Altavita D3 1000 IU, 7000 IU, 25000 IU soft capsules and 25,000 IU oral solution are licensed:

- 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.

What is Vitamin D's role:

  • Vitamin D through its active form (1,25-dihydroxyvitamin D) is essential for intestinal Ca absorption and plays a central role in maintaining Ca homeostasis and skeletal integrity
  • In vitamin D deficiency there is a decrease in the concentration of 25(OH) vitamin D (25-hydroxy vitamin D) and an increase of varying degrees in the parathyroid hormone (PTH) level
  • The increased serum PTH stimulates bone turnover, leading to bone loss
  • In periods of protracted vitamin D deficiency, bone loss is increased and this may lead to osteoporosis

Features of Vitamin D deficiency:

  • In young children, who have little mineral in their skeleton, vitamin D deficiency results in a variety of skeletal deformities classically known as rickets
  • In adults, the epiphyseal plates are closed and there is enough mineral in the skeleton to prevent skeletal deformities so that this mi
neralisation defect, known as osteomalacia, often goes undetected
  • However osteomalacia causes a decrease in Bone Mineral Density (BMD) and is associated with isolated or generalised aches and pains in bones and muscles
  • Recommendations for at risk groups:

    • The Food Safety Authority of Ireland (FSAI) in 2014 recommended that all babies living in Ireland should be given a vitamin D only supplement providing 5 μg (200 IU) daily vitamin D from birth to 12 months
    • It is expected that the vitamin D needs of other ‘at-risk’ groups, such as pregnant women and children aged 12 months to four years, will be addressed by the FSAI at a later date

    The National Osteoporosis Society in the UK (NOS) has identified the following adult groups at risk of vitamin D deficiency:

    • All pregnant and breastfeeding women, especially teenagers and young women
    • Older people, aged 65 years and over
    • People who have low or no exposure to the sun, for example those who cover their skin for cultural reasons, who are housebound or who are confined indoors for long periods
    • People who have darker skin, for example people of African, African-Caribbean or South Asian origin, because their bodies are not able to make as much vitamin D

    How to Take Altavita D3

    How to take Altavita D3 Soft Capsules

    • Altavita D3 soft capsules should be swallowed whole with water. They should be taken at mealtimes. 

    How to take Altavita D3 Oral Solution

    • Altavita D3 oral solution should be taken at meal times
    • If preferred, the contents can be emptied onto a spoon and taken orally or mixed with a little cold or lukewarm food immediately before use.
    • Patients should not be concerned about the small amount of oral solution remaining in the container after squeezing - it has been deliberately over filled.
    • It is important to keep taking your medicine as it has been prescribed – even if you feel healthy and well. 

    Children

    Altavita®  D3 Oral Solution can be mixed with a small amount of appropriate food such as

    • Yogurt
    • Milk
    • Other dairy product
    • Or lukewarm food.

    If mixing Altavita with food, parents should ensure that their child consumes the entire portion of food so that all of the Altavita is taken.
    Parents should not be concerned about the small amount of oral solution remaining in the container after squeezing - it has been deliberately over filled.

    Indications:

    • Altavita D3 25,000 IU soft capsules: Treatment and prophylaxis of Vitamin D deficiency in adolescents and adults with an identified risk. As an adjunct to specific therapy for osteoporosis in patients with Vitamin D deficiency or at risk of Vitamin D insufficiency. Altavita D3 25,000 IU oral solution: 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. 
    • Altavita D3 1,000 IU soft capsules and Altavita D3 7,000 IU soft capsules: Prophylaxis and treatment of vitamin D deficiency in children, adolescents and adults with an identified risk. Prophylaxis of vitamin D deficiency in pregnant and breast-feeding women with an identified risk. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D deficiency.

    Dosage and administration:

    Altavita D3 1,000 IU soft capsules are suitable for daily supplementation. 

    Paediatric posology: Doses of up to 1,000 IU/day may be required to prevent deficiency in some children. Treatment of deficiency 10-18 years 2,000 IU/day for 6 weeks, followed by maintenance therapy of 400-1,000 IU/day (such as one 1,000 IU soft capsule per day or one 7,000 IU soft capsule per week). Pregnancy and breastfeeding: Doses of 1,000 – 2,000 IU/day may be required to prevent deficiency in some women.

