Aminocaproic Acid (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of aminocaproic acid and studies to evaluate its mutagenic potential have not been conducted. Dietary administration of an equivalent of the maximum human therapeutic dose of aminocaproic acid to rats of both sexes impaired fertility as evidenced by decreased implantations, litter sizes and number of pups born.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with aminocaproic acid. It is also not known whether aminocaproic acid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminocaproic acid should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when aminocaproic acid is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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.

T o report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 g/kg and 12.0 g/kg, respectively, in the mouse and 3.2 g/kg 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

The dosage regimen for administering aminocaproic acid tablets is as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 10 aminocaproic acid 500 mg tablets (5 g) be administered during the first hour of treatment, followed by a continuing rate of 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 are supplied as round shape with notch, uncoated, biconvex, white to off-white tablets, debossed with identification marking “C” and “17” on either side of the score line on one side and plain on the other side.
They are available as follows:

Bottles of 30: NDC 69238-1637-3

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP.

REFERENCE

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


Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad 382213, INDIA


Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 12-2020-02

PRINCIPAL DISPLAY PANEL

NDC 69238-1637-3
Aminocaproic Acid Tablets USP, 500 mg
Rx only
30 Tablets
Amneal Pharmaceuticals LLC

dsdf
(click image for full-size original)
AMINOCAPROIC ACID
aminocaproic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1637
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 (15 MPA.S AT 5%)
MAGNESIUM STEARATE
POVIDONE
STEARIC ACID
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code C;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1637-3 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212492 11/30/2019
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Registrant — Amneal Pharmaceuticals of New York, LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit 650762060 ANALYSIS (69238-1637), LABEL (69238-1637), MANUFACTURE (69238-1637), PACK (69238-1637)

Revised: 12/2020 Amneal Pharmaceuticals NY LLC

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