Name:
Ezocar caps. 40mg per blister. in pack. №4х4
Description:
Capsules of white-blue color, size №2, with “Pharmakar” logo; the contents of the capsules are enteric-coated pellets of white or almost white color. The main active ingredient esomeprazole Release form Capsules Dosage 40 mg malignancy, since treatment with esomeprazole may reduce the severity of symptoms and thus delay the correct diagnosis. Patients taking the drug for a long period (especially more than 1 year) should be under regular medical supervision. During treatment with antisecretory drugs, incl. esomeprazole, the level of gastrin in the blood plasma increases as a result of a decrease in the secretion of hydrochloric acid. After stopping therapy, the gastrin level returns to baseline within a month. Patients taking antisecretory drugs for a long time are more likely to experience a relapse of the disease. There have been reports of the development of symptomatic and asymptomatic hypomagnesemia in patients taking proton pump inhibitors for at least 3 months, in most cases after 1 year of therapy. Serious side effects include tetany, arrhythmias, and seizures. Most patients required magnesium salts and discontinuation of proton pump inhibitors. Patients in whom long-term use of proton pump inhibitors or concomitant use of digoxin, or other drugs that can cause a decrease in magnesium levels (for example, diuretics), it is necessary to determine the concentration of magnesium in the blood serum before starting the use of proton pump inhibitors and periodically during use . Observational studies suggest that the use of proton pump inhibitors may be associated with an increased risk of hip, wrist, and spine fractures. The risk of fractures increased in patients who received proton pump inhibitors in high doses (multiple daily doses) and / or long-term therapy (1 year or more). It is recommended to take proton pump inhibitors in the minimum therapeutic dose, in accordance with the indications for use, the duration of the course of therapy should be minimal. Patients at risk of fracture should be treated according to approved guidelines. Use in Pediatrics The use of the drug in children is not recommended. Influence on the ability to drive vehicles and control mechanisms Ezokar does not affect the ability to drive vehicles and work with dangerous devices and mechanisms. Indications for use Gastroesophageal reflux disease (GERD): treatment of erosive reflux esophagitis; long-term maintenance treatment of patients with cured esophagitis to prevent relapses; symptomatic treatment of GERD. Peptic ulcer of the stomach and duodenum (as part of combination therapy): treatment of duodenal ulcer associated with Helicobacter pylori; prevention and treatment of peptic ulcers in patients with peptic ulcer disease. Patients taking NSAIDs for a long time: treatment of peptic ulcers associated with taking NSAIDs; prevention of peptic ulcers associated with NSAIDs. Dosage and administration The drug is taken orally immediately before meals or during meals. Capsules should be swallowed whole with liquid. Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks. An additional 4-week course of treatment is recommended in cases where, after the first course, esophagitis is not cured or symptoms persist. Prevention of recurrence in patients with cured esophagitis: 20 mg 1 time / day. Symptomatic treatment of GERD in patients without esophagitis: 20 mg 1 time / day. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient should be carried out. In combination with appropriate antibiotic therapy for eradication of Helicobacter pylori, treatment of duodenal ulcer associated with Helicobacter pylori, prevention of recurrence of peptic ulcers in patients with peptic ulcer associated with Helicobacter pylori: esomeprazole – 20 mg, amoxicillin – 1 g and clarithromycin – 500 mg 2 times / day for 7 days. In severe renal failure, with severe liver dysfunction, the maximum dose is 20 mg / day. Elderly patients, patients with mild to moderate renal insufficiency, and patients with mild to moderate hepatic impairment do not require dose adjustment. Application during pregnancy and lactation Adequate and strictly controlled studies of the safety of the drug during pregnancy have not been conducted, therefore, the appointment of the drug during this period is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. It is not known