Omicap-20 microphones treat duodenal and stomach ulcer, Zollinger-Ellison syndrome, 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

Omicap - 20 indicators in cases of duodenal and stomach ulcers, Zollinger syndrome - Ellison, esophagus reflux.

Pharmacokology

omeprazol inhibits the excretion of the acidic stomach due to inhibiting the restoration of hydrogen enzyme system - potassium adenosin triphosphatase (also called proton pump) in the border cells of the stomach. Fast effect, prolonged but recovered. Omeprazol does not work on receptor (receptor) acetylcholine or histamine receptor. Maximum effect after taking 4 days.

pharmacokinetics

omeprazol is completely absorbed in the small intestine after drinking for 3 to 6 hours. Biology is about 60%. Food does not affect the absorption of drugs in the intestine.

Omeprazol absorption depends on oral dose. The drug can increase its own absorption and bioavailability due to acidic excretion. The drug is attached to plasma proteins (about 95%) and is distributed in tissues, especially in the border cells of the stomach. The biological use of the first dose is about 35%, but will increase to about 60% when taking the next day. Although half -life is short (about 40 minutes), but the effect of inhibiting acid excretion is prolonged, so it can be used only once a day.

Omeprazol is almost completely metabolized in the liver, quickly excreted, mainly through urine (80%), the rest according to feces. The metabolites are not active, but interact with many other drugs due to inhibiting the enzymes of the cytochrom P450 of liver cells.

The pharmacokinetics of the drug are not changed significantly in the elderly or the patient with renal function. In people with liver function, the bioavailability of the drug increases and the clearance of drugs decreases, but there is no accumulation of drugs and metabolites of the drug in the body.

Before taking Omicap-20 microphones treat duodenal and stomach ulcer, Zollinger-Ellison syndrome, esophageal reflux (10 blisters x 10 tablets)

How to use

Omicap - 20 oral drugs. When taking the medicine, it is not allowed to break the tablet (not chewed, crushed) but must swallow the tablet with water. The appropriate time to take the medication is far from the meal (before breakfast and before bedtime).

Dosage

recommended dose:

A duodenal ulcer - progressive stomach: Take 20mg once a day, drink for 4-8 weeks. Week.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? No specific antidote. Omeprazole is strongly attached to plasma proteins, so it is not easy to absorb. When an overdose is overdosed, it is necessary to treat and treat symptoms

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Omicap - 20 drugs often encounter unwanted effects (ADR) such as:

The most common side effect (1 - 10% of patients) is headache, abdominal pain, constipation, diarrhea, bloating and nausea/vomiting.

The following side effects are recorded from clinical studies and during the circulation of drugs on the market. These side effects are not related to the dose. The frequency is classified as follows: Very common (≥1/10), common (≥1/100 to Blood disorders and border systems:

Rare: leukopenia, thrombocytopenia.

Rare: Hypersensitivity reactions, for example: fever, angioedema and anaphylaxis/anaphylaxis.

Rare: Hemorrhage reduction.

Less: Insomnia.

Rare: anxiety, confusion, depression.

Common: headache

Rare: blurred vision.

Less: Dizziness.

Rare: Bronchospasm.

Common: abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting,

rare: dry mouth, gastritis, bowel fungus.

Uncommon: increased liver enzymes.

Uncommon: Dermatitis, itching, rash, urticaria.

Rare: Hair loss, light sensitivity.

Uncommon: hip, wrist or spine injury.

Rare: joint pain, muscle pain.

Rare: interstitial nephritis.

Very rare: female mammary glands.

General and local disorders:

Uncommon: annoying, peripheral edema.The safety of Omeprazole has been evaluated over 310 children ages 0 to 16 years for diseases related to gastric acid. Data on safety for a long time is relatively limited, obtained in 46 children treating Omeprazole in a clinical study for children with heavy esophagitis for 749 days. Unwanted data is generally like adults when treated short or long. No data has been reported on the influence of omeprazole on puberty and growth

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Omicap - 20 contraindications in the following cases:

Hypersensitivity to the ingredients of the drug.

