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Fosavance Forte is an inhibitor of bone resorption in osteoporosis. Sodium alendronate refers to bisphosphonates - compounds that, localized in the areas of active bone resorption, under osteoclasts, inhibit the process of bone resorption due to osteoclasts, without having a direct effect on the formation of new bone tissue. Because bone resorption and new bone formation are interrelated, bone formation also decreases, but to a lesser extent than resorption, which leads to a progressive increase in bone mass. During sodium treatment with alendronate, normal bone tissue is formed, into the matrix of which alendronate is inserted, remaining pharmacologically inactive. At therapeutic doses, alendronate does not cause osteomalacia.
Colecalciferol It is produced in the skin by converting 7-dehydrocolecalciferol to vitamin D3 when exposed to ultraviolet light. In the absence of sunlight, vitamin D3 is an indispensable component of food. Vitamin D3 is metabolized to 25-hydroxyvitamin D in the liver, where it accumulates. Its transformation into the active calcium-mobilizing hormone 1,25-dihydrovitamin D (calcitriol), occurs in the kidneys and is carefully regulated. The principal mechanism of action of 1,25-dihydrovitamin D is to increase intestinal absorption of calcium and phosphate, as well as regulation of plasma calcium levels, excretion of calcium and phosphates by the kidneys, bone formation and its resorption.
Vitamin D3 is essential for normal bone formation. Vitamin D deficiency develops with inadequate exposure to sunlight and / or dietary errors. Vitamin D deficiency is associated with a negative calcium balance, loss of bone mass, and an increased risk of fractures. In acute cases, vitamin deficiency is associated with secondary hypoparathyroidism, hypophosphatemia, myasthenia, osteomalacia, a further increase in the risk of falls and fractures in patients with osteoporosis.
The bioavailability of sodium alendronate in a dose of 5-70 mg when administered on an empty stomach no later than 2 hours before the standard breakfast is 0.64% in women and 0.6% in men.
When taking sodium alendronate on an empty stomach 1-1.5 hours before a standard breakfast, bioavailability decreases by approximately 40%.
In patients with osteoporosis sodium, alendronate is effective when taken on an empty stomach, no later than 30 minutes before the first meal or liquid intake.
The bioavailability of sodium alendronate is insignificant when administered simultaneously with a meal or within 2 hours after a meal.
Simultaneous intake with coffee or orange juice reduces the bioavailability of the drug by approximately 60%.
When taking prednisolone at a dose of 20 mg 3 times a day for 5 days, there is no clinically significant change in the bioavailability of sodium alendronate.
When using Fosavance after morning sleep on an empty stomach 2 hours before a standard breakfast, the average AUC0-120 h for vitamin D3 is 296.4 ng x h / ml.
Cmax of vitamin D3 in plasma is 5.9 ng / ml. The average time to reach Cmax of vitamin D3 in the blood plasma is 12 hours.
The bioavailability of 2800 IU of vitamin D3 in the Fosavance tablet is similar to the bioavailability of 2800 IU of vitamin D3 when taken alone.
The average Vd in equilibrium (with the exception of bone tissue) is at least 28 liters. When taken in therapeutic doses, the concentration of the drug in the blood plasma is negligible (less than 5 ng / ml). The binding of sodium alendronate to plasma proteins is approximately 78%.
After absorption in the intestine, vitamin D3 enters the bloodstream as part of chylomicrons and is quickly distributed, mainly to the liver. Smaller amounts of vitamin D3 are distributed in adipose and muscle tissue, where they are cumulated in their native form for further gradual release into the bloodstream.Vitamin D3 circulates in the bloodstream associated with a vitamin D-binding protein.
There is no evidence that sodium alendronate is metabolized in humans or animals.
Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3 (the main form of vitamin accumulation) and gradually metabolized in the kidneys to 1.25-dihydroxyvitamin D3, which is the active form of the vitamin. Before removing the vitamin, its further hydroxylation occurs. A small amount of vitamin D3 before excretion is subject to glucuronidation.
After a single intravenous injection of sodium alendronate labeled with 14C, approximately 50% of the drug is excreted in the urine within 72 hours. The excretion of the labeled preparation with feces was insignificant or not detected. After a single intravenous administration of sodium alendronate at a dose of 10 mg, its renal clearance is 71 ml / min. After 6 h after intravenous administration, plasma concentration decreases by more than 95%. The final T1 / 2 exceeds 10 years, which reflects the release of the drug from the bone tissue.
When taking radioactive vitamin D3 in healthy individuals, the average excretion of the radioactive drug in the urine after 48 hours was 2.4%, with feces - 4.9% after 4 days. In both cases, the drug was excreted mainly in the form of its metabolites. T1 / 2 of vitamin D3 after oral administration of Fosavance is approximately 24 hours.
