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

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.

To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505, 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 Oral Solution as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 20 milliliter of Aminocaproic Acid Oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 5 milliliter of Aminocaproic Acid Oral Solution (1.25 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 Oral Solution, USP 0.25 g/mL

Each mL of clear colorless to yellow colored solution with raspberry order contains 0.25 g/mL of aminocaproic acid.

8 Fl. Oz. (236.5 mL) Bottle – NDC 66689-330-08

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]; Dispense in Tight Containers; Do Not Freeze.

REFERENCES

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

Manufactured for:

VistaPharm, Inc.

Largo, FL 33771, USA

VP2248

Rev. 04/2019

PRINCIPAL DISPLAY PANEL

NDC 66689-330-08

Aminocaproic Acid

Oral Solution, USP

0.25 grams/mL

PHARMACIST: Dispense in a tight container

with a child-resistant closure.

8 FL. Oz. (236.5 mL)

Rx Only

VistaPharm

launch Bottle
(click image for full-size original)

NDC 66689-330-08

Aminocaproic Acid

Oral Solution, USP

0.25 grams/mL

PHARMACIST: Dispense in a tight container

with a child-resistant closure.

8 FL. Oz. (236.5 mL)

Rx Only

VistaPharm

launch Carton
(click image for full-size original)
AMINOCAPROIC ACID
aminocaproic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-330
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 0.25 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
EDETATE DISODIUM
SACCHARIN SODIUM
SORBITOL
ANHYDROUS CITRIC ACID
WATER
Product Characteristics
Color YELLOW (clear to colorless) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66689-330-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 236.5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (66689-330-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212814 03/04/2020
Labeler — VistaPharm, Inc. (116743084)

Revised: 07/2018 VistaPharm, Inc.

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