Agi-Lanko Agimexpharm medicine for stomach and duodenal ulcer treatment (2 blisters x 10 tablets)

ATC code: A02BC03

Lansoprazol is a benzimidazole derivative that has an anti -stomach secretion effect. Lansoprazol is related to structure and pharmacology with omeprazol. Lansoprazols are not inversely linked to H+/K+ ATPASE is an enzyme system on the surface of the cell into the stomach, so the Lansoprazol inhibits the final transport of hydrogen ions into the stomach. Because the H+/K+ ATPASE enzyme system is considered the acid pump (proton) of the gastric mucosa, Lansoprazol and Omeprazol are called proton pump inhibitors. Lansoprazol inhibits the basic acid secretion and is stimulated by any stimulus. As a result, Lansoprazol is used for short -term treatment of stomach -duodenal ulcer and long -term treatment of hyperactive diseases (such as Zollinger - Ellison syndrome, endocrine multi -gland tumor, systemic nourishment).

The level of stomach acid secretion depends on the dose and treatment time, but the Lansoprazol inhibits acid secretion better than H2 receptor antagonists.

Lansoprazol can prevent Helicobacter pylori in people with stomach ulcer - duodenum infected with this bacterium. If combined with one or more anti -bacterial drugs (such as amoxicillin, clarithromycin), Lansoprazol may be effective in exporing H. pylori.

Dynamic pharmacokinetics

absorption: Lansoprazole absorbs fast, maximum concentration achieved in about 1.7 hours after drinking, with absolute biological use of over 80%. In healthy people, half -life in plasma is 1.5 (± 1.0) hours. Maximum medication concentration and area under the curve (AUC) decreased by about 50% if used for about 30 minutes after eating.

Distribution: Lansoprazol binds to plasma proteins about 97%.

Metabolism: Lansoprazol metabolizes in the liver thanks to the cytochrom P450 enzyme system to become two main metabolites: Sulfon Lansoprazol and Hydroxy Lansoprazol. The metabolites have very little or no more anti -acid effect.

Elimination: About 20% of the drug is excreted in bile and urine. Elimination of Lansoprazol is prolonged in people with severe liver disease, but does not change in people with severe renal failure. Therefore, the dose should be reduced for people with severe liver disease.

Be cautious when using

Similarly to other anti -ulcer therapy, it is necessary to eliminate the possibility of malignant tumors in patients before gastric ulcer treatment with Lansoprazols because Lansoprazol can cover symptoms, thus making late diagnosis.

Lansoprazol should be carefully used in patients with average and severe liver dysfunction. Need to reduce the dose for people with liver disease.

Reducing gastrifers caused by Lansoprazol may be expected to increase the number of bacteria that are often present in the digestive tract. Treatment with Lansoprazols as well as other proton pump inhibitors (PPI) may increase the risk of gastrointestinal tract infections such as Salmonellast and Campylobacter infection.

In patients with stomach ulcers, it is recommended to consider the possibility of PyloRinh an pathogenic factor.

If used combined with Lansoprazol with antibiotics to treat H.pylori, should follow the instructions for using these antibiotics.

Due to the restriction of safety data for patients to maintain for more than 1 year, it is necessary to periodically consider the treatment and assessment of risk/benefits, which should be done regularly in these patients.

Very rare cases of colitis have been reported in patients using Lansoprazol. Therefore, in case of severe and/or persistent diarrhea, treatment should be discontinued.

diarrhea related to Clostridium difficile: Studies show that proton pump inhibitors such as Lansoprazol may increase the risk of diarrhea caused by Clostridium difficile, especially in hospitalized patients. This diagnosis should be considered if diarrhea does not improve.

Patients should take the lowest dose and the shortest PPI treatment time to suit the condition being treated.

Preventive treatment for stomach ulcers in patients who need to use NSAIDs should be limited to high -risk patients (for example, previously punctured or ulcerative or gastrointestinal bleeding, high age, use and drugs that increase the likelihood of side effects on gastrointestinal tract such as corticosteroids or anticoagulant drugs), the presence of a serious and high -dose factor.

The risk of fractures: Proton pump inhibitors, especially if high doses and a long time (> 1 year), can increase the risk of hip fractures, wrist or spine due to osteoporosis, mainly in the elderly or other risk factors. Observatory studies show that proton pump inhibitors may increase the risk of fractures by 10-40%. Some of these increasing causes may be due to other risk factors. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and they should use enough vitamin D and calcium. Serious reduction in blood magnesium has been reported in patients treated with proton pump inhibitors such as Lansoprazol for at least three months, and most cases of treatment in a year. The serious manifestation of a decrease in blood in the blood such as fatigue, muscle spasms, delirium, convulsions, dizziness and ventricular arrhythmia may occur, but these manifestations may begin to implicitly and be ignored. In most affected patients, the reduction of magnesium in the blood is improved after adding magnesi and ppi stops.

For patients expected to be treated for prolonged treatment or using ppi with digoxin or drugs that can cause hematuria (such as diuretics), doctors should consider measuring magnesium levels before starting treatment with PPI and periodically during treatment.

Semi -acute lupus lupus (SCLE): Proton pump inhibitors are related to some cases of semi -acute lupus erythematosus rarely occur.If the lesions occur, especially in the skin exposed to the sun, and if accompanied by joint pain, patients need to quickly contact the doctor to consider stopping the use of Lansoprazols. People with semi -acute lupus lupus after treatment with proton pump inhibitors may increase the risk of semi -acute lupus erythematosus when treated with other proton pump inhibitors.

