Deksilant caps. with modif.vysv. 60 mg 28 pcs

$56.10

Deksilant caps. with modif.vysv. 60 mg 28 pcs

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SKU: 1916797950 Categories: , , Tag:

Description

Composition
Active substance:
30 mg 1 capsule contains: dekslansoprazol 30 mg 60 mg 1 capsule contains: 60 mg dekslansoprazol.
Excipients:
30 mg 1 capsule contains: sugar grit (500 microns to 710 microns) 28.8 mg magnesium carbonate 11.5 mg, 41.5 mg sucrose, 8.64 mg low substituted giproloza, giproloza 0.34 mg hypromellose 2910 7 , 54 mg, 16.64 mg of talc, 5.5 mg of titanium dioxide, the dispersion of methacrylic acid copolymer, 9.66 mg macrogol 8000 0.96 mg polysorbate 80 0.44 mg colloidal silicon dioxide 0.09 mg, methacrylic acid and methyl methacrylate copolymer [1: 2] 15.95 mg methacrylic acid-methyl methacrylate copolymer [1: 1] 5.32 mg, 2.12 mg of triethyl citrate; capsule shell: 0,192-0,624 mg carrageenan, potassium chloride 0,144-0,48 mg, 2.4768 mg of titanium dioxide, a coloring agent FD & C Blue aluminum lake №2 0.3456 mg dye black iron oxide 0.0576 mg hypromellose q.s. to 48 mg, gray ink purified markirovki3 for trace amounts. 60 mg 1 capsule contains: sugar grit (500 microns to 710 microns) 40.0 mg, 16.0 mg magnesium carbonate, sucrose 39.52 mg low substituted giproloza 12.0 mg, 0.48 giproloza mg hypromellose 2910 10 , 5067 mg, 27.5499 mg of talc, titanium dioxide 6.9933 mg, methacrylic acid dispersion sopolimera2 7.02 mg macrogol 8000 0.7 mg polysorbate 80 0.32 mg colloidal silicon dioxide 0.13 mg, methacrylic acid and methyl methacrylate copolymer [1: 2] 31.9 mg methacrylic acid-methyl methacrylate copolymer [1: 1] 10.64 mg triethyl citrate 4.24 mg. capsule shell: carrageenan 0,24-0,78 mg, 0,18-0,6 mg of potassium chloride, 2.52 mg of titanium dioxide, a coloring agent FD & C Blue №2 Aluminum Lake 1.08 mg hypromellose q.s. to 60 mg, gray ink purified markirovki3 for trace amounts.
Description:
Dosage 30 mg
Capsules with opaque blue cap and a gray opaque body. On the lid, dark gray ink applied logo “TAP”, on the case – the inscription “30”. Contents of capsules – granules from white to almost white.
Dosage 60 mg
Capsules with opaque blue cap and body. On the lid, dark gray ink applied logo “TAP” on the body -. The inscription “60” Contents of capsules – granules from white to almost white.
Product form:
Capsules modified release 30 mg and 60 mg. At 14 or 28 modified release capsules in a bottle of high-density polyethylene, sealed with aluminum foil and a sealed polypropylene screw cap. Placed in a vial container with desiccant containing silica gel. 1 bottle with instructions for use placed in a cardboard box. or
14 modified release capsules in AL / PVC blister. 1 or 2 blisters with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to any component of the drug. combined use with HIV protease inhibitors, absorption of which depends on the pH environment of the stomach (such as atazanavir, nelfinavir), due to a significant reduction of their bioavailability. age 18 years. pregnancy, lactation.
The preparation contains sucrose, therefore its use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or saharazno-izomaltaznoy insufficiency.
With careful preparation Deksilant® can be assigned: patients receiving tacrolimus. patients taking isoenzyme inhibitors of CYP2C19, such as fluvoxamine patients taking warfarin, under the control of prothrombin time and INR; patients taking methotrexate.
Dosage
60 mg
Indications
– treatment of erosive esophagitis any severity; – maintenance therapy after treatment of erosive esophagitis and heartburn relief manifestations; – symptomatic treatment of GERD gastroesophageal reflux disease (NERD i.e. – non-erosive reflux disease) ;.
Interaction with other drugs
Dekslansoprazol can be assigned without the risk of drug interaction in patients taking clopidogrel. In the case of co-administration of clopidogrel dose adjustment is required. It is also noted the absence of clinically significant drug interactions with phenytoin, theophylline and diazepam. Simultaneous application dekslansoprazola can affect the absorption of drugs, bioavailability which is dependent on the pH of the gastric environment (e.g., complex esters of ampicillin, digoxin, iron salts, ketoconazole, erlotinib). Simultaneous treatment with tacrolimus may increase tacrolimus concentrations in blood plasma, particularly in patients after transplantation, which are moderate or slow metabolizers of isoenzyme CYP2C19. When concomitantly with fluvoxamine is likely to increase systemic exposure dekslansoprazola. Simultaneous reception dekslansoprazola and methotrexate can lead to a high concentration and enhance the preservation of methotrexate and / or its metabolite in the blood serum, that, accordingly, can lead to methotrexate toxicity. If necessary, high-dose methotrexate recommended temporary cancellation dekslansoprazola reception.
Overdose
Reports of significant cases of overdose as a result of the drug Deksilant® noted. Multiple dosing of 120 mg, and single dose of 300 mg not cause severe side effects. Observed side effect of high blood pressure above 140/90 mm. Hg. Art. while taking the drug Deksilant® 60 mg 2 times a day. However, in the event of an overdose, and only in the presence of clinical manifestations of being symptomatic therapy. Dekslansoprazol is output by hemodialysis.
