What is Alendronate Sodium and Colecalciferol, MSD?
Alendronate Sodium and Colecalciferol, MSD is a medicine containing two active substances: alalendronic acid (as alendronate sodium trihydrate) and colecalciferol (vitamin D3). The medicine is available as white tablets (capsule-shaped: 70 mg of alendronic acid and 2 800 international units [IU] of cholecalciferol; rectangular in shape: 70 mg of alendronic acid and 5 600 IU of cholecalciferol).
This medicine is similar to Fosavance, already authorized in the European Union (EU). The company that makes Fosavance has considered that the scientific data relating to it could also be used for Alendronate Sodium and Colecalciferol, MSD.
What is Alendronate Sodium and Colecalciferol, MSD used for?
Alendronate Sodium and Colecalciferol, MSD (containing 2 800 or 5 600 IU cholecalciferol) is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women at risk of vitamin D insufficiency. Alendronate Sodium and Colecalciferol, MSD (70 mg / 5 600 IU) is recommended for patients not taking vitamin D supplements.
Alendronate Sodium and Colecalciferol, MSD reduces the risk of vertebral (spine) and hip fractures.
The medicine can only be obtained with a prescription.
How is Alendronate Sodium and Colecalciferol, MSD used?
The recommended dose is one tablet once a week. Alendronate Sodium and Colecalciferol, MSD should be used as a long-term therapy.
The tablet should be swallowed with a full glass of water (non-mineral), at least 30 minutes before the ingestion of any food, drink or other medicine (including antacids, calcium supplements and vitamins). To avoid irritating the esophagus, once the medicine is taken, the patient should not lie down until he has eaten something, which must occur at least 30 minutes after taking the tablet. The tablet should not be chewed or dissolved in the mouth.
If the normal diet does not ensure sufficient calcium intake, the patient will need to take calcium supplements. For more information, see the package leaflet.
How does Alendronate Sodium and Colecalciferol, MSD work?
The bones consist of living tissues constantly renewed through a process that erodes the existing bone tissue and replaces it with new tissue. Osteoporosis is a disease in which the bones become progressively thinner and more fragile, therefore more easily exposed to fractures. It is a disorder caused by an insufficient turnover of bone tissue that is consumed naturally.
Osteoporosis is more common in women who have passed menopause due to lowering estrogen levels, the hormones that allow healthy bones to be preserved.
The active substances present in Alendronate Sodium and Colecalciferol, MSD are alendronic acid and colecalciferol (vitamin D3). Alendronic acid, like alendronate sodium trihydrate, is a bisphosphonate, used for the treatment of osteoporosis since the mid-1990s. It blocks the action of osteoclasts, the cells responsible for the destruction of bone tissue. This inhibitory action reduces the loss of bone tissue. Vitamin D3 is a nutrient contained in some foods, but also produced by the skin when exposed to sunlight. Vitamin D3, as well as other forms of vitamin D, is necessary for the absorption of calcium and the normal formation of bone tissue. Since one of the causes of osteoporosis is the insufficient intake of vitamin D3 produced by exposure to sunlight, Alendronate Sodium and Colecalciferol, MSD contains vitamin D3.
How has Alendronate Sodium and Colecalciferol, MSD been studied?
As alendronate and vitamin D3 are already used separately in other medicines authorized in the European Union, the company presented data obtained from previous studies and published data in the scientific literature. The company also conducted a study on 35 men and 682 postmenopausal women with osteoporosis to demonstrate the efficacy of Alendronate Sodium and Colecalciferol, MSD in increasing vitamin D levels. Patients were given Alendronate Sodium and Colecalciferol, MSD (70 mg / 2 800 IU) or alendronate only once a week. The main parameter for assessing efficacy was the percentage of patients with vitamin D deficiency after 15 weeks. The study was prolonged for 652 patients for 24 weeks in order to compare the effects of continued intake of Alendronate Sodium and Colecalciferol, MSD (70 mg / 2 800 IU) alone or with the addition of 2 800 IU of vitamin D3 ( equivalent to using Alendronate Sodium and Colecalciferol, MSD, 70 mg / 5 600 IU).
What benefit has Alendronate Sodium and Colecalciferol, MSD, shown during the studies?
After 15 weeks of treatment, the percentage of patients with vitamin D deficiency was lower in patients treated with Alendronate Sodium and Colecalciferol, MSD, 70 mg / 2 800 IU, (11%) than those treated with alendronate alone (32% ). During the continuation of the study, although similar numbers of patients treated with Alendronate Sodium and Colecalciferol, MSD (70 mg / 2 800 IU) and Alendronate Sodium and Colecalciferol, MSD (70 mg / 5, 600 IU) presented vitamin D deficiency, patients treated with Alendronate Sodium and Colecalciferol, MSD (70 mg / 5 600 IU) showed a greater increase in vitamin D levels after the 24 weeks of the study. The company also presented evidence that the dose of alendronate contained in Alendronate Sodium and Colecalciferol, MSD is the same as is necessary to avoid bone loss.
What is the risk associated with Alendronate Sodium and Colecalciferol, MSD?
The most common side effects seen with Alendronate Sodium and Colecalciferol, MSD (seen in between 1 and 10 patients in 100) are headache, musculoskeletal pain (bones, muscles, joints) and gastrointestinal symptoms such as abdominal pain (stomach ache), dyspepsia (indigestion)), constipation, diarrhea, flatulence, ulcers in the esophagus, dysphagia (difficulty in swallowing), abdominal distention (swollen belly) and acid regurgitation. For the full list of all side effects reported with Alendronate Sodium and Colecalciferol, MSD, see the Package Leaflet.
Alendronate Sodium and Colecalciferol, MSD should not be used in patients who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients.
Alendronate Sodium and Colecalciferol, MSD should also not be used in the presence of abnormalities of the esophagus, in patients with hypocalcemia (calcium deficiency) or in patients unable to stand or sit upright for at least 30 minutes.
Why has Alendronate Sodium and Colecalciferol, MSD been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Alendronate Sodium and Colecalciferol, MSD outweigh its risks in the treatment of osteoporosis in postmenopausal women at risk of vitamin D insufficiency. The committee recommended the granting of the marketing authorization for Alendronate Sodium and Colecalciferol, MSD.
Other information on Alendronate Sodium and Colecalciferol, MSD:
On October 16, 2009, the European Commission issued to Merck Sharp & Dohme Ltd.
a marketing authorization for Alendronate Sodium and Colecalciferol, MSD, valid throughout the European Union . For the full EPAR of Alendronate Sodium and Colecalciferol, MSD, click here.
Last update of this summary: 08-2009.
