Date of approval.
Date of revision.
Fodorostam Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic name: Fudosteine Tablets
English name: Fudosteine Tablets
Chinese Pinyin: Fuduositan Pian
[Ingredients]
The main ingredient of this product is Fudosteine
Chemical Name: (2R)-2-amino-3-(3-hydroxypropylthio)propionic acid
Chemical structure formula.
Molecular formula: C6H13NO3S
Molecular weight: 179.24
[Properties] This product is a white film-coated tablet, which appears white after removing the coating.
[Indications]
For the expectorant treatment of bronchial asthma, chronic wheezing bronchitis, bronchiectasis, tuberculosis, pneumoconiosis, emphysema, chronic obstructive pulmonary emphysema, atypical branching bacillus, pneumonia, diffuse bronchitis and other respiratory tract diseases.
[Specification] 0.2g
[Dosage]
Take orally. Usually adults take 0.4g (2 tablets) three times a day with meals, and adjust the dose according to age and symptoms or as prescribed by the doctor.
[Adverse reactions]
1, digestive system: common (>1/100, <1/10) with loss of appetite, nausea, vomiting; occasional (>1/1000, <1/100) with diarrhea, chest tightness, stomach discomfort, burning sensation in the stomach; rare (>1/10,000, <1/1000) with abdominal pain, stomach pain, abdominal distension, dry mouth, constipation, tongue inflammation. of unknown incidence are stomatitis, labyrinthitis.
2. sensory organs: tinnitus and abnormal taste, both rare.
3, mental nervous system: headache is occasional; numbness, vertigo, drowsiness, are rare.
4, urinary system: elevated BUN, proteinuria, all rare.
5. skin and mucous membrane: rash and pruritus are occasional; erythema and urticaria are rare.
6, respiratory system: cough, dyspnea (incidence unknown).
7, Stevens-Johnson disease, toxic epidermal necrolysis (Lyell’s disease): it has been reported that similar drugs of this product may cause the above symptoms. Therefore, if similar symptoms occur when this product is given, the administration of the drug should be stopped and appropriate treatment measures should be taken.
8, liver function impairment: liver function impairment with elevated AST, ALT, ALP may occur (all common), should be closely observed, and if abnormalities occur, the drug should be stopped and appropriate treatment measures should be taken.
9, other reactions: fever, flushing, fatigue, chest tightness, urinary frequency, swelling, all rare; palpitations (incidence unknown).
[Precautions]
1. patients with hepatic impairment This product may cause further deterioration of liver function in patients with hepatic impairment.
2. Patients with cardiac impairment The same drug as this product has been reported to produce adverse effects in patients with cardiac insufficiency.
[For pregnant and lactating women]
1. This product should be given to pregnant women only when the beneficial effects of the treatment are judged to be greater than the risks (in a rabbit fetal organogenesis test, abortion occurred when 0.6g/kg of this product was given orally at approximately 30 times the clinical dosage; in rats, the development of the offspring was inhibited when 2g/kg of this product was given during perinatal and lactation periods at 100 times the clinical dosage).
2. Lactating women should stop breastfeeding when administering the drug, because animal tests (rats) have found that the product can enter the milk.
[The safety and efficacy of fordostane in pediatric patients have not been evaluated.
[Geriatric Use] Geriatric patients should be advised to take reduced doses or as directed by their physician due to reduced physiological function.
[Drug Interactions] Not known.
[Overdose]
In case of acute overdose, careful observation should be made and symptomatic treatment and supportive therapy should be provided.
[Pharmacology and Toxicology]
Pharmacological effects
This product is a mucolytic agent that inhibits the excessive formation of mucus-secreting cup cells in the trachea and inhibits the production of high-viscosity rockweed mucin, thus reducing the viscosity of sputum and making it easier to cough up. It also increases plasmatic tracheal secretion and has an inhibitory effect on tracheal inflammation.
Toxicological effects
Reproductive toxicity: No effect on fertility was seen in rats given a dose of 2g/kg; in rabbits given a dose of 0.6g/kg, abortion occurred in a few animals, and no teratogenic effect was seen.
Genotoxicity: The results of Ames test, Chinese hamster lung cell chromosome aberration test and mouse bone marrow micronucleus test were all negative.
[Pharmacokinetics]
Foreign pharmacokinetic studies showed that fordostane 0.4g was administered orally to healthy adult males on an empty stomach with a Tmax of 0.42±0.13h, a Cmax of 10.19±3.34μg/ml, a T1/2 of 2.6±0.6h and a 24h AUC of 23.41±6.03μg-h/ml, and was metabolized in the body mainly by the liver and kidneys and excreted mainly through the urine. The 36h urinary prodrug content <1%, and the main metabolite was N-acetyl fordosulfan (content about 53%). The pharmacological parameters of the drug generation were not significantly different when administered for 6 consecutive days, 0.4g/dose, 3 times/day; the drug generation of fodosartan was affected by feeding, with Tmax prolonged and Cmax decreased after feeding; however, it was not affected by age. The product is hardly bound to plasma proteins. [Storage] Store at room temperature.
[Package] Polyvinyl chloride solid pharmaceutical rigid tablets/aluminum foil for pharmaceutical packaging, polyester/aluminum/polyethylene composite film and bag for pharmaceutical packaging. 12 tablets/plate, 2 plates/bag, 1 bag/box.
[Expiry date] 24 months
[Executive Standard]
[Approval number]
[Manufacturer]
Company Name: Sichuan Keren Pharmaceutical Co.
Production Address: Ziyang Economic and Technological Development Zone Anyue Industrial Park (Shiqiaopu Town, Anyue County)
Zip code: 642350
Fax number: 028-86139152
Product complaint line: (028)-82860553
Pharmacovigilance line: (028)-67825853
Website: http://www.kelun.com