Fosamax Plus 70mg/5600iu Organon treat osteoporosis (1 blister x 4 tablets)
Dosage form Box of 1 blister x 4 tablets
Specifications Alendronic Acid, Vitamin D3
Ingredient
| Composition information | Content |
| Alendronic Acid | 70mg |
| Vitamin D3 | 5600iu |
Uses
Indications
Rxfosamax Plus ™ 70 mg/5600 IU is indicated in the following cases:
Sodium Alendronat is a bisphosphonate acting as a strong inhibitor and inhibit the bone elimination through intermediaries. Bisphosphonate are similar synthetic substances Pyrophosphate are linked to hydroxyapatite in bone.
colecalciferol:
Colecalciferol (Vitamin D3) is a secondosterol, a natural precursor of calcitriol hormone regulating calcium (1.25-dihydroxyvitamin D3).
Mechanism of action
Sodium Alendronat
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 is also reduced, but less than bone resorption, leading to gradual increase in bone mass. During the use of alendronate, the normal bone is formed and attached to the bone's mold and there will no longer have pharmacological activity.
Relatively inhibited activity on bone elimination and mineralization of Alendronat with Etidronate has been studied comparison on large young mice. The lowest dose of Alendronat has an influence on bone mineralization (leading to bone puree) 6,000 times higher than the bone -resistant dose. But the corresponding ratio of Etidronate is only 1: 1. These data shows that, unlike for Etidronat, if used for treatment, alendronat is very difficult to cause bone smooth.
colecalciferol
Vitamin D3 is created in the skin due to the optical conversion from 7-dehydrocholesterol to Vitamin D3 money with ultraviolet light. Next is the process of non -enzyme isomers that form vitamin D3. When the sun is not enough, vitamin D3 will be essential nutrients. Vitamin D3 in the skin and Vitamin D3 from nutrition (absorbed into the tremor) will be converted into 25-hydroxyvitamin D3 in the liver. The conversion into 1.25 -dihydroxyvitamine hormone D3 (Calcitriol) has a calcium mobilization activity in the kidney stimulated by both thyroid hormones and hypoglycemia - blood. The main effect of 1.25 dihydroxyvitamin D3 is to help increase the intestinal absorption of both calcium and phosphate, and regulate the serum calcium levels, the elimination of calcium and phosphate in the kidneys, bone formation and bone pepper.
Vitamin D3 is needed for normal bone formation. Vitamin D deficiency will increase when not exposed to sunlight and lack of nutritional supplements. Vitamin D deficiency associated with negative balance of calcium, bone chemistry and increased the risk of fractures. In serious cases, the deficiency of vitamin D will cause secondary hyperpointing glands, lower phosphate - blood, muscle weakness near the point of grip and bone puree, moreover also increases the risk of falling and fractures in people with osteoporosis.
Osteoporosis in postmenopausal women
Osteoporosis is characterized by low bone mass and leads to an increase in the risk of fractures, usually fractures in the spine, hip and wrist. Osteoporosis is common in men and women, but most common in postmenopausal women, when bone rotation increases and the percentage of bone pepper exceeds the rate of bone formation, leading to loss of bone mass.
Alendronat daily oral dose for postmenopausal women creates biochemical changes that show that the inhibition of the dose depends on bone resorption, including reduction of urinary calcium, reducing urine concentration of bone collagen-marked substances (such as hydroxyprolin, deoxypidinolin, n-delopeptides cross-bonding diagonal category I collagen). These biochemical changes will return to the original value of about 3 weeks after stopping the alendronat, even though the alendronat is accumulated in the bone.
Long-term treatment of osteoporosis with Fosamax 10 mg/day (in the up to 5 years) reduces the excretion through urine the biological marks of bone resorption, deoxypidinoline and n-textptids cross-binding Collagen, about 50% and 70%, to reach the same level as in healthy premenopausal women. The deceleration of bone pepper defined through these biological marks becomes significant after one month of taking the drug, reaching the highland level after 3-6 months of taking the drug, and maintained during the FOSAMAX treatment process. In studies to treat osteoporosis, FOSAMAX 10 mg/day reduces bone creation, osteocalcin and alkaline phosphatase specific bones of about 50%, reducing the total alkaline phosphatase in serum about 25 - 30%. Achieving the highlands after 6 - 12 months. The same reduction effect in the rate of bone rotation is also seen when using Fosamax 70 mg once a week in the study of osteoporosis for a year.
pharmacokinetic
absorption
Sodium Alendronat
Regarding intravenous reference dose, the average bioavailability of oral alendronate in women is 0.64% with a dose of 5-70 mg when used after 1 night without eating and 2 hours before standard breakfast. Oral bioavailability of men on men is similar to women (0.6%).