Be cautious when using

when there is any warning sign (such as losing weight and unintended, vomiting many times, difficulty swallowing, vomiting blood or going out of black feces) and when suspected or with stomach ulcers, it is necessary to eliminate malignant tumors because the use of drugs can reduce symptoms and slow diagnosis.

Simultaneous use of Atazanavir with proton pump inhibitors is not recommended. If required to coordinate, clinical symptoms are required (for example, the number of viruses) when used in combination with increased atazanavir dose to 400 mg with 100 mg of ritonavir; Do not use omeprazole exceeding the dose of 20 mg.

Like other acid secretions, omeprazole can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced gastric acid. This should be considered when taking drugs for patients to reduce reserve or have risk factors leading to reduced absorption of vitamin B12 when long -term treatment.

omeprazole is an enzyme inhibitor CYP2C19. When starting or stopping using Omeprazole, the likelihood of interaction with drugs that are metabolized through CYP2C19 enzymes need to be considered. The drug interaction between Omeprazole and Clopidogrel has been reported. The clinical significance of this interaction is not well known. However, to ensure safety and effectiveness, it is not recommended to simultaneously use these two drugs.

Some children with chronic diseases may need dime drugs for a long time although this is not recommended.

Reduce blood magnesium concentration:

Serious decreased magnesium magnesium concentration has been reported in patients using proton pump inhibitors such as omeprazole for at least 3 months and for most cases is 1 year. The serious manifestations of reduced magnesium concentration in the blood include fatigue, delirium, tetany syndrome, convulsions, dizziness, ventricular arrhythmia may occur but these symptoms start slowly and are often overlooked. In patients most affected, reducing blood magnesium improved after replacing magnesium and stopping proton pump inhibitors.

For patients who need long -term use or patients who use proton pump inhibitors with digoxin or drugs that can reduce blood magnesium (such as diuretics), medical staff should consider the ability to determine the magnesium levels in the blood before using proton pump inhibitors and periodically during the use of the drug.

Proton pump inhibitors (PPI) especially if used in high doses and long -term (over 1 year) may increase the risk of hip, wrist and spinal bone damage, mainly in the elderly or people with risk factors. Studies for ppi drugs may increase the risk of general injury from 10 to 40%. In some cases, this increase may be due to other risk factors. Patients with the risk of osteoporosis need to be monitored and treated according to treatment instructions and need to use vitamin D and calcium in appropriate doses.

Omeprazole capsules contain sucrose. Patients with rare genetic problems about fructose intolerance, malventia- galactose or deficient enzyme sucrase-isomtase should not use this drug. Treatment with PPI may increase the risk of digestive infections such as Salmonella and Campylobacter.

Disrupt the test results

Increasing CGA levels can interfere with tests related to endocrine nerve tumors. To avoid this influence, it is necessary to temporarily stop using Dune Omeprazole within 5 days before the CGA test.

Lupus erythematosus

PPIs are related to a small number of semi -exponent lupus lupus. If there is damage, especially the skin -exposed skin areas, and if accompanied by joint pain, patients should consult a doctor and doctor may consider stopping the use of omeprazole. Lupus erythematosus after taking a PPI drug may increase the risk of lupus erythema when taking another PPI.

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

Because Omicap - 20 drugs can cause headaches, dizziness, so need to be cautious when driving and operating machinery after taking the drug.

Use drugs for women during pregnancy and lactation

only use omeprazole during pregnancy when the benefits for the mother will exceed the risk of pregnancy.

Women during breastfeeding need to stop breastfeeding if the mother must use omeprazole.

Drug interaction

The influence of omeprazole on the pharmacokinetics of other drugs

The drugs that the absorption depends on the gastric pH

A decrease in stomach acid during treatment with omeprazole may increase or reduce the absorption of drugs with pH absorption.

nelfinavir, Atazanavir:

Nelfinavir and Atazanavir concentrations in plasma decreases when used with omeprazole.

contraindicated coordination Omeprazole with nelfinavir. Omeprazole (40 mg x 1 time/day) reduces 40% of Nelfinavir concentration and the concentration of metabolic metabolites with an activity M8 decreased by 75-90%. This interaction may also be due to CYP2C19 inhibition.

