Recogen
Generic Name
Cholecalciferol (Vitamin D3)
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| recogen 10000 iu injection | ৳ 3,900.00 | N/A |
Description
Overview of the medicine
Cholecalciferol (Vitamin D3) is essential for calcium and phosphate absorption and metabolism, crucial for bone health and immune function. This injection provides a high dose for rapid repletion of Vitamin D levels in cases of severe deficiency or malabsorption.
Uses & Indications
Dosage
Adults
For severe Vitamin D deficiency: 10,000 IU daily for 7 days or 60,000 IU weekly for 8 weeks, followed by maintenance. For moderate deficiency or maintenance: 10,000 IU weekly to monthly, or as directed by physician based on serum 25(OH)D levels.
Elderly
Similar to adult dosage, but close monitoring of renal function and calcium levels is advised due to increased susceptibility to hypercalcemia.
Renal_impairment
Dosage should be adjusted cautiously. Active forms of Vitamin D are often preferred in severe renal failure. Close monitoring of serum calcium, phosphate, and renal function is essential.
How to Take
Administer by deep intramuscular (IM) injection, typically into a large muscle mass like the gluteal muscle. Ensure proper aseptic technique. Administer slowly.
Mechanism of Action
Cholecalciferol is converted to calcifediol in the liver and then to calcitriol (the active form) in the kidneys. Calcitriol acts on intestinal cells, bones, and kidneys to regulate calcium and phosphate levels, promoting bone mineralization and modulating immune response.
Pharmacokinetics
Onset
Effects on calcium metabolism typically seen within hours to days. Full repletion of Vitamin D stores may take weeks.
Excretion
Primarily via bile into feces; a small amount is excreted in urine. Metabolites undergo enterohepatic recirculation.
Half life
Parent compound (Cholecalciferol) has a half-life of approximately 24 hours. The main circulating metabolite, 25-hydroxyvitamin D (calcifediol), has a half-life of about 15 days. The active form, 1,25-dihydroxyvitamin D (calcitriol), has a half-life of 3-6 hours.
Absorption
Rapidly absorbed after intramuscular injection, bypassing gastrointestinal absorption issues.
Metabolism
Hydroxylated in the liver to 25-hydroxycholecalciferol (calcifediol), then further hydroxylated in the kidneys to 1,25-dihydroxycholecalciferol (calcitriol).
Side Effects
Contraindications
- Hypersensitivity to Cholecalciferol or any excipients.
- Hypercalcemia or evidence of Vitamin D toxicity.
- Severe renal impairment with hyperphosphatemia.
- Nephrolithiasis (kidney stones) or predisposition to stone formation.
Drug Interactions
Corticosteroids
May antagonize the effects of Vitamin D by inhibiting calcium absorption and promoting renal calcium excretion.
Thiazide diuretics
May increase the risk of hypercalcemia by reducing urinary calcium excretion.
Cardiac glycosides (e.g., Digoxin)
Increased risk of cardiac arrhythmias if hypercalcemia occurs.
Phenytoin, barbiturates, carbamazepine
May increase Vitamin D metabolism, potentially reducing its efficacy.
Storage
Store below 25°C (77°F). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose (Vitamin D toxicity) include hypercalcemia (nausea, vomiting, loss of appetite, weakness, polyuria, polydipsia, constipation, headache, confusion), hypercalciuria, and ultimately renal damage. Management: Discontinue Vitamin D, low-calcium diet, hydration, loop diuretics, corticosteroids. Hemodialysis may be necessary in severe cases.
Pregnancy & Lactation
Pregnancy Category C. High doses may be teratogenic. Use only if potential benefit justifies the potential risk to the fetus. Excreted in breast milk; caution during lactation, as hypercalcemia in the infant is possible.
Side Effects
Contraindications
- Hypersensitivity to Cholecalciferol or any excipients.
- Hypercalcemia or evidence of Vitamin D toxicity.
- Severe renal impairment with hyperphosphatemia.
- Nephrolithiasis (kidney stones) or predisposition to stone formation.
Drug Interactions
Corticosteroids
May antagonize the effects of Vitamin D by inhibiting calcium absorption and promoting renal calcium excretion.
Thiazide diuretics
May increase the risk of hypercalcemia by reducing urinary calcium excretion.
Cardiac glycosides (e.g., Digoxin)
Increased risk of cardiac arrhythmias if hypercalcemia occurs.
Phenytoin, barbiturates, carbamazepine
May increase Vitamin D metabolism, potentially reducing its efficacy.
Storage
Store below 25°C (77°F). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose (Vitamin D toxicity) include hypercalcemia (nausea, vomiting, loss of appetite, weakness, polyuria, polydipsia, constipation, headache, confusion), hypercalciuria, and ultimately renal damage. Management: Discontinue Vitamin D, low-calcium diet, hydration, loop diuretics, corticosteroids. Hemodialysis may be necessary in severe cases.
Pregnancy & Lactation
Pregnancy Category C. High doses may be teratogenic. Use only if potential benefit justifies the potential risk to the fetus. Excreted in breast milk; caution during lactation, as hypercalcemia in the infant is possible.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date. Refer to the product packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic
Clinical Trials
Cholecalciferol has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in the treatment and prevention of Vitamin D deficiency, osteoporosis, and related conditions across diverse patient populations.
Lab Monitoring
- Serum 25(OH)D levels (to assess Vitamin D status and guide dosing).
- Serum calcium and phosphate levels (to monitor for hypercalcemia/hyperphosphatemia).
- Renal function tests (e.g., creatinine, BUN) periodically.
- Urinary calcium excretion (if hypercalciuria or kidney stone risk is a concern).
Doctor Notes
- Prioritize correction of severe Vitamin D deficiency with appropriate loading doses, followed by maintenance therapy.
- Thoroughly assess baseline Vitamin D, calcium, and phosphate levels, and monitor regularly during treatment.
- Educate patients on the symptoms of hypercalcemia and the importance of adherence to prescribed dosing and monitoring schedules.
- Consider underlying conditions affecting Vitamin D absorption or metabolism (e.g., malabsorption syndromes, liver/kidney disease).
Patient Guidelines
- Follow your doctor's instructions precisely regarding dosage and follow-up appointments.
- Report any signs of hypercalcemia immediately, such as severe nausea, vomiting, unusual thirst, or excessive urination.
- Maintain a balanced diet and ensure adequate calcium intake as advised by your healthcare provider.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
As this is an injection typically administered by a healthcare professional, contact your doctor or clinic if you miss an appointment for your injection. Do not attempt to self-administer or double the dose.
Driving Precautions
Recogen 10000 IU Injection generally does not impair the ability to drive or operate machinery. However, if you experience symptoms like severe fatigue or confusion due to hypercalcemia, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain regular sun exposure in moderation, if appropriate and safe, to naturally stimulate Vitamin D production.
- Engage in weight-bearing exercises to support bone health.
- Ensure adequate dietary calcium intake through dairy products, leafy greens, or fortified foods.
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