- 1 Important to know about Ogast ?
- 2 Ogast Dosage
- 3 How it works Ogast
- 4 Ogast Side Effects
- 5 Ogast Interactions
- 6 Ogast Warnings and Precautions
- 7 Drive and use machines
- 8 Ogast and PREGNANCY / BREAST FEEDING / FERTILITY:
- 9 What should I do if I miss a dose?
- 10 What happens if I overdose from Ogast ?
- 11 What is Forms and Composition Ogast?
Important to know about Ogast ?
Your doctor may prescribe Ogast for the following indications:
- Treatment of duodenal ulcer and gastric ulcer.
- Treatment of inflammation of the esophagus (reflux esophagitis).
- Prevention of reflux oesophagitis.
- Treatment of heartburn and acid regurgitation.
- Treatment of infections caused by Helicobacter pylori bacteria when prescribed in combination with antibiotic therapy
- Treatment or prevention of duodenal ulcer or gastric ulcer in patients requiring continuous NSAID treatment (NSAID therapy is prescribed for pain or inflammation).
- Treatment of Zollinger-Ellison syndrome
Your doctor may have prescribed Ogast for a different indication or at a different dose than indicated in this leaflet. Follow your doctor’s instructions for taking your medicine.
Swallow the capsule with a glass of water. If you find that the capsules are hard to swallow, your doctor may advise you on other ways to take the medicine. Do not crush or crush the capsules or their contents as this will alter their properties.
- If you take OGAST once a day, try taking it at the same time each day. You can get better results if you take OGAST as soon as you get up in the morning.
- If you take OGAST twice a day, take the first dose in the morning and the second dose in the evening.
The dosage of OGAST depends on your condition. The usual OGAST dosages for adults are shown below. Your doctor may sometimes prescribe a different dosage and will tell you the duration of the treatment.
- Treatment of heartburn and acid regurgitation: one capsule of 15 mg or 30 mg daily for 4 weeks. If symptoms persist, talk to your doctor. If your symptoms are not alleviated within 4 weeks, contact your doctor.
- Treatment of duodenal ulcer: one 30 mg capsule each day for 2 weeks.
- Treatment of gastric ulcer: one 30 mg capsule each day for 4 weeks.
- Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule each day for 4 weeks.
- Long-term prevention of reflux esophagitis: one 15 mg capsule daily; Your doctor may adjust the dosage to one 30 mg capsule daily.
- Treatment of Helicobacter pylori infection : The usual dosage is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. The treatment is to be taken every day generally for 7 days.
The recommended antibiotic combinations are:
- OGAST 30 mg with clarithromycin 250-500 mg and amoxicillin 1000 mg.
- OGAST 30 mg with clarithromycin 250 mg and metronidazole 400-500 mg.
If you are being treated for an ulcer infection, it is unlikely that it will reappear if the infection is treated successfully. For your medicine to work as well as possible, stick to the set times and do not miss a shot.
Treatment of duodenal ulcer or gastric ulcer in patients requiring treatment with NSAIDs (non-steroidal anti-inflammatory drugs) continuously: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal ulcer or gastric ulcer in patients requiring NSAID treatment (non-steroidal anti-inflammatory drugs) continuously: one 15 mg capsule daily; Your doctor may adjust the dosage to one 30 mg capsule daily.
Zollinger-Ellison Syndrome: The recommended starting dose is two 30 mg capsules per day to begin with, and depending on your response to OGAST, your doctor may decide to adjust the dose.
USE IN CHILDREN:
- OGAST should not be given in children.
- Always take the dose recommended by your doctor. If uncertain, consult your doctor.
How it works Ogast
Pharmacotherapeutic group: INHIBITORS OF THE PROTON PUMP ,
ATC Code: A02BC03 .
Lansoprazole is an inhibitor of the gastric proton pump. It makes it possible to inhibit the last stage of formation of gastric acid by inhibiting the activity of the H + / K + ATPase proton pump at the parietal cells of the stomach. Inhibition is reversible and dose-dependent. Its effects are exerted at the same time on the secretions of basal and stimulated gastric acid. Lansoprazole concentrates in parietal cells and becomes active in their acid environment and reacts with the sulfohydric group of the H + / K + ATPase proton pump resulting in inhibition of enzyme activity.
Effect on gastric acid secretion :
Lansoprazole is a specific proton pump inhibitor of parietal cells. A single oral dose of lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by approximately 80%. After repeated daily administration for a period of seven days, approximately 90% of the gastric secretion is inhibited. It has a similar effect on basal gastric acid secretion. Single oral administration of 30 mg reduces basal secretion by approximately 70%; patients’ symptoms are thus improved at the first dose. After 8 days of repeated administration, the reduction is approximately 85%. Rapid symptomatic relief is achieved with one capsule (30 mg) daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer or reflux esophagitis within 4 weeks. By reducing gastric acidity, lansoprazole creates an environment in which the appropriate antibiotics can be effective againstH. pylori .
