Name Lansazol caps. The main active ingredient Lansoprazole Release form capsules Dosage 30 mg Lansoprazole may mask symptoms and delay diagnosis. Lansazol should be used with caution in patients with moderate to severe hepatic impairment. Decreased gastric acidity due to the use of lansoprazole may lead to an increase in the number of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slight increase in the risk of developing gastrointestinal infections caused by Salmonella and Campylobacter. In patients suffering from peptic ulcer of the stomach and duodenum, the possibility of H. pylori infection should be considered as an etiological factor. When using lansoprazole for the eradication of H. pylori infection in combination with antibiotics, the instructions for use of these antibiotics must be followed. Due to limited safety data for patients on maintenance therapy for more than 1 year, monitoring and careful assessment of the risk/benefit ratio for these patients is necessary. Very rarely, cases of colitis have been reported in patients treated with lansoprazole. Thus, in the event of severe and/or persistent diarrhea, consideration should be given to discontinuing therapy. The use of lansoprazole for the prevention of peptic ulcer in patients requiring continuous treatment with NSAIDs should be limited at high risk of complications, for example: with a history of gastrointestinal bleeding in history, perforations or ulcers, old age, simultaneous use of drugs that increase the likelihood of adverse events. upper gastrointestinal events (eg, corticosteroids or anticoagulants), in the presence of serious comorbidities, or with long-term use of NSAIDs at the maximum prescribed doses. Cases of severe hypomagnesaemia have been reported in patients taking PPIs, including lansoprazole, for three months to a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can be dangerous and go unreported. In most patients, hypomagnesaemia improved after taking magnesium supplements and discontinuing PPI treatment. If a long-term treatment of a patient with a PPI is planned simultaneously with digoxin or other drugs that cause hypomagnesemia (for example, diuretics), the specialist should assess the level of magnesium before starting treatment and monitor it during treatment. Long-term use (>1 year) of high-dose proton pump inhibitors may increase the risk of hip, wrist, and spine fractures, predominantly in elderly patients or in the presence of other risk factors. Patients at risk of developing osteoporosis should be treated according to current clinical guidelines and receive sufficient vitamin D and calcium. Elevated levels of chromogranin A (CgA) can distort test results when conducting a diagnostic examination to detect neuroendocrine tumors. To avoid this, the use of proton pump inhibitors should be discontinued at least five days before the measurement of serum chromogranin levels. If the levels of CgA and gastrin have not returned to normal values after the initial measurement, the determination of the level of chromogranin should be repeated 14 days after stopping the proton pump inhibitors. Special precautions regarding excipients Lansazol® contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug. Indications for use: treatment of peptic ulcer of the stomach and duodenum; treatment of reflux esophagitis; prevention of reflux esophagitis; eradication of Helicobacter pylori (H. pylori) as part of complex antibiotic therapy; treatment and prevention of erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); symptomatic gastroesophageal reflux disease; Zollinger-Ellison syndrome. Method of administration and doses The use of this medicinal product is possible only after consulting a doctor! If you forget to take LANSAZOL®, take the capsule as soon as possible before the next dose is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, the drug is used according to the recommended dosing regimen. Do not stop taking LANSAZOL® without first consulting your doctor! If you have any doubts or questions, please contact your doctor. To achieve the optimal effect, Lansazol® should be taken once a day in the morning; in the eradication of H. pylori, the drug is taken twice a day: once in the morning, once in the evening. Lansoprazole should be taken orally, at least 30 minutes before meals, with a small amount of liquid. Capsules should be swallowed whole without chewing. If this is not possible, the capsule is opened and the contents are mixed with a small amount of apple/tomato juice (1 tablespoon) or added to a small amount of soft food (eg yogurt, applesauce). The contents of the capsule can also be mixed with 40 ml of apple juice and administered through a nasogastric tube. The drug should be used immediately after preparing the suspension or mixture. Capsules 30 mg can not be divided. If it is necessary to take lower dosages, another dosage form should be prescribed. Peptic ulcer of the duodenum – 30 mg (1 capsule) per day for 2 weeks, in resistant cases, treatment is continued up to 4 weeks. Gastric ulcer in the acute phase and erosive and ulcerative esophagitis – 30 mg per day for 4 weeks, if necessary, treatment is continued up to 8 weeks. Prevention of esophagitis – 15 mg per day. If necessary, the dose can be doubled to 30 mg per day. H. pylori eradication – 30 mg 2 times a day for 7 days (if necessary – up to 14 days) in combination with antibacterial agents of the following combination: clarithromycin 250-500 mg twice a day + amoxicillin 1 g twice a day; clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily. Erosive and ulcerative lesions of the gastrointestinal tract (GIT) caused by taking NSAIDs – 30 mg per day for 4-8 weeks. In resistant cases, treatment is continued for a longer period of time using higher dosages. Anti-relapse treatment of gastric and duodenal ulcers caused by NSAIDs in patients at risk (age over 65 years, history of peptic ulcers) – 15 mg per day. If necessary, the dose can be doubled to 30 mg per day. Symptomatic gastroesophageal reflux disease – 15-30 mg per day for 4 weeks. Zollinger-Ellison syndrome – the dose is selected individually. Usually start with a dose of 60 mg 1 time per day. If doses of more than 120 mg per day are needed, they should be divided into two doses. For treatment, a dose of up to 180 mg per day can be used. Impaired renal or hepatic function – Patients with impaired renal function do not require dose adjustment. Patients with moderate or severe hepatic impairment should be monitored and a 50% daily dose reduction is recommended. Elderly patients – the dose is selected individually. The daily dose of 30 mg should not be exceeded unless clinically indicated. Interactions with other drugs If you are currently or have recently taken other drugs, tell your doctor about this Effect of lansoprazole on other drugs Drugs with pH-dependent absorption Lansoprazole may interfere with the absorption of drugs for which the bioavailability of gastric pH is critical . Atazanavir Studies have shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a significant reduction in atazanavir exposure (a decrease in the area under the concentration-time curve (AUC) and Cmax was about 90%). Lansazol should not be used concomitantly with atazanavir. Ketoconazole and itraconazole Absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced in the presence of hydrochloric acid. The use of lansoprazole can lead to sub-therapeutic concentrations of ketoconazole and itraconazole, so co-administration should be avoided. Digoxin Co-administration of lansoprazole and digoxin may lead to increased plasma levels of digoxin. Therefore, it is necessary to monitor the plasma level of digoxin and, if necessary, adjust the dose of digoxin at the beginning and at the end of treatment with lansoprazole. Drugs metabolized by P450 enzymes Lansoprazole may increase plasma concentrations of drugs that are metabolized by CYP3A4. Caution is advised when lansoprazole is co-administered with these drugs with a narrow therapeutic window. Theophylline Lansoprazole reduces the concentration of theophylline in plasma, which may reduce the expected clinical effect. Caution is advised when using a combination of these drugs. Tacrolimus Co-administration of lansoprazole increases the plasma concentration of tacrolimus. Lansoprazole increases mean tacrolimus exposure by up to 81%. It is recommended to monitor plasma concentrations of tacrolimus at the beginning and end of co-administration with lansoprazole. Drugs transported by P-glycoprotein The ability of lansoprazole to inhibit the transport of P-glycoprotein has been established in vitro. The clinical significance of this feature has not been established. Effects of other drugs on lansoprazole Drugs that inhibit CYP2C19 Fluvoxamine Dose reduction should be considered when lansoprazole is co-administered with the CYP2C19 inhibitor fluvoxamine. The concentration of lansoprazole in plasma increases by 4 times. Medicinal products that induce CYP2C19 and CYP3A4 Inducers of CYP2C19 and CYP3A4 enzymes, such as rifampicin and St. John’s wort (Hypericum perforatum), may significantly reduce plasma concentrations of lansoprazole. Other drugs Warfarin When co-administered with warfarin, monitoring of prothrombin time and INR is necessary. Sucralfate/Antacids Sucralfate/antacids may reduce the bioavailability of lansoprazole. Therefore, lansoprazole should be taken more than 1 hour after taking these drugs. No clinically significant interactions of lansoprazole with NSAIDs have been demonstrated, but there are no studies on the formal interaction of this combination. Contraindications hypersensitivity to lansoprazole or any excipients; lansoprazole, like other proton pump inhibitors (PPIs), should not be co-administered with nelfinavir; malignant tumors of the gastrointestinal tract; pregnancy; lactation; age up to 18 years. One capsule contains: active ingredient – lansoprazole in the form of lansoprazole pellets 8.5% – 30 mg; excipients: mannitol, sucrose, calcium carboxymethylcellulose, magnesium carbonate; hydroxypropyl methylcellulose, methacrylic acid L30D, propylene glycol, cetyl alcohol, sodium hydroxide, tween-80, povidone S-630, titanium dioxide. Capsule composition: gelatin, titanium dioxide. Overdose Symptoms: not described (a single dose of 600 mg was not accompanied by clinical manifestations of an overdose). In case of increased manifestation of side effects, immediately consult a doctor. Side effects Classification of the incidence of side effects according to the World Health Organization: very common (? 1/10), frequent (? 1/100 to < 1/10), infrequent (? 1/1000 to < 1/100), rare (? 1 /10000 to < 1/1000), very rare (< 1/10000), unknown (cannot be estimated from the available data). The frequency of side effects is listed by individual organ systems. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Lansazole capsules 30mg No. 10x2 Price for Lansazole capsules 30mg No. 10x2
INN | LANSOPRAZOLE |
---|---|
The code | 42 385 |
Barcode | 4 810 201 008 059 |
Dosage | 30mg |
Active substance | Lansoprazole |
Manufacturer | Borisovsky ZMP, Belarus |
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