Savi Drinee effervescent treatment for menopause after menopause and osteoporosis in men (1 blister x 4 capsules)
Dosage form Box of 1 blister x 4 tablets
Specifications Alendronic Acid, Colecalciferol
Ingredient
| Composition information | Content |
| Alendronic Acid | 70mg |
| Colecalciferol | 2800iu |
Uses
indications
Savidrinate drugs are indicated in the following cases:
Pharmacokinus
Drugs: Bone treatment of bone bone bone group form combined.
ATC code: m05bb03.
alendronat
Alendronat is an aminobiphosphonate that inhibits specific bone pepper. Pre -clinical studies show that Alendronat accumulates selectively at the active bone pepper position, where Alendronat inhibits the operation of the cell cancel.
Clinical studies show that Alendronat treatment can significantly increase the volume of bone in the spine, femur and transfer. In clinical studies in menopausal women from 40 to 85 years old with osteoporosis (determined to have low bone mass, at least two standard deviations below the average before menopause), Alendronat treatment significantly reduces the number of spine fractures after 3 years of medication. The density of minerals in bone increases after 3 months of Alendronat treatment and continues during the use of the drug.
However, after 1-2 years of treatment, if the alendronat stop is stopped, the bone mass is not maintained. This proves to be constantly treated daily to maintain the healing effect.
colecalciferol
The term vitamin D refers to a group of sterol compounds with similar structures, preventing or treating rickets. These compounds include: colecalciferol (vitamin D, international common name: colecalciferol), alfacalcidol (1 alpha - hydroxycoleciferol), calcifediol (25 - hydroxycoleciferol), calcitriol (1 alpha, 25 - dihydroxecolecerol) and and dihydrotachysterol.
These substances, in their activity form (1.25 - dihydroxycoleciferol), along with parathyroid hormones and calcitonin regulating calcium concentration in serum. The main biological function of Vitamin D is to maintain normal calcium and phosphorus concentration in plasma by increasing the effectiveness of the absorption of minerals from diets, small intestine, and increased mobilization of calcium and phosphorus from bones to blood. Activities of Colecalciferol may have a negative response effect on the formation of parathyroid hormones (PTH: parathyroid hormone).
Calcifediol (25 - hydroxycolecalciferol; 25 - Ohd,) before converting into calcitriol {1 alpha, 25 - dihydroxycolecalciferol; 1.25 - (OH), D,}, itself has the effect of vitamin D.
Deficiency of vitamin D occurs when exposed to light is not enough or when the diet is deficient in vitamin D (especially in children) or in people with poorly absorbing fat syndrome, including people with liver, bile or gastrointestinal diseases and reduced fat absorption; Some conditions such as renal failure may also affect the metabolism of vitamin D into a activity form and lead to a deficiency of vitamin D.
Bone dysplasia caused by kidney is usually combined with chronic renal failure and characterized by reduced change of 25 - OHD, to 1 Alpha, 25 - (OH), D, (Calcitriol). Keeping phosphate reduces plasma calcium levels, leading to secondary and pathological hyperthyroidism, there are typical lesions of hyperthyroidism (fibrosis), of vitamin D deficiency (bone puree), or mixture of both cases. Vitamin D deficiency leads to symptoms characterized by lower blood calcium, lowering blood phosphate, not enough mineralization or decline of bone, bone pain, fracture, in adults called bone puree; In children, it can lead to bone deformation, especially long bone deformation, called rickets.
Dynamic pharmacokinetics
alendronat
Compared to an intravenous, medium -sized oral abuse of Alendronat in women is 0.7% with doses in the range of 5 - 40 mg, oral after one fasting night and 2 hours before a standard breakfast.
Prelise clinical studies show that after an intravenous injection of 1 mg/kg, an alendronat transient distribution in soft tissues but then re -distributed into the bone or excreted through the urine. Links to protein in human plasma is approximately 78%.
There is no evidence that alendronat is metabolized in humans.
