Orpiphar injection powder to treat duodenal and stomach ulcer (1 bottle of powder x 1 tube 10 ml)

Dosage form Box
Specifications Omeprazol

Ingredient

Composition information	Content
Omeprazol	40mg

Uses

Indications

Orapic drugs are indicated in cases of ineffective oral treatment:

Treatment of stomach - duodenal ulcer. muscle.

Treatment of reflux esophagitis.

Omeprazole inhibits the excretion of the acid secretion of the stomach due to inhibiting the restoration of the enzyme system Hydro - potassium adenosine triphosphatase (also known as proton pump) in the border cells of the stomach. Fast effect, prolonged but recovered. Omeprazole does not work on receptors (receptor) acetylcholine or histamine receptors.

Acting on acid secretion

Omeprazole inhibits gastric acid secretion dependent, so with intravenous or intravenous injection of 40 mg will reduce the concentration of acid in the stomach immediately and after 24 hours the concentration of stomach acid decreases by about 90%. The inhibition of gastric acid secretion depends on the area under the curve (AUC) regardless of Omeprazole at a time.

Acting on bacteria h. Pylori

h. Pylori is associated with peptic ulcer and is a factor that increases the risk of developing stomach cancer. Using omeprazole combined antibiotics helps kill bacteria h. Pylori and heal ulcers.

pharmacokinetic pharmacokinetics

Distribution

Expected distribution volume in healthy people is approximately 0.3 l/kg body weight. 97% Omeprazole binds to plasma proteins.

Metabolism

Omeprazole is completely metabolized by the Cytochrome P450 (CYP) system. The majority of omeprazole metabolizes through CYP2C19 enzyme forming hydroxyomeprazole, the main metabolite in plasma. The rest is transformed through CYP3A4 to produce omeprazole sulfone. About 3% of the white population and 15-20% of the Asian population lack the enzyme CYP2C19 function and are called poor metabolic.

In these people the metabolism of omeprazole can be catalyzed mainly by CYP3A4. After the dose of Omeprazole 20 mg repeats once a day, the average AUC in the metabolic person is 5 to 10 times higher than those with the CYP2C19 enzyme (strong metabolic). The average peak concentration in plasma is also 3 to 5 times higher. These findings have no meaning for the dose of omeprazole.

Elimination

Plasma clearance totals about 30-40 l/hour after a single dose. Omeprazole's waste duration of plasma is usually shorter than an hour after a single dose and a repeated dose once a day. Omeprazole is completely eliminated from plasma between doses without a tendency to accumulate when used once a day. Nearly 80% of Omeprazole dose is excreted in the form of metabolites in the urine, the rest through feces, mainly comes from bile secretion.

People with liver failure

The metabolism of omeprazole in patients with impaired liver failure, leading to an increase in AUC. Omeprazole does not show any trend of accumulation at a one -time dosage daily.

Renal failure

Omeprazole pharmacokinetics, including systemic bioavailability and unchanged excretion rate in patients with renal failure.

Elderly

Omeprazole metabolism speed decreases slightly in the elderly (75 - 79 years).

Before taking Orpiphar injection powder to treat duodenal and stomach ulcer (1 bottle of powder x 1 tube 10 ml)

How to use

dilute with 10 ml of solvent. The intravenous injection is at least 2.5 minutes at a speed of not more than 4 ml/min.

The solution after reconciliation should be used immediately or stable within 4 hours at 25 ° C.

Dosage

Dosage for adults when using ineffective oral routes

In patients who cannot take the drug, should use omeprazole in an intravenous 40 mg once daily.

Zollinger syndrome - Ellison

Often used in intravenous doses of 60 mg/day, which can be used higher depending on the patient. If the dose is higher than 60 mg/day, divide 2 times daily.

Renal failure

No need to adjust the dose in people with renal failure.

People with liver failure

In patients with liver failure, daily dose can be used 10 - 20 mg.

Elderly (65 years old)

No need to adjust the dose in the elderly.

Children

Safe data is limited when using omeprazole intravenously for children.

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?

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Orpaptic drugs, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache.

digestive: abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting, flesh tumor (benign).

Uncommon, 1/1000

Mental and nerves: insomnia, dizziness, paresthesia, drowsiness.

Liver: Increased liver enzymes.

Skin and subcutaneous tissue: Dermatitis, itching, rash, urticaria.

Fracture of hip, wrist or spine.

tired, edema.

Rare, 1/10000

Blood and lymph: leukopenia, thrombocytopenia.

immune: Hypersensitivity reactions such as fever, angioedema and anaphylaxis/reaction/anaphylaxis.

Metabolism and nutrition: Hypoglycemia.

Mental and nervousness: agitation, confusion, depression, taste disorders.

Eyes: blurred vision.

digestive: dry mouth, stomatitis, gastrointestinal candidia, microscopic colitis. Respiratory: Bronchospasm.

Hepatitis: Hepatitis has or without jaundice.

Skin and subcutaneous tissue: Hair loss, light sensitivity.

