Aristo-D3
Generic Name
Cholecalciferol (Vitamin D3)
Manufacturer
Aristopharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| aristo d3 200000 iu injectable solution oral im | ৳ 120.00 | N/A |
Description
Overview of the medicine
Aristo-D3 200000 IU is a high-dose Cholecalciferol (Vitamin D3) solution indicated for the treatment and prevention of severe vitamin D deficiency. It can be administered orally or intramuscularly.
Uses & Indications
Dosage
Adults
For severe deficiency, 200,000 IU as a single oral or intramuscular dose. Subsequent doses and maintenance therapy should be individualized based on serum 25(OH)D levels and clinical response, under medical supervision.
Elderly
Similar to adults, but with careful monitoring for hypercalcemia due to potential age-related changes in renal function and sensitivity.
Renal_impairment
Use with caution. Regular monitoring of serum calcium, phosphate, and parathyroid hormone levels is crucial. Dose adjustment may be necessary based on specific clinical guidelines and severity of impairment.
How to Take
The solution can be taken orally, typically diluted in a beverage or with food, to enhance absorption. Alternatively, it can be administered as a deep intramuscular injection by a healthcare professional.
Mechanism of Action
Cholecalciferol (Vitamin D3) is biologically inactive and is converted in the liver to calcifediol (25-hydroxyvitamin D) and then in the kidneys to calcitriol (1,25-dihydroxyvitamin D), the active form. Calcitriol regulates calcium and phosphate metabolism, promoting absorption from the gut and reabsorption in the kidneys, thereby maintaining mineral homeostasis and supporting bone health.
Pharmacokinetics
Onset
Therapeutic effects are typically observed within days to weeks of administration, with peak serum 25(OH)D levels achieved within days for oral, and weeks for IM administration.
Excretion
Primarily excreted via the bile into the feces; a small amount is excreted in the urine.
Half life
The half-life of the parent compound (Cholecalciferol) is short, while its primary metabolite, calcifediol, has a half-life of approximately 2-3 weeks. The active form, calcitriol, has a half-life of 4-6 hours.
Absorption
Cholecalciferol is well absorbed from the gastrointestinal tract, especially in the presence of fatty meals. Intramuscular administration provides a slower and more sustained release.
Metabolism
Initially metabolized in the liver by 25-hydroxylase to calcifediol, and subsequently in the kidneys by 1-alpha-hydroxylase to calcitriol.
Side Effects
Contraindications
- Hypersensitivity to Cholecalciferol or any excipients.
- Hypercalcemia (elevated blood calcium levels).
- Hypervitaminosis D (excessive vitamin D levels).
- Nephrolithiasis (kidney stones) or nephrocalcinosis.
- Severe renal impairment with hyperphosphatemia.
Drug Interactions
Corticosteroids
May reduce the effects of vitamin D.
Cardiac glycosides
Concurrent use may increase the risk of arrhythmia due to potential hypercalcemia.
Thiazide diuretics
May increase the risk of hypercalcemia.
Cholestyramine, mineral oil
May reduce the gastrointestinal absorption of vitamin D.
Anticonvulsants (e.g., phenytoin, barbiturates)
May increase the metabolism of vitamin D, potentially reducing its effectiveness.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose (hypervitaminosis D) are primarily due to hypercalcemia and include nausea, vomiting, constipation, polyuria, polydipsia, weakness, headache, and confusion. Severe cases can lead to renal impairment and soft tissue calcification. Treatment involves discontinuing vitamin D, a low-calcium diet, hydration, and in severe cases, corticosteroids or bisphosphonates.
Pregnancy & Lactation
Vitamin D is essential during pregnancy and lactation. However, high doses like 200,000 IU should only be administered if clearly indicated and under strict medical supervision due to the risk of hypercalcemia in the mother and fetus/infant.
Side Effects
Contraindications
- Hypersensitivity to Cholecalciferol or any excipients.
- Hypercalcemia (elevated blood calcium levels).
- Hypervitaminosis D (excessive vitamin D levels).
- Nephrolithiasis (kidney stones) or nephrocalcinosis.
- Severe renal impairment with hyperphosphatemia.
Drug Interactions
Corticosteroids
May reduce the effects of vitamin D.
Cardiac glycosides
Concurrent use may increase the risk of arrhythmia due to potential hypercalcemia.
Thiazide diuretics
May increase the risk of hypercalcemia.
Cholestyramine, mineral oil
May reduce the gastrointestinal absorption of vitamin D.
Anticonvulsants (e.g., phenytoin, barbiturates)
May increase the metabolism of vitamin D, potentially reducing its effectiveness.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose (hypervitaminosis D) are primarily due to hypercalcemia and include nausea, vomiting, constipation, polyuria, polydipsia, weakness, headache, and confusion. Severe cases can lead to renal impairment and soft tissue calcification. Treatment involves discontinuing vitamin D, a low-calcium diet, hydration, and in severe cases, corticosteroids or bisphosphonates.
Pregnancy & Lactation
Vitamin D is essential during pregnancy and lactation. However, high doses like 200,000 IU should only be administered if clearly indicated and under strict medical supervision due to the risk of hypercalcemia in the mother and fetus/infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on storage conditions.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Extensive clinical trial data and real-world evidence support the efficacy and safety of cholecalciferol in treating and preventing vitamin D deficiency across various populations.
Lab Monitoring
- Serum calcium levels (regularly, especially during high-dose therapy).
- Serum phosphate levels.
- Serum 25(OH)D levels (to assess vitamin D status and guide therapy).
- Serum creatinine and BUN (to monitor renal function).
Doctor Notes
- Emphasize the importance of patient education regarding hypercalcemia symptoms.
- Regularly monitor serum calcium, phosphate, and 25(OH)D levels, especially in patients receiving high-dose or long-term therapy.
- Assess for potential drug interactions, particularly with thiazide diuretics, cardiac glycosides, and anticonvulsants.
- Advise patients on appropriate administration route (oral vs. IM) and dietary considerations for optimal absorption.
Patient Guidelines
- Always follow your doctor's instructions regarding the dose and frequency of Aristo-D3.
- Report any symptoms of hypercalcemia, such as nausea, vomiting, increased thirst, or frequent urination, to your doctor immediately.
- Maintain adequate calcium intake through diet unless advised otherwise by your doctor.
- If taking orally, consider taking it with a meal for better absorption.
Missed Dose Advice
As Aristo-D3 200000 IU is often a single or infrequently administered high-dose therapy, consult your doctor immediately if a scheduled dose is missed. Do not take a double dose to compensate.
Driving Precautions
Aristo-D3 is not known to affect the ability to drive or operate machinery. However, if you experience any side effects that could impair your concentration or vision, avoid such activities.
Lifestyle Advice
- Maintain a balanced diet rich in calcium and vitamin D, if appropriate.
- Engage in regular weight-bearing exercise for bone health.
- Sensible sun exposure can help with natural vitamin D synthesis, but avoid excessive exposure.
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