D-CURE ORAL SOLUTION 25000IU [SIN15254P]

Product Info

D-CURE ORAL SOLUTION 25000IU

[SIN15254P]

4.1 Therapeutic indications
Indicated for the prevention and treatment of vitamin D deficiency.

As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

4.2 Posology and method of administration
Paediatrics:

• Prevention of deficiency 0–1 years 25000 international units (1 single-dose oral solution in ampoule) every 8 weeks

• Prevention of deficiency 1–18 years 25000 international units (1 single-dose oral solution in ampoule) every 6 weeks

• Treatment of deficiency 0–18 years 25000 international units (1 single-dose oral solution in ampoule) once every 2 weeks for 6weeks (followed by maintenance therapy of 400–1000 international units/day)

Administration to children:
In children, Cholecalciferol (D-Cure) can be mixed with a small amount of children's foods, yogurt, milk, cheese or other dairy products. The parents should be warned not to mix Cholecalciferol (D-Cure) into a bottle of milk or container of soft foods in case the child does not consume the whole portion, and does not receive the full dose. The parents should ensure that their child takes the entire dose. For children who are not breast-feeding, the prescribed dose should be administered with a meal.

Adults:

• Prevention of vitamin D deficiency 25000 international units/month (1 single-dose oral solution in ampoule)

• Treatment of vitamin D deficiency (<25 ng/ml) 50000 international units/week (2 single-dose oral solution in ampoule) for 6–8weeks, followed by maintenance therapy (1400–2000 international units/day may be required; follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved)

• As an adjunct to specific therapy for osteoporosis: 25000 international units/month (1 single-dose oral solution in ampoule)

Administration to adults:
Cholecalciferol (D-Cure) is an oral solution packaged in single-dose container. The content of the single-dose oral solution (in ampoule) is to be emptied directly into the mouth and swallowed orally. To help the patient, the full content of the single-dose oral solution (in ampoule) may be emptied onto a spoon and taken orally. D-Cure can also be taken by mixing with a small amount of cold or lukewarm food immediately prior to use. Cholecalciferol (D-Cure) is only for oral use.

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 (e.g., anticonvulsant medications, glucocorticoids)

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

• Those recently treated for vitamin D deficiency, and requiring maintenance therapy

Special populations
Renal impairment
Cholecalciferol (D-Cure) 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

Method of administration
Patients should be advised to take D-Cure preferably with meal (see section 5.2 Pharmacokinetic properties – “Absorption” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

See also section 6.6, Special precautions for handling and disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substance(s) or to any of the excipients.

• Hypercalcaemia and/or hypercalciuria.

• Nephrolithiasis and/or nephrocalcinosis

• Serious renal impairment

• Hypervitaminosis D

• Pseudohypoparathyroidism as the vitamin D requirement may be reduced due to phases of normal vitamin D sensitivity, involving the risk of prolonged overdose. Better-regulatable vitamin D derivatives are available for this.