Dona powder for solution for oral administration 1500mg in bags (sachets) №20

Name:
of the Don.
Description:
White crystalline powder, odorless. Release form Powder for solution for oral administration. Dosage 1.5 g. Composition One sachet contains: active ingredient: crystalline glucosamine sulfate 1884 mg (contains glucosamine sulfate 1500 mg and sodium chloride 384 mg). excipients: aspartame, anhydrous citric acid, macrogol 4000, sorbitol. Pharmacotherapeutic group Other nonsteroidal anti-inflammatory and antirheumatic drugs. ATH code: M01AX05. Indications for use Relief of symptoms (mild to moderate pain) in adequately diagnosed osteoarthritis of the knee. Method of administration and doses Adults and elderly patients: the contents of 1 sachet, equivalent to 1500 mg of glucosamine sulfate, dissolve in a glass of water and take 1 time per day, preferably with meals. Glucosamine is not intended for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may occur only after several weeks of use, and in some cases longer. If no improvement in symptoms occurs after 2-3 months of use, treatment should be reassessed. Patients should seek medical advice if pain worsens after starting glucosamine. Contraindications Hypersensitivity to glucosamine or any of the excipients. Powder for oral solution contains aspartame and is therefore contraindicated in patients with phenylketonuria. Powder for oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The drug should not be used in patients allergic to shellfish, since the active substance is derived from shellfish. Precautions Before using the drug, you should consult with your doctor to rule out the presence of diseases of the joints, for which other methods of treatment are provided. Cases of exacerbation of symptoms of bronchial asthma after the start of glucosamine are described. Patients suffering from bronchial asthma should be informed about the possible worsening of the symptoms of the disease. This medicinal product contains 151 mg of sodium per daily dose, which should be taken into account by patients on a sodium restricted diet. Patients with impaired glucose tolerance should be careful when taking glucosamine. Patients with diabetes mellitus are advised to monitor glycemic levels and determine the need for insulin before starting and periodically during treatment. No special studies have been conducted in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profiles of glucosamine suggest no limitations for these patients. However, the use of glucosamine in patients with severe hepatic or renal insufficiency should be carried out under the supervision of a physician. Interaction with other drugs and other forms of interactionSpecial studies on the interaction of glucosamine with other drugs have not been conducted. However, the physicochemical and pharmacokinetic properties of glucosamine sulfate indicate a low potential for such interactions. In one study, glucosamine was found not to be an inhibitor of the activity of the following cytochrome P450 enzymes: CYP1A2, CYP2E1, CYP2C19, CYP2C9, CYP2D6, CYP3A4, as investigated by metabolite formation from selective substrates for each of the CYP enzymes studied. In fact, the compound does not compete for absorption mechanisms and does not bind to plasma proteins after absorption, and its metabolism as an endogenous compound that is incorporated into proteoglycans or degraded independently of the cytochrome enzyme system is unlikely to result in interactions with other drugs. There are reports of an increased effect of coumarin anticoagulants, therefore, in patients who are simultaneously taking coumarin anticoagulants (for example, warfarin or acenocoumarol), more careful monitoring of coagulation parameters is necessary. Oral administration of glucosamine sulfate may increase the absorption of tetracyclines in the gastrointestinal tract, but the clinical significance of this interaction is small. It is acceptable to take steroidal or non-steroidal anti-inflammatory drugs at the same time as glucosamine. Application during pregnancy and lactation Due to the lack of sufficient clinical data on the use of glucosamine in pregnant women or excretion in breast milk, the use of the drug during pregnancy and breastfeeding is not recommended. Influence on the ability to drive a car and work with mechanisms Studies on the effect of the drug on the ability to drive a car and other mechanisms have not been conducted. You should be careful when driving vehicles and performing work that requires attention. In the event of