pharmachologic effect
Pharmacological group:
Gastric glands secretion lowering agent – a proton pump inhibitor.
Pharmacodynamics:
Dekslansoprazol is an inhibitor of the proton pump inhibiting gastric acid secretion by inhibiting H + / K + -ATPase in the parietal cells of the stomach. Blocks final step of acid secretion. In applying antisecretory drugs in serum gastrin levels increased in response to a reduction of gastric acid secretion. Also it occurs raising chromogranin A (CgA) by reducing the acidity in the stomach. Elevated levels of CgA may hinder diagnosis of neuroendocrine tumors. Published data suggest that the use of proton pump inhibitors (PPIs) should stop for 5-14 days to determine the level of CgA, it allows to return to the normal concentration level of falsely elevated CgA, occurring after reception of proton pump inhibitors. Capsule Deksilant® preparation disintegrates in the stomach and contains two types of granules, enteric-coated, which release the active substance depending on the pH in various areas of the small intestine. This combination helps to prolong the effect of dekslansoprazola and reduces gastric acid secretion for an extended period.
Pharmacokinetics:
Suction
Dekslansoprazol well absorbed when taken orally. Its bioavailability is 76% or more. Two-component composition Deksilant® preparation causes suction in the form of two pH-dependent phases. The first peak concentration of the active substance occurs in the range of 1 to 2 hours after ingestion (phase 1 release of active substance) and from 4 to 5 hours (2 phase release of active substance), respectively. After 5 days of receiving dekslansoprazola in doses of 30 mg and 60 mg of the maximum plasma concentration (Cmax) of 658 ng / mL and 1397 ng / ml, respectively. The area under the curve “concentration-time» (AUC) is equal to 3275 ng h / ml and 6529 ng h / mL after 5 days of dekslansoprazola in doses of 30 mg and 60 mg, respectively.
Distribution
Dekslansoprazola Binding to plasma proteins was 96.1 – 98.8%.
Metabolism
Dekslansoprazol extensively metabolized in the liver to inactive metabolites as a result of oxidation, reduction and the subsequent formation of sulfate, glutathione and glyukoronidnyh compounds. The oxidation is carried out by the enzyme cytochrome P450, which participates in the process of hydroxylation (preferably isoenzyme CYP2C19), and in the oxidation process (isoenzyme CYP3A4). Isoenzyme CYP2C19 is a polymorphic liver isoenzyme, which exists in 3 fractions, exhibit different properties in the metabolism of substrates: fast, moderate and slow metabolizers. Dekslansoprazol is the main component in plasma independent of the type of metaboliser isoenzyme CYP2C19. In the case of medium and strong CYP2C19 metabolisers of isoenzyme major metabolite in plasma is 5-gidroksidekslansoprazol and glucuronic compound. When poor metabolisers of isoenzyme CYP2C19 – dekslansoprazola sulfone.
breeding
The half-life of the drug – Clearance 1-2 hours after 5 days of dekslansoprazola 11.4 and 11.6 l / h for the dosage of 30 mg and 60 mg, respectively.. The drug is eliminated via the kidneys (approximately 51%) and 48% is excreted through the intestines. Since the drug is extensively metabolized in the liver, while applying dekslansoprazola in patients with impaired renal function dose reduction is required. As in patients with normal renal function to alter the pharmacokinetics are not expected.
Pregnancy and breast-feeding
Use of the drug Deksilant® during pregnancy is contraindicated. If necessary, use during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
The most frequent (at least 2%) adverse reactions are diarrhea, flatulence, abdominal pain, nausea, vomiting, upper respiratory tract infection. Below shows the adverse drug reactions, depending on the frequency of their occurrence:
Very often> 1/10
Often> 1/100 and 1/1000, and 1/10000 and
Frequency not known (can not be estimated from the available data).
Disorders of immune system: the frequency is unknown, hypersensitivity (including anaphylactic reactions), malignant erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, exfoliative dermatitis, anaphylactic shock.
Violations of the metabolism and nutrition: unknown frequency-hypomagnesemia, hyponatremia.
Disorders of the gastrointestinal tract: often, diarrhea, discomfort and abdominal pain, constipation, flatulence, nausea; infrequently, dry mouth, vomiting; rare-oral candidiasis; frequency is unknown, swelling of the mouth, pancreatitis
Violations of the kidneys and urinary tract: unknown frequency-acute renal failure
Violations of the liver and biliary tract: rarely-changing parameters of functional activity of the liver; the frequency is unknown, drug-induced hepatitis.
Violations of the skin and subcutaneous tissue disorders: rarely, rash, hives, itching; the frequency is unknown, leukocytoclastic vasculitis, generalized rash, subacute cutaneous lupus erythematosus.