Birth is similarly reduced (about 40%) when Alendronat is used an hour or half an hour before the standard breakfast. In studies on fosamax osteoporosis, it is too effective when used at least 30 minutes before meals or drinking first of the day. Birth will be negligible when drinking Alendronat with or within 2 hours after the standard breakfast. Drinking Alendronat with coffee or orange juice will reduce about 60% of the bioavailability of Alendronat.
In healthy volunteers, the oral Prednison (20 mg, 3 times a day, used for 5 days) does not change the clinical significance of the bioavailability of alendronat orally (an average increase of 20 - 44%).
colecalciferol
After taking Fosamax Plus (70 mg/5600 IU) after 1 night without eating and 2 hours before the standard breakfast, seeing the area under the average curve of serum concentration - time (AUC 0 - 80 hours) with Vitamin D3 La 490.2 ng -ml/ml (unchanged for endogenous vitamin D3). The average peak concentration in plasma (CMAX) of Vitamin D3 is 12.2 ng/ml and the average time to reach the peak concentration in plasma (TMAX) is 10.6 hours. Biomedical of vitamin D3 in Fosamax Plus (70 mg/5600 IU) is equivalent to the corresponding dose of vitamin D3 orally.
Distribution
Sodium Alendronat
Research on rats shows that alendronat is temporarily distributed into soft tissues after intravenous injection of 1 mg/kg, but then quickly distributed into the bone or eliminated through the urine. The average distribution volume in a stable state, except in bones, is at least 28 liters in humans. The concentration of the drug in plasma after the oral treatment dose is too low to be detected by analysis (
colecalciferol
After absorbing, vitamin D3 into the bloodstream according to the tremor. Vitamin D3 is distributed quickly, mostly into the liver, where it will be transferred to 25-hydroxyvitamin D3 is the main cumulative form. The smaller amount is distributed into adipose tissue, muscle tissue and there is accumulated in the form of vitamin D3, and then gradually transferred to the circulation. Vitamin D3 circulation is associated with protein-Vitamin d.
Metabolism
Sodium Alendronat
There is no evidence that alendronate has been metabolized in animals or in humans.
colecalciferol
Vitamin D3 is rapidly metabolized through the hydroxylation reaction in the liver so that into 25-hydroxyvitamin D3, then converted in the kidney to 1.25-dihydroxyvitamin D3 is a biological activity form. The hydroxylation reaction continues before elimination. A small amount of Vitamin D3 will undergo a combination of glucuro-Glucuro-before elimination.
Elimination
Sodium Alendronat
After intravenous injection a single dose [L4C] Alendronat, about 50% of the markers are discharged through urine for 72 hours and very few or no markers are excreted in the feces. After the only 10 mg intravenous intravenous injection, the kidney purification of the alendronate is 71 ml/min. Plasma concentrations decreased by> 95% in 6 hours after intravenous injection. The last time of the expected person is more than 10 years, reflecting the release of Alendronat from the bone. Alendronat does not eliminate through acid or basic transportation systems in the kidneys of rats, and therefore does not affect the elimination of other drugs through these transportation systems in humans.
colecalciferol
When healthy people use vitamin D3 marking radiation, the average elimination of the meter is marked through the urine after 48 hours is 2.4%, and after 4 days the average elimination through the stool of the marker is 4.9%. In both cases, the markers are eliminated mostly the metabolites of the original drug. The average selling time for vitammm D3 in serum after taking a dose of Fosamax Plus is about 24 hours.
Characteristics in patients
Prelise clinical research shows that the non -dependent alendronate component will be quickly discharged through the urine. There is no evidence of saturation when importing bones after long -term use of accumulated venous dose up to 35 mg/kg on animals. Although there is no clinical information, it may be the same as in animals, the elimination of the kidneys will be reduced if used for kidney failure. Therefore, in patients with renal function, maybe the accumulation of alendronate in the bone will be a bit bigger.
Before taking Fosamax Plus 70mg/5600iu Organon treat osteoporosis (1 blister x 4 tablets)
How to use
must drink Fosamax Plus with cool boiled water for at least 30 minutes before eating, taking or taking other medication for the first time of the day. Other drinks (including mineral water), food and some drugs can reduce the absorption of alendronat.
To easily put the drug down to the stomach to reduce the ability to irritate the esophagus, take Fosamax Plus with a full cup of water (200 ml or more) at the time of waking up during the day. The patient must not lie until the first meal of the day and this meal must be after taking Fosamax Plus at least 30 minutes. The patient must not chew or leave the pill in the mouth because of the risk of throat ulcers. Without compliance with these instructions, the risk of adultery on the esophagus may increase.
