LOMAC -20 CIPLA Treatment of stomach ulcers - duodenum, esophageal reflux (10 blisters x 10 tablets)
Dosage form Box of 10 blisters x 10 tablets
Specifications Omeprazol
Ingredient
| Composition information | Content |
| Omeprazol | 20mg |
Uses
Indications
omeprazol are indicated in the treatment of cases:
Adults
Children over 1 year old and ≥ 10kg:
Pharmacokology
Omeprazol belongs to the Benzimidazol subdivision capable of inhibiting the acid excretion of the stomach through specific effects on the enzyme system H+/K+ ATPAS The drug has the effect of preventing the final stage of gastric acid secretion. This inhibition depends on the effective doses on both basic acid secretion and acid secretion due to stimulating stimuli. Animal studies show that after not being found in plasma more than a day later, omeprazol may be found again in the gastroentric mucus.
Besides, omeprazol can restrain Helicobacter pylori in patients with duodenal ulcer and/or reflux esophagitis infected with this bacteria. Combining omeprazol with some antibacterial drugs such as clarithromycin, amoxicillin can eradicate H.pylori and heal ulcers, long -term remission.
Acid secretion activity:
After taken, the acid secretion effect of omeprazol begins to achieve within 1 hour, and the maximum effect is about 2 hours. Acid secretion reaches about 50% for 24 hours and lasts up to 72 hours. The anti -secretion effect is much longer than half a life eliminated in a very short plasma (less than 1 hour), which is probably due to the combination with the impact on the enzyme system H+/K+K+ATPASE in the gastric cell wall. Omeprazol's acid secretion effect increases in doses when used once a day, reaching maximum after taking 4 days after taking the drug. For some patients, the single dose of omeprazol oral daily from 10mg to 40mg can create 100% acid secret inhibition in the stomach for 24 hours.
affect serum gastrin concentration:
In the study related to over 200 patients, serum gastrin concentration increased simultaneously with acid secretion inhibition in week 1 to test week 2 when using omeprazol doses once a day. The serum gastrin concentration does not increase when continuing to treat. Compared to H2 receptor antagonists, the average increase when using Omeprazol dose of 20mg is higher (up 1.3 - 3.6 times compared to 1.1 - 1.8 times). Gastrin concentration can return to the level as before treatment within 1 to 2 weeks after stopping the drug.
Affects chrome -like cells in the intestine (Enerochromaffin - Like Cell, ECL):
Research on the person's gastric biopsy samples taken from over 3,000 patients treated with Omeprazol in prolonged clinical trial shows that the rate of ELC cell hyperplasia increases over time. However, there is no ECL cancer cell lymph nodes, dysplasia or tumors in these patients, and does not have enough data to eliminate the effects of omeprazol on the progression of any type of malignant cancer when taking long -term drugs.
Other effects:
So far, Omeprazole has not been seen affecting the nervous system, cardiovascular and respiratory system. Omeprazol in doses of 30 or 40mg for 2 to 4 weeks, does not affect thyroid function, carbohydrate metabolism or concentration of parathyroid hormones, cortisol, estradiol, testosteron, prolactin, cholecystokinin or secretin in the body. In healthy people, the single dose of omeprazol intravenously (0.35mg/kg) does not affect the secretion of intrinsic factors. The dose does not affect the stimulating or natural Pepsin output.
pharmacokinetics
omeprazol is quickly absorbed with the plasma peak concentration of omeprazol achieved within 0.5 to 3.5 hours. The plasma peak concentration of omeprazol and AUC is proportional to the dose in the dose of up to 40mg. Absolute bioavailability (compared to intravenously) is approximately 30-40% with a dose of 20 - 40mg, because most of the drug is metabolized before going into the bloodstream. Food (does not affect the absorption of the drug after the single dose.
The distribution of healthy people is about 0.3L/kg.
After absorption, omeprazol is almost completely metabolized and mainly in the liver thanks to the cytochrom P450 enzyme system (CYP), especially isenzyme CYP2C19 to become hydroxyl omeprazol, and a small part transformed through CYP3A4 to form Omeprazol Sulfon. Two identified metabolites are hydroxyomeprazol and carboxylic acid respectively. These metabolites have very little or no anti -stomach secretion activity, excreted in the urine and partially in the feces.
The drug is linked to plasma proteins about 95%. The majority of oral dose (about 77%) is eliminated in urine in the form of metabolites, the rest is eliminated in the stool, in healthy objects, the sale time of the drug is about 30 minutes to 1 hour.
