Foroza tab p / 70 mg of the film 4 pcs

Description

Composition
Active substance:
1 tablet contains: Sodium alendronate trihydrate 91.350 mg which is equivalent to 70.0 mg of alendronic acid).
Excipients:
261.250 mg of microcrystalline cellulose; Anhydrous colloidal silica 3.500 mg; 1,280 mg croscarmellose sodium; 2.620 mg magnesium stearate. sheath: Lustre Clear LC 103 7.000 mg (microcrystalline cellulose – 44%, carrageenan – 18%, macrogol 8000 – 38%).
Description:
White round, biconvex tablet, film-coated, engraved «ALN 70″ on one side.
Product form:
Tablets, film-coated, 70 mg.
2 or 4 tablets in blister aluminum / aluminum.
1, 2, 3, 4 or 6 blisters together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to alendronate or other components of the formulation; esophageal stricture, achalasia, and other conditions that lead to dysphagia and slow progress on the esophagus food; deficiency of vitamin D; the patient’s inability to stand or sit for 30 minutes; severe renal impairment (creatinine clearance less than 35 mL / min); severe disorders of mineral metabolism (hypocalcemia); pregnancy, breast-feeding; children’s age (efficacy and safety have not been established).
Precautions: diseases of the gastrointestinal tract (GIT), such as dysphagia, gastritis, esophageal disease, duodenitis, peptic ulcer disease in the acute stage, active gastrointestinal bleeding or surgery in the upper gastrointestinal tract in the year preceding the beginning of treatment; hypovitaminosis D.
Dosage
70 mg
Indications
Treatment of osteoporosis in postmenopausal women, including reducing the risk of spinal compression fractures and hip fractures; Treatment of osteoporosis in men to prevent fractures; treatment of osteoporosis caused by prolonged application of glucocorticosteroid drugs.
Interaction with other drugs
Simultaneous use of calcium preparations (including food supplements), antacids and other drugs for oral administration, as well as meal-liquid (including mineral water) affects the absorption of alendronic acid. In this regard, it is recommended to take other medicines, not earlier than 30 minutes after application Foroza® preparation.
Nonsteroidal anti-inflammatory drugs (including aspirin) may potentiate the side effects of alendronic acid in the gastrointestinal mucosa.
In clinical studies in patients taking drugs that contain estrogen (intravaginally, transdermally or orally), in conjunction with alendronate showed no clinically significant interaction.
Despite the fact that the special studies of drug interactions is not performed, the use of alendronate in clinical trials with a large number of widely used drugs are not accompanied by development of a clinically significant interaction.
Overdose
Against the background of an overdose of the drug may develop hypocalcemia, hypophosphatemia, and symptoms such as abdominal pain, dyspepsia, dysphagia, heartburn, esophagitis, gastritis, ulceration of the mucous membranes of the gastrointestinal tract.
Treatment: symptomatic. Shows the use of milk and antacids to bind alendronate. Due to the risk of injury of the esophagus should not induce vomiting, the patient must be in an upright position.
pharmachologic effect
Pharmacological group:
Bone resorption inhibitor – bicfosfonat.
Pharmacodynamics:
Non-hormonal specific inhibitor of osteoclastic bone resorption. Stimulates bone formation and restores a positive balance between bone resorption and bone recovery, increases bone mineral density (regulates calcium and phosphorus metabolism), promotes the formation of bone tissue with normal histology.
Pharmacokinetics:
Absorption. Bioavailability alendronic acid 70 mg ingestion fasting for 2 hours before a standard breakfast was 0.64% in women, in men – 0.59%. When receiving for 1 hour or half an hour before breakfast reduced bioavailability of alendronic acid to 0.46% and 0.39%, respectively. In clinical studies confirmed the effectiveness of the use of alendronic acid at not less than 30 minutes before the first ingestion of food or beverage, in the application of alendronic acid with food or for 2 hours after a meal the drug absorption is drastically reduced, alendronic acid bioavailability becomes small. When co-administered with coffee or orange juice reduced bioavailability by approximately 60%.
Distribution. Alendronic acid after intravenous administration at a dose of 1 mg / kg temporarily distributed into soft tissue and then rapidly redistributed to bone or excreted in urine. The average volume of distribution at steady state, not counting the bone tissue in humans is about 28 liters. in the blood plasma concentration of the drug is low (less than 5 ng / ml). Communication with the plasma proteins, about 78%.
Metabolism. There is no evidence that alendronate is metabolized in the human body.
Withdrawal. After a single intravenous administration of alendronic acid, carbon atoms labeled [14C] for 72 h kidneys released about 50% of the material and a small quantity – through the intestine. Terminal half-life exceeds 10 years, reflecting release of alendronic acid from the bone.
Pharmacokinetics in special patient groups
Gender: Bioavailability of alendronate is not significantly different in men and women.