Dosage
recommended dose is 1 tablet 70 mg/5600 IU once a week. For most patients with appropriate dose osteoporosis is 1 tablet 70 mg/5600 IU once a week. The optimal drug time in how long has not been clearly defined. All patients using bisphosphonat therapy should be used continuously and re -evaluate periodically.
Patients need calcium and/or vitamin D supplements if the amount of diet is not enough. Doctors also need to pay attention to the amount of vitamin D in vitamins and supplements. Fosamax Plus 70 mg/5600 IU provides vitamin D for each week, based on the daily dose of 800 units.
No need to adjust the dose for the elderly or patients with mild to moderate kidney failure (creatinine clearance from 35 to 60 ml/minute). It is not recommended to use fosamax plus for more severe renal impairment (creatinine clearance ratio Pediatric patients: The safety and effectiveness of Fosamax Plus has not been set in children under 18 years old. Fosamax plus should not be used for children under 18 because there is currently no data on combination of alendronic acid/colecalciferol.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?
There is no special information on overdose treatment with Alendronat. Overdose can cause hypocalcemia, lower hemorrhagic phosphate, existing adverse effects in the gastrointestinal tract such as digestive disorders, heartburn, esophagitis, inflammation or ulcer. Need to drink milk or antacids to combine alendronat. Due to the risk of esophageal irritation, do not cause vomiting and patients need to be completely vertical.
colecalciferol
There is no data to recognize the toxicity of vitamin D when taken for prolonged adults with a dose of less than 100,000 IU/day. In healthy adults, daily doses of 400 IU of vitamin D3 in the up to 5 months do not see increased calcium or hypercalcemia.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Fosamax Plus, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Disorders in the ears and inner ears: external ear necrosis (type of bisphosphonate side reaction).
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Fosamax plus drugs contraindicated in the following cases:
Be cautious when using
Harmful reactions in the gastrointestinal tract above:
Alendronat can cause local gastrointestinal irritation. Vi has the potential to make the disease worse and cautious when using Alendronate for patients who are having the gastrointestinal problems such as difficulty swallowing, esophagitis, gastritis, duodenum, ulcers, or recently (within a year ago) had gastrointestinal diseases such as gastric ulcer or gastrointestinal bleeding, or surgical surgery in the gastrointestinal tract except for the pyloric, in the patient, the patient should be considered in the pyloric, the patient should consider the benefit of the barran And the potential risk of Alendronat in each patient.
There have been reports on esophageal reactions (sometimes severe and hospitalized), such as esophagitis , esophagus ulcers and esophageal tissue rarely lead to esophageal stenosis, in patients using alendronat. Therefore, doctors should be wary of any signs or symptoms that signal a possible esophageal reaction and patients need to be instructed to stop alendronat and find medical care if they have symptoms of esophageal stimulation such as difficulty swallowing, pain when swallowing or pain or heartburn appears or worse.
The risk of severe harmful reactions in the esophagus appears more in patients who do not perform properly using alendronate and/or those who continue to use alendronate after the suggested symptoms of esophageal stimulation. It is important to provide adequate medication instructions, and patients understand how to use. It is advisable to notify the patient that if not in accordance with these instructions may increase the risk of esophageal problems. Not observing the risk of increasing in widespread clinical trials with Alendronate, there have been rare post -circulating reports on stomach and duodenal ulcers, in some severe and complicated cases.
Jaw bone necrosis:
Jaw necrosis, often associated with tooth extraction and/or local infection (including bone mystitis), has been reported in cancer patients under the treatment regimen including bisphosphonate drugs mainly intravenously. Many of these patients are also using chemotherapy and corticosteroids. Jaw bone necrosis has also been reported in patients with osteoporosis using oral bisphosphonate.
The following risk factors should be considered when assessing the risk of gy bone necrosis in each patient:
Consider a dental exam with appropriate prevention before treatment with oral bisphosphonate in patients with poor dental condition.
During treatment, these patients may avoid invasive dental procedures. For patients with jaw bone necrosis while treating bisphosphonate, teeth surgery can worsen this condition. For patients who need a dental procedure, there is no available data to suggest whether or not bisphosphonate stops reduces the risk of jaw bone necrosis. The treatment doctor should assess the clinical assessment to guide the management plan of each patient based on the assessment of risk benefits in each patient.
During the treatment of bisphosphonate, all patients need to be encouraged to maintain good oral hygiene, regular teeth test, and report if any oral symptoms are wobbly, painful or swollen.
