Class A
Domperidone Tablets Instructions
Please read the instructions carefully and use according to the instructions or buy and use under the guidance of a pharmacist.
Drug Name
Generic Name: Domperidone Tablets
English name: Domperidone Tablets
Hanyu Pinyin: Duopanlitong Pian
Ingredients
Each tablet contains 10 mg of Domperidone. Excipients: corn starch, hydrogenated cottonseed oil, lactose, magnesium stearate, microcrystalline cellulose, povidone K90, pregelatinized starch, sodium dodecyl sulfate, film-coated premix.
Characteristic】
This product is white or off-white film-coated tablets, white after removing the coating.
【Action Category】It is a non-prescription drug of gastrointestinal prokinetic drug.
Application
Indications
Indications】For indigestion, bloating, belching, nausea, vomiting, abdominal distension and pain.
Specification】10mg
Dosage】Orally. Adults take 1 tablet once, 3 times a day, 15-30 minutes before meals.
Adverse reactions
1. Occasionally dry mouth, headache, insomnia, hypersensitivity, dizziness, drowsiness, lethargy, abdominal cramps, diarrhea, reflux, nausea, heartburn, rash, pruritus, urticaria, stomatitis, conjunctivitis, etc.
2. It sometimes leads to increased serum prolactin levels, breast overflow, feminization of male breasts, and menstrual disorders in women, but it can return to normal after stopping the drug.
The risk of severe ventricular arrhythmias and even sudden cardiac death has been reported to be increased in patients with daily doses exceeding 30 mg and/or with cardiac disease, in patients with tumors receiving chemotherapy, in patients with serious organic diseases such as electrolyte disorders, and in patients older than 60 years of age.
[Contraindicated].
1. Contraindicated in patients with mechanical gastrointestinal obstruction, gastrointestinal bleeding or perforation. Contraindicated when increasing gastric motility may be dangerous (e.g., the aforementioned symptoms).
2. Contraindicated in patients with prolactin-secreting pituitary tumors (prolactinoma), pheochromocytoma, or breast cancer.
3. Contraindicated in combination with oral preparations of ketoconazole, erythromycin, or other potent inhibitors of CYP3A4 enzymes that may prolong the QTc interval (e.g., fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, itraconazole, posaconazole, ritonavir, saquinavir, trabectedin).
4. Contraindicated in patients with moderate to severe hepatic insufficiency.
5. Combination of drugs that prolong the QT interval is prohibited.
6. Contraindicated in patients with cardiac conduction abnormalities such as prolonged QTC interval, patients with significant electrolyte disturbances, and patients with underlying cardiac disease such as heart failure.
7. Contraindicated in patients with known hypersensitivity to domperidone or any of the components of this product.
Precautions
1. Consult your physician or pharmacist if your symptoms are not relieved after 3 days of use of this product. The duration of drug use should not exceed 1 week.
2. Caution should be exercised in patients with heart disease, cancer patients receiving chemotherapy, and patients with electrolyte disorders, as it may aggravate heart rhythm disorders.
3. Patients with severe vomiting and acute abdominal pain should be seen by a hospital.
4. Pregnant women should use with caution and breastfeeding women should stop breastfeeding during the use of this product.
5. Since domperidone is mainly metabolized in the liver, it should be used with caution in patients with abnormal hepatic and biochemical indices.
6. Elderly patients over 60 years old should be used under the guidance of a physician.
7. Patients with renal insufficiency should be used under the guidance of a physician.
8. Use with caution in patients who are using digitalis and aminophylline.
9. If overdose or serious adverse reactions occur, seek immediate medical attention.
10. This product contains lactose and may not be suitable for patients with lactose intolerance, galactosemia or impaired glucose/galactose absorption.
11. This product is contraindicated in patients with hypersensitivity and should be used with caution in allergic patients.
12. The use of this product is prohibited when its properties are changed.
13. Keep this product out of the reach of children.
If you are using other drugs, please consult your physician or pharmacist before using this product.
15. If signs or symptoms occur that may be related to cardiac arrhythmia, discontinue treatment with this product and consult a physician promptly.
16. Antacids or drugs that inhibit gastric acid secretion may reduce the bioavailability of this product when taken orally and should not be taken at the same time as this product. This product should be taken before meals, and antacids or drugs that inhibit gastric acid secretion should be taken after meals.