drowsiness, fatigue, dizziness or visual impairment, driving and operating other mechanisms is prohibited. Application features Use in children and adolescents Do not use in children under 18 years of age, since the safety and efficacy of the drug for such patients have not been established. Use in the Elderly No specific pharmacokinetic studies have been conducted, but according to clinical experience, dose adjustment is not required in the treatment of the elderly. Patients with impaired renal and / or liver function In patients with impaired renal and / or liver function, no recommendations for dose adjustment exist, since no relevant studies have been conducted. Side effects To determine the frequency of adverse events, the following categories of their occurrence in patients were used: Very often (≥ 1/10) Often (≥ 1/100 to < 1/10) Infrequently (≥ 1/1000 to < 1/100) Rarely (≥ 1/10,000 to < 1/1000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data). General Adverse Event Profile The most common adverse reactions associated with oral glucosamine are nausea, abdominal pain, dyspepsia, flatulence, constipation and diarrhea. These adverse reactions, as a rule, were moderately severe and transient. In the following table, adverse reactions have been grouped based on the MedDRA classification. System or organ class Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Very rare ≤ 1/10 000 Unknown* From the side of the immune system Allergic reactions** From the side of metabolism and nutrition Inadequate glycemic control in diabetes Mental disorders Insomnia From the side of the nervous system Headache Drowsiness Dizziness From the side of the organ of vision Visual disturbances From the side of the heart Arrhythmias, including tachycardia From the side of the vascular system Hot flushes Respiratory, chest and mediastinal Asthma / worsening of asthma Gastrointestinal tract Diarrhea Constipation Nausea Flatulence Abdominal pain Dyspepsia Vomiting Skin, subcutaneous tissue Erythema Itching Rash Angioedema Urticaria Liver and biliary tract Increased levels of "liver" enzymes in the blood and jaundice *** General disorders Fatigue Edema / peripheral edema Laboratory and physiological indicators Increased "liver" enzymes, blood glucose levels, increased blood pressure, fluctuations in the INR * Frequency cannot be estimated from the available data. **Severe allergic reactions to glucosamine may develop in susceptible patients. *** Increasing liver enzymes have been reported and jaundice has been reported, but a causal relationship with glucosamine use has not been established. Cases of hypercholesterolemia have been reported, but a causal relationship with glucosamine use has not been demonstrated. All cases of unusual reactions associated with the use of the drug must be reported by e-mail to the representative of the applicant ([email protected]). Overdose No cases of accidental or intentional overdose are known. Based on acute and chronic toxicity studies in animals, symptoms of toxicity are unlikely to occur even at doses up to 200 times the therapeutic dose. In case of an overdose, glucosamine should be discontinued, symptomatic treatment aimed at restoring fluid and electrolyte balance. Pharmacological properties Pharmacodynamics Mechanism of action Glucosamine sulfate is a salt of the amino monosaccharide glucosamine, which is an endogenous component and a preferred substrate for the synthesis of glycosaminoglycans and proteoglycans of articular cartilage and synovial fluid. Previous in vitro studies have shown that glucosamine sulfate stimulates the synthesis of glycosaminoglycans and, accordingly, articular proteoglycans. However, glucosamine sulfate has been shown to inhibit the activity of the interleukin-1 beta intracellular signaling pathway by blocking intracellular activation and nuclear translocation of nuclear factor kappa-B in cartilage chondrocytes and other similar cells. Clinical efficacy and tolerability The safety and efficacy of glucosamine sulfate has been confirmed in clinical trials with a treatment duration of up to three years. Short- and medium-term clinical studies have shown that the effectiveness of glucosamine sulfate in relation to the symptoms of osteoarthritis is observed after 2-3 weeks of its use. However, unlike NSAIDs, glucosamine sulfate has a long-term effect that lasts from 6 months to 3 years. Clinical studies with daily administration of glucosamine sulfate for up to 3 years have shown a gradual improvement in symptoms of the disease and a slowdown in structural changes in