NAMES
Cisapride Tablets
Cisapride Pian
Xishabili Pian
Xi Sha Bi Li Pian
西沙比利片
Cisapride Tablets for functional dyspepsia or excessive belching
ACTIONS and INDICATIONS
Total gastrointestinal stimulator.Mainly used for functional dyspepsia, upper gastrointestinal discomfort with negative X-ray and endoscopy, symptoms of early satiety, satiation after meal, eat less, stomach distension, excessive belching, lack of appetite, nausea, vomiting or similar ulcer chief complaint (upper abdominal burning pain).It can also be used to treat mild reflux esophagitis.
INGREDIENTS
The main ingredient is cisapride.Chemical name: cis - amino - 4-5 - chloro - N - [1 - [3 - (4 - fluorine phenoxy) propyl] oxygen - 3 - methyl - 4 pyridyl] - 2 - methyl aniline oxygen.Molecular formula: C23H29C1FN304 molecular weight: 465.95
PROPERTIES
White tablets.
Spec.
5mg*10 capsules/box.
USAGE AND DOSAGE
(1) the maximum daily dose is 30mg (that is, 6 tablets).
(2) adults: according to the severity of the disease, the total daily dose is 15-30mg(i.e., 3-6 tablets), administered in 2-3 times, with each dose of 5mg(i.e., 1 tablet) (the dose can be doubled).
(3) children who weigh 25-50 kg: the maximum dose is 5mg(that is, 1 tablet), four times a day.Oral tablet or oral suspension.
(4) infants and children who weigh less than 25 Kg each: 0,2mg/Kg each time, 3 to 4 times a day.Better use suspension.
(5) it is recommended to avoid taking with grapefruit juice as much as possible.
(6) in cases of renal insufficiency, it is recommended to cut the daily dosage by half.
For pregnant and lactating women:
1. Although the formation of embryos is not affected in animals, there is no original embryo toxicity or teratogenic effect, the advantages and disadvantages should be weighed in pregnancy, especially in the first three months of pregnancy.
2. It is recommended that breastfeeding mothers be banned even though the amount of milk excreted is small.
Children's medicine:
Premature infants younger than 34 weeks should be used with caution.
Drugs for the aged:
In the elderly, with moderate prolongation of the clearance half-life, the steady-state plasma concentration will generally increase, so the treatment dose should be appropriately reduced.
ADVERSE REACTION
1. Instant abdominal cramps, abdominal singing and diarrhea are occasionally seen, and the dose can be halved;
2. Occasional reports of allergy, mild and transient headache or dizziness, and dose-related urinary frequency;
3. Rare reversible liver dysfunction with or without bile stasis;
4. The incidence of gynecomastia and galactosis in male breast, as measured on a large scale (< 0.1%), did not exceed the common values in the general population, and was reversible after drug withdrawal.The causal relationship is not clear;
5. Rare effects on central nervous system, namely convulsive epilepsy, extrapyramidal response and urinary frequency.
CONSTRAINDICATION
1. Patients are prohibited to use this product if allergic to it.
2. Prohibit the simultaneous oral or parenteral use of potent inhibitor CYP3A4, including: triazole antifungal drugs;Macrolides;HIV protease inhibitors;Naproxen.
3. Patients with heart disease, arrhythmia and prolonged QT interval shall be prohibited, and shall not be used together with drugs causing prolonged QT interval;Patients with water and electrolyte disturbance are prohibited, especially those with low blood potassium and low blood magnesium.No use for bradycardia;Family history of extended QT or extended QT interval syndrome is prohibited;Patients with pulmonary, hepatic and renal insufficiency are prohibited.
4. Contraindication for patients with diseases (such as gastrointestinal obstruction) that increase gastrointestinal motility and can cause harm.5. For premature infants, this product is not recommended for treatment.
PRECAUTION
1. Patients with increased gastrointestinal motility that can cause harm should be used with caution, and premature infants less than 34 weeks should be used with caution;
2. In cases of hepatic and renal insufficiency, it is recommended to halve the starting daily dosage, which can be adjusted appropriately according to the therapeutic effect and possible side effects;
3. In the elderly, due to the moderately prolonged clearance half-life, the steady-state plasma concentration will generally increase, so the treatment dose should be appropriately reduced;
4. Taking other drugs and had cardiovascular disease (CVD) and/or in the potential factors of arrhythmia patients between QT - duration and/or torsade DE points of individual cases, the relationship between this and this product is not yet clear, but in the period between may cause QT - extend the patient such as unadjusted electrolyte (k/mg) disorders, congenital QT - between lengthened or are taking known will produce QT - interphase prolong drug or shall be given due consideration when patients;
5. Although the formation of embryos is not affected in animals, there is no original embryo toxicity or teratogenic effect, the advantages and disadvantages should be weighed in pregnancy, especially in the first three months of pregnancy;
6. It is recommended not to be used by lactating mothers even though the amount of excreted milk is very small;
7. It does not affect psychomotor function and does not cause sedation and drowsiness.However, the uptake of central nervous system inhibitors, such as barbiturates, alcohol, etc., can be accelerated, so care should be taken at the same time.
DRUG INTERACTIONS
1. This product is a potent inhibitor of CYP3A4, so it should not be used with drugs mainly metabolized by CYP3A4, such as imidazoles, macrolides, etc., to avoid serious adverse reactions;
2. This product can accelerate the gastric emptying of drugs, reduce the absorption rate of drugs absorbed through the stomach and increase the absorption rate of drugs absorbed through the intestine.
VALIDITY
24 months.
STORAGE
Preserve in tightly closed containers,stored in a cool and dry place.
APPROVAL NUMBER
State medical permitment number.H20041577.
Manufactured
ZHEJIANG ANLIKANG PHARMACEUTICAL CO.,LTD
Tips: part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.
This product has not been evaluated by the FDA. It is not intended to
diagnose, treat, cure, or prevent any disease.
We highly recommend that you consult with a Traditional Chinese Medical
practitioner or physician before taking any products or if you have any
questions regarding your health.