For the treatment of postmenopausal osteoporosis in patients who additionally do not take vitamin D drugs and are at risk of developing vitamin D deficiency. The drug reduces the risk of vertebral and hip fractures; to increase bone mass in men with osteoporosis.
1 tablet contains:
active substances: alendronic acid 70 mg, colecalciferol 140 mcg.
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Dosage and Administration
1 tablet, at least 30 minutes before the first meal, liquid or medicine (including antacids, calcium preparations and vitamins), with a full glass of plain water (not mineral water). Other drinks (including
mineral water), food and some drugs can reduce the absorption of the drug Fosavance Forte.
To reduce the risk of esophageal irritation, Fosavance Forte should be taken according to the following rules:
- Take in the morning immediately after getting out of bed, at least 30 minutes before the first meal, liquid or medicine, drink a full glass of water (not mineral) to facilitate the flow of the pill into the stomach.
- Do not chew the pills and do not dissolve them in the mouth due to the possible formation of ulcers in the mouth and throat. Patients should not go to bed before the first meal, which should be done at least 30 minutes after taking the drug Fosavance Forte.
- The drug Fosavance Forte should not be taken at bedtime or before getting out of bed.
The recommended dose is 1 tablet of the drug Fosavance Forte 1 time per week.
Patients should additionally take calcium supplements if their dietary intake is insufficient. The drug Fosavance Forte meets the weekly need for vitamin D, based on a daily dose of 800 ME.
For elderly patients and patients with mild to moderate renal insufficiency (CC from 35 to 60 ml / min) dose adjustment is not required. The recommended dose is 1 tablet of the drug Fosavance Forte 1 time per week.
If you accidentally skip the drug, you must take 1 tablet in the morning of the next day. You should not take 2 doses on the same day, but later you need to return to taking the drug once a week on the day of the week that was chosen at the beginning of the treatment.
The most frequently reported adverse events are unwanted reactions from the upper GI tract, including abdominal pain, dyspepsia, esophageal ulcer, dysphagia, abdominal distention and sour belching (≥ 1/100, <1/10).
The following adverse reactions were reported during clinical studies and / or post-marketing use of alendronate.
Additional adverse reactions for the drug Fosavance Forte has not been established.
The frequency of adverse reactions is set as follows: very frequent (> 1/10); frequent (> 1/100, <1/10); infrequent (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000).
|Disorders of the immune system||Rare: hypersensitivity reactions, including urticaria and angioedema.|
|Metabolic and nutritional disorders||Rare: symptomatic hypocalcemia, often against a background of predisposition factors.1|
|Nervous system disorders||Frequent: headache, dizziness2
Infrequent: taste disturbance2
|Violations of the organs of sight||Infrequent: eye inflammation (uveitis, scleritis, episcleritis)|
|Hearing and labyrinth disorders||Frequent: systemic vertigo2|
|Gastrointestinal disorders||Frequent: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer3dysphagia3, bloating, sour belching
Infrequent: nausea, vomiting, gastritis, esophagitis3esophageal erosion3melena2
Rare: esophageal stricture3ulceration of the esophagus3, perforation, ulcers, upper gastrointestinal bleeding1gastroesophageal reflux
|Violations of the skin and subcutaneous tissue||Frequent: alopecia2itching2
Infrequent: skin rash, erythema
Rare: photosensitive skin rash, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis4
|Musculoskeletal and connective tissue disorders||Very frequent: musculoskeletal (bones, muscles or joints) pain, sometimes severe pain1,2
Frequent: joint swelling2
Rare: osteonecrosis of the jaw1,4, atypical, subversive and diaphyseal femur fractures (undesirable reaction of the bisphosphonate class)5
|General disorders and disorders at the site of administration||Frequent: asthenia2peripheral edema2
Infrequent: transient symptoms as a reaction of the acute phase (myalgia, malaise and rarely - fever), usually due to the start of treatment2
1 See section "Special instructions"
2 In clinical studies, the frequency was comparable for the group of the drug and the placebo group.
3 See sections "Directions for use and dosage" and "Special instructions"
4 This undesirable reaction was established during post-marketing surveillance. The frequency of "rare" was established on the basis of relevant clinical studies.
5 Installed in post-marketing application.
- in case of exacerbation of diseases of the upper GI tract, such as dysphagia, esophageal diseases, gastritis, duodenitis or gastric ulcer (including anamnestic information about a peptic ulcer, active gastrointestinal bleeding, surgery on the upper gastrointestinal tract during the year before admission Fosavance Forte).
- in diseases associated with hyperproduction of calcitriol (leukemia, lymphoma, sarcoidosis) and concomitant hypercalcemia and / or hypercalciuria.
