GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU [SIN17171P]

Product Info

GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU

[SIN17171P]

Indication
Treatment of vitamin D deficiency

Posology and Method of Administration:
Posology
1 capsule contains 25,000 international units Vitamin D3.

Adults
Treatment of Vitamin D deficiency: 50,000 international units/week (2 capsules) for 6–8 weeks

Certain populations are at high risk of Vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D:

• Institutionalised or hospitalised individuals

• Dark skinned individuals

• Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens

• Obese individuals

• Patients being evaluated for osteoporosis

• Use of certain concomitant medications (eg, anticonvulsant medications, glucocorticoids)

• Patients with malabsorption, including inflammatory bowel disease and coeliac disease

• Those recently treated for Vitamin D3 deficiency, and requiring maintenance therapy.

Special populations
Renal impairment
Should not be used in combination with calcium in patients with severe renal impairment.

Hepatic impairment
No posology adjustment is required in patients with hepatic impairment.

Pregnancy and breastfeeding
The high strength formulation is not recommended

Pediatric population
Not recommended in children and adolescents under 18 years of age.

Method of administration
Oral – The capsules should be swallowed whole with water.
Patients should be advised to take preferably with a meal.

Contraindications:

• Diseases and/or disorders resulting in hypercalcemia or hypercalciuria.

• Nephrolithiasis.

• Nephrocalcinosis.

• Hypervitaminosis D

• Severe renal impairment.

• Pseudohypoparathyroidism

• Hypersensitivity to the active substance or to any of the excipients listed.