| Customization: | Available |
|---|---|
| Certification: | ISO 9001, FDA |
| Use: | Healthy |
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| product name | Dabigatran Etexilate Mesylate |
| CAS NO. | 872728-81-9 |
| Specification | 99% |
| Appearance | White powder |
| packing | 1kg/bag,25kgs/drum |
| MOQ | 100G |
Capsules: 1. Used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation: (1) Recommended adult dose: 150 mg twice a day for patients with Ccr>30 ml/min, orally: 75 mg twice a day for patients with Ccr of 15-29 ml/min; contraindicated for patients with Ccr<15 ml/min or dialysis. (2) During clinical treatment, renal function needs to be evaluated and the dose adjusted in a timely manner. When using this product, if the patient develops acute renal failure, this product should be discontinued and other anticoagulant treatments should be considered. (3) Instruct patients not to chew, break or open the capsules: If a dose is missed, take a make-up dose at least 6 hours before the next dose, otherwise skip the dose. (4) When switching from to this product, when INR < 2.0, stop using and start taking this product. (5) When switching from this product to adjust the usage time according to creatinine clearance as follows: 1.For patients with Ccr > 50ml/min, start using 3 days before stopping using this product. 2.For patients with Ccr of 30-50ml/min, start using 2 days before stopping using this product. 3.For patients with Ccr of 15-29m/min, start using1 day before stopping using this product. (6) When switching from intravenous anticoagulants to this product, start taking this product 0-2 hours before the next dose, or start taking this product after stopping continuous administration (such as intravenous administration of undifferentiated heparin) (7) When switching from this product to intravenous anticoagulants, adjust the intravenous anticoagulant treatment time according to creatinine clearance as follows: 1. For patients with Ccr >30ml/m, start using intravenous anticoagulants 12 hours after stopping this product. 2.For patients with Ccr <30ml/minute, start using intravenous anticoagulants 24 hours after stopping this product. (8) Temporarily stop taking this product before minimally invasive surgery or surgical surgery, and resume taking the drug immediately after the surgery. The suspension time is as follows: For patients with Ccr >50ml/minute, temporarily stop taking this product 1-2 days before surgery. 2. For patients with Ccr <50ml/minute, temporarily stop taking this product 3-5 days before surgery.
2. For the prevention of venous thromboembolism after total hip or knee replacement: (1) For healthy adults, 220 mg, once a day, oral administration: Ccr is 30ml-50ml/min, 150 mg, once a day, oral administration: Ccr < 30ml/min is prohibited (2) Oral administration within 1-4 hours after the completion of the surgery, the starting dose is 110 mg, the maintenance dose is 220 mg, once a day; if not used on the day of surgery, the starting dose is 220 mg, once a day; if bleeding occurs, the medication is suspended. (3) Treatment course: 1.The total number of days for the prevention of venous thromboembolism after knee replacement is 10 days. 2.The total number of days for the prevention of venous thromboembolism after hip replacement is 28-35 days. (4) When this product is used simultaneously with amiodarone or verapamil, the dose should be reduced to 150 mg/day.
Adverse reactions:
1. Common adverse reactions are bleeding, including intracranial hemorrhage, gastrointestinal bleeding and gastrointestinal adverse reactions, and rare allergic reactions. 2. Gastrointestinal adverse reactions include indigestion (including abdominal pain, abdominal discomfort, upper abdominal discomfort) and gastritis-like syndrome
| Item | Specification | Test result |
| Appearance | white powder | Conforms |
| Assay | 99% | Conforms |
| Heavy metal | ≤10ppm | Conforms |
| Lead | ≤2.0ppm | Conforms |
| As | ≤2.0ppm | Conforms |
| Ca | ≤1.0ppm | Conforms |
| Me | ≤0.1ppm | Conforms |
| Total aerobic microbial count | ≤1000CFU/g | Conforms |
| Total moulds&yeast count | ≤100CFU/g | Conforms |
| Enterobacterial | ≤10MPN/g | Conforms |
| Salmonella | N.D/25g | Conforms |
| Escherichia coli | N.D/10g | Conforms |
| Staphylococcus aureus | N.D/10g | Conforms |
| Pseudomonas aeruginosa | N.D/10g | Conforms |
| Conclusion: Conform with specification. | ||
Uses: API for blood system; anticoagulant; used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; dabigatran is a new type of synthetic direct thrombin inhibitor, a prodrug of dabigatran, and a non-peptide thrombin inhibitor. Oral administration and gastrointestinal absorption.
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