Is it Safe to Use Omeprazole in Pregnancy?

Omeprazole magnesium tablets, the indications are for the treatment of duodenal ulcer, gastric ulcer and reflux esophagitis; combined with antibiotics, for treatment of duodenal ulcer infected with Helicobacter pylori; treatment of non-steroidal anti-inflammatory Drug-related peptic ulcer and gastroduodenal erosion; prevention of peptic ulcer, gastroduodenal erosion or indigestion caused by non-steroidal anti-inflammatory drugs; also used for chronic recurrent peptic ulcer and Maintenance treatment of fluid esophagitis; symptomatic treatment of heartburn and reflux in gastro-esophageal reflux disease; symptomatic treatment of ulcer-like symptoms and acid-related dyspepsia; treatment of Zoe-Essler syndrome.

Drug Name: Omeprazole magnesium tablets

Drug type: Prescription drugs, medicines for medical workers' injuries
Use classification: Drugs that inhibit gastric acid secretion

Omeprazole magnesium tablets ingredients

Ingredients: Omeprazole.
Chemical name is: 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl) -methyl] -sulfinyl] -1H-benzimidazole : C ₁₇ H ₁₉ N ₃ O ₃ S
Molecular weight: 345.42

Omeprazole magnesium tablets

Losec MUPS 10mg: Pale pink, oval, double-convex coated tablets, engraved with "" on one side, and "10MG" on the other, each tablet containing 10.3mg omeprazole magnesium (equivalent to 10mg Omeprazole) enteric coated microparticles.
Losec MUPS 20mg: Pink, oval, double-convex coated tablets, engraved with "" on one side, and "20MG" on the other side, each tablet contains 20.6 mg of omeprazole magnesium (equivalent to 10 mg Omeprazole) enteric coated microparticles.

Omeprazole magnesium tablets indications

Treatment of duodenal ulcer, gastric ulcer and reflux esophagitis;
Combined with antibiotics to treat duodenal ulcers infected with Helicobacter pylori;
Treatment of non-steroidal anti-inflammatory drugs related to peptic ulcer and gastroduodenal erosion;
Prevention of peptic ulcer, gastroduodenal erosion or indigestion caused by non-steroidal anti-inflammatory drugs;
It is also used for maintenance treatment of chronic recurrent peptic ulcer and reflux esophagitis;
For symptomatic treatment of heartburn and reflux in gastric-esophageal reflux disease;
Symptomatic treatment of ulcer-like symptoms and acid-related dyspepsia;
For the treatment of Zollinger-Ellison syndrome.

Omeprazole magnesium tablets specifications

20 mg.

