AMINOCAPROIC ACID tablet AMINOCAPROIC ACID syrup

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)

Dostupné z:

Akorn Operating Company LLC

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings ). Aminocaproic acid should not be used when there is evidence of an

Prehľad produktov:

Aminocaproic Acid Oral Solution USP, 0.25 g/mL Each mL of raspberry-flavored oral solution contains 0.25 g/ mL of aminocaproic acid. 8 Fl. Oz. (237 mL) Bottle - NDC 17478-447-08 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze. Aminocaproic Acid Tablets USP, 500 mg Each round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right, contains 500 mg of aminocaproic acid. Bottle of 30 – NDC 17478-768-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze. Aminocaproic Acid Tablets USP, 1000 mg Each oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right, contains 1000 mg of aminocaproic acid. Bottle of 30 – NDC 17478-769-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze.

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
AMINOCAPROIC ACID- AMINOCAPROIC ACID SYRUP
AKORN OPERATING COMPANY LLC
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AMINOCAPROIC ACID TABLETS USP 500 MG, 1000 MG AND ORAL SOLUTION 0.25
G/ML
RX ONLY
DESCRIPTION
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it is sparingly soluble in
methanol and practically insoluble in chloroform.
Aminocaproic acid oral solution for oral administration, contains 0.25
g/mL of
aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%,
edetate disodium
0.30% as preservatives and the following inactive ingredients: sodium
saccharin, sorbitol
solution, citric acid anhydrous, natural and artificial raspberry
flavor and an artificial
bitterness modifier.
Each aminocaproic acid tablet for oral administration contains either
500 mg or 1000 mg
of aminocaproic acid and the following inactive ingredients: povidone,
crospovidone,
stearic acid, and magnesium stearate.
CLINICAL PHARMACOLOGY
The fibrinolysis-inhibitory effects of aminocaproic acid appear to be
exerted principally
via inhibition of plasminogen activators and to a lesser degree
through antiplasmin
activity.
In adults, oral absorption appears to be a zero-order process with an
absorption rate of
5.2 g/hr. The mean lag time in absorption is 10 minutes. After a
single oral dose of 5 g,
absorption was complete (F=1). Mean ± SD peak plasma concentrations
(164 ± 28
mcg/mL) were reached within 1.2 ± 0.45 hours.
After oral administration, the apparent volume of distribution was
estimated to be 23.1
± 6.6 L (mean ± SD). Correspondingly, the volume of distribution
after intravenous
administration has been reported to be 30.0 ± 8.2 L. After prolonged
administration,
aminocaproic acid has been found to distribute throughout
extravascular and
intravascular compartments of the body, penetrating human red blood
cells as well as
other tissue cells.
Renal excretion is the primary route of el