Ostemaks 70 mg tablets 4's
- $23.90
OCTEMAKC
(OSTEMAX) ACIDUM ALENDRONICUM M05B A04 Polpharma
STRUCTURE AND PACKAGING:
tablets of 70 mg, No. 4 39,2 of UAH
Alendronovaya acid
of 70 mg
Other ingredients: lactoses monohydrate, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate, silicon colloidal anhydrous.
1 tablet contains 91.36 mg of the alendronat of sodium of trihydrate that corresponds to 70 mg of alendronovy acid.
PHARMACOLOGICAL PROPERTIES: alendronovy acid — bisfosfonat, oppressing an osteoklasny resorption of bones without direct effect on their forming. In preclinical trials the drug tropnost to places of an active resorption of a bone is revealed. The average bioavailability of the alendronat at women at intake in the morning on an empty stomach for 2 h to food (in the range of doses from 5 to 70 mg) is 0.64%. The bioavailability decreased to 0.46 and 0.39% at reception of the alendronat for 1 h or for 1/2 h to food. In general the efficiency of drug is sufficient if it to accept at least for 1/2 h before the first meal. The bioavailability is insignificant if it alendronat is accepted during a breakfast or during 2 h after it. At reception of the alendronat with coffee or orange juice the bioavailability decreases approximately by 60%. Oral administration of Prednisonum (on 20 mg 3 times a day within 5 days) did not cause clinically significant change of bioavailability of the alendronat in healthy volunteers (the last increased on average by 20–44%). The average volume of distribution in a condition of equilibrium concentration (except for bones) at the person is at least 28 l. Concentration of drug in blood plasma after oral administration in a therapeutic dose is too small for analytical definition (≤5 ng/ml). Linking with proteins of blood plasma makes about 78%. In a human body it is not metabolized.
INDICATIONS: treatment of postclimacteric osteoporosis, reduction of risk of developing of vertebralny and/or femoral fractures.
USE: the recommended dose — inside on 1 tablet (70 mg) once a week. Drug is appointed only the adult. The pill needs to be taken at least in 30 min. prior to the first meal, drink, or it is accepted in the afternoon, washing down with water. Other drinks (including mineral water), food and some medicines can reduce absorption of the alendronat. On a mucous membrane of an oral cavity and a gullet it is necessary for decrease in irritant action of drug: • to take the drug, washing down with a full glass of water (not less than 200 ml) in the morning after the patient got up, • it is impossible to chew or rassasyvat a tablet in an oral cavity as at the same time there is a risk of developing of ulcers of an oral cavity and throat, • the first meal is possible only in 30 min. after reception of a tablet, • after reception of a tablet the patients should not lie at least 30 more min., • the drug cannot be taken before going to bed or lying in a bed after night sleep, • it is necessary to take in addition the drugs of calcium and vitamin D at insufficient intake of these substances with food. Patients with clearance of creatinine have ≥35 ml/min. and also elderly people (65 years are more senior) have no need for dose adjustment of drug. Patients with clearance of creatinine of ≤35 ml/min. are not recommended to take the drug due to the lack of experience of its use for such patients. Effect of drug at children was not studied therefore it is not necessary to appoint it by it. Effect of drug was not investigated and at treatment of the osteoporosis caused by reception of GKS.
CONTRAINDICATIONS: the period of pregnancy and feeding by a breast, a stricture or an achalasia of a gullet, inability of the patient to stand or sit directly within at least 30 min., intolerance of components of drug, a hypocalcemia.
SIDE EFFECTS: From a GIT — a dysphagy, an esophagitis, an abdominal pain, dyspepsia, a constipation, diarrhea, a meteorism. Seldom — nausea, vomiting, gastritis, a melena, a stricture of a gullet, an ulcer of a mucous membrane of a mouth and throat, a gullet ulcer, perforation of an ulcer of a gullet with bleeding. From a musculoskeletal system — bone, muscles and joints pain.From nervous system — a headache. From an organ of sight — a uveitis, a sclerite. Allergic reactions — urticaria, a Quincke's disease, it was reported about isolated cases of emergence of syndromes of Stephens — Johnson and Layell. Others — rash, an itching, an erythema, a photodermatosis, a symptomatic hypocalcemia. Data of laboratory researches — insignificant and passing decrease in levels of calcium and phosphates in blood serum. Typical symptoms in connection with an initiation of treatment — myalgia, an indisposition, it is rare — fever.