Omeprazole magnesium tablets dosage

It must be swallowed whole, at least with half a cup of liquid. The tablets cannot be chewed or crushed. They can be dispersed in water or a slightly acidic liquid (such as fruit juice). The dispersion must be taken within 30 minutes.
Duodenal ulcer : the normal dose is 20 mg of this product, once a day, usually the ulcer can be cured within 2 weeks. If the initial course of treatment is not sure, it should be treated for another 2 weeks. For duodenal ulcers that are ineffective with other drugs, use 40 mg once a day, usually within 4 weeks. For relapsed patients, treatment can be repeated.
Eradication of Helicobacter pylori :
Triple therapy: 20 mg of this product, 1000 mg of amoxicillin and 500 mg of clarithromycin, 2 times a day for 1 week. Or 20 mg of this product, 250 mg of clarithromycin and 400 mg of metronidazole, both twice a day for 1 week.
Dual therapy: This product is 40 mg once a day and clarithromycin 500 mg three times a day for 2 weeks. Or this product is 20 mg, amoxicillin 750-1000 mg, both twice a day for 2 weeks. To ensure cure, refer to the recommended dose of duodenal ulcer.
Non-steroidal anti-inflammatory drugs related to duodenal ulcer or duodenal erosion, with or without non-steroidal anti-inflammatory drugs : the normal dose is 20 mg once a day. It is usually cured within 4 weeks. If the initial course of treatment is not sure, the treatment should be continued for another 4 weeks.
Prevention of non-steroidal anti-inflammatory drugs related to duodenal ulcer, duodenal erosion or indigestion : the normal dose is 20 mg once a day.
In order to prevent the recurrence of recurrent duodenal ulcers that are ineffective for Helicobacter pylori eradication, the dose can be adjusted individually according to the severity of the disease. The effect was dose-dependent. The normal dose is 20 mg of this product, once a day. 10 mg daily may be sufficient for some patients; if this dose is not effective, it can be increased to 40 mg.
Gastric ulcer : The normal dose is 20 mg of this product, once a day, usually can be cured within 4 weeks. If the initial course of treatment is not completely cured, it should be treated for another 4 weeks. For other patients with gastric ulcers who have failed treatment, this product can be given 40 mg once a day, usually within 8 weeks. Relapse cases can be treated repeatedly.
Non-steroidal anti-inflammatory drugs related gastric ulcer or gastric mucosal erosion, with or without non-steroidal anti-inflammatory drugs : the normal dose is 20 mg once a day. It is usually cured within 4 weeks. If the initial course of treatment is not sure, the treatment should be continued for another 4 weeks.
Prevention of non-steroidal anti-inflammatory drugs-related gastric ulcers, gastric mucosal erosions or indigestion symptoms : the normal dose is 20 mg once a day.
Maintenance treatment of gastric ulcer : 20 mg of this product, once a day. If treatment fails, the dose can be increased to 40 mg once a day.
Reflux esophagitis : The dose can be adjusted individually according to the severity of the disease. The normal dose is 20 mg of this product, once a day. It is usually cured within 4 weeks. If the initial course of treatment is not sure, the treatment should be continued for another 4 weeks. For other patients with reflux esophagitis, 40 mg of this product can be given once a day, usually within 8 weeks. Once relapse, treatment should be repeated.
For maintenance treatment of chronic recurrent reflux esophagitis, the dose can be adjusted individually according to the severity of the disease. The effect was dose-dependent. The normal dose is 20 mg of this product, once a day. 10 mg daily may be sufficient for some patients; if this dose is not effective, it can be increased to 40 mg once daily.
Symptomatic treatment of gastro-esophageal reflux disease : the normal dose is 20 mg of this product, once a day. In some patients, 10 mg daily may be sufficient; if 20 mg daily treatment does not control symptoms for 2-4 weeks, further examination is recommended.
Treatment of ulcer-like symptoms : The normal dose is 20 mg of this product, once a day. 10 mg daily may be sufficient for some patients. If 20 mg of daily treatment for 2-4 weeks does not control the symptoms, further examination is recommended.
Acid-related dyspepsia : relief of symptoms in patients with upper abdominal pain or discomfort, with or without heartburn symptoms, the recommended dose is 20 mg, once a day. 10 mg daily may be sufficient for some patients, so 10 mg can be used as a starting dose. If 20 mg of daily treatment for 4 weeks does not control the symptoms, further examination is recommended.
Zhuo-Ellison syndrome : The recommended starting dose is 60 mg of this product, once a day. The dose should then be adjusted individually, and the course of treatment should be determined based on clinical manifestations. More than 90% of patients can control the symptoms by 20-120 mg per day. If the daily demand exceeds 80 mg, they should be taken in two doses.
Hepatic impairment : Those with severe liver impairment do not exceed 20 mg per day.
For patients who cannot take the drug orally, the parenteral dosage form of omeprazole can be used, see the instructions of Roseck injection or powder injection 40 mg.

Omeprazole magnesium tablets adverse reactions

Clinical trials have shown that headaches and gastrointestinal symptoms such as diarrhea, nausea, and constipation are the most common, and their incidence is 1-3%.
More common (> 1/100):
Whole body-headache
Gastrointestinal tract-diarrhea, nausea / vomiting, constipation, abdominal pain and bloating.
Rarely occurs:
Whole body-dizziness, drowsiness, fatigue;
Central nervous system-sleep disorders, paresthesias;
Skin-rash, itching, hives;
Liver-liver function test abnormal.
Rare (<1/1000):
Whole body-hyperhidrosis, peripheral edema, hyponatremia;
Allergic reactions-angioedema, fever and anaphylactic shock;
Hematology-leukopenia, thrombocytopenia, agranulocytosis, pancytopenia;
Central nervous system (especially in critically ill patients): reversible insanity, irritability, depression and hallucinations;
Endocrine-male and female breasts;
Gastrointestinal tract-dry mouth, abnormal taste, stomatitis, candidiasis;
Skin-hair loss, photosensitivity, erythema multiforme;
Liver-hepatic encephalopathy (previously severe liver disease), jaundice or non-jaundice hepatitis, liver failure;
Respiratory-bronchial spasm;
Musculoskeletal-joint pain, myalgia, muscle fatigue;
Genitourinary system-interstitial nephritis;
Eyes-blurred vision.
There have been reports of Stevens-Johnson syndrome and toxic epithelial necrosis in individual cases, but no causal relationship has been identified.
Clinical trials suggest that the combination of omeprazole and clarithromycin can increase the incidence of central nervous system (mainly headache) and gastrointestinal adverse reactions.

Omeprazole magnesium taboo

People who are allergic to omeprazole.