After intravenous injection of a single dose of 10 mg, the renal clearance of the alendronate is 71 ml/min. Plasma concentration decreased by more than 95% within 6 hours after intravenous injection. In humans, the sale time of the drug is estimated to exceed 10 years, perhaps reflecting the release of Alendronat from the skeleton.
colecalciferol
Vitamin D is well absorbed through the gastrointestinal tract. Both vitamin D2 and D3 are absorbed from the small intestine, vitamin D3 can be absorbed better. The exact part of the intestine absorbs many vitamin D depending on the environment that Vitamin D is dissolved. Necessary bile for absorption of vitamin D in the intestine. Because vitamin D is soluble in lipids, it is concentrated in microorganisms, and is absorbed in the lymphatic system; approximately 80% of vitamin D orally absorbed by this mechanism. Vitamin D and its metabolites rotate in the blood associated with specific alpha globulin. The semi -discharged time in vitamin D is 19-25 hours, but the drug is stored for a long time in adipose tissue.
colecalciferol is hydroxylation in the liver forming 25 - hydroxycolecalcerol. These substances continue to be hydroxylation in the kidneys to form metabolites of 1.25 active substances - dihydroxycolecalciferol and derivatives 1, 24, 25 - Trihydroxy.
The liver is the place to convert vitamin D to 25 - OHD, which is linked to protein and the blood circulation. In fact, 25 - OHD has high affinity with protein than the mother compound. Discipline 25 - Hydroxy has a half -life of 19 days and is the main form of vitamin D in the blood. The concentration in the stable state of 25 - OHD is 15 - 50 nanogam/ml. Vitamin D and its metabolites are mainly exported through bile and feces, only a small amount appears in the urine. Some vitamin D can be secreted into milk.
Before taking Savi Drinee effervescent treatment for menopause after menopause and osteoporosis in men (1 blister x 4 capsules)
How to use
drug in the form of effervescent tablets, oral use: Dissolve a bubbling tablet in a glass containing about 100 - 150 ml of cool boiled water and drink as soon as the drug is completely dissolved.
Characteristics to note when taking the drug:
Due to the progressive characteristics of osteoporosis, it may be necessary to use Savidrinate for a long time.
Optimal time use bisphosphonate to treat unknown osteoporosis. Whether or not to continue treating or no need to rely on the periodic re -assessment of effectiveness and risks may occur in each specific patient, especially patients taking 25 years.
Patients should use calcium supplements if the diet does not provide enough calcium. The addition of vitamin D -containing preparations should be considered based on the specific condition of the patient.
There is no study on the equivalent of taking 2800 vitamin D, weekly in Savidrine and the daily dose of vitamin D 400 IU.
Elderly:
In clinical studies, there is no age difference that affects the effectiveness and safety when using alendronat. Therefore, it is not necessary to adjust the dose for the elderly.
kidney failure:
It is not recommended to use Savidrinate for patients with renal failure with creatinine ClCr 35 ml/min.
Hepatic failure:
There was evidence that alendronat was not metabolized or excreted into bile, no research was conducted in patients with liver failure. It is not necessary to adjust the alendronat dose in this case.
Children:
Savidine's safety and effectiveness in children
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 using overdose?
Symptoms: Hypacentia, lowering blood phosphate and unwanted reactions in the gastrointestinal tract, such as discomfort in the stomach, heartburn, esophagitis, inflammation or stomach ulcers.
Management: There is no information on the overdose of Alendronat. If overdose, milk or antacid can be linked to alendronat. Due to increased risk of irritation of the esophagus, should not vomit and patients should hold vertical posture.
colecalciferol
There is no data on vitamin D poisoning when using the dose In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? Then continue taking the medication as usual.
Do not take 2 Savidrinate tablets on the same day.
Side Effects
When using the drug, there are common unwanted effects (ADR) such as:
Common (can affect 1/10 people):
Very common (AD ≥ 1/10):
Common (1/100 ≤ ADR Nervous system: headache, dizziness.
