Agostini Agimexpharm treatment for osteoporosis (1 blister x 4 tablets)

Alendronate sodium

Alendronate sodium is a bisphosphonate acting as a powerful inhibitor and inhibit the bone elimination through intermediaries. Bisphosphonate are similar synthetic substances Pyrophosphate are linked to hydroxyapatite in bone.

Alendronat is a bisphosphonate that in animal studies, has a priority characteristic characteristic of bone pepper, especially under the cell cancel and inhibits bone resorption due to the cancellation of the cell, without direct effect in bone formation. Because bones and bone resorption go hand in hand, bone formation also decreased, but less than bone resorption, resulting in an increase in bone mass. During the use of alendronate, the normal bone is formed and attached to the bone mold and there, the drug will no longer activate the pharmacological activity.

cholecalciferol (vitamin D3)

Cholecalciferol (Vitamin D3) is a secondosterol, a natural precursor of calcitriol hormone regulating calcium (1.25 - dihydroxyvitamin D3).

Vitamin D3 is created in the skin due to optical conversion from 7 - Dehydrocholesterol to Vitamin D3 money with ultraviolet light. When the sun is not enough, Vitamin D3 will be essential nutrients. Vitamin D3 is required for normal bone formation. Vitamin D deficiency will increase when not exposed to sunlight and lack of nutritional supplements. Vitamin D is related to negative balance of calcium, bone loss and increased the risk of fracture. In serious cases, vitamin D deficiency will cause secondary energy to the parathyroid gland, lower blood phosphate, muscle weakness near the point of clinging and bone puree, moreover also increases the risk of falling and fractures in people with osteoporosis.

pharmacokinetic pharmacokinetics

alendronate sodium

Compared to an intravenous standard, oral bioavailability in women is 0.7% with doses in the range of 5 - 40 mg, oral after 1 fast fast and 2 hours before a standard breakfast.

Alendronat is transiently distributed in soft tissue, then redistributed to the bone or exit through the urine. Links to plasma proteins about 78%.

After an intravenous injection of 10mg, the renal clearance is 71 ml/min. The sale time of drugs is over 10 years, probably due to the release of Alendronat from the bone.

cholecalciferol (vitamin D3)

Vitamin D3 is absorbed in the intestinal mucosa thanks to bile salt and lipid, accumulated in the liver, fat, bones, muscles and intestinal mucosa. The drug is linked to plasma globulin. In the body, Vitamin D3 metabolizes in the liver and kidneys that produce an active metabolite of 1.25 - dihydroxycholeciferol thanks to the enzyme hydroxylase. Vitamin D3 is excreted mainly through feces, a small part of urine excretion, the sale time is 19 - 48 hours.

Notice the unwanted effects when using the drug.

Precautions when using

Gastrointestinal tract above:

Like other drugs containing bisphosphonat, Agostini can cause irritation at the gastrointestinal mucosa.

There have been reports on harmful esophageal reactions such as esophagitis, esophagitis and esophageal erosion, rarely leading to stenosis or perforation of the esophagus in patients treated with alendronat. Some severe cases have to be hospitalized. Therefore, it is necessary to be wary of any signs or symptoms that signal the esophageal reaction and patients should be instructed to stop taking the medicine and notify the physician immediately if it is difficult to swallow, swallow pain, pain behind the breastbone, heartburn appears or get worse.

The risk of serious reactions to the esophagus is greater if the patient is lying after taking Agostini, and/ or not taking medicine with a cup of water, and/ or continue taking the drug when there are suspected symptoms of esophageal irritation. Therefore, providing sufficient information for patients so that they understand the instructions of dosage, how to use is very important (see the dosage and usage).

Although there is no increased risk in expanded clinical trials, there have been a number of rare reports (after bringing the drug to the market) on stomach and duodenal ulcers, some severe cases with complications.

Because Alendronat can have the effect of irritating the above gastrointestinal mucosa and have the potential to worsen the disease, so it is necessary to be cautious when the patient has the above gastrointestinal problems such as difficulty swallowing, esophagus, inflammation or peptic ulcer, duodenum when using Agostini.

localized jaw bone necrosis:

localized jaw bone necrosis (ONJ), often associated with tooth extraction and/or local infections have been met (although rarely) when using oral bisphosphonate. Most of the cases of jaw bone necrosis due to using bisphosphonate are in cancer patients treated with intravenous bisphosphonate. Onj risk factors including cancer diagnosis, coordinated therapy (for example, chemotherapy, radiation, corticosteroid), poor dental hygiene, diseases simultaneously (previous teeth diseases, anemia, blood clotting, infection). Patients with localized jaw bone necrosis (ONJ) ​​need appropriate care of an oral surgeon and consider stopping using biphosphonate depending on the results of the risk/benefit assessment on each specific patient. Teeth can make it worse.

Muscle, bone, joint pain:

Patients with bisphosphonate sometimes have bone, joints and/or muscle pain. According to the experience after bringing the drug to the market, these symptoms are rarely at severe and/or losing their ability to exercise. The time starting to appear symptoms ranges from one day to months after the beginning of treatment. Most patients reduce symptoms after stopping the drug. Some patients recur when reused with the same medicine or with another bisphosphonate.

Do not use Agostini for patients with creatinine clearance

It is necessary to consider the causes of osteoporosis other than the deficiency of estrogen, high age and use glucocorticoid.

Metabolism of mineral salts:

Sodium alendronate: Must adjust the phenomenon of lowering blood calcium before starting to use Agostini (see the contraindications section). It is also necessary to actively treat other disorders that affect mineral metabolism (such as vitamin D deficiency). For patients who have these disorders, serum calcium concentration should be monitored and symptoms of blood calcium lower during treatment with Agostini. Due to the positive effects of alendronat increases bone mineral, may occur mitigation and asymptomatic concentration of calcium and phosphate in serum.

Cholecalciferol: Vitamin D3 can increase the level of hypercalcemia and/ or hypercalciemia when used for people with diseases associated with an excessive increase in calcitriol level without regulating (for example, leukemia, lymphoma, sarcoid disease). For people who need to monitor calcium levels in urine and serum.

Patients with malabsorption will may not absorb adequate vitamin D3.

To be out of reach of children.

The ability to drive and operate machinery

Use carefully for the driver and operate machinery because the drug can cause unwanted effect dizziness, dizziness for users.

Pregnancy

The drug has not been studied in pregnant women so it is not used for this case.

Breastfeeding period

The drug has not been studied in nursing women, so it is not used for this case.

Drug interaction

Alendronate sodium

If used at the same time, it is possible that calcium supplements, antacids and other oral drugs will affect the absorption of alendronat. Therefore, the patient must wait at least half an hour after taking Agostini before taking another medicine.

Simultaneous use of hormone replacement drugs (HRT) (estrogen ± progestin) and sodium alendronat have been assessed in two clinical studies for one and two years in postmenopausal osteoporosis women. Using a combination (HRT + Alendronate sodium) has increased bone volume more, while minimizing bone degeneration, compared to each separate medicine. In these studies, records on safety and intolerance of coordinated therapy with the safety and tolerance of each drug separately.

Special interactive studies have not been conducted. Sodium/ cholecalciferol alendronate has been used in studies on osteoporosis in men and postmenopausal women with a range of conventional prescription drugs, there is no evidence of clinical harmful interactions.

cholecalciferol

olestra, mineral oils, orlistat, bile acid bonds (for example: Cholestyramin, Colestipol) can hinder the absorption of vitamin D. anti -convulsions, cimetidine and thiazid diuretic may increase vitamin D.