Muscle pain, joint pain, interstitial nephritis, increased sweating.

Very rare, ADR

Blood and lymph: Losing leukocytes, reducing all bloody globe.

Metabolism and nutrition: Lower blood magnesium.

Mental: assault, hallucinations.

liver: Liver failure, brain disease in patients had liver disease in advance.

Skin and subcutaneous tissue: Diverse roses, Stevens - Johnson syndrome, poisoned epidermal necrosis (Ten).

Weak muscles, big breasts in men.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Orali drugs are contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Hypersensitivity to benzimidazole.

Precautions when using

When there is any warning symptoms (such as significant weight loss, vomiting, difficulty swallowing, blood or black feces) and when suspected or suffering from stomach ulcers, it is necessary to eliminate malignant tumors because treatment can cover symptoms and make late diagnosis.

Omeprazole may reduce the absorption of vitamin B12 (cyanocobalamine) due to reduced or deficient gastric acid. Therefore, it is necessary to be careful in patients with reduced body reserves or there are risk factors that reduce the absorption of vitamin B12 in long -term treatment.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, it is advisable to consider the ability to interact with drug products transformed through CYP2C19. The interaction between clopidogrel and omeprazole. The clinical involvement of this interaction is uncertain. To prevent, should stop using Omeprazole and Clopidogrel.

Combining Atazanavir with proton pump inhibitors is not recommended. If it is required to use these drugs at the same time, clinical monitoring must be closely monitored and increased the dose of Atazanavir to 400 mg with 100 mg of ritonavir; Omeprazole dose should not exceed 20 mg.

Proton pump inhibitors can lead to a slight increase in the risk of gastrointestinal infections such as Salmonella and Campylobacter. Severe blood magnesium decreased in patients treated with Omeprazole for at least 3 months, and in most cases when treated for 1 year. The serious manifestation of blood magnesium blood like fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhythmia appears but may start silently and be overlooked. In most patients with this condition, reducing the magnesium is improved after compensation for magnesium and stopping the pump inhibitors.

For patients who have to treat long -term or simultaneous use of proton pump inhibitors with digoxin or drugs that can cause blood magnesium (such as diuretics), need magnesium measurement before starting and during treatment with proton pump inhibitors.

Use high -dose and long -dose proton pump inhibitors (> 1 year) that increases the risk of hip, wrist and spine fractures, mainly in the elderly or other risk factors.

Proton pump inhibitors are related to the very rare cases of lupus erythema (SCLE). If the damage occurs, especially in the skin exposed to the sun, and if it comes with joint pain, patients should quickly find health help and health experts should consider stopping omeprazole injecting. If you have been scratched after treatment with proton pump inhibitors may increase the risk of SCLE when taking other proton pump inhibitors.

affect tests

Increased chromographin A (CGA) can interfere with the detection of endocrine nerve tumors. To avoid this influence, Omeprazole should be discontinued for at least 5 days before CGA measurement. If the CGA and Gastrin levels do not return to the reference range after the initial measurement, after 14 days of stopping the treatment of proton pump inhibitors. Patients should be monitored regularly in all long -term treatments, especially when the treatment time exceeds 1 year.

The ability to drive and operate machinery

The drug can cause headaches, drowsiness, dizziness, need to be cautious when used for drivers or operating machinery.

Pregnancy

Although experiments do not see omeprazole has the ability to cause deformities and toxic to the fetus, but should not be used for pregnant people, especially in the first 3 months.

Breastfeeding period

Drug interaction

omeprazole may increase the concentration of cyclosporine in the blood.

Omeprazole increases the effect of antibiotic eradication h. Pylori, increasing anticoagulants of Dicoumarol.

Omeprazole moderate inhibits CYP2C19, thus significantly increasing the concentration of drugs metabolized by CYP2C19: Warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

omeprazole inhibits the metabolism of warfarin, but rarely changes bleeding time.

Omeprazole reduces nifedipine metabolism at least 20% and may increase the effects of nifedipine.

Simultaneous use Omeprazole 40 mg/day reduces Nelfinavir's plasma concentrations by 40% and 75 - 90% of M8 activity metabolites, may be due to CYP2C19 metabolic enzyme inhibitor. Sometimes, Omeprazole 40 mg/day with 300 mg of Atazanavir/Ritonavir 100 mg reduces the level of ATAZANAVIR plasma concentrations by about 75%.

Omeprazole significantly reduces the absorption of Posaconazole, Erlotinib, Ketoconazole, Itraconazole when shared.

Omeprazole increases the bioavailability of drugs: digoxin, saquinavir or ritonavir, methotrexate, tacrolimus.

When using Omeprazole with clopidogrel, it reduces the active metabolites of clopidogrel, resulting in a decrease in the resistance to plateloon of clopidogrel.

Clarithromycin, voriconazole inhibit omeprazole metabolism and make Omeprazole concentration doubled.

Rifampicin induction drugs increase omeprazole metabolism, thus reducing the concentration of omeprazole in plasma.

Storage

Store in dry places, the temperature does not exceed 30 ° C, avoiding light.

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