Nolpaza coated pills 40mg N56
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Active ingredients
Pantoprazole
Release form
Pills
Composition
Active ingredient: bismuth tri-potassium dicitrate 303.03 mg (equivalent to bismuth oxide 120 mg) excipients: corn starch - 72.17 mg; Povidone K30 - 18 mg; policrilin potassium - 23.8 mg; macrogol 6000 - 6 mg; magnesium stearate - 2 mg membrane film: Opadry II transparent (polyvinyl alcohol - 4.505 mg, macrogol 4000 - 2.295 mg; talc - 1.7 mg) - 8.5 mg; titanium dioxide (E171) - 1.5 mg
Pharmacological effect
Proton pump inhibitor
Pharmacokinetics
Pantoprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma (1–1.5 mcg / ml) is reached 2–2.5 hours after ingestion, while the value of Cmax remains constant during repeated administration. Bioavailability of the drug is 77%. Simultaneous food intake does not affect the AUC, Cmax and bioavailability; there is only a change in the onset of the drug. Communication with plasma proteins is about 98%. Vd is about 0.15 L / kg, and clearance is 0.1 L / h / kg. Pantoprazole is almost completely metabolized in the liver. It is an inhibitor of the CYP2C19 enzyme system. T1 / 2 - 1 h. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T1 / 2 does not correlate with the duration of the therapeutic effect. Excretion of metabolites (80%) mainly through the kidneys; the rest is excreted in the bile. The main metabolite, determined in serum and urine, is desmethylpanthoprazole, which is conjugated with sulfate. T1 / 2 of desmethyl pantoprazole, the major metabolite (approximately 1.5 hours) is much more than the T1 / 2 of pantoprazole itself. In chronic renal failure (including those on hemodialysis), no change in the dose of the drug is required. T1 / 2 is short, as in healthy individuals. Very small amounts of pantoprazole can be dialyzed. In patients with cirrhosis of the liver (classes A and B according to the Child, Pugh classification), when taking pantoprazole 20 mg / day, T1 / 2 increases to 3–6 h, AUC increased 3–5 times, and Cmax - 1.3 times compared with healthy individuals. A slight increase in AUC and an increase in Cmax in elderly patients compared with the corresponding data in younger patients are not clinically significant.
Indications
Gastroesophageal reflux disease (GERD), incl. Erosive and ulcerative reflux esophagitis and symptoms associated with GERD: heartburn, acid regurgitation, pain when swallowing; erosive and ulcerative lesions of the stomach and duodenum, associated with the intake of NSAIDs; gastric ulcer and duodenal ulcer,treatment and prevention; eradication of Helicobacter pylori in combination with two antibiotics; Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion
Contraindications
Hypersensitivity to pantoprazole or other components of the drug; the drug contains sorbitol, therefore it is not recommended for persons with a rare hereditary fructose intolerance; neurotic dyspepsia; children's age up to 18 years (efficiency and safety are not studied). With caution: pregnancy, lactation, liver failure, risk factors for cyanocobalamin deficiency (vitamin B12), especially against the background of hypo- and achlorhydria
Use during pregnancy and lactation
Experience with pantoprazole in pregnant women is limited. In pregnancy and lactation, it can be used only if the positive effect on the mother justifies the possible risk to the fetus and child. There is no data on the release of pantoprazole with breast milk.