17. Combination with anticholinergic drugs (e.g. dextromethorphan, diphenhydramine) may antagonize the effect of this product in the treatment of dyspepsia.
18. Domperidone is mainly metabolized by CYP3A4 enzyme. Data from in vitro and human trials indicate that co-administration with drugs that significantly inhibit the CYP3A4 enzyme may result in increased blood levels of domperidone.
19. This product is not intended for use in infants, children (under 12 years of age), adolescents, and adults weighing less than 35 kg.
20. Drug overdose has been reported primarily in infants and children. Symptoms of overdose include agitation, altered consciousness, convulsions, disorientation, drowsiness, and extrapyramidal reactions. There is no specific antidote for this product. In case of massive overdose, gastric lavage and administration of activated charcoal within one hour of dosing may be helpful, and close clinical monitoring and supportive therapy are recommended. Anticholinergic drugs or anti-Parkinsonian syndrome drugs may be helpful in controlling extrapyramidal reactions.
21. Dizziness and drowsiness have been observed following the use of domperidone. Therefore, patients should be advised not to engage in driving, operating machinery, or other activities requiring consciousness and coordination until the effects of this product on them have been determined.
Drug Interactions]
1. Not to be combined with azole antifungal drugs such as ketoconazole, itraconazole, macrolide antibiotics such as erythromycin, HIV protease inhibitor anti-HIV drugs and nefazodone.
2. Anticholinergic drugs such as painkiller, bromoproterenol, scopolamine, belladonna tablets, etc. will weaken the effect of this product and should not be taken together with this product.
3. Antacids and drugs that inhibit gastric acid secretion may reduce the bioavailability of this product when used together with this product, so it is recommended to use at intervals.
4. The absorption rate of acetaminophen, ampicillin, levodopa and tetracycline will be increased when the product is used together with these drugs.
5. Combination with calcium antagonists (e.g., diltiazem and verapamil) and aripitant will result in increased blood levels of domperidone.
6. The combination of this product with digoxin will reduce the absorption of the latter.
7. Domperidone does not enhance the effect of neuroleptics and can be used simultaneously; it should not be used simultaneously with monoamine oxidase inhibitors (MAOI).
8. Because domperidone has a gastric motility-promoting effect, it theoretically affects the absorption of oral drugs used in combination, especially extended-release or enteric-coated preparations. However, the co-administration of domperidone does not affect the blood levels of digoxin or acetaminophen in patients whose plasma drug concentrations are already at stable levels.
9. Drug interactions may occur if used concomitantly with other drugs; consult your physician or pharmacist for details.
10. Domperidone may reduce the peripheral side effects of dopaminergic agonists (e.g. bromocriptine, levodopa), such as gastrointestinal symptoms, nausea and vomiting, but it does not antagonize their central effects and can be used simultaneously.
Pharmacological effects]
It acts directly on the gastrointestinal wall to increase the peristalsis and tension of the gastrointestinal tract, promote gastric emptying, increase the movement of the gastric sinus and duodenum, and coordinate the contraction of the pylorus, and also enhance the peristalsis of the esophagus and the tension of the lower esophageal sphincter to suppress nausea and vomiting. This product does not easily cross the blood-brain barrier.
Storage】Store under light and seal.
Package】This product is packed in aluminum-plastic package, and the composition of the package is polyvinyl chloride solid pharmaceutical hard tablets/aluminum foil for pharmaceutical packaging. Package specification: 18 tablets per board, 1 board per box; 24 tablets per board, 1 board per box; 30 tablets per board, 1 board per box; 16 tablets per board, 2 boards per box; 24 tablets per board, 2 boards per box; 18 tablets per board, 2 boards per box.
【Validity】24 months
【Execution standard
【Approval number】
[Date of revision of instruction]
【Manufacturing enterprise】 【Manufacturing enterprise
Company Name: Huadong Medicine (Xi’an) Bohua Pharmaceutical Co.
Production Address: West Construction Road, Huayin City, Shaanxi Province
Postal Code: 714203
Telephone number: (0913) 4359077
Fax number: (0913) 4359037
Web
Address: www.bohua.com
If you have any questions, please contact with the manufacturer