    Adults: Prevention of vitamin D deficiency: 1,000 IU/day. As an adjunct to specific therapy for osteoporosis: 1,000 IU/day. Treatment of deficiency: 1,000 IU – 4,000 IU/day for up to 12 weeks, followed by maintenance therapy of 1,400 – 2,000 IU/day (such as two 1,000 IU soft capsules per day)

    Altavita D3 7,000 IU soft capsules: Suitable for weekly supplementation, which should be taken into consideration and dosage should be established by a physician. The dose of 1,000 IU/day is considered equivalent to 7,000 IU/week. Pregnancy and breastfeeding: Doses of 1,000 – 2,000 IU/day may be required to prevent deficiency in some women (see below). Even higher doses may be required during breast-feeding if women choose not to give the infant a vitamin D supplement. Adults - prevention of vitamin D deficiency 1,000 IU/day.As an adjunct to specific therapy for osteoporosis: 1,000 IU/day. Treatment of deficiency: 1,000 IU – 4,000 IU/day for up to 12 weeks, followed by maintenance therapy of 1,400 – 2,000 IU/day, such as two 7,000 IU soft capsules per week). 

    Altavita D3 25,000 IU soft capsules: Children aged 10-18 years: Prevention of deficiency, 25,000 IU (1 capsule) every 6 weeks. Treatment of deficiency, 25,000 IU (1 capsule) once every 2 weeks for 6 weeks followed by maintenance therapy of 400 – 1,000 IU/day, such as 1 capsule per month. Pregnancy and breastfeeding: The high strength formulation is not recommended.

    Altavita D3 25,000 IU soft capsules & Altavita 25,000 IU oral solution: Adults: Prevention of deficiency, 25,000 IU/month (1 capsule or single dose oral solution); higher doses and monitoring of serum 25(OH)D may be required in populations at high risk of vitamin D deficiency (* see below) Adjunct to specific therapy for osteoporosis, 25,000 IU/month (1 capsule or single dose oral solution). Treatment of deficiency (<25 nmol/L), 50,000 IU/week (2 capsules or single dose oral solution) for 6-8 weeks followed by maintenance therapy 1,400 – 2,000 IU/day, may be required such as 2 capsules or oral solutions per month; follow-up 25(OH)D measurements should be made approximately 3-4 months after initiating maintenance therapy to confirm that the target level has been achieved.

    Altavita 25,000 IU oral solution: Paediatric posology: Prevention of deficiency 0-1 years 25000 IU (1 single dose oral solution) every 8 weeks, Prevention of deficiency 1-18 years 25,000 IU (1 single dose oral solution) every 6 weeks. Treatment of deficiency 0-18 years 25,000 IU (1 single dose oral solution) once every 2 weeks for 6 weeks, followed by maintenance therapy of 400-1000 IU/day (such as 1 25,000 IU single dose oral solution per month).

    *Altavita D3 1,000 & 7,000 IU soft capsules , Altavita D3 25,000 IU soft capsules & Altavita 25,000 IU oral solution: Populations at high risk of vitamin D deficiency include those who are institutionalised or hospitalised, dark skinned, obese, being evaluated for osteoporosis, with limited effective sun exposure due to protective clothing or consistent use of sun screens, using certain concomitant medication e.g. anticonvulsants or glucocorticoids, with malabsorption, including inflammatory bowel disease and coeliac disease and recently treated for vitamin D deficiency, and requiring maintenance therapy. Special populations: 

    • Altavita D3 25,000 IU soft capsules and oral solution should not be used in combination with calcium in patients with severe renal impairment. Administration to Adults: Altavita D3 should be taken orally – the capsules should be swallowed whole with water, for the oral solution the full contents of the single dose oral solution should be either emptied into the mouth and swallowed orally, or emptied onto a spoon and taken orally. AltavitaD3 can also be taken by mixing with a small amount of cold or lukewarm food immediately prior to use. Patients should be advised to take Altavita D3 25,000 IU preferably with a meal. Administration to children: In children, Altavita D3 oral solution can be mixed with a small amount of children’s foods, yogurt, milk, cheese or other dairy products. Parents should be warned not to mix Altavita D3 oral solution 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. They should ensure that their child takes the entire dose. For children who are not being breast-fed, the prescribed dose should be administered with a meal.

    Contraindications:

    Altavita D3 1,000 IU soft capsules, Altavita D3 7,000 IU soft capsules, Altavita D3 25,000 IU soft capsules & AltaVita 25,000 IU oral solution: Hypersensitivity to the active substance or to any of the excipients; hypercalcaemia and/or hypercalciuria; nephrolithiasis and/or nephrocalcinosis; hypervitaminosis D. Pregnancy and breastfeeding: Due to lack of clinical data Altavita D3 25,000 IU is not recommended.

    References:

    http://www.altavita.ie/altavita-d3-prescribing-information

    http://www.altavita.ie/welcome-hcp

    http://www.altavita.ie/vitamin-d3-the-evidence