Suction of alendronate may be impaired if the drug is taken simultaneously with food, drinks (including mineral water), calcium preparations, antacids and other drugs for oral use. In this regard, the interval between taking the drug Fosavance Forte and other drugs taken orally should be at least 30 minutes.
Since the use of NSAIDs is associated with the development of erosive and ulcerative lesions of the gastrointestinal tract, caution should be exercised with the simultaneous use of NSAIDs and alendronate.
Olestra, mineral oils, orlistat, as well as bile acid sequestrants (colestyramine, colestipol) can impede the absorption of vitamin D.
Anticonvulsants, cimetidine, thiazide diuretics can accelerate vitamin D catabolism.
Pregnancy and Lactation
The drug Fosavance Forte is intended for the treatment of women only in the post-menopausal period and is contraindicated during pregnancy and during breastfeeding.
Data on the use of the drug Fosavance Forte during pregnancy are not available. Animal studies of alendronate revealed no direct damaging effects on pregnancy, embryo / fetus development, or postnatal development. The use of alendronate in rats during pregnancy caused a violation of labor due to hypocalcemia. Animal studies show hypercalcemia and reproductive toxicity with high-dose vitamin D.
It is not known whether alendronate passes into breast milk. Colecalciferol and some active metabolites pass into breast milk.
Bisphosphonates are incorporated into bone tissue, from which they are gradually released over many years. The amount of bisphosphonate that can build up in the bone and thus return to the systemic circulation is directly proportional to the dose and duration of bisphosphonate use. There are no data on the risk to the fetus in a person, but there is a theoretical risk of damage to the fetus, especially the bone skeleton, if pregnancy occurs at the end of the bisphosphonate course. The effect of variables such as the length of the period between discontinuation of bisphosphonate therapy and conception, the specific type of bisphosphonate and the route of administration (intravenous or oral) for this risk has not been studied.
Undesirable reactions from the upper GI tract
Alendronate may cause local irritation of the mucous membrane of the upper GI tract. In connection with the possibility of deterioration of the underlying disease while taking alendronate, care should be taken when prescribing the drug to patients with diseases of the upper GI tract, for example, dysphagia, esophageal disease, gastritis, duodenitis, ulcers, as well as with a serious GI disease, transferred previous 12 months, for example, peptic ulcer, with gastrointestinal bleeding, surgery, surgery on the upper GI tract, with the exception of pyroloplasty. For patients with a diagnosed Barrett esophagus, the question of prescribing alendronate should be decided individually on the basis of an assessment of the ratio of the expected benefit to possible risk.
In the treatment of alendronate, there are cases of adverse reactions from the esophagus (esophagitis, an ulcer or erosion of the esophagus), sometimes proceeding in a severe form, requiring inpatient treatment, and in rare cases complicated by the formation of a stricture. In this regard, physicians should pay particular attention to any signs or symptoms indicating possible esophageal abnormalities, and patients should be warned about the need to stop taking alendronate and consult a doctor if they develop symptoms of esophageal irritation, such as dysphagia, pain when swallowing or chest pain, the appearance or strengthening of heartburn.
The risk of severe side effects from the esophagus is higher in those patients who violate the recommendations for taking alendronate and / or continue to take it when symptoms of irritation of the esophagus appear. It is extremely important to fully inform patients about the importance of compliance with the rules of taking the drug and make sure that they understand it. They should be warned that the risk of developing a lesion of the esophagus increases in the event of non-compliance with these recommendations.
Although there was no increase in risk in extended clinical trials of alendronate, rare post-morbidity was reported in post-marketing reports. The stomach and duodenal ulcers were sometimes severe and complicated.
Osteonecrosis of the jaw
Cancer patients who were treated with intravenous bisphosphonates were treated with osteonecrosis of the jaw, mainly due to previous extraction of the tooth and / or local infection. (including osteomyelitis). Many of them also received chemotherapy and glucocorticosteroids.
There are also cases of osteonecrosis of the jaw in patients with ossoporosis when ingesting bisphosphonates.
In assessing the individual risk of developing jaw necrosis, the following risk factors should be considered:
- the strength of the bisphosphonate (the highest in zoledronic acid), the route of administration (see above) and the total dose;
- cancer, chemotherapy, radiotherapy, glucocorticosteroids, smoking;
- diseases of the teeth in history, poor oral hygiene, paradontosis, invasive dental procedures and poorly chosen dentures.
Before starting oral bisphosphonate therapy, dental examination and preventive treatment are recommended for patients with unsatisfactory dental status.
