General name: Omeprazole Sodium for injection
[ingredient] omeprazole sodium.
[indications] as an alternative therapy for the following diseases when oral therapy is not applicable: duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger Ellison syndrome.
[usage and dosage] 1.
2. Before use, dissolve the contents of the bottle in 100 ml 0.9% sodium chloride injection or 100 ml 5% glucose injection. After dissolution, the intravenous drip time should be 20-30 minutes or longer.
3. When the oral therapy is not suitable for patients with duodenal ulcer, gastric ulcer and reflux esophagitis, it is recommended that the dosage of this product is 40mg, once a day.
4. For patients with Zollinger Ellison syndrome, 60 mg omeprazole sodium is recommended as the starting dose, once a day. The daily dose may be higher, and the dose should be individualized. When the daily dose exceeded 60 mg, the drug was given twice.
[adverse reactions] 1. Omeprazole is well tolerated, and most of the adverse reactions are mild and reversible. The following adverse reactions have been reported in clinical trials or routine use, but in many cases the causal relationship with omeprazole treatment itself has not been established. Among the following adverse reactions: 2. Common refers to the incidence of & Ge; 1 / 100; uncommon refers to the incidence of & Ge; 1 / 1000, but 1 / 100; rare refers to the incidence of 1 / 10000. Common: Central and peripheral nervous system: headache. Digestive system: diarrhea, constipation, abdominal pain, nausea / vomiting and flatulence. Uncommon: Central and peripheral nervous system: dizziness, paresthesia, drowsiness, insomnia and vertigo. Liver: liver enzymes increased. Skin: rash and / or itching, urticaria. Others: discomfort. Rare: Central and peripheral nervous system: reversible psychosis, agitation, aggressive behavior, depression and hallucination, more common in severe patients. Endocrine system: male breast feminization. Digestive system: dry mouth, stomatitis and gastrointestinal candidiasis. Blood system: leukopenia, thrombocytopenia, agranulocytosis and various types of hemocytopenia. Liver: encephalopathy (seen in patients with previous severe liver disease), hepatitis or jaundice hepatitis, liver failure. Muscle and bone; arthralgia, muscle weakness and myalgia. Skin: photosensitive erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrosis (ten), alopecia; other: allergic reactions such as angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Increased sweating, peripheral edema, blurred vision, taste disorders and hyponatremia. Another severe patient who received omeprazole intravenously, especially at high dose, had irreversible visual impairment, but there was no causal relationship.
[contraindication] it is forbidden to use this product for allergic patients.
[precautions] 1. This product has a strong inhibitory effect on gastric acid secretion for a long time, so it is not suitable to take other antacids or antacids at the same time. In order to prevent excessive acid suppression, it is not recommended to use large dose for a long time in general diseases such as peptic ulcer (except Zhuo Yi AI syndrome). 2. Because this product can significantly increase the pH value in the stomach, it may affect the absorption of many drugs. 3. It is not necessary to adjust the dosage for patients with renal function impairment; it should be used with caution for patients with liver function impairment. 4. In the treatment of gastric ulcer, gastric cancer should be excluded before using this product, so as not to delay the diagnosis and treatment.
[medication for special population] precautions for children:
At present, there is no experience for children to use this product.
Precautions during pregnancy and lactation:
Although no adverse effects on pregnancy and lactation, or toxic or teratogenic effects on fetus were found in animal experiments, it is recommended that pregnant and lactating women should not use it as much as possible.
Precautions for the elderly:
There is no need to adjust the dose in elderly patients.
[drug interaction] because this product can reduce the acidity in the stomach, the absorption of some drugs may be changed. Therefore, the absorption of ketoconazole and itraconazole will decrease when omeprazole or other acid inhibitors or antacids are used. Omeprazole is metabolized by cytochrome P4502C19 (CYP2C19) in the liver, which can prolong the clearance of other hydrolysates such as diazepam, warfarin (R-warfarin) and phenytoin. The combination of warfarin and phenytoin should be monitored. If necessary, the dose of warfarin or phenytoin should be reduced. The blood concentration of phenytoin was not affected by continuous phenytoin treatment with 20 mg once a day. Similarly, the continuous use of warfarin in the treatment of patients with a daily dose of 20 mg, does not change the clotting time. When omeprazole is combined with clarithromycin, their plasma concentration increases. But there was no interaction with metronidazole or amoxicillin. These antibiotics combined with omeprazole can eradicate Helicobacter pylori.
[pharmacological action] 1. This product is a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the secretion of H +, K + - ATPase on the top membrane of parietal cells and tubular vesicles in cytoplasm, so as to effectively inhibit the secretion of gastric acid. As H +, K + - ATPase is the last process of acid secretion of parietal cells, the product has strong acid inhibition ability. It can not only inhibit gastric acid secretion induced by gastrin, histamine, choline, food and vagus nerve stimulation, but also inhibit some basic gastric acid secretion which is not affected by choline or H2 receptor antagonist. It also has strong and lasting inhibitory effect on gastric acid secretion stimulated by dibutyl cyclic adenosine monophosphate (dcamp), which cannot be inhibited by H2 receptor antagonist. 2. This product also has inhibitory effect on pepsin secretion, and has no obvious change on gastric mucosal blood flow, nor does it affect body temperature, gastric cavity temperature, arterial blood pressure, venous hemoglobin, arterial oxygen partial pressure, carbon dioxide partial pressure and arterial blood pH.
[storage] airtight, in a cool and dark place.
[Specification] 40mg (based on c17h19n3o3s)
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General name: Omeprazole Sodium for injection
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