typically affect the ability to drive or operate machinery. However, if a patient develops hypercalcemia, they may experience confusion or dizziness, which would impair these activities.
There is no direct chemical interaction between alcohol and cholecalciferol. However, chronic excessive alcohol consumption can interfere with the liver's ability to process Vitamin D and can also interfere with the absorption of fats and fat-soluble vitamins in the gut, potentially making the supplement less effective.
For most patients, cholecalciferol can be stopped without a tapering process. However, if it was being used to treat a severe deficiency or to support a specific bone health regimen, stopping the medication may result in a return to a deficient state and an increased risk of bone loss. Always consult your doctor before discontinuing a prescribed supplement.
> Important: Discuss all your medical conditions, especially kidney disease, heart disease, or sarcoidosis, with your healthcare provider before starting Cholecalciferol.
While few drugs are absolutely contraindicated, cholecalciferol should not be used in patients currently experiencing Hypercalcemia or Vitamin D Toxicity. Using cholecalciferol in these states will exacerbate the condition and may lead to life-threatening complications.
Hypercalcemia caused by excessive Vitamin D can potentiate the effects of digoxin, significantly increasing the risk of digitalis toxicity. This can lead to fatal cardiac arrhythmias. Patients taking digoxin must have their calcium levels monitored very closely if they are also taking cholecalciferol.
Thiazide diuretics reduce the excretion of calcium by the kidneys. When taken with cholecalciferol, there is a synergistic effect that significantly increases the risk of developing hypercalcemia. Blood calcium levels should be checked regularly in patients on this combination.
These drugs are used to lower cholesterol but can also bind to fat-soluble vitamins in the gut. They can significantly reduce the absorption of cholecalciferol. It is recommended to take cholecalciferol at least 1 hour before or 4 to 6 hours after taking these medications.
Orlistat, a weight-loss medication, works by preventing the absorption of fats. Since cholecalciferol requires fat for absorption, orlistat can reduce its bioavailability. These two agents should be separated by at least 2 hours.
These medications induce hepatic microsomal enzymes (specifically CYP450 enzymes) that increase the catabolism (breakdown) of Vitamin D into inactive metabolites. Patients on long-term anticonvulsant therapy often require much higher doses of cholecalciferol to maintain adequate serum levels.
Steroids can interfere with Vitamin D metabolism and reduce intestinal calcium absorption. Long-term steroid use is a major risk factor for osteoporosis, and while cholecalciferol is often prescribed to counteract this, the dose may need to be higher than standard maintenance levels.
Cholecalciferol supplementation will directly increase results for serum 25(OH)D tests. It may also increase serum calcium and phosphorus levels. It does not typically interfere with standard blood counts or liver enzyme tests, but it can affect the interpretation of Parathyroid Hormone (PTH) tests, as Vitamin D naturally suppresses PTH.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those purchased without a prescription.
Cholecalciferol must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis and intensive monitoring:
Patients who have had a severe allergic reaction to other Vitamin D analogs, such as Ergocalciferol (D2), Calcitriol, or Doxercalciferol, should be monitored closely for cross-sensitivity, although the chemical structures differ slightly. Most 'allergic' reactions to Vitamin D supplements are actually reactions to the carrier oils (like soybean or peanut oil) or dyes used in the capsule shell.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of high calcium or kidney stones, before prescribing Cholecalciferol.
Cholecalciferol is generally considered safe and is essential during pregnancy. The FDA has not assigned a formal pregnancy category to cholecalciferol, but it is widely used to support fetal skeletal development and maternal bone health.
Cholecalciferol is excreted into breast milk in small amounts. While maternal supplementation increases the Vitamin D content of breast milk, it is generally insufficient to meet the needs of a nursing infant.
Cholecalciferol is approved for use in children of all ages, including neonates. It is vital for preventing rickets and ensuring proper bone growth.
Older adults represent a primary target population for cholecalciferol.
In patients with mild to moderate renal impairment (CrCl > 30 mL/min), cholecalciferol is used normally. In Stage 4 or 5 Chronic Kidney Disease, the conversion to active calcitriol is impaired. While cholecalciferol may still be given to maintain 25(OH)D levels, it cannot be relied upon to manage the complex mineral bone disorders associated with end-stage renal disease.