Before taking LOMAC -20 CIPLA Treatment of stomach ulcers - duodenum, esophageal reflux (10 blisters x 10 tablets)
How to use
Should take Lomac before meals in the morning, take intact pills with water, do not chew or crush the pill before swallowing.
Dosage
Adults
Treatment of duodenal ulcer:
recommended dose for patients with duodenal ulcer is 20mg at a time daily. Most patients recovered within two weeks. In cases where it is not possible to heal completely after the first treatment, it can be cured when the treatment lasts for about two more weeks. For patients with duodenal ulcer, the recommended dose is 40mg at a time, recovering after about 4 weeks of treatment.
Recurrent duodenal ulcerative room:
In order to prevent the recurrence of duodenal ulcers for negative patients with H. pylori or when it is impossible to eradicate H. pylori, the recommended dose is 20mg, once a day. In some cases, the daily dose of 10mg may be effective. In case of failure, the dose can be increased to 40mg.
Treatment of stomach ulcers:
The recommended dose is 20mg once a day. Most patients recovered within 4 weeks. In cases where it is not possible to heal completely after the first treatment, it is possible to recover from the next 4 weeks of treatment. For patients with poor response, the recommended dose is 40mg once a day, and often recovered after about 8 weeks of treatment.
Rooming stomach ulcer for patients with poor response, recommended dose is 20mg, once a day. Can increase the dose to 40mg, once a day if needed.
Destroy H. pylori in patients with gastrointestinal ulcer:
To eradicate H. pylori, it is necessary to choose the appropriate antibiotic, consider the tolerance of each patient, according to the treatment instructions and the drug resistance of the region and the country. Some combined regimens recommend:
Omeprazol 20mg + Clarithromycin 500mg + Amoxicillin 1000mg, 2 times daily for 1 week, or omeprazol 20mg + Clarithromycin 250mg (or 500mg) + Metronidazol 400mg (or 500mg or Tinidazol 500mg), 2 times a day for 1 week, or omeprazole 40mg 1 times a day 500mg and Metronidazol 400mg (or 500mg or Tinidazol 500mg), both types used 3 times/day for 1 week.
Each regimen, if the patient is still positive for H. Pylori after the drug, can be treated again.
Treatment of duodenal and stomach ulcers related to the use of NSAID:
recommended dose is 20mg, once a day. Most patients heal for four weeks. In the case of not being completely healed after the first treatment, the disease usually recovers after another four weeks of treatment.
Prevention of gastric and duodenal ulcers related to NSAIDs for patients at risk (> 60 years old, a history of stomach ulcer, duodenum, history of gastrointestinal bleeding):
recommended dose is 20mg, once a day.
Treatment of reflux esophagitis:
recommended dose is 20mg, once a day. Most patients heal for four weeks. In the case of not being completely healed after the first treatment, the disease usually recovers after another four weeks of treatment. For patients with severe esophagitis, the dose can be up to 40mg, and often heal after 8 weeks of treatment.
Long -term control for patients with reflux esophagitis:
recommended dose is 10mg, once a day. If necessary, the dose can be increased to 20 - 40mg once a day.
Treatment of gastroesophageal reflux symptoms:
recommended dose is 20mg daily. The patient may respond to a dose of 10mg daily, so the dose can be adjusted to each case. If the symptoms cannot be controlled after four weeks of treatment at a dose of 20mg per day, it is necessary to check and consider further.
Treatment of Zollinger syndrome - Ellison:
Need to adjust the dose and duration of treatment for each case according to clinical state. The recommended starting dose is 60mg per day. All patients with serious illness and insufficient response to other therapies have been effectively controlled and over 90% of patients take the maintenance dose of 20 - 120mg daily. When the dose exceeds 80mg per day, divide the oral dose 2 times daily.
Children
Over 1 year and ≥ 10kg:
Treatment of reflux esophagitis and treatment of heartburn and acid reflux in gastroesophageal reflux disease.