SPECIAL INSTRUCTIONS: it is necessary to stop administration of drug if the patient had symptoms of irritation of a gullet, such as dysphagy, pain when swallowing or pain behind a breast, appeared heartburn or the course of already existing worsened. If the patient missed administration of drug, it is necessary to take 1 pill in the morning after he remembers it. It is impossible to take 2 pill in 1 day, but it is necessary to resume administration of drug in the day chosen earlier once a week. In case of a hypocalcemia it is necessary to fill calcium reserves in an organism prior to treatment alendronaty. In the course of treatment alendronaty the level of calcium and phosphates in blood serum can decrease. This decrease is usually insignificant and asymptomatic. However it was reported about a symptomatic hypocalcemia, sometimes heavy and usually at patients with the corresponding contributing factors (for example with the accompanying hypoparathyrosis, deficiency of vitamin D or malabsorption of calcium). Adequate intake of calcium and vitamin D is especially important for the patients accepting GKS. Drug is not appointed the patient with rare hereditary diseases — intolerance of a galactose, deficiency of lactases or glyukozo-galaktozny malabsorption. Drug does not affect ability to run vehicles and to work with potentially dangerous mechanisms.
INTERACTIONS: food and drinks (including mineral water), nutritional supplements, calciferous, antacids and some medicines can worsen absorption of the alendronat at the combined reception. Patients have to wait at least 30 min. after administration of drug before accepting any other oral medicine. Other clinically significant interactions are not revealed. During reception of the alendronat in clinical trials some patients received estrogensoderzhashchy medicines (vaginalno, transdermalno or orally). Any side effects connected with their concomitant use are not revealed.
OVERDOSE: it is shown by a hypocalcemia, a hypophosphatemia, an esophagitis, gastritis or an ulcer of an upper part of a GIT. The patient has to be in vertical position and drink milk or antacids. Due to the risk of irritation of a gullet you should not cause vomiting.
STORAGE CONDITIONS: in the dry, protected from light place at a temperature not above 25 °C.
(OSTEMAX) ACIDUM ALENDRONICUM M05B A04 Polpharma
STRUCTURE AND PACKAGING:
tablets of 70 mg, No. 4 39,2 of UAH
Alendronovaya acid
of 70 mg
Other ingredients: lactoses monohydrate, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate, silicon colloidal anhydrous.
1 tablet contains 91.36 mg of the alendronat of sodium of trihydrate that corresponds to 70 mg of alendronovy acid.
PHARMACOLOGICAL PROPERTIES: alendronovy acid — bisfosfonat, oppressing an osteoklasny resorption of bones without direct effect on their forming. In preclinical trials the drug tropnost to places of an active resorption of a bone is revealed. The average bioavailability of the alendronat at women at intake in the morning on an empty stomach for 2 h to food (in the range of doses from 5 to 70 mg) is 0.64%. The bioavailability decreased to 0.46 and 0.39% at reception of the alendronat for 1 h or for 1/2 h to food. In general the efficiency of drug is sufficient if it to accept at least for 1/2 h before the first meal. The bioavailability is insignificant if it alendronat is accepted during a breakfast or during 2 h after it. At reception of the alendronat with coffee or orange juice the bioavailability decreases approximately by 60%. Oral administration of Prednisonum (on 20 mg 3 times a day within 5 days) did not cause clinically significant change of bioavailability of the alendronat in healthy volunteers (the last increased on average by 20–44%). The average volume of distribution in a condition of equilibrium concentration (except for bones) at the person is at least 28 l. Concentration of drug in blood plasma after oral administration in a therapeutic dose is too small for analytical definition (≤5 ng/ml). Linking with proteins of blood plasma makes about 78%. In a human body it is not metabolized.
INDICATIONS: treatment of postclimacteric osteoporosis, reduction of risk of developing of vertebralny and/or femoral fractures.