During the course of bisphosphonates, it is recommended that such patients avoid invasive dental procedures. If a patient develops osteonecrosis during bisphosphonate therapy, dental surgery can worsen his condition. It is not known whether stopping bisphosphonates reduces the risk of osteonecrosis of the jaw in patients who require dental procedures. In each case, the decision must be made by the attending physician based on an assessment of the ratio of the expected benefit to the possible risk for the particular patient.
During therapy with bisphosphonates, patients should be told about the importance of proper oral hygiene, preventive examinations, and also to warn them about the need to report any symptoms from the oral cavity, such as tooth mobility, pain or swelling.
Pain in bones and muscles
It is known about the occurrence of pain in the bones, joints and / or muscles during the course of bisphosphonates. In post-marketing use, in rare cases, these symptoms were severe and / or resulted in disability. The time of onset of symptoms ranged from one day to several months after the start of treatment. In most patients, symptoms were resolved after discontinuation of treatment. In some of them, the symptoms reappeared when the same drug or another bisphosphonate was taken again.
Atypical hip fractures
There are cases of subversion or diaphyseal fractures of the hip during treatment with bisphosphonates, mainly in patients receiving long-term therapy for osteoporosis. These transverse or oblique fractures can occur along the entire length of the thigh from the small skew of the femur to the epistemological expansion. These fractures occur after a minor injury or without it, some patients experience severe pain in the hip or groin, which is often combined with radiological symptoms of stress fractures, weeks or months before the full picture of the hip fracture appears. Fractures are often bilateral, so patients with a hip fracture taking bisphosphonates should examine the second (contralateral) hip. It is known that these fractures grow poorly. If an atypical hip fracture is suspected, the possibility of discontinuing therapy with bisphosphonates should be considered before conducting an individual assessment of the relationship of expected benefit to possible risk.
During therapy with bisphosphonates, patients should be advised to report any pain in the hip or groin. All patients admitted with such complaints should be examined for a hip fracture.
The drug Fosavance Forte is contraindicated in patients with renal insufficiency with glomerular filtration rate of less than 35 ml per minute.
Bone and mineral metabolism
Other causes of osteoporosis should be taken into account, in addition to estrogen deficiency and age.
In the presence of Gicalcemia, the concentration of calcium in the blood must be normalized before the start of treatment with Fosavance Forte.
Other disorders of mineral metabolism (for example, vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting treatment with Fosavance Forte. The content of vitamin D in Fosavance Forte is insufficient for correcting vitamin D hypovitaminosis. In patients with these disorders during Fosavance Forte treatment, it is necessary to control serum calcium concentration and symptoms of hypocalcemia.
Since alendronate increases the mineral content in bones, a decrease in serum calcium and phosphate levels may be observed, especially when taking glucocorticosteroids, which decrease calcium absorption. Usually such a decrease is slight and asymptomatic. However, rare cases of symptomatic hypocalcemia are known, which sometimes reached a severe degree and developed in patients with a corresponding predisposition (for example, hypoparathyroidism, hypovitaminosis D and calcium malabsorption).
Vitamin D3 may contribute to the severity of hypercalcemia and / or hypercalciuria, when used in patients with diseases that cause uncontrolled calcitriol hyperproduction (for example, leukemia, lymphoma, sarcoidosis). In such patients, it is necessary to control the calcium content in urine and serum.
Patients with malabsorption may have impaired absorption of vitamin D3.
This drug contains lactose and sucrose. Patients with rare hereditary diseases of intolerance to fructose and galactose, lactase deficiency, glucose-galactose malabsorption and sucrose-isomaltase deficiency should not take this drug.
Influence on ability to steer the car and other mechanisms
There is no evidence that Fosavance Forte directly affects the ability to drive or use other mechanisms. Some adverse events; for example, blurred vision, dizziness, severe pain in the joints or muscles (see section "Side Effects"), observed when taking the drug Fosavance Forte, can affect the ability to drive a car and other mechanisms.
In case of overdose, hypocalcemia, hypophosphatemia and undesirable reactions from the upper part of the gastrointestinal tract are possible: dyspepsia, heartburn, esophagitis, gastritis, gastric ulcer and esophagus.
There is no specific treatment for alendronate overdose. In case of overdose of the drug Fosavance Forte, you should take milk or antacids to bind alendronate. In order to avoid irritation of the esophagus should not induce vomiting. Patients should be kept upright.
The toxicity of vitamin D was not observed in healthy adults with chronic intakes in doses below 10,000 IU per day. In clinical studies involving healthy adults, taking vitamin D3 at a daily dose of 4000 ME for 5 months did not cause hypercalciuria or hypercalcemia.
- Brand name: Fosavance Forte
- Active ingredient: Alendronic acid, Colecalciferol
- Dosage form: Pills.
- Manufacturer: Merck Sharp & Dohme
- Country of Origin: USA