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Domperidone Capsules

Function and Efficacy

1. 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 motility 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. 2. Toxicity studies: 1) Genetic toxicity: No evidence related to genetic mutations was found in the dominant lethal study of male and female mice, the micronucleus test of female mice and female rats, the chromosome abnormality study of human lymphocytes, the sex-linked recessive lethal test of fruit flies, and the Ames metabolic activity test of Salmonella typhi. 2) Carcinogenicity: In carcinogenicity studies in which mice were dosed for 18 months and rats were dosed for 24 months, an increased incidence of malignant breast tumors was found in female mice and rats when the dose was 25 times the maximum human dose, and an increased incidence of pituitary tumors was found in male rats when the dose was 25 times the human dose. There were no other dose-related effects.

Ingredients

Domperidone.

Name Description Content CAS NO. Manufacturer
DomperidoneIngredients

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.

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57808-66-9 20

Appearance

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

Indication

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

Usage and Dosage

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 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. For nausea and vomiting 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 each time according to body weight, 3-4 times a day, and the maximum dose does not exceed 30 mg per day.

Adverse Reactions

Clinical trials have shown that the incidence of adverse reactions to this product is less than 7%. Most adverse reactions disappear or are tolerated by patients during the use of this product. Some 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. 1. Central nervous system: The incidence of adverse reactions is 4.6%, including dry mouth (1.9%), headache or migraine (1.2%), insomnia, nervousness, dizziness, hunger, thirst, drowsiness, and irritability (the incidence is less than 1%). Extrapyramidal reactions are rare in adults. When the blood-brain barrier is not fully developed (such as in infants) or is damaged, the possibility of central adverse reactions cannot be ruled out. 2. Digestive system: The incidence of adverse reactions is 2.4%, including abdominal cramps and diarrhea

Precautions

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.

Special Population Medication

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.

Drug Interactions

1. Anticholinergic drugs, such as Tongjingping, 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 the liver microsomal CYP3A4 enzyme. In vitro tests have shown that co-use with CYP3A4 enzyme inhibitors (such as imidazole antifungal drugs, macrolide antibiotics, HIV protease inhibitors, nefazodone) will lead to an increase in the blood concentration of domperidone. 5. Because domperidone has the effect of promoting gastric motility, it will theoretically affect the oral drugs used in combination.

Storage

Keep away from light and store in a sealed container.

Packaging Specification

10mg

Validity Period

24 months

Manufacturer

Beijing Saier Biological Pharmaceutical Co., Ltd.

  • Founded in:

    2002-10-24
  • Address:

    No. 35, Keyuan Road, Industrial Development Zone, Daxing District, Beijing
  • Tax NO.:

    91110115742602836G
  • Registered Funds:

    28 million yuan
  • Website:

  • Email:

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