Acute interstitial nephritis: Acute interstitial nephritis has been observed in patients using PPI including Lansoprazol. Acute interstitial nephritis can occur at any time during PPI treatment and often due to hypersensitivity reactions. Stop using Lansoprazol if acute interstitial nephritis develops.

Reducing vitamin B12 absorption: Daily treatment with any acid -reducing drugs for a long time (several years) can lead to reducing cyanocobalamin absorption (vitamin B12) due to reduction or deficiency of chlorydric acid in gastric juice. Lack of cyanocobalamin should be considered in patients with Zollinger - Elison syndrome and other hyperactive conditions that need long -term treatment. This should be considered in patients with reduced reserves in the body or with risk factors for reduced absorption of vitamin B12 (such as elderly people) when long -term treatment.

Interventions in tests: Increasing chromogranin A (CGA) level can hinder the monitoring of nerve - endocrine tumors. To avoid this intervention, Lansoprazol treatment should be stopped at least 5 days before CGA measurement. If CGA and Gastrin concentrations do not return to the initial reference level, it is advisable to measure after 14 days of stopping the treatment of proton pump inhibitors.

Be cautious when used in pregnant and nursing mothers.

The effect of the drug on the ability to drive and operate machinery

Caution when taking the drug for the driver or operating machinery because the drug can cause headaches, dizziness.

Use drugs for women during pregnancy and lactation

Pregnancy:

There is no notice of using Lansoprazols for pregnant women. It is unknown whether the drug passes through the fetus into the fetus. Therefore, avoiding for pregnant women, at least in the first 3 months, but it is best not to be used in any stage during pregnancy.

breastfeeding period:

Both Lansoprazols and metabolites are excreted in the mouse milk in the mouse and may excrete through the mother's milk. Because the cancer effect of the drug on animals has been proven, should be avoided in nursing mothers.

Drug interaction

The effect of Lansoprazol on other drugs:

Popular absorption drugs

Lansoprazol can hinder the absorption of other drugs, where the stomach pH is an important factor that determines the bioavailability of oral drugs.

HIV Protease inhibitors:

Do not use combination of Lansoprazols with HIV protease inhibitors, but the absorption depends on the pH in an acidic environment, such as Atazanavir and Nelfinavir, due to significant reduction in bioavailability.

A study showed that it was used to combine Lansoprazol (60 mg x 1 time/day) with Atazanavir 400 mg in healthy volunteers that significantly reduced the exposure of Atazanavir (down about 90% AUC and CMAX).

ketoconazole and itraconazole:

The absorption of ketoconazole and iTraconazole from the gastrointestinal tract is enhanced by the presence of stomach acid. The use of Lansoprazols can lead to the concentration of ketoconazole and iTraconazole below this treatment and combination level should be avoided.

digoxin:

Using combination of Lansoprazol and Digoxin can increase digoxin levels in plasma. Digoxin concentration should be checked in plasma and if necessary to adjust the dose of digoxin at the beginning and end treatment with Lansoprazol.

The drugs are metabolized by the P450 enzyme

Lansoprazol is metabolized by the Cytochrom P450 enzyme system, so interact with other drugs metabolized by the same enzyme system. Therefore, the Lansoprazol should not be used with other drugs that are also metabolized by Cytochrom P450.

warfarin:

There have been reports on Inr and prothrombin time in patients using simultaneous PPIS and Warfarin. Inrendet and prothrombin time can lead to abnormal bleeding and even death. Patients with simultaneous treatment of Lansoprazol and warfarin may need to be monitored on Inr increase and prothrombin time.

Theophylin:

Lansoprazol reduces theophylin concentration in plasma, patients should be monitored if used simultaneously Lansoprazol with theophylin.

tacrolimus:

Used in combination with Lansoprazols increases the concentration of Tacrolimus in plasma (is a CYP3A and p - GP). Lansoprazol increases the average level of Tacrolimus exposure to 81%. Need to monitor the concentration of tacrolimus in plasma when starting and ending treatment with Lansoprazol.

The drugs transported by P-Glycoprotein

Lansoprazol has been observed in inhibition of transport protein, p - glycoprotein (P-GP) in vitro. Clinical relevance of this inhibitor is not known.

The effect of other drugs on Lansoprazol:

CYP2C19 inhibitors

Fluvoxamin:

Dose reduction can be considered when combining Lansoprazol with fluvoxamine is CYP2C19 inhibitor. One study showed that Lansoprazol concentration in plasma increased 4 times.

Touch drugs/substances CYP2C19 and CYP3A4

Touch enzyme affects CYP2C19 and CYP3A4 such as rifampicin, and St John (Hypericum Perforatum) may significantly reduce the concentration of Lansoprazol in plasma.

Other interactions

methotrexate:

Using Lansoprazol simultaneously with high doses of methotrexate may increase and prolong the concentration of methotrexate and/or its metabolic substance in serum, which can lead to toxicity of methotrexate.

Sucralfate /antacids:

Sucralfate/antacids can reduce the bioavailability of Lansoprazol. Sucralfate slowed down and reduced the absorption of Lansoprazol (about 30%). Therefore, Lansoprazols should be used for at least 1 hour after using these products.

Steroid anti -inflammatory products:

There is no significant clinical interaction of Lansoprazol with non -steroid anti -inflammatory drugs that have been proven, although there is no official interactive studies have been conducted.

The cavalry of the drug:

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.