the joint, as demonstrated by plain radiography. Glucosamine sulfate has been shown to be well tolerated during short and long-term treatment courses. PharmacokineticsAbsorption After oral administration of 14C-labeled glucosamine, it is rapidly and almost completely absorbed, and about 90% of the radioactive label is recorded in the systemic circulation. The absolute bioavailability of glucosamine in humans after oral administration was 44%, taking into account the first effect of the first pass. Following daily oral administration of 1500 mg glucosamine sulfate to fasting healthy volunteers, peak plasma concentrations at steady state (Cmax, cc) averaged at 3 h (Tmax) of about 1602 ± 426 ng/mL between 1.5–4 h ( median: 3 h, tmax). At steady state, the AUC was 14564 ± 4138 ng h/mL. It is not known whether food intake has a significant effect on oral bioavailability. The pharmacokinetics of glucosamine is linear over the 750–1500 mg dose range, deviating from linearity at the 3000 mg dose due to lower bioavailability. There are no gender differences in absorption and bioavailability of glucosamine. The pharmacokinetics of glucosamine was similar in healthy volunteers and patients with osteoarthritis of the knee. Distribution Following oral absorption, glucosamine is distributed into various vascular compartments, including the synovial fluid, with an apparent volume of distribution 37 times greater than the total fluid volume in humans. Glucosamine does not bind to plasma proteins. Therefore, it is highly unlikely that glucosamine is capable of drug interactions when co-administered with other drugs that are highly bound to plasma proteins. Metabolism The metabolic profile of glucosamine has not been studied because it is endogenous; it is used as a "building block" for the biosynthesis of articular components of cartilage. Glucosamine is primarily metabolized to hexosamine, independent of the cytochrome system. Crystalline glucosamine sulfate does not act as either an inhibitor or an inducer of human CYP450 isoenzymes, including CYP3A4, 1A2, 2E1, 2C9, and 2D6.00, even when tested at glucosamine concentrations 300 times the peak plasma concentration observed in a patient after therapeutic doses crystalline glucosamine sulfate. There is no clinically significant interaction of glucosamine with other drugs that could be realized through the inhibition and / or induction of human CYP450 isoforms. Excretion In humans, the plasma half-life of glucosamine is 15 hours. After oral administration of 14C-labeled glucosamine, urinary excretion was 10 ± 9%, and fecal excretion was 11.3 ± 0.1% of the administered dose. The average excretion of unchanged glucosamine after oral administration in humans is about 1% of the administered dose, suggesting that the kidneys and liver do not play a significant role in the elimination of glucosamine, its metabolites and/or its degradation products. Pharmacokinetics in various categories of patients In patients with renal or hepatic insufficiency Studies of the pharmacokinetics of glucosamine in patients with renal or hepatic insufficiency have not been conducted. These studies were deemed inappropriate due to the insignificant contribution of the liver and kidneys in the processes of metabolism, degradation and excretion of glucosamine. Therefore, given the favorable safety profile and good tolerability of glucosamine, patients with renal or hepatic insufficiency do not require dose adjustment. Children and adolescents The pharmacokinetics of glucosamine have not been studied in children and adolescents. Elderly patients Pharmacokinetic studies have not been conducted in elderly patients, however, clinical trials of the efficacy and safety of glucosamine have mainly included elderly patients. It has been shown that in this category of patients there is no need for dose adjustment. Presentation A three-layer material sachet consisting of paper/aluminum/polyethylene fused together by heating from four sides. 20 or 30 sachets, along with instructions for use, are placed in a cardboard box. Shelf life 3 years Do not use after the expiration date printed on the package. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Release from pharmacies Released by prescription. Applicant MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg, Germany Manufacturer ROTTAFARM Ltd., Damastaun Industrial Park, Malhaddart, Dublin 15, Ireland Buy Dona powder for oral solution 1500mg in sachets #20 Powder for solution for oral administration 1500mg in sachets (sachets) No. 20 Instructions for use for Don