Omez capsules 40mg №7×4

Name:
OMEZ capsules 40mg in blisters in a package No. 7×4
Description:
Enteric-soluble hard gelatin capsules, opaque, size No0, with a light purple body, yellow cap and black marking “OMEZ 40” on the cap and capsule body; the contents of the capsules are granules from almost white to light yellow in color. The main active ingredient is Omeprazole. Release form Enteric-soluble hard gelatin capsules, opaque, size No0, with a light purple body, yellow cap and black marking “OMEZ 40” on the cap and capsule body; the contents of the capsules are granules from almost white to light yellow. 1 caps. omeprazole 40 mg Excipients: mannitol – 236 mg, crospovidone – 18 mg, poloxamer (407) – 5 mg, hypromellose (1828) – 8 mg, meglumine – 3 mg. Coating composition: Povidone K30 – 26.8 mg. The composition of the enteric coating: copolymer of methacrylic acid and ethyl acrylate (1:1) (methacrylic acid copolymer type C) – 72 mg, triethyl acetate – 7.2 mg, magnesium stearate – 4 mg. Capsule body composition: Brilliant Blue (E133), Sunset Yellow (E110), Charming Red (E129), Phloxin B (D&C Red#28), Titanium Dioxide (E171), Sodium Lauryl Sulfate, Water, Gelatin . The composition of the capsule cap: iron dye yellow oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin. The composition of the black inscription on the capsules: ink S-1-8114: shellac (20% esterified) in ethanol, iron dye black oxide (E172), n-butanol, propylene glycol (E1520), indigo carmine dye (E132), alluring red dye ( E129), Quinoline Yellow (E104), Brilliant Blue (E133); ink S-1-8115: shellac (20% esterified) in ethanol, iron oxide black (E172), ethanol, methanol, indigo carmine dye (E132), alluring red dye (E129), quinoline yellow dye (E104), brilliant dye blue (E133). 7 pcs. – blisters (4) – packs of cardboard. Dosage 40 mg in blisters in a package No. 7×4 Special instructions Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with gastric ulcer), since treatment, masking symptoms, may delay the correct diagnosis. Taking the drug simultaneously with food does not affect its effectiveness. Influence on the ability to drive vehicles and control mechanisms The impact of omeprazole on driving and using other equipment is unlikely. Pharmacological action Specific inhibitor of the proton pump: inhibits the activity of H + -K + -ATPase in the parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing the production of hydrochloric acid. Omeprazole is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells of the stomach. The effect is dose-dependent and provides effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor. The antisecretory effect after taking 20 mg occurs within the first hour, maximum after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours. disappearing by the end of 3-4 days after the end of the reception. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH above 3 for 17 hours. Pharmacokinetics Absorption Absorption is high, the time to reach Cmax is 0.5-3.5 hours. Bioavailability is 30-40%. Distribution Possessing high lipophilicity, it easily penetrates into the parietal cells of the stomach. Plasma protein binding (albumin and acid alpha1-glycoprotein) – 90-95%. Metabolism Almost completely metabolized in the liver with the participation of the cytochrome P450 (CYP) enzyme system, with the formation of 6 pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfonic derivatives, etc.). It is an inhibitor of the CYP2C19 isoenzyme. Withdrawal T1 / 2 is 0.5-1 h; total plasma clearance – from 0.3 to 0.6 l / min. There is no change in T1 / 2 during treatment. Excreted with urine (70-80%) and bile (20-30%). Pharmacokinetics in special clinical situations In hepatic insufficiency, bioavailability increases to almost 100%; T1 / 2 is 3 hours. In chronic renal failure, excretion decreases in proportion to the decrease in CC. In elderly patients, excretion decreases, bioavailability increases. Indications for use peptic ulcer of the stomach and duodenum (including prevention of recurrence); – reflux esophagitis; – hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis); – NSAID-gastropathy; – eradication of Helicobacter pylori in infected patients with gastric ulcer and duodenal ulcer (as part of combination therapy); – prevention of aspiration of acidic stomach contents into the respiratory tract during general anesthesia (Mendelssohn’s syndrome). Dosage and administration Take orally with a small amount of water (the contents of the capsule should not be chewed), 30 minutes before meals or immediately before meals. With exacerbation of peptic ulcer of the stomach and duodenum, reflux esophagitis and NSAID gastropathy – 20 mg 2 times / day. The course of treatment for duodenal ulcer – 2-3 weeks, if necessary – 4-5 weeks; with gastric ulcer and reflux esophagitis – 4-8 weeks. In Zollinger-Ellison syndrome, the dose is selected individually depending on the initial level of gastric secretion, usually starting with 60 mg / day; if necessary, the dose is increased to 80-120 mg / day (in this case, it is prescribed in 2-3 doses). For the prevention of Mendelssohn’s syndrome – 40 mg 1 hour before surgery. For the prevention of recurrence of peptic ulcer of the stomach and duodenum – 10-20 mg 1 time / day. Anti-relapse treatment of reflux esophagitis – 20 mg / day for a long period. For the eradication of Helicobacter pylori – 20 mg 2 times / day for 7-14 days (depending on the treatment regimen used) in combination with antibacterial agents. In elderly patients, there is no need to adjust the dose. Use during pregnancy and lactation The drug is contraindicated for use during pregnancy and lactation. Precautions With caution, the drug should be prescribed for renal and / or hepatic insufficiency. Prescribing the drug to children is contraindicated. In elderly patients, there is no need to adjust the dose. Interaction with other drugs May reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being inhibitors of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants (warfarin), phenytoin (drugs that are metabolized in the liver through the CYP 2C19 isoenzyme), which in some cases may require a reduction in doses of these drugs. At the same time, long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentration. . Plasma concentrations of omeprazole and clarithromycin increase during co-administration of these drugs, while evidence of an interaction of omeprazole with metronidazole and amoxicillin has not been identified. There was no interaction with concomitantly taken antacids. Contraindications children’s age; – pregnancy; – lactation period; – Hypersensitivity to the drug. Composition of somemeprazole 40 mg Excipients: mannitol – 236 mg, crospovidone – 18 mg, poloxamer (407) – 5 mg, hypromellose (1828) – 8 mg, meglumine – 3 mg. Coating composition: Povidone K30 – 26.8 mg. The composition of the enteric coating: copolymer of methacrylic acid and ethyl acrylate (1:1) (methacrylic acid copolymer type C) – 72 mg, triethyl acetate – 7.2 mg, magnesium stearate – 4 mg. Capsule body composition: Brilliant Blue (E133), Sunset Yellow (E110), Charming Red (E129), Phloxin B (D&C Red#28), Titanium Dioxide (E171), Sodium Lauryl Sulfate, Water, Gelatin . The composition of the capsule cap: iron dye yellow oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin. The composition of the black inscription on the capsules: ink S-1-8114: shellac (20% esterified) in ethanol, iron dye black oxide (E172), n-butanol, propylene glycol (E1520), indigo carmine dye (E132), alluring red dye ( E129), Quinoline Yellow (E104), Brilliant Blue (E133); ink S-1-8115: shellac (20% esterified) in ethanol, iron oxide black (E172), ethanol, methanol, indigo carmine dye (E132), alluring red dye (E129), quinoline yellow dye (E104), brilliant dye blue (E133). Overdose Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia. Treatment: symptomatic therapy, hemodialysis is not effective enough. Side effects The frequency of side effects is classified according to the frequency of occurrence of the case: often (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01%, including individual reports). From the hemopoietic system: very rarely – leukopenia, thrombocytopenia, agranulocytosis, pancytopenia. From the digestive system: sometimes – diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely – increased activity of liver enzymes, taste disturbances; very rarely – dry mouth, stomatitis, in patients with previous severe liver disease – hepatitis (including with jaundice), impaired liver function. From the nervous system: in patients with severe concomitant somatic diseases – dizziness, headache, agitation, depression, in patients with previous severe liver disease – encephalopathy. From the musculoskeletal system: very rarely – arthralgia, myasthenia gravis, myalgia. From the side of the skin: rarely – skin rash and / or itching; in some cases – photosensitivity, erythema multiforme exudative, alopecia. Allergic reactions: often – urticaria; very rarely – angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Others: rarely – gynecomastia, malaise, visual disturbances, peripheral edema, increased sweating, formation of gastric glandular cysts during long-term treatment (due to inhibition of hydrochloric acid secretion, is benign , reversible nature) Storage conditions The drug should be stored out of the reach of children, dry, dark place at a temperature not exceeding 25 ° C Buy Omez capsules 40mg No. 7×4 Price for Omez capsules 40mg No.