Product Overview
[Drug Name]
Generic Name: Famotidine Tablets
Trade Name: XinFaDing Famotidine Tablets 20mg*30 Tablets
Pinyin Full Code: XinFaDing FaMoTiDingPian 20mg*30 Tablets
[Main Ingredient]
Chemical Name: 3-[[[2-[(Diaminomethylene)amino]-4-thiazolyl]methyl]thio]-N-sulfamoylpropionamidine
[Properties]
This product is available as a sugar-coated or film-coated tablet. After removal of the sugar-coated or film-coated tablet, it appears white or off-white.
[Indications/Main Functions]
It is indicated for peptic ulcer disease (gastric and duodenal ulcers), stress ulcers, acute gastric mucosal bleeding, gastrinoma, and reflux esophagitis.
[Specifications]
20mg*30 tablets
[Dosage and Administration]
Oral: 20mg (1 tablet at a time), twice daily, after breakfast, dinner, or before bed. A course of treatment is 4-6 weeks. The maintenance dose can be reduced after the ulcer heals.
[Adverse Reactions]
A small number of patients may experience dry mouth, dizziness, insomnia, constipation, diarrhea, rash, and facial flushing. Occasionally, leukopenia and mild elevation of transaminases may occur.
[Contraindications]
1. Contraindicated in patients with allergies, severe renal insufficiency, and pregnant or lactating women.
2. Use with caution in patients with hepatic or renal insufficiency and in infants and young children.
[Precautions]
This product should be used only after gastric cancer has been ruled out.
[Drug Interactions]
This drug does not interact with hepatic cytochrome P450 enzymes and therefore does not affect the metabolism of drugs such as theophylline, phenytoin, warfarin, and diazepam, nor does it affect the distribution of drugs such as procainamide. However, probenecid may inhibit the renal tubular excretion of famotidine.
[Pediatric Use]
Use with caution in infants and young children.
[Elderly Use]
Dose adjustment is generally not required for elderly patients, except those with hepatic or renal insufficiency.
[Pregnant and Lactating Women Use]
This drug is contraindicated in pregnant and lactating women.
[Overdose]
Unknown.
[Pharmacology and Toxicology]
This drug is a histamine H2 receptor blocker. It has a significant inhibitory effect on gastric acid secretion and may also inhibit pepsin secretion, demonstrating a protective effect against experimental ulcers in animals. The onset of action is approximately one hour after administration, and the effect lasts for more than 12 hours.
[Pharmacokinetics]
Following oral administration, 14C-famotidine is rapidly absorbed in healthy volunteers in China, reaching peak blood concentrations in approximately 2 hours and a half-life of approximately 3 hours. Literature reports indicate that after oral or intravenous administration of 14C-famotidine to rats, radioactivity is elevated in the digestive tract, liver, kidneys, submandibular gland, and pancreas. 80% of the unchanged substance is excreted in the urine, and the inhibitory effect on hepatic enzymes is minimal.
[Storage]
Store in a sealed, light-proof container.
[Expiry Period]
36 months
[Approval Number]
National Medicine Standard H10950278
[Manufacturer]
Shanghai SPH Pharmaceuticals Co., Ltd.
