E-capro

• Approved Indications:
• Treatment and prevention of excessive bleeding due to hyperfibrinolysis (e.g., following surgery, trauma, or in bleeding disorders).
• Control and reduction of bleeding in patients with hemophilia undergoing dental or surgical procedures, often as adjunctive therapy to factor replacement.
• Management of bleeding associated with fibrinolytic therapy or excessive fibrinolytic activity (e.g., disseminated intravascular coagulation with predominant fibrinolysis).
• Off-label/Clinically Accepted Uses:
• Prophylaxis and treatment of bleeding in patients with other acquired or congenital bleeding disorders involving hyperfibrinolysis.
• Use in menorrhagia (heavy menstrual bleeding) to reduce blood loss.
• Adjunctive therapy in traumatic bleeding or intracranial hemorrhage in selected cases.

• Adults:
• Oral: Initial dose 4 to 5 grams per day divided into 3 to 6 doses, typically 1 gram every 6 hours. Maintenance dose usually 1 to 1.5 grams every 6 hours.
• Intravenous (IV): Loading dose 4 to 5 grams over 1 hour, followed by 1 gram/hour infusion or intermittent doses as clinically indicated.
• Duration depends on bleeding severity and clinical response; often continued for several days.
• Pediatrics:
• Oral: 50 to 100 mg/kg/day divided into 3 to 6 doses.
• IV dosing guided by clinical condition and weight; careful monitoring recommended.
• Elderly:
• Use caution; start at lower doses and adjust based on renal function and bleeding risk.
• Renal Impairment:
• Dose reduction necessary due to renal excretion; monitor renal function closely.
• Hepatic Impairment:
• Use with caution; no specific dose adjustment guidelines but monitor for efficacy and toxicity.
• Administration Route:
• Oral tablets or solution; intravenous infusion under medical supervision.

Aminocaproic acid is a synthetic lysine analogue that competitively inhibits the activation of plasminogen to plasmin by binding to lysine binding sites on plasminogen molecules. This inhibition prevents plasmin from degrading fibrin clots, thereby stabilizing formed clots and reducing bleeding. By blocking fibrinolysis, aminocaproic acid promotes clot preservation and enhances hemostasis in conditions characterized by excessive fibrinolytic activity.

• Absorption:
• Well absorbed orally with peak plasma concentrations reached within 1 to 2 hours.
• Distribution:
• Widely distributed in body fluids and tissues.
• Approximately 20% bound to plasma proteins.
• Metabolism:
• Minimally metabolized; primarily excreted unchanged.
• Elimination:
• Primarily excreted unchanged by the kidneys via glomerular filtration and tubular secretion.
• Half-life:
• Approximately 2 hours in healthy individuals; prolonged in renal impairment.
• Bioavailability:
• Oral bioavailability approximately 90%.

• Pregnancy:
• FDA pregnancy category C. Animal studies have shown some adverse effects at high doses; no well-controlled studies in humans. Use only if clearly needed and benefits outweigh risks.
• Lactation:
• Unknown if excreted in human milk; caution advised. Use only if clearly necessary and monitor infant for adverse effects.
• Limited human data; use with caution during pregnancy and lactation.

• Antifibrinolytic Agent
• Hemostatic Agent

• Known hypersensitivity to aminocaproic acid or any formulation components.
• Active intravascular clotting such as disseminated intravascular coagulation without concurrent heparin therapy.
• History of thrombosis or thromboembolic disease unless benefits clearly outweigh risks.
• Severe renal impairment without dose adjustment.

• Risk of thrombosis or thromboembolism; use cautiously in patients with a history of clotting disorders.
• Monitor renal function closely; dose adjustments required in renal impairment.
• Use caution in patients with disseminated intravascular coagulation; may exacerbate condition if not properly managed.
• Monitor for signs of hypersensitivity reactions, including rash and anaphylaxis.
• Observe for muscle necrosis or myopathy in rare cases.
• Patients should be monitored for signs of excessive clot formation and ischemia.

• Common:
• Gastrointestinal disturbances (nausea, vomiting, diarrhea)
• Hypotension (especially with rapid IV administration)
• Dizziness, headache
• Serious/Rare:
• Thromboembolic events (deep vein thrombosis, pulmonary embolism)
• Muscle necrosis or myopathy
• Hypersensitivity reactions including rash, urticaria, and anaphylaxis
• Visual disturbances (rare)
• Excessive clotting leading to ischemic complications

• Concomitant use with other procoagulants or antifibrinolytics may increase risk of thrombosis.
• Use cautiously with anticoagulants; aminocaproic acid may reduce their efficacy.
• No significant CYP450 enzyme interactions reported.
• Concurrent use with estrogen-containing drugs may increase thrombotic risk.
• Avoid concomitant use with thrombolytic agents except under careful medical supervision.

• Updated guidelines emphasize aminocaproic acid use as adjunctive therapy for bleeding associated with hyperfibrinolysis, particularly in hemophilia and surgical settings.
• Safety warnings about thromboembolic risk have been reinforced; clinicians advised to assess thrombotic risk before use.
• FDA and other regulatory bodies recommend renal function monitoring and dose adjustment in patients with renal impairment.
• No recent changes in approved indications; clinical practice guidelines encourage cautious use in trauma-related bleeding.

• Store at controlled room temperature between 20°C and 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep container tightly closed when not in use.
• Do not freeze; avoid extreme temperatures.
• Oral solutions should be stored according to manufacturer instructions and discarded after recommended period.