whether esomeprazole is excreted in breast milk, so Ezocar should not be prescribed during breastfeeding. In experimental animal studies, no direct or indirect negative effects of esomeprazole on the development of the embryo or fetus have been identified. The introduction of the racemic preparation also did not have any negative effect on pregnancy, childbirth, and also during postnatal development. Interaction with other drugs Esomeprazole reduces the absorption of ketoconazole and itraconazole. Esomeprazole inhibits CYP2C19 and CYP3A4 isoenzymes, therefore, concomitant use with other drugs in the metabolism of which CYP2C19 is involved (including diazepam, citalopram, imipramine, clomipramine, phenytoin) may lead to an increase in their plasma concentrations and require a dose reduction. When co-administered with esomeprazole at a dose of 30 mg and diazepam, the clearance of the enzyme-substrate complex (CYP2C19-diazepam) is reduced by 45%. With the simultaneous administration of esomeprazole at a dose of 40 mg, the minimum plasma concentrations of phenytoin in patients with epilepsy increased by 13%. In this regard, it is recommended to control plasma concentrations of phenytoin at the beginning of treatment with esomeprazole and when it is canceled. In healthy volunteers, co-administration of esomeprazole at a dose of 40 mg and cisapride led to an increase in the values of the pharmacokinetic parameters of cisapride: AUC – by 32% and T1 / 2 – by 31%, however, the concentration of cisapride in plasma did not change significantly. With this combination, the effect of cisapride on the electrophysiological parameters of the heart did not change. The combined use of esomeprazole with clarithromycin (500 mg 2 times / day), which inhibits CYP3A4, leads to a 2-fold increase in the AUC of esomeprazole. Correction of the dosing regimen of esomeprazole in this case is not required. Esomeprazole does not cause clinically significant changes in the pharmacokinetics of amoxicillin, quinidine and warfarin. Contraindications concomitant use with nelfinavir; lactation period (breastfeeding); hypersensitivity to esomeprazole, substituted benzimidazoles or other components of the drug in history. The drug should be used with caution during pregnancy. Ingredients: esomeprazole (in the form of pellets 8.5%) 235 mg, which corresponds to the content of esomeprazole 20 mg sodium hydroxide. Overdose At present, no cases of overdose have been described. With a single dose of esomeprazole at a dose of 80 mg, no adverse effects were observed. Treatment: if necessary, carry out symptomatic and supportive therapy. The specific antidote is unknown. Dialysis is ineffective, because. Esomeprazole is highly bound to plasma proteins. Adverse reactions The following adverse reactions have been identified during clinical trials of esomeprazole and during post-registration safety monitoring. No dose-dependence was determined for any of the adverse reactions. The frequency of adverse reactions is indicated in accordance with the following classification: very common (>1/10), frequent (>1/100 to <1/10), infrequent (>1/1000 to <1/100), rare (>1/100). 10000 to <1/1000), very rare (<1/10000); the frequency is not known (cannot be determined from the available data). From the hemopoietic system: rare - leukopenia, thrombocytopenia; very rare - agranulocytosis, pancytopenia. From the immune system: rare - hypersensitivity reactions such as fever, angioedema and anaphylactic reactions / shock. From the side of metabolism: infrequent - peripheral edema; rare - hyponatremia; very rare - hypomagnesemia, severe hypomagnesemia may be associated with hypocalcemia. On the part of the psyche: infrequent - insomnia; rare - agitation, confusion, depression; very rare - aggressiveness, hallucinations. From the nervous system: frequent - headache; infrequent - dizziness, paresthesia, drowsiness; rare - taste disorders. On the part of the organ of vision: rare - blurred vision. On the part of the organ of hearing and labyrinth: infrequent - dizziness. From the respiratory system: rare - bronchospasm. From the digestive system: frequent - abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting; infrequent - dryness of the oral mucosa, increased activity of liver enzymes; rare - stomatitis, gastrointestinal candidiasis, hepatitis with or without jaundice; very rare - liver failure, encephalopathy in patients with