Ogast Side Effects
Common side effects (may affect up to 1 in 10 people):
- · Headache, dizziness,
- · Diarrhea, constipation, stomach pain, nausea, vomiting, flatulence, dryness or mouth / throat pain,
- · Extensive skin rash, itching,
- · Disruption of liver function (liver),
- · Fatigue,
- · Benign polyps of the stomach.
Uncommon side effects (may affect up to 1 in 100 people):
- · Depression,
- · Muscle or joint pain,
- · Fluid retention or dime,
- · Changes in the blood count
Rare side effects (may affect up to 1 in 1000 people):
- · Fever,
- · Agitation, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo,
- · Taste alteration, loss of appetite, inflammation of the tongue (glossitis),
- · Skin reactions, such as burning or tingling, hematoma, redness and sweating,
- · Photosensitivity,
- · Hair loss,
- · Tingling (paresthesia), tremors,
- · Anemia (pallor),
- · Kidney problems,
- · Pancreatitis,
- · Hepatitis (which may be manifested by a yellowing of the skin or eyes),
- · Swelling of breasts in men, impotence,
- · Candidiasis (infection of the skin or mucous membranes due to fungi),
- · Angioedema; contact your doctor immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty swallowing, hives, or difficulty breathing.
Very rare side effects (may affect up to 1 in 10,000 people):
- · Severe hypersensitivity including shock. Symptoms of hypersensitivity may include fever, extensive rash, dementia, and sometimes a drop in blood pressure.
- · Inflammation of the mouth (stomatitis),
- · Colitis (intestinal inflammation),
- · Changes in the levels of sodium, cholesterol and triglycerides in the blood,
- · Very severe skin reactions with redness, bullous appearance, severe inflammation and desquamation,
- · Very rarely OGAST can cause a decrease in the number of white blood cells that can alter the resistance to infections. If an infection appears with symptoms such as fever and severe deterioration of your condition, or fever with symptoms of local infection, such as sore throat / pharynx / mouth or urinary problems, consult your doctor immediately. A blood test will be performed to monitor a possible decrease in white blood cells (agranulocytosis).
· If you take OGAST for more than 3 months, it is possible that the level of magnesium in your blood will decrease. Low levels of magnesium can lead to fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you experience any of these symptoms, please inform your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may decide to have regular blood tests to monitor your magnesium levels.
· Rash, possibly with joint pain.
Effects of lansoprazole on other medicines
Drugs with pH-dependent absorption
Lansoprazole may interfere with the absorption of other drugs, for which gastric pH is a determining factor in their oral bioavailability.
HIV Protease Inhibitors:
- Concomitant administration of lansoprazole and HIV protease inhibitors, for which absorption is pH-dependent (atazanavir, nelfinavir), is not recommended as this may significantly reduce their bioavailability (see section 5.2). caution and precautions for use ).
Ketoconazole and itraconazole:
- The absorption of ketoconazole and itraconazole in the gastrointestinal tract is increased in the presence of gastric acid. Administration of lansoprazole may induce concentrations below the therapeutic threshold of ketoconazole and itraconazole and the combination should be avoided.
- The combination of lansoprazole and digoxin may result in increased plasma concentration of digoxin. Plasma digoxin concentrations should therefore be monitored and the dose of digoxin adjusted if necessary at the beginning and end of lansoprazole treatment.
- Concomitant use of high doses of methotrexate may increase and prolong blood levels of methotrexate and / or its metabolites that may lead to methotrexate toxicity. Therefore, in situations where high doses of methotrexate are used, temporary discontinuation of lansoprazole should be considered.
- The combination of 60 mg lansoprazole and warfarin did not affect the pharmacokinetics of warfarin or INR. However, some cases of increased INR and prothrombin time have been reported with concomitant administration of warfarin and PPI. An increase in INR and prothrombin time can cause bleeding, potentially fatal. Therefore, in patients treated concurrently with lansoprazole and warfarin, monitoring of INR and prothrombin time is recommended, particularly at the start and end of concomitant therapy.
Drugs metabolized by cytochrome P450 enzymes
- Lansoprazole may increase the plasma concentrations of drugs metabolized by CYP3A4. Caution is advised when lansoprazole is combined with drugs that are metabolized by this enzyme and have a low therapeutic margin.
- Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect. The patient should be monitored with concomitant administration of lansoprazole and theophylline.
- Concomitant administration of lansoprazole increases plasma concentrations of tacrolimus (a substrate of CYP3A and P-gp). Taking lansoprazole increases the average rate of tacrolimus up to 81%. Monitoring plasma concentrations of tacrolimus is recommended at the beginning or end of lansoprazole therapy.
