GMP Certified / Apixaban Tablets 2.5mg

• Customization: Available
• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Model NO.: Tablet
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 2.5mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Apixaban Tablets 2.5mg
Strength	2.5mg
Packing	56 tablets /box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Apixaban Tablets 2.5mg

Character:
This product is a yellow film coating, after removing the coating, white to almost white.

Indications:
For adult patients undergoing elective hip or knee replacement to prevent venous thromboembolic events (VTE).

Matters needing attention:
Bleeding risk
As with other anticoagulants, patients taking Apixaban should be closely monitored for signs of bleeding. Apixaban should be used with caution in patients at risk for: congenital or acquired bleeding disorders; Active gastrointestinal ulcer disease; Bacterial endocarditis; Thrombocytopenia; Abnormal platelet function; History of hemorrhagic stroke; Uncontrolled severe hypertension; Recently had brain, spine, or eye surgery. If severe bleeding occurs, Apixaban should be discontinued (see Drug Overdose).
Renal damage
Patients with mild or moderate renal impairment do not need to adjust the dose (see Pharmacokinetics).
Limited clinical data in patients with severe renal impairment (creatinine clearance 15-29ml/min) suggest elevated plasma concentrations of apixaban in this patient population, and apixaban alone or in combination with acetylsalicylic acid should be used with caution in these patients due to a possible increased risk of bleeding (see Pharmacokinetics).
Apixaban is not recommended in patients with creatinine clearance <15ml/min or in dialysis patients because there are no clinical data available (see Pharmacokinetics).
Elderly patients
There is limited clinical experience in the use of apixaban in combination with acetylsalicylic acid in elderly patients. Elderly patients should be cautious when taking these two drugs in combination because of a possible increased risk of bleeding.
Liver damage
Apixaban is contraindicated in patients with liver disease associated with coagulation abnormalities and clinically relevant bleeding risk (see contraindications).
Apixaban is not recommended for patients with severe liver damage (see Pharmacokinetics).
Apixaban should be taken with caution in patients with mild and moderate liver damage (Child Pugh grade A or B) (see Pharmacokinetics).
Because patients with elevated liver enzymes ALT/AST>2*ULN or total bilirubin ≥1.5*ULN were not included in clinical trials, Apixaban should be used with caution in these populations (see Pharmacokinetics). ALT should be routinely detected before surgery.
Hip fracture surgery
There are no clinical trials evaluating the efficacy and safety of apixaban in patients undergoing hip fracture surgery, and therefore Apixaban is not recommended in these patients.
Auxiliary material information
This product contains lactose. Patients with rare genetic galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this product.
Effects on driving and mechanical ability
Apixaban has no or negligible effect on driving and mechanical ability.

Pharmacology and toxicology:
It is an oral selective activation factor X inhibitor that prevents blood clots but has a lower risk of bleeding than the older drug warfarin, which is used to prevent blood clots in patients who have undergone hip or knee replacement surgery.

Storage:
Store below 30ºC