previous liver disease; the frequency is not known - microscopic colitis. From the skin and subcutaneous tissue: infrequent - dermatitis, itching, rash, urticaria; rare - alopecia, photosensitivity; very rare - erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis. From the musculoskeletal system: rare - arthralgia, myalgia; very rare - muscle weakness, bone fractures. From the urinary system: very rare - interstitial nephritis. From the reproductive system and mammary glands: very rare - gynecomastia. On the part of the body as a whole: rare - weakness, increased sweating. Storage conditions The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30 ° C. Buy Ezocar capsules 40 mg No. 4x4 Price for Ezocar capsules 40 mg No. 4x4
INN | Esomeprazole |
---|---|
The code | 68 212 |
Barcode | 6 251 595 708 060 |
Dosage | 40mg |
Active substance | Esomeprazole |
Manufacturer | Farmakar PLC, Palestine |
Indications Applications | Gastroesophageal reflux disease (GERD): treatment of erosive reflux esophagitis; long-term maintenance treatment of patients with cured esophagitis to prevent relapses; symptomatic treatment of GERD. Peptic ulcer of the stomach and duodenum (as part of combination therapy): treatment of duodenal ulcer associated with Helicobacter pylori; prevention and treatment of peptic ulcers in patients with peptic ulcer disease. Patients taking NSAIDs for a long time: treatment of peptic ulcers associated with taking NSAIDs; prevention of peptic ulcers associated with NSAIDs. |
Contraindications | simultaneous reception with nelfinavir; lactation period (breastfeeding); hypersensitivity to esomeprazole, substituted benzimidazoles or other components of the drug in history. The drug should be used with caution during pregnancy. |
Side effects | The following adverse reactions were identified during clinical trials of esomeprazole and during post-registration safety monitoring. No dose-dependence was determined for any of the adverse reactions. The frequency of adverse reactions is indicated in accordance with the following classification: very common (>1/10), frequent (>1/100 to <1/10), infrequent (>1/1000 to <1/100), rare (>1/100). 10000 to <1/1000), very rare (<1/10000); the frequency is not known (cannot be determined from the available data). From the hemopoietic system: rare – leukopenia, thrombocytopenia; very rare – agranulocytosis, pancytopenia. From the immune system: rare – hypersensitivity reactions such as fever, angioedema and anaphylactic reactions / shock. From the side of metabolism: infrequent – peripheral edema; rare – hyponatremia; very rare – hypomagnesemia, severe hypomagnesemia may be associated with hypocalcemia. On the part of the psyche: infrequent – insomnia; rare – agitation, confusion, depression; very rare – aggressiveness, hallucinations. From the nervous system: frequent – headache; infrequent – dizziness, paresthesia, drowsiness; rare – taste disorders. On the part of the organ of vision: rare – blurred vision. On the part of the organ of hearing and labyrinth: infrequent – dizziness. From the respiratory system: rare – bronchospasm. From the digestive system: frequent – abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting; infrequent – dryness of the oral mucosa, increased activity of liver enzymes; rare – stomatitis, gastrointestinal candidiasis, hepatitis with or without jaundice; very rare – liver failure, encephalopathy in patients with previous liver disease; the frequency is not known – microscopic colitis. From the skin and subcutaneous tissue: infrequent – dermatitis, itching, rash, urticaria; rare – alopecia, photosensitivity; very rare – erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis. From the musculoskeletal system: rare – arthralgia, myalgia; very rare – muscle weakness, bone fractures. From the urinary system: very rare – interstitial nephritis. From the reproductive system and mammary glands: very rare – gynecomastia. On the part of the body as a whole: rare – weakness, increased sweating. |
Use during pregnancy and lactation | Forbidden to use |
Application Gender | Any |
Release Form | Capsules |
Main Active Substances | esomeprazole |
Composition Means | esomeprazole (in the form of pellets 8.5%) 235 mg, which corresponds to the content of esomeprazole 20 mg sodium hydroxide. |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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