Drug transported by P-glycoprotein
- Inhibition of P-glycoprotein (P-gp) by lansoprazole was observed in vitro . Clinical relevance is unknown.
- Effects of other drugs on lansoprazole
Drugs inhibiting CYP2C19
- A dose reduction may be considered when lansoprazole is combined with fluvoxamine, a CYP2C19 inhibitor. Plasma concentrations of lansoprazole are increased up to 4 times normal.
Drugs inducing CYP2C19 and CYP3A4
- Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St. John’s wort ( Hypericum perforatum) can significantly reduce plasma concentrations of lansoprazole.
- Sucralfate / Anti-acids:
- Sucralfate and antacids may decrease the bioavailability of lansoprazole. Therefore, lansoprazole should be taken at least 1 hour after taking these medications.
- No clinically significant interactions between lansoprazole and nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interaction studies have been performed.
Ogast Warnings and Precautions
As with all other anti-ulcer treatments, the possibility of malignant gastric tumor should be ruled out when treating gastric ulcer with lansoprazole because it may mask the symptoms and delay the diagnosis.
Cases of severe hypomagnesemia have been reported in patients treated with proton pump inhibitors (PPIs) such as lansoprazole for at least three months and in most cases for one year. Hypomagnesaemia may be manifested by severe clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it may start insidiously and go unnoticed.In most patients, hypomagnesemia is improved after magnesium supplementation and stopping the PPI.
In patients requiring prolonged treatment or in combination of PPIs with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before start treatment with IPP and then regularly during treatment.
Lansoprazole should be used with caution in patients with severe or moderate hepatic impairment (see sections Dosage and Administration and Pharmacokinetics ).
A decrease in gastric acidity due to lansoprazole may increase the levels of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slight increase in the risk of gastrointestinal infections, particularly due to Salmonella and Campylobacter.
In patients with peptic ulcer disease, the possibility of H. pylori infection as an etiological factor should be considered.
If lansoprazole is used in combination with antibiotics for the treatment of eradication of H. pylori , then the conditions of use of these antibiotics should also be followed.
Due to limited safety data for patients on maintenance treatment for more than one year, regular monitoring of the treatment and a thorough benefit-risk assessment should be performed regularly in these patients.
Very rare cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and / or persistent diarrhea, discontinuation of treatment should be considered.
Treatment for the prevention of peptic ulceration in patients requiring continuous NSAID treatment should be limited to high-risk patients (eg, history of gastrointestinal bleeding, perforation or ulcer, advanced age, drug combination known to increase probability occurrence of adverse events of the upper gastrointestinal tract [example: corticosteroids or anticoagulants], presence of a serious factor of co-morbidity or prolonged use of NSAIDs at the maximum recommended doses).
Proton pump inhibitors, particularly if used in high doses over a prolonged period (> 1 year), may moderately increase the risk of fracture of the hip, wrist and vertebrae, mainly in patients aged or in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%. This increase may be due in part to other risk factors. Patients at risk for osteoporosis should be managed according to the recommendations in force, and receive appropriate vitamin D and calcium intake.
Due to the presence of sucrose, this drug is contraindicated in cases of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary metabolic diseases).
Drive and use machines
Adverse reactions such as dizziness, vertigo, visual disturbances and drowsiness may occur. Under these conditions, the ability to react can be decreased.
Ogast and PREGNANCY / BREAST FEEDING / FERTILITY:
- There are no data on the use of lansoprazole in pregnant women. Studies in animals have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, childbirth or postnatal development.
- Therefore, the use of lansoprazole is not recommended during pregnancy.
- It is not known if lansoprazole is excreted in breast milk. Studies in animals have shown the excretion of lansoprazole in milk.
- A decision should be made either to continue / interrupt breastfeeding or to continue / discontinue lansoprazole treatment, taking into account the benefit of breastfeeding for the benefit of treatment for the woman.
- No data on the effect of lansoprazole on human fertility is available. Lansoprazole did not affect fertility in male and female rats.
What should I do if I miss a dose?
- If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. If this is the case, do not take the missed dose, and normally take the other capsules. Do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from Ogast ?
The effects of lansoprazole overdosage in humans are not known (although the acute toxicity is likely to be low), and therefore no treatment behavior can be specified. However, daily doses up to 180 mg lansoprazole orally and up to 90 mg lansoprazole intravenously have been administered in clinical trials without significant adverse effects.
Please refer to the section Adverse Reactions for possible symptoms of lansoprazole overdosage.
In the case of a suspected overdose, the patient should be monitored. Lansoprazole is not significantly removed by hemodialysis. If necessary, gastric lavage, charcoal use and symptomatic treatment are recommended.
What is Forms and Composition Ogast?
- Each capsule contains 30 mg lansoprazole.
- Excipients with known effect: Each capsule contains 59.8 mg of sucrose.
- For the full list of excipients, see section 6.1.
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