Dosage and administration
Inside, the pill should not be chewed and broken. The tablet is swallowed whole, washed down with a small amount of liquid, before meals, usually before breakfast. When taking a second dose of the drug is recommended to take before dinner. GERD, incl. erosive and ulcerative reflux esophagitis and associated symptoms: heartburn, acid regurgitation, pain when swallowing: - mild: recommended dose - 1 tab. drug Nolpaza 20 mg / day; - moderate and severe: the recommended dose is 1-2 pills. Nolpase 40 mg / day (40–80 mg / day). Relief of symptoms usually occurs within 2-4 weeks. The course of therapy is 4-8 weeks. For prophylaxis, as well as supporting long-term therapy, they take 20 mg / day (1 tab. Of the Nolpase preparation at 20 mg), if necessary, increase the dose to 40–80 mg / day. It is possible to take the drug on demand, if symptoms occur. Erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs: the recommended dosage is 1-2 pills. drug Nolpaza 40 mg (40-80 mg / day). The course of therapy is 4-8 weeks. For the prevention of erosive lesions on the background of long-term use of NSAIDs - 20 mg. Peptic ulcer disease of the stomach and duodenum (treatment and prevention) - is prescribed for 40-80 mg / day.The course of treatment for acute exacerbation of duodenal ulcer is usually 2 weeks, gastric ulcer is 4-8 weeks. If necessary, the duration of therapy is increased. Eradication of Helicobacter pylori (in combination with antibiotics): the recommended dose is 1 table. Nolpase (40 mg) 2 times a day in combination with two antibiotics, usually a course of anti-Helicobacter therapy is 7-14 days. Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: the recommended starting dose of long-term therapy with pantoprazole is 80 mg (2 tab. Of Nolpaza 40 mg) per day divided into 2 doses. In the future, the daily dose can be titrated depending on the initial level of gastric secretion. Perhaps a temporary increase in the daily dose of pantoprazole to 160 mg in order to adequately control gastric secretion. The duration of therapy is selected individually. Severe abnormal liver function: the dose of pantoprazole should not exceed 40 mg / day and it is recommended to regularly monitor the activity of hepatic enzymes, especially with long-term treatment with pantoprazole. With increasing activity of liver enzymes, it is recommended to cancel the drug. Elderly people and patients with kidney disease: the maximum daily dose of pantoprazole is 40 mg. In elderly individuals receiving Helicobacter pylori eradication therapy, the duration of therapy usually does not exceed 7 days.
Side effects
From the side of blood-forming organs: very rarely - leukopenia, thrombocytopenia. On the part of the digestive system: often - abdominal pain, diarrhea, constipation, flatulence; infrequently - nausea, vomiting; rarely, dry mouth; very rarely, increased activity of hepatic transaminases and gamma glutamine transferase (GGT), severe liver damage, leading to jaundice with or without liver failure. On the part of the immune system: very rarely - anaphylactic reactions, including anaphylactic shock. From the musculoskeletal system: rarely - arthralgia; very rarely - myalgia. From the central and peripheral nervous system: often - a headache; infrequently - dizziness, blurred vision (blurred vision). Mental disorders: very rarely - depression. From the genitourinary system: very rarely - interstitial nephritis.Allergic reactions: infrequently - itching and rash; very rarely - urticaria, angioedema, Stevens-Johnson syndrome, erythema polymorphism or Lyell's syndrome, photosensitization. General disorders: very rarely - peripheral edema, hyperthermia, weakness, painful breast tension, increased triglyceride levels. With the development of severe adverse effects, drug treatment should be discontinued.
Overdose
Symptoms of an overdose in humans are unknown. Treatment: symptomatic, specific antidote does not exist. In the case of an overdose of the drug, accompanied by the usual signs of intoxication, detoxification measures are used.
Interaction with other drugs
Nolpase reduces the absorption of drugs, the bioavailability of which depends on the pH of the stomach and absorbed at acidic pH values (for example ketoconazole). Pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system. Pantoprazole interactions with drugs that are metabolized by the same system cannot be ruled out. However, in clinical studies, no significant interaction with digoxin, diazepam, diclofenac, ethanol, phenytoin, glibenclamide, carbamazepine, caffeine, metoprolol, naproxen, nifedipine, piroxicam, theophylline and oral contraceptives was found. Although with simultaneous use with warfarin in clinical pharmacokinetic studies, no significant interaction was found, several separate reports of a change in MHO were noted. In patients receiving coumarin anticoagulants simultaneously with pantoprazole, it is recommended to regularly monitor PV or MHO. While taking pantoprazole with antacids, no drug interactions have been registered.
special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant neoplasm (endoscopic control, if necessary with a biopsy - especially in case of a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis. If after 4 weeks of therapy with pantoprazole, the patient does not have the desired therapeutic effect, he should be re-examined.Like other proton pump inhibitors, pantoprazole may reduce the absorption of cyanocobalamin (vitamin B12) on the background of hypo- and achlorhydria. This should be especially taken into account in long-term treatment and in patients with risk factors for vitamin B12 deficiency. Conducting long-term therapy, especially for more than 1 year, requires regular monitoring of the patient. Influence on the ability to drive a car and other mechanical means. The drug does not affect the ability to drive a car or other technical means.