Old age: Bioavailability and excretion of alendronate are similar in elderly and younger patients.
Race: Pharmacokinetic differences due to race have not been studied.
Impaired renal function: in healthy volunteers, alendronate, do not accumulate in bone is rapidly excreted in the urine. Controlled pharmacokinetic studies on the use of alendronic acid with renal failure has been conducted, but in patients with severe renal impairment probably alendronic acid excretion will be reduced. Therefore we can expect a larger number of alendronic acid accumulation in the bone tissue of patients with impaired renal function. If creatinine clearance (CC) from 35 to 60 ml / min the dose correction is not required. Use alendronic acid in patients with CC less than 35 ml / min is not recommended due to the absence of such experience.
Patients with impaired hepatic function it is not necessary to adjust the dose of alendronate, since it is not metabolized and excreted in the bile.
Pregnancy and breast-feeding
Foroza® The drug is contraindicated in pregnancy and during breastfeeding. Data on the effect of alendronate on the fetus when using the drug during pregnancy are not available. However, there is a theoretical risk of adverse effects on the fetus (especially bone), if pregnancy occurs after a course of bisphosphonate therapy. After ingestion of bisphosphonates are incorporated into the bone matrix, from which gradually released over several years. The number of bisphosphonate is inserted into the bone matrix and able to get back into the systemic circulation, it is directly dependent on the dose and duration of drug application.
In animal studies revealed formation of bone disorders fetal tissue with high doses of alendronic acid and dysfunction of labor associated with hypocalcaemia.
It is unknown whether alendronic acid penetrates into breast milk, so the use of the drug during breast feeding is contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
In a one-year study conducted in postmenopausal women with osteoporosis, general safety profiles receiving alendronic acid 70 mg once a week (n = 519) and 10 mg / day (n = 370) were similar.
The two three-year studies virtually identical design conducted among postmenopausal women (alendronic acid, 10 mg / day: n = 196; placebo: n = 397), the general safety profile of alendronic acid and placebo were similar.
Adverse effects noted by researchers as possibly related to alendronate, probably related and accurately due to the action of the drug, are presented below. The incidence of adverse events was> 1% in the same treatment group (a one-year study or in a three-year studies alendronate with a daily intake of 10 mg / d) or higher frequency of adverse effects in patients receiving placebo: abdominal pain, dyspepsia, regurgitation of acid, nausea, bloating, constipation, diarrhea, dysphagia, metiorizm, gastritis, gastric ulcers, esophageal ulcers, skiletno, muscle pain, muscle cramps, headache.
In clinical practice (including data from clinical trials and post-marketing use of data) reported the following adverse effects, which are classified according to their rate of development (WHO classification): very common (> 1/10); common (> 1/100,
special instructions
Wash down Foroza® tablets should only ordinary water, as other beverages (including mineral water, tea, coffee, fruit juices) degrade the drug absorption. Receiving alendronic acid before going to bed or in a horizontal position increases the risk of esophagitis.
Alendronate can cause local irritation of the mucosa of the upper gastrointestinal tract. Foroza® drug should be used with caution in patients with exacerbation of diseases of the upper gastrointestinal tract, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, as well as with the active gastrointestinal bleeding, surgery in the upper gastrointestinal tract in the year preceding the beginning of treatment except pyloroplasty, since the use of the drug can lead to worsening of the underlying disease.
The decision to treat should be taken for each patient individually after careful assessment of risk / benefit ratio, especially for patients with Barrett’s esophagus.
When alendronate are cases undesirable reactions of the esophagus (esophagitis, esophageal ulcer, or erosion) sometimes it is severe and demanding patient treatment and, in rare cases complicated by stricture formation. It is necessary to monitor the possibility of any adverse reactions on the part of the esophagus. The patient should be informed of the need to stop taking the drug and to see a doctor when dysphagia development, pain in swallowing, chest pain and heartburn.
In post-marketing reports of reports of rare cases of gastric and duodenal ulcers, sometimes severe and complicated, but in extensive clinical studies alendronate increase this risk was observed.
The risk of severe side effects from the esophagus is higher in patients taking alendronate in violation of these instructions and / or continue its reception after the onset of symptoms indicative of oesophageal irritation. It is important to explain in detail the rights of patients taking the drug and to make sure that he understood them. Patients should be aware of the increased risk of adverse events on the part of the esophagus in the case of deviations from the requirements of the instructions.
Before the start of therapy with Foroza® necessary correction of hypocalcemia and other metabolic disorders (such as lack of vitamin D). In connection with an increase of alendronic acid therapy of bone mineral density, a slight reduction in clinically asymptomatic concentrations of calcium and phosphate in serum, especially in patients receiving corticosteroids in which the absorption of calcium can be reduced. It is therefore important to provide a sufficient amount of calcium and vitamin D in the body, which is particularly important in patients receiving corticosteroids.
