arnings and Precautions (5)].
2.1 Adult DosageProphylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of FRAGMIN Injection is 120 IU/kg of body weight, but not more than 10,000 IU, subcutaneously every 12 hours with concurrent oral aspirin (75 to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 to 8 days. Concurrent aspirin therapy is recommended except when contraindicated.
Table 1 lists the volume of FRAGMIN, based on the 9.5 mL multiple-dose vial (10,000 IU/mL), to be administered for a range of patient weights.
Table 1
Volume of FRAGMIN to be Administered by Patient Weight, Based on
9.5 mL Vial (10,000 IU/mL)
Patient
weight (lb) < 110 110 to 131 132 to 153 154 to 175 176 to 197 ≥ 198
Patient
weight (kg) < 50 50 to 59 60 to 69 70 to 79 80 to 89 ≥ 90
Volume of
FRAGMIN (mL) 0.55 0.65 0.75 0.90 1.0 1.0
Prophylaxis of Venous Thromboembolism Following Hip Replacement Surgery: Table 2 presents the dosing options for patients undergoing hip replacement surgery. The usual duration of administration is 5 to 10 days after surgery; up to 14 days of treatment with FRAGMIN have been well tolerated in clinical trials.
Table 2
Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First
Dose
of FRAGMIN Dose of FRAGMIN to be Given Subcutaneously
10 to 14 Hours
Before Surgery Within 2 Hours
Before Surgery 4 to 8 Hours
After Surgery1 Postoperative
Period2
Postoperative
Start --- --- 2500 IU3 5000 IU once daily
Preoperative
Start - Day of
Surgery --- 2500 IU 2500 IU3 5000 IU once daily
Preoperative
Start - Evening
Before Surgery4 5000 IU --- 5000 IU 5000 IU once daily
1 Or later, if hemostasis has not been achieved.
2 Up to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 to 10 days postoperatively.
3 Allow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.
4 Allow approximately 24 hours between doses.
Abdominal Surgery: In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of FRAGMIN is 2500 IU administered by subcutaneous injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively. The usual duration of ad |