recommended dose is as follows:
≥ 1 year old Treatment time: reflux esophagitis: 4 - 8 weeks. Treatment of heartburn and acid reflux in gastric esophageal reflux disease: 2 - 4 weeks; If the symptoms are not controlled after 2-4 weeks of treatment, it is necessary to examine and consider further. Children and teenagers over 4 years old: Treatment of duodenal ulcer caused by H. pylori: When choosing a combination of drug combination regimen, it is necessary to consider more national standard treatment instructions, due to drug resistance. The treatment time is usually 7 days but sometimes up to 14 days, using appropriate antibiotics. Recommended dose: kidney failure There is no need to adjust the dose for people with impaired renal function. Omeprazol's kinetic pharmacokinetics in patients with impaired renal function. liver failure 10 - 20mg daily dose may be appropriate. Omeprazol metabolism in patients with impaired liver function, increasing AUC. Omeprazol does not tend to accumulate at a daily dose. dose for the elderly Omeprazol's metabolic speed is somewhat reduced in the elderly (75 - 79 years old). However, there is no need to adjust the dose for the elderly. Asian groups Consider reducing the dose if needed, especially in the treatment of esophageal inflammation. The manifestations may change, but often encountered, dreamy, blurred, tachycardia, nausea, vomiting, sweating, blushing face, headache, dry mouth, and other reactions similar to the side effects seen in normal treatment. There is no specific antidote when overdosing Omeprazol. Omeprazol is attached to plasma proteins so it is impossible to use hematoma to increase the elimination of the drug. If overdose, mainly treat million. What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed. What to do when overdose? The notice of Omeprazol overdose in humans when using the dose is very high up to 2400mg (120 times the usual dose recommended in clinical).
Side Effects
Omeprazol is well tolerated and unwanted effects are relatively less common, light and recovered.
Common (≥ 1/100):
Warnings
Contraindicated
contraindicated use of Lomac - 20mg in case of hypersensitivity to omeprazol, benzimidazol derivatives or any ingredients of the drug.
Not used simultaneously with nelfinavir.
Be cautious when taking drugs
Before using omeprazol for people with stomach ulcers, ensuring the possibility of malignant tumor, because the drug can cover symptoms, limit and slow diagnosis.
Omeprazol can interfere with studies that diagnose endocrine nerve tumors due to increased chromographin - A (CGA) levels, so it is recommended to suspend Omeprazol for at least 5 days before measuring CGA levels.
As with all long -term medication treatments, especially when the treatment time is over 1 year, patients need to be monitored regularly. Using proton pump inhibitors can increase the risk of gastrointestinal infections such as Salmonella and Campylobacter due to somewhat changing environmental pH.
Like acid secretion inhibitors, omeprazol can reduce the absorption of vitamin B12 due to reduced or deficient gastric acid. This should be considered in patients with reduced body reserves or have risk factors that reduce vitamin B12 absorption when long -term treatment.
There has been a serious reduction of blood magnesium in patients treated with proton pump inhibitors such as Omeprazol (> 3 months, most cases of 1 year). The serious manifestation of hypoglycemia such as fatigue, muscle spasms, delirium, convulsions, dizziness and ventricular arrhythmia may occur but often potential (not clearly shown) and easily ignored. In most severe cases, symptoms are improved after supplementing Magnesi and stopping proton inhibitors, which should be monitored for magnesium concentration for prolonged or simultaneous treatment patients with omeprazol with digoxin before starting and periodically during treatment.
Use proton pump inhibitors, especially when taking high doses and for a long time (> 1 year), it may increase (10 - 40%) of the risk of fracture (spine, hip, wrist), especially in the elderly or people who are available to other risk factors. Other risks such as osteoporosis should be taken care of according to clinical instructions, adequate vitamin D and calcium.
The drug contains sucrose, patients with rare genetic problems are free -intolerant, Glucose - Galactose or SUCRASE - Isomaltase should not be used. Proton pump inhibitors are involved in cases of subacute lupus lupus (subacute cutaneous lupus erythematosus (SCLE), although rare.
If the damage occurs, especially in skin areas exposed to light, accompanied by joint pain, patients need to be examined promptly and health care, and should stop using omeprazol. If you have been scratched after the first treatment with proton pump inhibitors, there is a risk of SCLE when taking other proton pump inhibitors.
Be cautious when using drugs that can interact with omeprazol (see the drug interaction).
The ability to drive and operate machinery
The drug does not affect the ability to drive or operate the machine. However, unwanted effects such as dizziness, vision disorders may occur. If these unwanted effects occur, avoid driving or operating machinery.
Pregnancy and lactation
Pregnancy
Research on the influence of omeprazol on animal reproduction and studies in pregnant women using omeprazol in the first 3 months of no increased risk of congenital abnormalities or causing intentional adverse reactions in pregnant women. There are no adequate control studies on the use of omeprazol for pregnant women. Because reproductive studies in animals are not always a forecast for humans, so it should only be used during pregnancy if really necessary.
