Enoxaparin Sodium (Page 5 of 16)
Elevations of Serum Aminotransferases
Asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than three times the upper limit of normal of the laboratory reference range have been reported in up to 6.1% and 5.9% of patients, respectively, during treatment with enoxaparin sodium injection. Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like enoxaparin sodium injection should be interpreted with caution.
Local Reactions
Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of enoxaparin sodium injection.
Adverse Reactions in Patients Receiving Enoxaparin Sodium Injection for Prophylaxis or Treatment of DVT, PE:
Other adverse reactions that were thought to be possibly or probably related to treatment with enoxaparin sodium injection, heparin, or placebo in clinical trials with patients undergoing hip or knee replacement surgery, abdominal or colorectal surgery, or treatment for DVT and that occurred at a rate of at least 2% in the enoxaparin sodium injection group, are provided below (see Tables 8 to 11).
Dosing Regimen | ||||
---|---|---|---|---|
Enoxaparin Sodium Injection 40 mg daily subcutaneously n = 1228 % | Heparin 5000 U q8h subcutaneously n = 1234 % | |||
Adverse Reaction | Severe | Total | Severe | Total |
Hemorrhage | <1 | 7 | <1 | 6 |
Anemia | <1 | 3 | <1 | 3 |
Ecchymosis | 0 | 3 | 0 | 3 |
Dosing Regimen | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Enoxaparin Sodium Injection 40 mg daily subcutaneously | Enoxaparin Sodium Injection 30 mg q12h subcutaneously | Heparin 15,000 U/24h subcutaneously | Placebo q12h subcutaneously | |||||||
Peri-operative Period n = 288 * % | Extended Prophylaxis Period n = 131 † % | n = 1080 % | n = 766 % | n = 115 % | ||||||
Adverse Reaction | Severe | Total | Severe | Total | Severe | Total | Severe | Total | Severe | Total |
| ||||||||||
Fever | 0 | 8 | 0 | 0 | <1 | 5 | <1 | 4 | 0 | 3 |
Hemorrhage | <1 | 13 | 0 | 5 | <1 | 4 | 1 | 4 | 0 | 3 |
Nausea | – | – | – | – | <1 | 3 | <1 | 2 | 0 | 2 |
Anemia | 0 | 16 | 0 | <2 | <1 | 2 | 2 | 5 | <1 | 7 |
Edema | – | – | – | – | <1 | 2 | <1 | 2 | 0 | 2 |
Peripheral edema | 0 | 6 | 0 | 0 | <1 | 3 | <1 | 4 | 0 | 3 |
Dosing Regimen | ||
---|---|---|
Adverse Reaction | Enoxaparin Sodium Injection 40 mg daily subcutaneously n = 360 % | Placebo daily subcutaneously n = 362 % |
Dyspnea | 3.3 | 5.2 |
Thrombocytopenia | 2.8 | 2.8 |
Confusion | 2.2 | 1.1 |
Diarrhea | 2.2 | 1.7 |
Nausea | 2.5 | 1.7 |
Dosing Regimen | ||||||
---|---|---|---|---|---|---|
Enoxaparin Sodium Injection 1.5 mg/kg daily subcutaneously n = 298 % | Enoxaparin Sodium Injection 1 mg/kg q12h subcutaneously n = 559 % | Heparin aPTT Adjusted Intravenous Therapy n = 544 % | ||||
Adverse Reaction | Severe | Total | Severe | Total | Severe | Total |
Injection Site Hemorrhage | 0 | 5 | 0 | 3 | <1 | <1 |
Injection Site Pain | 0 | 2 | 0 | 2 | 0 | 0 |
Hematuria | 0 | 2 | 0 | <1 | <1 | 2 |
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