Rare (1/10,000 ≤ ADR The immune system: Hypersensitivity reactions include urticaria and angioedema. pharyngeal ulcer; Perforation, ulcerative or gastrointestinal hemorrhage.
Instructions on how to handle ADR:
Notify the physician with unwanted effects when using the drug. Come see the doctor immediately if you encounter unwanted effects later (may be severe or need medical emergency).
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Savidrine drugs contraindicated in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
alendronat
Unwanted effects in the digestive tract on Alendronate can cause stimulation at the spot of the gastrointestinal mucosa. Because it is more likely to get worse than the disease, it is necessary to be careful when using alendronat for patients with above gastrointestinal disorders such as difficulty swallowing, esophagus, gastritis, duodenitis, ulcers or recently (within 1 year) suffering from severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal bleeding or above gastrointestinal surgery. In patients with Barrett's esophagus, the effect and risk of Alendronat should be considered for each specific patient.
There have been reports on the esophagus reactions (sometimes severe and needed to be hospitalized) such as inflammation, ulcers and esophagus, rarely occur in patients with esophageal stenosis being treated with alendronat. Therefore, it should be noted for the signs or symptoms of the esophagus reactions, patients should be instructed to stop using alendronat and medical intervention if there is progression of symptoms stimulating esophagus such as difficulty swallowing, pain when swallowing, pain in breast or heartburn.
The risk of unwanted effects in the esophagus is higher in patients who have failed with Alendronat and/or patients who continue to treat with alendronat after the progression of esophageal stimulating symptoms. Patients need to be instructed that this treatment failure may increase the risk of esophageal disorders.
Jaw bone necrosis:
Jaw bone necrosis occurs during tooth extraction, on -site infections reported in cancer patients (mainly bishosphonate intravenous injection) or use of corticosteroids, or in people with osteoporosis using oral bisphosphonate.
Should check dentistry before treatment with oral bisphosphonate in patients with poor dental condition.
During treatment, these patients should avoid dental surgery if possible. For people with lower jaw bone necrosis during bisphosphonate treatment, dental surgery can make this condition worse. For patients to be dental techniques, no data shows that the suspension of bisphosphonate can reduce the risk of jaw bone necrosis. Doctors need to consider the benefits and risks for these patients.
During treatment, patients should have good oral hygiene, regular dental examination and report to the doctor any symptoms of dental such as buckets of teeth, toothache, swelling.
Did the outer ear necrosis:
There have been reports on external ear necrosis caused by biphosphonate, mainly when taking the drug for a long time. Risk factors that can cause external ear necrosis include steroid and chemotherapy and/or local risk factors such as infection or injury. The ability to necrosis of the external ear canal should be considered in patients who are being treated with biphosphonate with symptoms in the ears such as pain or discharge, chronic ear infections.
muscle pain:
There have been reports on bone, joint pain and/or muscle pain in patients using biphosphonate. In fact, the use of drugs, rarely these symptoms are severe and/or cause disabilities. The onset of these symptoms varies from 1 day to months after the beginning of treatment. Most patients recover these symptoms after stopping treatment. A small number of patients recur these symptoms when treated with that drug or other biphosphons.
Not typical femoral fractures
There have been reports on long bone fractures and underbone bones that are not typical when using bisphosphonate, mainly in patients treating long -term osteoporosis. The fracture may occur in any position from the bottom of the sample to the convex on the bridge, after an injury or not; Some patients with thigh pain or groin several weeks to a few months before the femoral fracture was detected by film shooting. Fractures usually occur on both sides, so the femoral femur should be checked in patients with a thigh fracture while using bisphosphonate. These cracks are difficult to heal, so it is necessary to consider whether or not to use bisphosphonate in patients suspected of having a thigh fracture.
During the bishosphonate treatment, if the patient has any of the following symptoms: femoral pain, hip pain or groin pain, the doctor should check the femur.
kidney failure
Do not recommend this medication for patients with renal impairment with ClCr
Bones and metabolism
Except for the deficiency of estrogen and age, other causes of osteoporosis should be considered.