Breastfeeding period
Because omeprazol can produce breast milk and are likely to cause serious side effects for children being breastfed. It is necessary to consider the importance of the drug for the mother to decide whether to stop breastfeeding or should stop taking this medication. Constantly taking the drug without a doctor's opinion.
Other special subjects
Elderly groups
Omeprazole's excretion rate is somewhat decreased in the elderly, so bioavailability increases, reaching about 76% (the elderly) compared to 58% (young) when taking the single dose of 40mg of omeprazol. Nearly % of the dose is found in urine in the form of metabolites. Omeprazol's plasma removal in the elderly about 250ml/minute (about half of the value in young volunteers), the sale time of plasma is 1 hour, nearly twice as higher than the young healthy volunteer.
Children
Omeprazol's dynamic pharmacokinetics have also been studied in children and shows that 5 -year -old children) have an AUC of Omeprazol lower in older children (6-16 years old) and adults.Hepatic failure
In patients with chronic liver failure, bioavailability increases to approximately 100% compared to intravenous dose, showing the initial metabolic effect through the liver decreases, and the sale time of plasma discharge of the drug decreases nearly 3 hours compared to the selling time of emissions in normal people is 0.5 - 1 hour. The average plasma clearance is 70ml/min, compared to the value of normal people is 500 - 600ml/min. Therefore, it is necessary to consider reducing the dose, especially when indicated for the maintenance of esophagitis due to reflux for patients with liver failure.
kidney failure
In patients with chronic renal impairment, creatinine clearance between 10 - 62ml/minute/1.73m2, the distribution of omeprazol is similar to that of a healthy volunteer despite being used slightly. Because the metabolites of omeprazole are excreted mainly through the urinary tract, the elimination of these metabolites decreases corresponding to the decrease in creatinine. No need to reduce the dose of omeprazol for patients with renal failure.
Asian groups
In pharmacokinetic studies using single doses of 20mg omeprazol, it is found that AUC in Asians increases about 4 times compared to the group of white people. It is necessary to consider reducing the dose, especially when indicated for maintenance of esophagitis due to reflux for Asian patients.
Medicinal interaction
Humiliated drugs are affected by gastric pH: Because the inhibition of prolonged gastric acid secretion, omeprazol theoretically affects the bioavailability of drugs, depends on pH (such as ketoconazol, ampicillin and iron salts).
Metabolized drugs by Cytochrome P450 (CYP): Omeprazol is a CYP2C19 inhibitor, so it may occur interactive with metabolic drugs through CYP2C19. There was an interaction between clopidogrel and omeprazol, but it was unclear clinically related. Disecoded to simultaneously use Omeprazol and Clopidogrel.
Omeprazol may inhibit the metabolism (extending the elimination time) of the drugs metabolized in the liver such as diazepam, phenytoin and warfarin. The International Normalized Ratio) has not been notified to increase the results of blood clotting test results and prothrombin time in patients who are taking proton pump inhibitors, including omeprazol at the same time as warfarin. Inrombin increase and prothrombin time can lead to bleeding even death. Patients treated with proton and warfarin inhibitors should be monitored on Inr and Prothrombin.
Although in normal objects, there is no interaction with theophylin or propranolol, there has been clinical notice of interaction with other drugs transformed through the enzyme system in Cytochrom P450 (such as cyclosporin, disulfiram, benzodiazepine). It is necessary to monitor patients to determine whether or not to adjust the dose of these drugs when used simultaneously with Lomac - 20mg.
Concomitance use of omeprazol with voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) can lead to omeprazol exposure more than 2 times. Normally, there is no need to adjust the dose of omeprazol, however, in patients with Zollinger - Ellison syndrome, it is necessary to consider adjusting the dose when the dose is higher than 240mg/day.
Nelfinavir: exposure to Nelfinavir in plasma is reduced by 40% (Nelfinavir concentration) and 75 - 90% (metabolites work) when used simultaneously with omeprazol (dose of 40mg once a day). Convincidation to simultaneously use omeprazol with nelfinavir. This interaction may be related to CYP2C19 inhibition.
Atazanavir: It is not recommended to simultaneously use Atazanavir with proton pump inhibitors. The simultaneous use of Atazanavir with proton pump inhibitors can significantly reduce Atazanavir levels in plasma and therefore can reduce the treatment effect.
tacrolimus: simultaneous use of omeprazol and tacrolimus may increase the concentration of tacrolimus in serum.
Storage
You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer.
You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.
Keep pills out of reach of children and pets.
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