Product Overview
[Drug Name]
Generic Name: Domperidone Tablets
Trade Name: Domperidone Tablets 10mg*30 Tablets
Pinyin Code: MaDingZuo DuoPanLiTongPian 10mg*30 Tablets
[Main Ingredients]
Main Ingredient: Domperidone 10mg, with excipients: starch, hydrogenated vegetable oil, lactose hydrate, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, pregelatinized starch, and sodium lauryl sulfate.
[Properties]
This product is a white tablet.
[Indications/Main Functions]
Used for indigestion, abdominal distension, belching, nausea, vomiting, and abdominal pain.
[Specifications]
10mg*30 tablets (Domperidone)
[Dosage and Administration]
Oral. Adults: 1 tablet three times a day, 15-30 minutes before meals.
[Adverse Reactions]
1. Mild abdominal cramps, dry mouth, rash, headache, diarrhea, nervousness, fatigue, drowsiness, and dizziness may occasionally occur.
2. Elevated serum prolactin levels, galactorrhea, and gynecomastia may occur occasionally, but these symptoms return to normal after discontinuation of the drug.
3. Excitement and amenorrhea may occur in rare cases.
4. Very rare adverse reactions include angioedema, allergic reactions, pruritus, abnormal liver function tests, convulsions, urticaria, and extrapyramidal side effects (such as drooling and hand tremors, which resolve completely on their own after discontinuation of the drug).
[Contraindications]
1. Patients with known hypersensitivity to domperidone or any of the ingredients in this product.
2. Contraindicated in cases where increased gastric motility could be dangerous (e.g., gastrointestinal bleeding, mechanical obstruction, perforation).
3. Contraindicated in patients with prolactin-secreting pituitary tumors (prolactinomas).
4. Contraindicated in patients with pheochromocytoma, breast cancer, mechanical intestinal obstruction, or gastrointestinal bleeding.
5. Do not use with oral ketoconazole, erythromycin, or other strong CYP3A4 inhibitors that may prolong the QTc interval (e.g., fluconazole, voriconazole, clindamycin, amiodarone, telithromycin).
[Precautions]
1. Use with caution in pregnant women. Breastfeeding women should discontinue breastfeeding while using this product.
2. Domperidone suspension is recommended for children.
3. Caution is advised when using this product in patients with heart disease (arrhythmias) or cancer patients undergoing chemotherapy, as it may aggravate arrhythmias.
4. In case of overdose or serious adverse reactions, seek medical attention immediately.
5. Do not use this product if you are allergic to it. Use with caution if you have allergic reactions.
6. Do not use this product if its properties change.
7. Keep this product out of reach of children.
8. If you are using other medications, consult a physician or pharmacist before using this product. 9. This product contains lactose and may not be suitable for patients with lactose intolerance, galactosemia, or glucose/galactose malabsorption.
10. When antacids or drugs that inhibit gastric acid secretion are used with this product, the former two drugs should not be taken before meals but should be taken after meals. In other words, they should not be taken simultaneously with this product.
11. Because domperidone is primarily metabolized in the liver, it should be used with caution in patients with impaired liver function.
12. In patients with severe renal insufficiency (serum creatinine >6 mg/100 ml, i.e., >0.6 mmol/L), the elimination half-life of domperidone increases from 7.4 hours to 20.8 hours, but blood concentrations are lower than those in healthy volunteers. Because minimal unchanged drug is excreted through the kidneys, patients with renal insufficiency may not require dose adjustment for a single dose. However, if repeated dosing is necessary, the frequency of dosing should be reduced to once or twice daily based on the severity of renal impairment.
[Drug Interactions]
Unknown.
[Storage]
Store in a dark, airtight container.
[Packaging]
Aluminum-plastic blister pack, 30 tablets/pack/box
[Expiry Period]
60 months
[Approval Number]
National Medical Product Approval No. H10910003
[Manufacturer]
Xi'an Janssen Pharmaceuticals Co., Ltd.