Patients with biliary cirrhosis or other obstructive liver diseases may have impaired absorption of cholecalciferol due to lack of bile salts. These patients may require water-miscible formulations or higher doses. Patients with severe liver parenchymal disease may have reduced 25-hydroxylation, requiring monitoring of serum levels to ensure the supplement is being activated.
> Important: Special populations, particularly pregnant women and those with kidney disease, require individualized medical assessment and frequent lab monitoring.
Cholecalciferol (Vitamin D3) is a prohormone. Its primary molecular mechanism involves the activation of the Vitamin D Receptor (VDR). Following its two-step hydroxylation into 1,25-dihydroxyvitamin D (calcitriol), it binds to the VDR in the cytoplasm of target cells (primarily in the intestine, bone, and kidneys). This ligand-receptor complex then moves to the nucleus and acts as a transcription factor, binding to Vitamin D Response Elements (VDRE) on DNA. This results in the up-regulation of genes such as TRPV6 (a calcium channel) and Calbindin-D9k, which facilitate the active transport of calcium across the intestinal wall into the bloodstream.
The pharmacodynamic effect of cholecalciferol is delayed because it requires metabolic activation and gene transcription. The increase in intestinal calcium absorption typically begins 12 to 24 hours after administration and peaks at 48 to 72 hours. The duration of effect is long, as the stored Vitamin D in adipose tissue can continue to be released and activated for weeks.
| Parameter | Value |
|---|---|
| Bioavailability | ~50% to 80% (Highly dependent on dietary fat) |
| Protein Binding | >99% (Primarily to Vitamin D-Binding Protein and Albumin) |
| Half-life | 15 to 25 days (for the 25(OH)D metabolite) |
| Tmax | 7 to 24 hours (for cholecalciferol itself) |
| Metabolism | Hepatic (CYP2R1) to 25(OH)D; Renal (CYP27B1) to 1,25(OH)2D |
| Excretion | Fecal (>95%), Renal (<5%) |
Cholecalciferol is classified as a Vitamin D [EPC]. It is specifically the D3 isoform, which is generally considered more effective at raising and maintaining serum 25(OH)D levels compared to the plant-derived D2 (ergocalciferol) isoform.
Common questions about Growth Supportpatch, Hautuki
Cholecalciferol, or Vitamin D3, is primarily used to treat and prevent Vitamin D deficiency, which can lead to bone-weakening conditions like rickets in children and osteomalacia in adults. It is also a critical component in the management of osteoporosis, as it helps the body absorb the calcium necessary for maintaining strong bones. Healthcare providers may also prescribe it for patients with hypoparathyroidism or those with chronic kidney disease who have mineral imbalances. Beyond bone health, it is often used as a daily supplement to support overall immune function and muscle health in individuals with limited sun exposure. Always use the specific dose recommended by your doctor based on your blood test results.
At standard recommended doses, cholecalciferol is very well tolerated and rarely causes side effects. However, some people may experience mild digestive issues such as constipation, nausea, or stomach upset, particularly when taking higher therapeutic doses. A metallic taste in the mouth or a loss of appetite can also occur in some cases. If you experience more severe symptoms like extreme thirst, frequent urination, or confusion, these could be signs of high calcium levels (hypercalcemia) and require immediate medical attention. Most mild side effects can be managed by taking the supplement with food and ensuring adequate hydration. Always report any persistent or bothersome symptoms to your healthcare provider.
There is no known direct chemical interaction between alcohol and cholecalciferol that would cause an immediate safety concern. However, chronic and excessive alcohol consumption can interfere with the liver's ability to process Vitamin D and can damage the lining of the gut, reducing the absorption of fat-soluble vitamins. Alcohol also acts as a diuretic, which can affect the balance of minerals like calcium and magnesium in your body. For the best results in treating a Vitamin D deficiency, it is advisable to limit alcohol intake. If you do choose to drink, moderate consumption is generally not expected to interfere significantly with your supplement. Discuss your alcohol habits with your doctor to ensure they don't interfere with your bone health goals.