It is not recommended to use omeprazole with Atazanavir. In healthy people volunteering, when using omeprazole (40 mg x 1 time/day) with Atazanavir 300 mg/ritonavir 100 mg, Atazanavir concentration drops 75%. Increasing the dose of Atazanavir to 400 mg does not compensate for the effects of omeprazole on Atazanavir. When using omeprazole (20 mg x 1 time/day) with Atazanavir 400 mg/ritonavir 100 mg in healthy people volunteering shows that Atazanavir concentration drops approximately 30% when compared to Atazanavir 300 mg/ritonavir 100 mg 1 time/day.

Digoxin: Use Omeprazole (20 mg/day) with Digoxin in healthy people volunteering to increase the bioavailability of digoxin to 10%. Rarely reports on Digoxin poisoning. However, caution should be used when using high -dose omeprazole in the elderly. Need to increase monitoring when treating with digoxin.

clopidogrel:

In a clinical study, patients use Clopidogrel (300 mg of starting dose, then 75 mg/day) alone and coordinated with omeprazole (80 mg of clopidogrel) for 5 days. The amount of metabolic products of Clopidogrel decreased by 46% (day 1) and 42% (day 5) when used in combination. The effect of inhibiting platelet aggregation decreases an average of 47% (24 hours) and 30% (day 5) when used in combination. In other research, the use of two drugs apart does not prevent interactions between these drugs and these interactions have the inhibitory effects of omeprazole on the enzyme CYP2C19.

Other drugs:

When used simultaneously with Omeprazole, the absorption of Posaconazole, Erlotinib, Ketoconazole and Itraconazole has been reduced sharply and therefore, clinical efficiency may decrease. Avoid combining omeprazole with Posaconazol and Erlotinib.

Metabolic drugs through CYP2C19

Omeprazole is a medium inhibitor CYP2C19, the main metabolic enzyme of omeprazole. Therefore, the metabolism of the metabolic drugs through CYP2C19 may decrease and increase the concentration of these substances when shared Omeprazole. Examples of these drugs are R-Warfarin and anti-vitamin K, Cilostazol, Diazepam and Phenytoin.

cilostazol: Omeprazole, taking a dose of 40 mg in healthy people in a cross -study, increasing CMAX and AUC of Cilostazol, equivalent to 18% and 26%, and one of the metabolites with the corresponding activity of 29% and 69%.

Phenytoin: Monitoring the blood in the blood is recommended for the first 2 weeks after starting to use omeprazole and, if you adjust the phenytoin dose, monitor and adjust the phenytoin doses when stopping using Omeprazole.

Interactive mechanisms are not well known

saquinavir: Concomitance Omeprazole with Saquinavir/Ritonavir increases blood concentration about 70% for Saquinavir related to DUE recharging well for HIV -infected patients.

tacrolimus: Concentrated with omeprazole has been reported to increase blood concentration of Tacrolimus, need to strictly control the concentration of Tacrolimus in the blood as well as kidney function (creatinine clearance) and may have to adjust the tacrolimus dose

Methotrexate: When used with PPI, in some patients, methotrexate levels increase. When using high doses of methotrexate, the doctor may temporarily consider Omeprazole for patients.

The effect of other drugs on Omeprazole's pharmacokinetics

CYP2C19 and/or CYP3A4 inhibitors:

Because Omeprazole is metabolized by CYP2C19 and CYP3A4, CYP2C19 or CYP3A4 inhibitors (such as Clarithromycin and Voriconazole) can increase the omeprazole concentration in blood to reduce the speed of Omeprazole metabolism. Using the same time with voriconazole increases the amount of omeprazole in the body more than twice. Because omeprazole is highly tolerated, it usually does not need to adjust the dose of omeprazole. However, it is possible to consider adjusting the dose in patients with severe liver failure and if prolonged treatment

CYP2C19 and/or CYP3A4 induction drugs:

Activated drugs CYP2C19 or CYP3A4 or both (such as rifampicin) can reduce the concentration of omeprazole in the blood by increasing the speed of omeprazole metabolism

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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