Precautions for omeprazole magnesium tablets

When peptic ulcer is suspected, diagnosis should be confirmed by X-ray and endoscopy as soon as possible to avoid improper treatment.
When treating gastric ulcers, malignancies must be ruled out.
When a gastric ulcer is diagnosed or suspected, or one or more of the following warning symptoms occur, malignancy must be ruled out. Treatment with this product can mask its symptoms and delay the diagnosis: significant unconscious weight loss, repeated vomiting, difficulty breathing, vomiting blood or melena. This product is not effective for abnormal movement of the gastrointestinal tract.
For patients diagnosed with esophagitis endoscopically and taking omeprazole for a long time, the response rate of 10 mg daily treatment is lower than 20 mg daily treatment, so those who take 10 mg daily should be monitored endoscopically.

Omeprazole magnesium tablets for pregnant and lactating women

Epidemiological studies have shown that omeprazole has no adverse effects on pregnant women or healthy fetuses / newborns and can be used during pregnancy.
Omeprazole can be secreted into breast milk and its effects on infants are unknown. Use with caution when breastfeeding.

Omeprazole magnesium tablets for children

Limited experience with children.

Omeprazole magnesium tablets for elderly

No dosage adjustment is needed for elderly patients.

Omeprazole magnesium tablets drug interactions

Avoid combination with ketoconazole or itraconazole.
No interaction with other antacids. Omeprazole is metabolized by the cytochrome P450 enzyme system and may interact with other drugs metabolized by this system. Controlled clinical studies have confirmed that it is related to non-steroidal anti-inflammatory drugs (piroxicam, diclofenac, naproxen) or theophylline, caffeine, quinidine, lidocaine, propranolol, metoprolol There were no interactions with acetone, ethanol or amoxicillin.

Omeprazole magnesium tablets overdose

A single oral dose of up to 400 mg did not show any severe symptoms, and as the dose increased, the clearance (first-order pharmacokinetics) did not change and no special treatment was required.

Omeprazole magnesium tablets pharmacology and toxicology

Omeprazole is a substituted benzimidazole compound, a racemate of a pair of active optical enantiomers. Omeprazole uses a special machine to make a proton pump for parietal cells to reduce gastric acid secretion. This effect is reversible.
Omeprazole is a weak base, which is concentrated and converted into the active form in the acidic environment of parietal cells, which inhibits the last part of the production of hydrochloric acid in gastric juice: H ⁺ , K ⁺ -ATPase, the inhibitory effect is dose-dependent It has effects on basic and stimulated gastric acid secretion, regardless of the type of stimulus. Omeprazole has no effect on cholinergic and histamine receptors. Similar to H2 blockers, omeprazole Decrease gastric acidity, so that gastrin increases in proportion to the decrease in acidity. The increase of gastrin is reversible. It has been reported that in the long-term treatment, the occurrence of gastric gland cysts increases. These changes are all affected by gastric acid secretion. The physiological result of inhibition is benign and reversible.
In addition to the effect on gastric acid secretion, other clinically significant pharmacodynamic effects of omeprazole have not been observed. The effect on gastric acid secretion is directly related to blood concentration and area under the time curve (AUC), but it is related to the given The actual blood concentration of time is irrelevant. Oral Rosecco MUPS 20 mg, gastric acid secretion is reduced within 2 hours, once a day, for three to five consecutive days, the maximum effect can be obtained. For patients with duodenal ulcer, the average gastric acidity within 24 hours is reduced by about 80 %; 24 hours after administration, the peak acid output decreased by an average of 70% after pentagastrin stimulation. Omeprazole inhibited gastric acid secretion for a long period of time, and gastric acid secretion returned to normal within 5 days after stopping medication. One tablet (20 mg) relieves symptoms on the first day. Most duodenal ulcers can be cured in two weeks, while gastric ulcers and reflux esophagitis can be cured in four weeks.
Omeprazole can increase the antibacterial effect of some antibiotics on H. pylori.

Pharmacokinetics of Omeprazole Magnesium Tablets

Omeprazole is absorbed in the small intestine and is usually fully absorbed within 3-6 hours.
The bioavailability after repeated administration is about 60%, and the simultaneous intake of food has no effect on its bioavailability. The plasma protein binding rate of omeprazole is 95%.
Omeprazole is mainly completely metabolized in the liver. Its metabolites are sulfone, sulfide, and hydroxy omeprazole. These products have no significant effect on gastric acid secretion. The average concentration of omeprazole in plasma and the elimination phase of the time curve The half-life is about 40 minutes (30-90 minutes), and there is no change during treatment, about 80% of the metabolites are excreted from the urine, and the rest are excreted from the feces.

Omeprazole magnesium tablets storage

Store below 25 ° C.

Omeprazole Magnesium Packaging

20 mg: 7 tablets / box.

Expiry date of omeprazole magnesium tablets

36 months. ^[1]