AMINOCAPROIC ACID (Page 2 of 2)

ADVERSE REACTIONS

Aminocaproic acid is generally well tolerated. The following adverse experiences have been reported:

General: Edema, headache, malaise.

Hypersensitivity Reactions: Allergic and anaphylactoid reactions, anaphylaxis.

Cardiovascular: Bradycardia, hypotension, peripheral ischemia, thrombosis.

Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting.

Hematologic: Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia.

Musculoskeletal: CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS), myositis, rhabdomyolysis.

Neurologic: Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope.

Respiratory: Dyspnea, nasal congestion, pulmonary embolism.

Skin: Pruritis, rash.

Special Senses: Tinnitus, vision decreased, watery eyes.

Urogenital: BUN increased, renal failure. There have been some reports of dry ejaculation during the period of aminocaproic acid treatment. These have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. However, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc., at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

A few cases of acute overdosage with aminocaproic acid administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal failure leading to death. One patient with a history of brain tumor and seizures experienced seizures after receiving an 8 gram bolus injection of aminocaproic acid. The single dose of aminocaproic acid causing symptoms of overdosage or considered to be life-threatening is unknown. Patients have tolerated doses as high as 100 grams while acute renal failure has been reported following a dose of 12 grams.

The intravenous and oral LD₅₀ of aminocaproic acid were 3.0 and 12.0 g/kg, respectively, in the mouse and 3.2 and 16.4 g/kg, respectively, in the rat. An intravenous infusion dose of 2.3 g/kg was lethal in the dog. On intravenous administration, tonic-clonic convulsions were observed in dogs and mice.

No treatment for overdosage is known, although evidence exists that aminocaproic acid is removed by hemodialysis and may be removed by peritoneal dialysis. Pharmacokinetic studies have shown that total body clearance of aminocaproic acid is markedly decreased in patients with severe renal failure.

DOSAGE AND ADMINISTRATION

An identical dosage regimen may be followed by administering aminocaproic acid tablets as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 Aminocaproic acid 1000 mg Tablets or 10 Aminocaproic acid 500 mg Tablets (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 Aminocaproic acid 1000 mg Tablet or 2 Aminocaproic acid 500 mg Tablets (1 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.

HOW SUPPLIED

Aminocaproic acid Tablets USP, 500 mg

Each white, round, standard concave tablet debossed with “LP 231” on one side and scored on other side, contains 500 mg of aminocaproic acid.

Bottle of 30 – NDC 70377-102-11

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers.

Aminocaproic acid Tablets USP, 1000 mg

Each white, caplet shaped tablet debossed with “LP 232” on one side and scored on other side, contains 1000 mg of aminocaproic acid.

Bottle of 30 – NDC 70377-103-11

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers.

REFERENCE

¹ Stefanini M, Dameshek W: The Hemorrhagic Disorders, Ed. 2, New York, Grune and Stratton; 1962:510-514.

Manufactured by:

Carnegie Pharmaceuticals, LLC

Delran, NJ 08075, USA

Distributed by:

Biocon Pharma Inc.,

Iselin, New Jersey, 08830-3009

USA

Rev. 08/22

AMINOCAPROIC ACID aminocaproic acid tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 500 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE MAGNESIUM STEARATE POVIDONE STEARIC ACID

Product Characteristics Color white (white to off white) Score 2 pieces Shape ROUND (round standard concave) Size 13mm Flavor Imprint Code LP;231 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70377-102-11 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213928 03/15/2021

AMINOCAPROIC ACID aminocaproic acid tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-103 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 1000 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE MAGNESIUM STEARATE POVIDONE STEARIC ACID

Product Characteristics Color white (white to off white) Score 2 pieces Shape CAPSULE (caplet shaped) Size 22mm Flavor Imprint Code LP;232 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70377-103-11 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213928 03/15/2021

Labeler — Biocon Pharma Inc. (080000063)

Registrant — Carnegie Pharmaceuticals, LLC (079839141)

Establishment
Name	Address	ID/FEI	Operations
Carnegie Pharmaceuticals, LLC		079839141	manufacture (70377-102), analysis (70377-102), pack (70377-102), manufacture (70377-103), analysis (70377-103), pack (70377-103)

Revised: 08/2021 Biocon Pharma Inc.