Patients should be warned that if you accidentally missed doses with a 1 times a week they should take 1 tablet in the morning the next day (not allowed to take 2 pills in one day). In the future we should continue to take 1 tablet on the day of the week, which was selected at the beginning of therapy.
There are also information about the development of osteonecrosis of the jaw in patients with osteoporosis receiving bisphosphonates inside. In assessing individual risk of developing osteonecrosis of the jaw should take into account risk factors such as bisphosphonate activity (the highest in the zoledronic acid), route of administration, and the total dose of the drug; cancer, chemotherapy, radiation therapy, glyukokortikosteriodov reception, reception angiogenesis inhibitors, smoking; dental diseases in history, poor oral hygiene, periodontal disease, invasive dental procedures, poorly selected prosthesis. Before therapy with bisphosphonates for oral administration to patients need to undergo dental examination with appropriate preventive dentistry. During treatment, these patients should, if possible, avoid invasive dental treatment. For patients during treatment with bisphosphonates appeared osteonecrosis of the jaw, dental surgical intervention may lead to a worsening condition.
Information about a possible reduction in the risk of developing osteonecrosis of the jaw after discontinuation of bisphosphonate therapy in patients requiring dental procedures, there are no. In each case, the decision should be made by the attending physician on the basis of an estimate of the expected benefit to the possible risk for the individual patient. During bisphosphonate therapy should explain to patients the importance of proper oral hygiene, preventive examinations, as well as to warn of the need to report any symptoms from the oral cavity, such as loose teeth, pain or swelling appears.
It reported adverse event such as osteonecrosis of the external auditory canal, which was predominantly associated with the prolonged use of alendronate. Possible risk factors for osteonecrosis of the outer ear canal include the use of steroids, chemotherapy, infection, trauma.
It reported the occurrence of pain in the bones, joints and / or muscles in patients receiving bisphosphonates. These symptoms are rarely worn by the heavy nature and / or lead to disability. Time of onset of symptoms varied from one day to several months after initiation of therapy. In most patients, symptoms resolved after cessation of treatment. In some patients, symptoms appear again when you resume receiving the same drug or another bisphosphonate.
Patients receiving long alendronic acid, there may be abnormal (i.e., when exposed to small forces or spontaneous) subtrochanteric fractures and fractures of the proximal femoral diaphysis. Fractures can occur with minimal trauma, or in its absence. Some patients may experience pain in the hip, often with external signs of stress fracture for several weeks / months before the complete fracture of the femur.
Atypical fractures of the proximal femoral shaft were often bilateral, so patients with long-term fracture of the femoral shaft taking bisphosphonates should conduct a survey of the opposite thigh. It is known that bad fuse described fractures. Discontinuation of bisphosphonates in patients with stress fractures is expediently carried out after assessing their state on the basis of an individual evaluation of risk / benefit ratio.
During bisphosphonate therapy patients should be advised to report any pain in the hip or groin. All patients admitted with such complaints should be examined for an incomplete femur fracture.
During post-marketing applications have been rare reports of severe skin reactions, including Stevens-Johnson syndrome and Lyell’s syndrome (toxic epidermal necrolysis).
It is necessary to take into account other causes of osteoporosis, in addition to age and estrogen deficiency.
Studies on the effects of alendronate on the ability to drive and use machines have not been undertaken. However, since in patients receiving alendronate may develop dizziness and other side effects, caution should be exercised when driving, mechanisms, and to refrain from performing these activities in case of side effects.
Storage conditions
In dry protected from light at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside.
The drug should be used for providing the daily requirements of calcium and vitamin D.
The optimal duration of use of the drug has not been established. The need for continued bisphosphonate therapy should be evaluated on a regular basis, particularly after 5 or more years of use.
To ensure proper absorption of the drug Foroza® tablets to be taken in the morning on an empty stomach, at least 30 minutes before the first meal, drink or other drugs, with a glass of ordinary water (at least 200 ml). Other drinks (including mineral water) can reduce the absorption of the drug.
To reduce the risk of esophageal irritation: 1) Foroza® drug should be taken only after waking up and getting up; 2) the tablet be swallowed whole (it is impossible to chew, dissolve, or dissolve them in the mouth because of the possible formation of ulcers in the mouth and pharynx, and 3) should not take a horizontal position before the first meal (first meal – no earlier than 30 minutes after administration ); 4) Do not take the medication at bedtime or before the morning rise from the bed.
Рекомендуемая доза составляет 70 мг (1 таблетка) один раз в неделю.
Для пожилых пациентов и пациентов с нарушением функции печени, умеренным нарушением функции почек (КК более 35 мл/мин) коррекции дозы не требуется.
У пациентов с выраженным нарушением функции почек (КК менее 35 мл/мин) применять препарат не рекомендуется, поскольку отсутствует опыт применения в данной популяции.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist