Instructions for use LANSAZOL
H+-K+-ATPase inhibitor. Antiulcer drug. Blocks the final stage of hydrochloric acid formation, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Possessing high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them and has a cytoprotective effect, increasing oxygenation of the gastric mucosa and increasing the selection of bicarbonate. The rate and degree of inhibition of basal and stimulated secretion of hydrochloric acid are dose-dependent:
- after taking 15 mg and 30 mg, the pH begins to increase after 1-2 hours and 2-3 hours, and secretion decreases to 80-97%, respectively. Restoration of H+-K+-ATPase activity occurs with a half-life of 30-48 hours. The average daily pH value of gastric juice rises to 2.9 (the percentage of time pH>3 is maintained is 47.6). After discontinuation of administration, the acid level remains below 50% of the basal value for 39 hours, and no rebound increase in secretion is observed. In patients with Zollinger-Ellison syndrome, the effect lasts longer. Increases the concentration of pepsinogen in the blood serum and inhibits the production of pepsin. Promotes the formation of specific IgA to Helicobacter pylori in the gastric mucosa, suppressing their growth, and increases the anti-Helicobacter activity of other drugs. Reduces blood flow in the antrum of the stomach, pylorus and duodenal bulb by an average of 17%, inhibits the motor-evacuation function of the stomach. Inhibition of secretion is accompanied by an increase in the number of nitrosobacteria and an increase in the concentration of nitrates in gastric secretions. Increases the concentration of gastrin in the blood serum by 50-100% (gastrin levels reach a plateau after 2 months of treatment and return to initial values after the end of treatment).
Effective in the treatment of gastric and duodenal ulcers resistant to histamine H2 receptor blockers. Provides faster healing of ulcers in the duodenum (85% of duodenal ulcers heal after 4 weeks of treatment at a dose of 30 mg/day). The recurrence rate of peptic ulcers after treatment is 55-62%. With reflux esophagitis, complete cure of patients is observed by the end of 8 weeks of treatment (30 mg/day) in 88.7%. In the experiment, when administered in high doses, lansoprazole causes hyperplasia of enterochromafin-like (ECL-) cells, increases the frequency of metaplasia of the epithelium of the gastric mucosa and the formation of adenoma in the interstitial tissue of the testes.
Lansazole capsules 30 mg No. 10x2
Name
Lansazole caps. 30 mg in container pack No. 10x2
Description
Hard gelatin capsules No. 0, cylindrical in shape with hemispherical ends, white.
Main active ingredient
Lansoprazole
Release form
capsules
Dosage
30 mg
special instructions
When treating gastric ulcer with lansoprazole, as in the case of anti-ulcer therapy with other drugs, it is necessary to exclude the presence of a malignant tumor of the stomach, because Lansoprazole may mask symptoms of the disease and delay diagnosis. Lansazole® should be used with caution in patients with moderate to severe impairment of hepatic function. Reduced 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 gastrointestinal infections caused by Salmonella and Campylobacter. In patients suffering from gastric and duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be taken into account. When using lansoprazole to eradicate H. pylori infection in combination with antibiotics, you must follow the instructions for use of these antibiotics. Due to limited safety data for patients on maintenance therapy for more than 1 year, observation and careful assessment of the risk/benefit ratio for these patients is necessary. Cases of colitis have been very rarely reported in patients taking lansoprazole. Therefore, in case of severe and/or persistent diarrhea, discontinuation of therapy should be considered. The use of lansoprazole for the prevention of peptic ulcers in patients requiring continuous treatment with NSAIDs should be limited if there is a high risk of complications, for example: with a history of gastrointestinal bleeding, perforations or ulcers, old age, concomitant use of drugs that increase the likelihood of adverse events upper gastrointestinal effects (eg, corticosteroids or anticoagulants), in the presence of serious concomitant diseases, or with long-term use of NSAIDs at maximum prescribed doses. Cases of severe hypomagnesemia have been reported in patients taking PPIs, including lansoprazole, for three months to a year. Serious manifestations of hypomagnesemia such as fatigue, tetany, delirium, seizures, dizziness and ventricular arrhythmia may be dangerous and remain undiagnosed. In most patients, hypomagnesemia improved after taking magnesium supplements and stopping PPI treatment. If long-term treatment of a patient with a PPI is planned concomitantly with digoxin or other drugs that cause hypomagnesemia (for example, diuretics), the specialist must assess magnesium levels before starting treatment and monitor it during treatment. Long-term use (>1 year) of proton pump inhibitors in high doses may increase the risk of hip, wrist and spine fractures, primarily in elderly patients or those with other risk factors. Patients at risk of developing osteoporosis should be treated in accordance with current clinical guidelines and receive adequate amounts of vitamin D and calcium. Elevated levels of chromogranin A (CgA) may interfere with diagnostic testing for neuroendocrine tumors. To avoid this, use of proton pump inhibitors should be discontinued at least five days before measuring serum chromogranin levels. If CgA and gastrin levels have not returned to normal after the initial measurement, chromogranin levels should be repeated 14 days after stopping proton pump inhibitors. Special warnings regarding excipients of the drug Lansazol® contain sucrose. Patients with rare congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug.
Indications for use
treatment of gastric and duodenal ulcers; treatment of reflux esophagitis; prevention of reflux esophagitis; eradication of Helicobacter pylori (H. pylori) as part of complex antibacterial 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.
Directions for use and doses
The use of this medicine is possible only after consultation with a doctor! If you forget to take LANSAZOL®, take the capsule as soon as possible before your next dose is due. If it is time for your next dose of medication, do not take the missed dose. Do not double the dosage of the drug to compensate for the missed one! Next, the drug is used according to the recommended dosage regimen. Do not stop taking LANSAZOL® without first consulting your doctor! If you have any doubts or questions, contact your healthcare provider. To achieve the optimal effect, Lansazole® should be taken once a day in the morning; when eradicating 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, open the capsule and mix its contents with a small amount of apple/tomato juice (1 tablespoon) or add to a small amount of soft food (eg, yogurt, apple sauce). 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. 30 mg capsules cannot be divided. If it is necessary to take lower dosages, a different dosage form should be prescribed. Duodenal ulcer - 30 mg (1 capsule) per day for 2 weeks, in resistant cases treatment is continued for up to 4 weeks. Gastric ulcer in the acute phase and erosive-ulcerative esophagitis - 30 mg per day for 4 weeks, if necessary, treatment is continued for up to 8 weeks. Prevention of esophagitis - 15 mg per day. If necessary, the dose can be doubled to 30 mg per day. Eradication of H. pylori - 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 taking 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 must be divided into two doses. For treatment, a dose of up to 180 mg per day can be used. Impaired renal or hepatic function - no dosage adjustment is required in patients with impaired renal function. Patients with moderate or severe liver dysfunction should be monitored, and a 50% reduction in the daily dose is recommended. Elderly patients - the dose is selected individually. The daily dose of 30 mg should not be exceeded unless clinically indicated.
Interaction with other drugs
If you are currently or have recently taken other medicines, tell your doctor. Effect of lansoprazole on other medicines Medicines with pH-dependent absorption Lansoprazole may affect the absorption of medicines for which gastric pH is critical for bioavailability. Atazanavir Studies have shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg in healthy volunteers resulted in a significant reduction in atazanavir exposure (about 90% reduction in area under the concentration-time curve (AUC) and Cmax). Lansazole® 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 may result in subtherapeutic concentrations of ketoconazole and intraconazole, so coadministration should be avoided. Digoxin Concomitant use of lansoprazole and digoxin may lead to increased plasma levels of digoxin. Therefore, it is necessary to monitor plasma digoxin levels and, if necessary, adjust the dose of digoxin at the beginning and end of treatment with lansoprazole. Drugs metabolized by P450 enzymes Lansoprazole may increase plasma concentrations of drugs metabolized by CYP3A4. Caution is recommended when simultaneous use of lansoprazole and these drugs with a narrow therapeutic window. Theophylline Lansoprazole reduces plasma theophylline concentrations, which may reduce the expected clinical effect. Caution is recommended when using a combination of these drugs. Tacrolimus Concomitant use of lansoprazole increases plasma concentrations of tacrolimus. Lansoprazole increased the mean exposure of tacrolimus to 81%. Monitoring tacrolimus plasma concentrations is recommended at the beginning and end of concomitant use with lansoprazole. Drugs transported by P-glycoprotein The ability of lansoprazole to inhibit P-glycoprotein transport has been established in vitro. The clinical significance of this feature has not been established. Effect of other drugs on lansoprazole Medicines that inhibit CYP2C19 Fluvoxamine Dose reduction should be considered when lansoprazole is used concomitantly with the CYP2C19 inhibitor fluvoxamine. The concentration of lansoprazole in plasma increases 4 times. Medicines that induce CYP2C19 and CYP3A4 Inducers of CYP2C19 and CYP3A4 enzymes, such as rifampicin and St. John's wort (Hypericum perforatum), may significantly reduce lansoprazole plasma concentrations. Other drugs Warfarin When taken together 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 between lansoprazole and NSAIDs have been demonstrated, but there are no formal interaction studies with this combination.
Contraindications
hypersensitivity to lansoprazole or any excipients; Lansoprazole, like other proton pump inhibitors (PPIs), should not be used concomitantly with nelfinavir; malignant tumors of the gastrointestinal tract; pregnancy; lactation; age up to 18 years.
Compound
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 overdose). If side effects increase, consult a doctor immediately.
Side effect
Classification of the frequency of side effects according to the World Health Organization: very common (? 1/10), frequent (? 1/100 to
Storage conditions
In a place protected from light and moisture, at a temperature not exceeding 25 °C. Keep out of the reach of children.
What do people write?
As a rule, people leave good reviews about this drug. In them they note high efficiency, low cost, a large number of analogues, and also the fact that the pain went away within an hour after taking the first tablet.
The disadvantages include an extensive list of side effects, which frightens some to such an extent that they are forced to refuse to take this drug and purchase a less harmful drug.
Doctors reassure patients by stating that adverse reactions are very rare.
How might an adverse reaction occur?
Sometimes, as a result of taking a medicine, the patient's body may respond to the treatment - adverse reactions.
This condition can be recognized by symptoms such as:
It is necessary to consult a doctor and also read the instructions before using the drug. Diarrhea, increased/decreased appetite, abdominal pain, nausea, constipation, gastrointestinal candidiasis, ulcerative colitis, hepatotoxicity, pancreatitis;- Head pain, dizziness, blurred vision, depression, convulsions, drowsiness, sleep disturbance, hallucinations, anxiety, increased irritability, loss of orientation;
- Pharyngitis, inflammation of the upper respiratory tract, cough, rhinitis;
- Thrombocytopenia, agranulocytosis, anemia, pancytopenia, eosinophilia, leukopenia;
- Urinary retention, nephritis;
- Gynecomastia;
- Skin rash, photosensitivity, erythema, Stevens-Johnson syndrome, necrolysis, severe dermatological manifestations;
- Myalgia, flu-like syndrome, increased risk of fractures of the spine, hip, wrist.
If you begin to notice at least one of these manifestations, then you should stop taking this remedy. In the future, the patient must go to the hospital to select a similar drug or adjust the dosage.
Actions in case of overdose
There is no information about the occurrence of this condition. However, doctors do not exclude the possibility of an overdose if the maximum permissible dose is regularly exceeded. When this condition appears, an increase in side effects may occur.
If this happens, you should consult a doctor or cleanse your stomach yourself, and carry out all the necessary treatment.
Efficacy of Lansazole/Omeprazole
Conditions for which medication should not be taken
The drug is prohibited for use if the patient has a malignant neoplasm of the gastrointestinal tract. In addition, you should also avoid taking it if you have an individual intolerance to certain substances.
Elderly people, as well as those under the age of 18, should not take the medicine.
Use during pregnancy
You should avoid taking the drug during pregnancy. This measure is due to the fact that the active substance of the drug has the ability to penetrate the placenta, having a detrimental effect on the baby. As a result of such exposure, the baby begins to develop serious deviations from the norm while still in the womb.
If you are breastfeeding, you should also stop taking Lansazole.
Lansoprazole
Proton pump inhibitor (H+/K+-ATPase); metabolized in the parietal cells of the stomach to active sulfonamide derivatives, which inactivate H+/K+-ATPase. Blocks the final stage of HCl secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Possessing high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them and has a cytoprotective effect, increasing oxygenation of the gastric mucosa and increasing the secretion of bicarbonate.
The rate and degree of inhibition of basal and stimulated HCl secretion are dose-dependent: pH begins to rise 1-2 hours and 2-3 hours after taking 15 and 30 mg, respectively; inhibition of HCl production at a dose of 30 mg is 80-97%.
Does not affect gastrointestinal motility. The inhibitory effect increases in the first 4 days of administration. After stopping the intake, acidity remains below 50% of the basal level for 39 hours, and there is no “rebound” increase in secretion. Secretory activity returns to normal 3-4 days after the end of administration.
In patients with Zollinger-Ellison syndrome, the effect lasts longer. Increases the concentration of pepsinogen in the blood serum and inhibits the production of pepsin.
Promotes the formation of specific IgA to Helicobacter pylori in the gastric mucosa, suppressing their growth, and increases the anti-Helicobacter activity of other drugs.
Reduces blood flow in the antrum of the stomach, pylorus and duodenal bulb by an average of 17%, inhibits the motor-evacuation function of the stomach. Inhibition of secretion is accompanied by an increase in the number of nitrosobacteria and an increase in the concentration of nitrates in gastric secretions.
Increases the concentration of gastrin in the blood serum by 50-100% (gastrin levels reach a plateau after 2 months of treatment and return to initial values after the end of treatment).
Effective in the treatment of gastric and duodenal ulcers resistant to H2-histamine receptor blockers. Provides faster healing of ulcerative defects in the duodenum (85% of duodenal ulcers heal after 4 weeks of treatment at a dose of 30 mg/day). The recurrence rate of peptic ulcers after treatment is 55-62%. With reflux esophagitis, complete cure of patients is observed by the end of 8 weeks of treatment (30 mg/day) in 88.7%.
In the experiment, when administered in high doses, lansoprazole causes hyperplasia of enterochromaffin-like (ECL-) cells, increases the incidence of metaplasia of the epithelium of the gastric mucosa and the formation of adenoma in the interstitial tissue of the testes.
