NEODOSE

INDICATIONS

• For the treatment of heparin-induced bleeding.
• For the treatment of low molecular weight heparin-induced bleeding. Although the safety effectiveness of protamine sulfate among pediatric patients has not been approved by the US Food and Drug Administration, the American College of Chest Physicians (AACP) Evidence Based Clinical Practice Guidelines state that for treatment of low molecular weight heparin (LMWH)-induced bleeding, protamine sulfate will neutralize anti-IIa activity and partially neutralize anti-Xa activity. Protamine sulfate dosing is dependent on the dose of the LMWH administered and repeated doses may be required.

ADVERSE EFFECTS

Excessive doses can cause serious bleeding problems. Hypotension, bradycardia, dyspnea, and transitory flushing have been reported in adults.

ADMINISTRATION

Administer intravenously. Recommended to be given undiluted, but if necessary, may further dilute in D5W or NS. Infusion rate of a 10 mg/mL solution (undiluted) should not exceed 5 mg/min

BLACK BOX WARNING

Hypotension, cardiovascular collapse, pulmonary edema, pulmonary vasoconstriction, and pulmonary hypertension may occur. Cases of life-threatening pulmonary hypertension and severe hemorrhagic pulmonary edema have been reported in infants after protamine administration. Risk factors for severe protamine adverse reactions include high doses, rapid administration, repeated doses, previous exposure to protamine or protaminecontaining drugs (eg, NPH insulin, protamine zinc insulin, and certain beta blockers), known hypersensitivity reactions to fish, severe left ventricular dysfunction, and abnormal preoperative pulmonary hemodynamics. Vasopressors and resuscitation equipment should be available. Should not be used for bleeding occurring without prior heparin use.

MONITORING

Monitor vital signs, clotting functions, and blood pressure continuously. Observe for bleeding.