Disorders of the respiratory system, chest and mediastinum: Frequently-infectious upper respiratory tract disease; infrequently-cough; the frequency is unknown, swelling of the throat, tightness in the throat.
Blood disorders and lymphatic system: the frequency is unknown, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura
Violations by musculoskeletal and connective tissue disorders: rare-fracture of the femur, wrist, or spine bones
Violations by vessels: rarely-attack of fever ( “hot flashes”), increased blood pressure
Disorders of the nervous system: often, headache; infrequently, dizziness, dysgeusia; rarely, paresthesia, convulsions; frequency is unknown, stroke, transient ischemic attack
Violations by the organ of vision: rarely, blurred vision; frequency is unknown, blurred vision (blurred).
Violations by the organ of hearing and labyrinth disorders: vertigo, rarely; unknown-frequency hearing loss.
Mental disorders: rarely, insomnia, depression; rarely, auditory hallucinations.
General disorders: rarely, weakness, changes in appetite; frequency is unknown, swelling of the face.
special instructions
Before treatment dekslansoprazolom should exclude the possibility of cancer because the drug may mask the symptoms and delay the correct diagnosis. If symptoms persist despite adequate treatment, it should be further examination. When receiving the proton pump inhibitors, which include dekslansoprazol, increases the risk of gastrointestinal infections, diarrheal pathogens which are bacteria of the genus Clostridium difficile, particularly in hospitalized patients. It must be taken into account if the treatment of diarrhea, the patient’s condition does not improve
Patients in this case it is recommended to take the lowest effective dose of at least dekslansoprazola duration of treatment. In patients receiving high-dose or long-term therapy with proton pump inhibitors (PPIs) for a year or more increases the risk of bone osteoporotic fractures of hips, hands and spine. Patients with the risk of osteoporotic fractures should adhere to recommended dosages (see. The section “Method of administration and dose”). In rare cases, patients had symptomatic and asymptomatic hypomagnesemia while taking PPI drugs for at least three months, and in most cases – for admission to the course of the year. Symptoms are hypomagnesemia tetany, arrhythmias and seizures. Treatment – magnesium replenishment and cancel reception PPI drugs. Patients who need long term treatment, or simultaneously taking drugs PPIs with digoxin or other medications that can cause hypomagnesemia (e.g. diuretics), it is necessary to control serum magnesium concentration before and during treatment.
The use of proton pump inhibitors may be due to very rare cases of subacute cutaneous lupus erythematosus (PKKV). When the outbreak of the disease, especially in the areas of skin exposed to sunlight, and if there is pain in the joints, the patient should seek immediate medical attention, and the use of the drug is recommended to stop Deksilant®. It should be noted that in the case of PKKV after treatment proton pump inhibitor may further increase the risk of PKKV the application of other PPI. Please note that an elevated level of chromogranin A (CgA) can inhibit the diagnosis of neuroendocrine tumors. In order to avoid the application of such influence Deksilant® preparation should be discontinued for at least 5 days prior to determining the level of CgA. If the levels of gastrin CgA and do not return to normal values ​​after the first determination, the analysis should be repeated at 14 days after discontinuation of proton pump inhibitors.
The effect on the ability of driving vehicles / machines.
Due to the likelihood of dizziness and blurred vision should refrain from driving and other mechanisms that require attention.
Storage conditions
Stored in original package at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside: a capsule taken as a whole, regardless of the meal. You can also open the capsule, pour out of it in a tablespoon of granules and mix them with applesauce; then immediately, without chewing, swallowing.
Treatment of erosive esophagitis any severity. The recommended dose is 60 mg 1 time per day. The course of treatment – 8 weeks
Maintenance therapy after treatment of erosive esophagitis and heartburn relief manifestations. The recommended dose is 30 mg 1 time per day. In the studies of treatment course was up to 6 months. Erosive esophagitis patients with moderate and severe recommended dose is 60 mg 1 time per day. In the studies of treatment course was up to 6 months.
Symptomatic treatment of GERD gastroesophageal reflux disease (NERD i.e. – non-erosive reflux disease). The recommended dose is 30 mg 1 time per day. The course of treatment – 4 weeks
Patients with impaired liver function moderate severity (class B Chayld- Pugh) daily dose should not exceed 30 mg dekslansoprazola. Clinical data on the admission of the drug in patients with severe impairment of patients (class C by Child-Pugh) are absent. Dose adjustment in elderly patients, patients with renal dysfunction and impaired liver function mild (Class A according to Child-Pugh) is not required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TAKEDA

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