Did the outer ear necrosis:
external ear necrosis has been reported to bisphosphonat, mainly related to long -term treatment. The possible risk factors of the external ear canal include the use of steroids and chemotherapy and/or intrinsic risk factors such as infection or injury should consider the possibility of external ear necrosis in patients using bisphosphonates that manifest symptoms in the ears such as pain or fluid, or chronic ear infections.
musculoskeletal pain:
There have been reports on muscle and/or bone pain, joints in patients using bisphosphonate. According to experience after circulating these symptoms rarely severe and/or loss of ability. The onset of symptoms is different from a day to several months after the beginning of treatment. Most patients reduce symptoms after treatment. A small group has symptoms when testing again with the same drug or another bisphosphonate.
Not typical femoral fractures:
There have been reports on the typical transfer and thigh bone fractures with bisphosphonate therapy mainly in patients with long -term treatment of osteoporosis. The horizontal or short -skewer fractures can occur in any position along the thigh bone from the bottom of the small shift to the top of the upper bridge. These fractures occur after a small or no injury and some patients with thigh pain or groin, often associated with the typical image of stress fractures, from weeks to months before a complete femur fracture. The fractures are often symmetrical; Therefore, patients who are undergoing bisphosphonate have a constant thigh fracture should check the femur. The poor work of these fractures has also been reported. Consider to stop using bisphosphonate therapy in patients suspected of having a typical femoral fracture based on assessment of risk/benefits in each patient.
Should advise the patient to report if there is any thigh pain, hip or any company and any patient with such symptoms should be assessed for an incomplete femur fracture.
kidney failure:
It is not recommended to use fosamax plus for patients with renal failure with creatinine clearance below 35 ml/min.
Bone metabolism and minerals:
Consider other causes of osteoporosis in addition to estrogen deficiency and age. Lower blood calcium must be adjusted before starting treatment with Fosamax Plus.
Other disorders that affect the metabolism of minerals (such as vitamin D and parathyroid failure) also need to be effectively treated before starting to use Fosamax Plus. The vitamin D content in Fosamax Plus is not suitable for adjusting the deficiency of vitamin D. In patients with these conditions, should monitor serum calcium levels and symptoms of lower blood calcium during treatment with Fosamax Plus.
Due to the positive effects of alendronat increases bone mineral, there may be a decrease in calcium and phosphate levels in serum especially in patients using glucocorticoids. Because in these patients, calcium absorption may be impaired. These conditions are usually mild and have no symptoms. However, there have been rare reports of symptomatic blood calcium, which sometimes severe and often occurs in patients with premise conditions (for example: parathyroid insufficiency, vitamin D deficiency and calcium absorption).
colecalciferol:
Vitamin D3 can increase the level of calcium-hypertension and/or increase calcium-calcium when used for people suffering from diseases related to an 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
Excipients:
This drug contains lactose and sucrose. This drug should not be used for patients with rare genetic problems in non-intolerance of fructose, galactose, lactase lactase enamel deficiencies, glucose-galactose malabsorption or deficiency of sucrase-isomtase.
The ability to drive and operate machinery
has not conducted any research on affecting the ability to drive and operate machinery. However, some of Fosamax Plus's adultery have been reported that can affect the patient's ability to drive and operate machinery. The response of each individual with Fosamax Plus may vary.
During pregnancy
No or limited data on the use of alendronat in pregnant women. Animal studies have shown reproductive toxicity. Using alendronat in pregnant mice causes difficulty related to lower blood calcium. Animal studies have shown high doses of vitamin D causing hypercalcemia and reproductive toxicity. Do not use fosamax plus during pregnancy.
Nursing period
unknown alendronat or its metabolic substance is excreted through breast milk or not. Can not rule out the risk for babies and bamboo children. Colecalciferol and some of its active metabolites go into breast milk. Do not use Fosamax Plus while breastfeeding.
Drug interaction
Sodium Alendronat
If used at the same time, calcium supplements may be supplemented. Anti -acid drugs and other oral drugs will imagine the absorption of Alendronat. Therefore, the patient waits for at least half an hour after taking Fosamax Plus and then drinking another. Simultaneous use of hormone replacement drugs (HRT) (estrogen ± progestin) and Fosamax® (sodium alendronat) were assessed in two clinical studies for one and two years in postmenopausal osteoporosis women. Using HRT and Fosamax combinations has increased more bone volume, while minimizing bone degeneration compared to each separate medicine.
Due to nonsteroidal anti -inflammatory drugs (NSAID), the stomach irritation, need to be cautious when coordinating with alendronat, colecalciferol.
olestra, mineral oils, orlistates, bile acid recovery substances (for example, cholestyramin, colestipol) can hinder the absorption of vitamin D. anticonvulsants, cimetidin, and thiazid -group urinary gums that can increase vitamin D.
Storage
Store no more than 30 ° C. Avoid moisture and light. Collection of tablets in the blister until use.
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