Yes, cholecalciferol is not only safe but essential during pregnancy for the development of the baby's skeleton and the maintenance of the mother's bone health. Most pregnant women are advised to take a prenatal vitamin that contains Vitamin D, but some may require additional supplementation if their blood levels are low. Maintaining adequate levels can help reduce the risk of complications such as preeclampsia and low birth weight. However, it is vital not to exceed the recommended dose, as excessively high levels of Vitamin D can cause high calcium levels, which may be harmful to both the mother and the fetus. Always consult with your obstetrician before starting any new supplements during pregnancy. They will determine the correct dose based on your specific nutritional needs.
The time it takes for cholecalciferol to work depends on the severity of the deficiency and the dose being taken. While the body begins absorbing the vitamin within hours and converting it in the liver shortly after, it typically takes several weeks of consistent daily or weekly dosing to see a significant rise in blood levels of 25-hydroxyvitamin D. For patients with severe deficiency, it may take 2 to 3 months of high-dose therapy to reach the optimal therapeutic range. Improvements in bone density or the resolution of symptoms like bone pain can take even longer, often 6 months or more. Your healthcare provider will usually re-check your blood levels after 8 to 12 weeks of treatment to assess your progress. Consistency is key to achieving the desired clinical outcomes.
In most cases, you can stop taking cholecalciferol suddenly without experiencing immediate withdrawal symptoms, as it is a vitamin and not a habit-forming drug. However, if you were prescribed cholecalciferol to treat a chronic deficiency or as part of an osteoporosis treatment plan, stopping it will eventually cause your Vitamin D levels to drop back down. This can lead to a return of symptoms like fatigue or bone pain and may increase your risk of fractures over time. If you are experiencing side effects, it is better to discuss a dose adjustment with your doctor rather than stopping the medication entirely. Always consult your healthcare provider before making changes to your supplement regimen to ensure your bone health remains protected. They can provide a plan to maintain your levels through diet or sunlight if appropriate.
If you miss a daily dose of cholecalciferol, take it as soon as you remember that same day. However, if it is already almost time for your next scheduled dose, 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 Vitamin D is stored in the body and taking too much at once can increase the risk of side effects. If you are on a high-dose weekly regimen and miss a dose, contact your doctor or pharmacist for guidance on when to take it. Because Vitamin D has a long half-life in the body, a single missed dose is unlikely to impact your long-term health significantly. Simply return to your routine as soon as possible to keep your levels stable.
There is no clinical evidence to suggest that cholecalciferol causes weight gain; in fact, some research suggests that maintaining adequate Vitamin D levels may actually assist with weight management. Vitamin D is fat-soluble and is stored in adipose (fat) tissue, which means that individuals with a higher Body Mass Index (BMI) often require higher doses of cholecalciferol to reach the same blood levels as someone with a lower BMI. Some patients may notice changes in appetite when they begin supplementation, but this is typically a normalization of their metabolic state. If you experience unexpected weight gain while taking this supplement, it is likely due to other factors such as diet, lifestyle, or other medications. Discuss any concerns about weight with your healthcare provider, who can help identify the underlying cause. Overall, Vitamin D is considered weight-neutral.
Cholecalciferol can be taken with many other medications, but there are several important interactions to be aware of. For instance, certain weight-loss drugs like orlistat or cholesterol medications like cholestyramine can block the absorption of Vitamin D, so they should be taken at different times of the day. Some diuretics (water pills) can raise calcium levels in the blood, and taking them with Vitamin D increases the risk of hypercalcemia. Additionally, some anti-seizure medications can cause the body to break down Vitamin D more quickly, requiring a higher dose of the supplement. It is crucial to provide your doctor or pharmacist with a complete list of all the medications and herbal supplements you are taking. They can help you create a dosing schedule that avoids these interactions and ensures the supplement is effective.
Yes, cholecalciferol is widely available as a generic medication and is also the active ingredient in many brand-name supplements and over-the-counter products. Because it is a naturally occurring form of Vitamin D, it is produced by many different manufacturers in various forms, including tablets, capsules, and liquid drops. Generic versions are generally just as effective as brand-name products and are often much more cost-effective for long-term use. When purchasing over-the-counter, look for products that have been third-party tested (such as by USP or NSF) to ensure the potency and purity of the ingredient. Whether you use a prescription-strength generic or an over-the-counter version, the biological effect on your Vitamin D levels will be the same. Your pharmacist can help you select a high-quality version that meets your specific needs.
Other drugs with the same active ingredient (Cholecalciferol)