Must treat blood calcium loss, other disorders affect the metabolism of minerals (such as vitamin D deficiency and parathyroid failure) before starting Savidrinate treatment. In these patients, serum calcium should be monitored and symptoms of blood calcium lower during treatment with Savidrinate.
Because alendronat increases mineral in bones, the concentration of calcium and serum phosphate can decrease, especially in patients treated with glucocorticoids (due to reduced calcium absorption in these people). Reducing blood calcium is usually small and no symptoms. However, some cases of severe blood calcium hypacidia, symptoms often occur in patients with an existing risk (such as adjacental impairment, vitamin D deficiency and underdigible calcium).
colecalciferol
Vitamin D, may increase the level of hypercalcemia and/or increase calcium calcium in patients with abnormal calcitriol secretion (such as leukemia, lymphoma, sarcoid infection). Need to monitor plasma calcium and urinary calcium in these patients.
excipients
Be cautious when used for people with phenylketonuria because the preparation contains aspartam - is a source of phenylalanin.
A Savidrinate bubbling contains 227 mg of sodium. Precautions when used in people who are in the salt diet.
The effect of the drug on driving and operating machinery
Savidrinate does not or less directly affects the ability to drive and operate machinery. Patients may experience some unwanted side effects such as blurred vision, dizziness and muscle pain or severe joints. This situation can affect the ability to drive and operate machinery.
Using drugs for women during pregnancy and lactation
Savididine is only for postmenopausal women, so they are not for pregnant women or breastfeeding women.
Pregnant women
Lack of data on the use of alendronat for pregnant women. Animal studies have shown toxic drugs on reproductive process. Alendronat when used for pregnant mice causes difficult delivery due to lower blood calcium. Animal studies have shown hypercalcemia and toxicity to the reproductive process at high doses of Vitamin D. Do not use Savidrine during pregnancy.
breastfeeding women
Do not know if Alendronat is secreted into breast milk or not. The risk is not excluded with infants and young children. Colecalciferol and its metabolites can be through breast milk. Do not use this medication for breastfeeding women.
Interactive drug
Interaction of estrogen drugs: Safe and effectiveness of simultaneous use of hormone replacement therapy and alendronat for postmenopausal women have not been determined, so it is not recommended this simultaneous usage.
Calcium supplements and anti -acid drugs (antacids): can reduce the absorption of alendronat. Therefore, patients need to wait at least half an hour after taking Alendronat before taking any other medicine.
Aspirin: In clinical studies, the proportion of unwanted reactions in the gastrointestinal tract on patients with simultaneously alendronat, dose greater than 10 mg/day, with aspirin containing compounds.
Non -steroid anti -inflammatory drugs (NSAID: Nonsteroidal Anti - Inflammatory Drug): Alendronat can be used in patients who are taking NSAID drugs. However, NSAID drugs often cause gastrointestinal irritation, so they must be cautious when used with Alendronat.
Do not use the drug simultaneously with cholestyramin or colestipol hydrochloride, as it can lead to reduced vitamin D absorption in the intestine.
Take the medication simultaneously with the diuretic diuretics for those who are parathyroidism can lead to hypercalcemia. In that case, it is necessary to reduce the dosage of vitamin D or stop taking vitamin D temporarily. Using thiazid diuretics in those who are parathyroidism causing hypercalcemia is probably due to bone release from bone release.
Take the medication simultaneously with phenobarbital and/or phenytoin (and may be with other drugs that cause liver enzyme induction) because these drugs can reduce the concentration of 25 - hydroxycolecalciferol in plasma and increase vitamin D into non -active substances.
Do not use medication simultaneously with corticosteroids because corticosteroids hinder the effect of vitamin D.
Do not use medication simultaneously with cardiac glycosides because of the toxicity of glycosides that support cardioving due to hypercalcemia, leading to arrhythmia.
Interactive drugs can affect the activity of the drug or cause side effects.
Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.
Tyeum of drugs
Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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