Domperidone Capsules

Pharmacological action: This product is a peripheral dopamine receptor antagonist, which can promote the peristalsis and tension of the upper gastrointestinal tract to return to normal, promote gastric emptying, increase the movement of the gastric antrum and duodenum, coordinate the contraction of the pylorus, and also enhance the peristalsis of the esophagus and the tension of the lower esophageal sphincter, inhibit nausea and vomiting, and do not affect the secretion of gastric juice. This product is not easy to pass through the blood-brain barrier and has almost no antagonistic effect on dopamine receptors in the brain. Therefore, it generally has no adverse reactions to the mental and central nervous systems. Toxicity study: Carcinogenicity: In the carcinogenicity study of mice administered for 18 months and rats administered for 24 months, it was observed that the incidence of malignant breast tumors increased when the dose given to female mice and rats was 25 times the maximum human dose, and the incidence of pituitary tumors increased when the dose given to male rats was 25 times the human dose. There was no other dose-related effect. Genotoxicity: No evidence of genetic mutation was found in dominant lethal studies in male and female mice, micronucleus tests in female mice and female rats, chromosomal abnormality studies in human lymphocytes, sex-linked recessive lethality tests in Drosophila, and the Ames metabolic activity assay in Salmonella typhi.

Main ingredients: The active ingredient of this product is domperidone Chemical name: 5-chloro-1-{1-[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl}-1,3-dihydro-2H-benzimidazol-2-one Chemical structure: Molecular formula: C22H24ClN5O2 Molecular weight: 425.91

This product is a hard capsule, and the contents are white or off-white powder.

Used to treat reflux esophagitis, functional dyspepsia, gastric ulcer, duodenal ulcer, etc.

1. Adults: For the treatment of upper gastrointestinal motility disorders, the common oral dose for adults is 1 tablet (10 mg) each time, 3 to 4 times a day, 15 to 30 minutes before meals or at bedtime. For patients with severe conditions or who have developed tolerance, the dose can be increased to 2 tablets (20 mg) each time, 3 to 4 times a day or as directed by a doctor. For nausea and vomiting caused by taking anti-Parkinson's dopamine receptor agonists, adults can take an oral dose of 2 tablets (20 mg) each time, 3 to 4 times a day. If nausea and vomiting is caused by intravenous infusion of anti-Parkinson's dopamine receptor agonists, the therapeutic dose needs to be increased. 2. Children aged 2 years and above: 0.2-0.3 mg/kg per body weight, 3-4 times a day, with a maximum dose of no more than 30 mg per day.

Clinical trials have shown that the incidence of adverse reactions to this product is less than 7%. Most adverse reactions can disappear or be tolerated by patients with continued use of this product. Other more serious adverse reactions, such as galactorrhea, gynecomastia in men, and menstrual disorders in women, are related to the dosage and can disappear by reducing the dosage or stopping the medication. Central nervous system: The incidence of adverse reactions is 4.6%, dry mouth (1.9%), headache or migraine (1.2%), insomnia, nervousness, dizziness, hunger, thirst, drowsiness, irritability (all incidences are less than 1%). Digestive system: The incidence of adverse reactions is 2.4%, abdominal cramps, diarrhea, reflux, changes in appetite, nausea, heartburn, constipation (all incidences are less than 1%). Endocrine system: The incidence of adverse reactions is 1.3%, facial flushing

1. It is contraindicated for patients with pheochromocytoma, breast cancer, mechanical intestinal obstruction, gastrointestinal bleeding, etc. 2. It should be used with caution in infants under one year old and pregnant women.

Precautions for children: Use with caution in infants under one year old. Precautions for pregnancy and lactation: Use with caution in pregnant women. Precautions for the elderly: Use the same medication as adults for elderly patients.

1. Anticholinergic drugs such as tamoxifen, propantheline bromide, scopolamine, belladonna tablets, etc. will weaken the effect of this product and should not be taken at the same time. 2. When this product is used together with acetaminophen, ampicillin, levodopa, tetracycline, etc., the absorption rate of these drugs will increase. 3. Antacids and anti-secretory drugs will reduce the oral bioavailability of domperidone and should not be taken with this product at the same time. 4. Domperidone is mainly metabolized by CYP3A4 enzyme. In vitro test data show that co-administration with drugs that significantly inhibit CYP3A4 enzymes will lead to an increase in the blood concentration of domperidone. Examples of CYP3A4 enzyme inhibitors are as follows: imidazole antifungal drugs, macrolide antibiotics, HIV protease inhibitors, and nefazodone. In a study using healthy volunteers, ketoconazole significantly inhibited the first-pass effect of domperidone mediated by CYP3A4, resulting in a 3-fold increase in the Cmax and AUC of domperidone at steady state. In the domperidone-ketoconazole interaction study, it was observed that the co-administration of domperidone (10 mg/time, 4 times/day) and ketoconazole (200 mg/time, 2 times/day) increased the QT interval by 10-20 milliseconds. This phenomenon was not observed when domperidone was used alone (10 mg/time, 4 times/day). The mechanism of QT interval prolongation caused by the combination of these two drugs is still unclear, and the pharmacokinetic data of domperidone cannot explain this phenomenon. In another repeated dose study using healthy volunteers, no significant changes in the QT interval were observed when domperidone monotherapy was 40 mg/time, 4 times/day (160 mg per day, 2 times the maximum daily dose). The plasma concentration of domperidone in this study was similar to that in the previous domperidone-ketoconazole interaction study. 5. Since domperidone has a gastric motility-promoting effect, it can theoretically affect the absorption of oral drugs used in combination, especially sustained-release or enteric-coated preparations. When this product is used in combination with digoxin, the absorption of the latter will be reduced. 6. Domperidone does not enhance the effects of neuroleptics; this product should not be used simultaneously with monoamine oxidase inhibitors (MAOIs). 7. Domperidone will reduce the peripheral side effects of dopamine agonists (such as bromocriptine and levodopa), such as gastrointestinal symptoms, nausea and vomiting, but will not antagonize their central effects. 8. When used in combination with phenothiazines, butyrophenones, and rauwolfia alkaloids, endocrine dysfunction or extrapyramidal symptoms are likely to occur, so it should be used with caution. 9. Use with caution in patients who are currently using digitalis and theophylline.

Keep away from light and store in sealed container.

10mg

24 months.

Qingdao Huanghai Pharmaceutical Co., Ltd.

• Founded in:

  1982-02-10

• Address:

  No. 17, Keyuanjingsi Road, Laoshan District, Qingdao

• Tax NO.:

  91370200163567984Y

• Registered Funds:

  182.18928 million yuan

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