USE: the recommended dose — inside on 1 tablet (70 mg) once a week. Drug is appointed only the adult. The pill needs to be taken at least in 30 min. prior to the first meal, drink, or it is accepted in the afternoon, washing down with water. Other drinks (including mineral water), food and some medicines can reduce absorption of the alendronat. On a mucous membrane of an oral cavity and a gullet it is necessary for decrease in irritant action of drug: • to take the drug, washing down with a full glass of water (not less than 200 ml) in the morning after the patient got up, • it is impossible to chew or rassasyvat a tablet in an oral cavity as at the same time there is a risk of developing of ulcers of an oral cavity and throat, • the first meal is possible only in 30 min. after reception of a tablet, • after reception of a tablet the patients should not lie at least 30 more min., • the drug cannot be taken before going to bed or lying in a bed after night sleep, • it is necessary to take in addition the drugs of calcium and vitamin D at insufficient intake of these substances with food. Patients with clearance of creatinine have ≥35 ml/min. and also elderly people (65 years are more senior) have no need for dose adjustment of drug. Patients with clearance of creatinine of ≤35 ml/min. are not recommended to take the drug due to the lack of experience of its use for such patients. Effect of drug at children was not studied therefore it is not necessary to appoint it by it. Effect of drug was not investigated and at treatment of the osteoporosis caused by reception of GKS.
CONTRAINDICATIONS: the period of pregnancy and feeding by a breast, a stricture or an achalasia of a gullet, inability of the patient to stand or sit directly within at least 30 min., intolerance of components of drug, a hypocalcemia.
SIDE EFFECTS: From a GIT — a dysphagy, an esophagitis, an abdominal pain, dyspepsia, a constipation, diarrhea, a meteorism. Seldom — nausea, vomiting, gastritis, a melena, a stricture of a gullet, an ulcer of a mucous membrane of a mouth and throat, a gullet ulcer, perforation of an ulcer of a gullet with bleeding. From a musculoskeletal system — bone, muscles and joints pain.From nervous system — a headache. From an organ of sight — a uveitis, a sclerite. Allergic reactions — urticaria, a Quincke's disease, it was reported about isolated cases of emergence of syndromes of Stephens — Johnson and Layell. Others — rash, an itching, an erythema, a photodermatosis, a symptomatic hypocalcemia. Data of laboratory researches — insignificant and passing decrease in levels of calcium and phosphates in blood serum. Typical symptoms in connection with an initiation of treatment — myalgia, an indisposition, it is rare — fever.
SPECIAL INSTRUCTIONS: it is necessary to stop administration of drug if the patient had symptoms of irritation of a gullet, such as dysphagy, pain when swallowing or pain behind a breast, appeared heartburn or the course of already existing worsened. If the patient missed administration of drug, it is necessary to take 1 pill in the morning after he remembers it. It is impossible to take 2 pill in 1 day, but it is necessary to resume administration of drug in the day chosen earlier once a week. In case of a hypocalcemia it is necessary to fill calcium reserves in an organism prior to treatment alendronaty. In the course of treatment alendronaty the level of calcium and phosphates in blood serum can decrease. This decrease is usually insignificant and asymptomatic. However it was reported about a symptomatic hypocalcemia, sometimes heavy and usually at patients with the corresponding contributing factors (for example with the accompanying hypoparathyrosis, deficiency of vitamin D or malabsorption of calcium). Adequate intake of calcium and vitamin D is especially important for the patients accepting GKS. Drug is not appointed the patient with rare hereditary diseases — intolerance of a galactose, deficiency of lactases or glyukozo-galaktozny malabsorption. Drug does not affect ability to run vehicles and to work with potentially dangerous mechanisms.
INTERACTIONS: food and drinks (including mineral water), nutritional supplements, calciferous, antacids and some medicines can worsen absorption of the alendronat at the combined reception. Patients have to wait at least 30 min. after administration of drug before accepting any other oral medicine. Other clinically significant interactions are not revealed. During reception of the alendronat in clinical trials some patients received estrogensoderzhashchy medicines (vaginalno, transdermalno or orally). Any side effects connected with their concomitant use are not revealed.
OVERDOSE: it is shown by a hypocalcemia, a hypophosphatemia, an esophagitis, gastritis or an ulcer of an upper part of a GIT. The patient has to be in vertical position and drink milk or antacids. Due to the risk of irritation of a gullet you should not cause vomiting.
STORAGE CONDITIONS: in the dry, protected from light place at a temperature not above 25 °C.
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