- Approval Id
- 968eb42fc9089842
- Drug Name
- GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU
- Product Name
- GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU
- Approval Number
- SIN17171P
- Approval Date
- 2025-01-27
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, LIQUID FILLED
- Dosage
- <p><strong>Posology and Method of Administration:</strong><br>
<strong>Posology</strong><br>
1 capsule contains 25,000 international units Vitamin D3.</p>
<p><strong>Adults</strong><br>
Treatment of Vitamin D deficiency: 50,000 international units/week (2 capsules) for 6–8 weeks</p>
<p>Certain populations are at high risk of Vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D:</p>
<ul>
<li>Institutionalised or hospitalised individuals</li>
<li>Dark skinned individuals</li>
<li>Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens</li>
<li>Obese individuals</li>
<li>Patients being evaluated for osteoporosis</li>
<li>Use of certain concomitant medications (eg, anticonvulsant medications, glucocorticoids)</li>
<li>Patients with malabsorption, including inflammatory bowel disease and coeliac disease</li>
<li>Those recently treated for Vitamin D3 deficiency, and requiring maintenance therapy.</li>
</ul>
<p><strong>Special populations</strong><br>
<u>Renal impairment</u><br>
Should not be used in combination with calcium in patients with severe renal impairment.</p>
<p><u>Hepatic impairment</u><br>
No posology adjustment is required in patients with hepatic impairment.</p>
<p><u>Pregnancy and breastfeeding</u><br>
The high strength formulation is not recommended</p>
<p><u>Pediatric population</u><br>
Not recommended in children and adolescents under 18 years of age.</p>
<p><strong>Method of administration</strong><br>
Oral – The capsules should be swallowed whole with water.<br>
Patients should be advised to take preferably with a meal.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indication</strong><br>
Treatment of vitamin D deficiency</p>
- Contraindications
- <p><strong>Contraindications:</strong></p>
<ul>
<li>Diseases and/or disorders resulting in hypercalcemia or hypercalciuria.</li>
<li>Nephrolithiasis.</li>
<li>Nephrocalcinosis.</li>
<li>Hypervitaminosis D</li>
<li>Severe renal impairment.</li>
<li>Pseudohypoparathyroidism</li>
<li>Hypersensitivity to the active substance or to any of the excipients listed.</li>
</ul>
- Atc Code
- A11CC05
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
