AMICAR Solution, Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Clover Pharmaceuticals Corp.

Λέξεις κλειδιά

49411-052 49411-050 49411-051

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1. Description

AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: AMICAR is soluble in water, acid, and alkaline solutions; it is sparingly soluble ...

2. Clinical Pharmacology

The fibrinolysis-inhibitory effects of AMICAR appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. In adults, oral absorption appears ...

3. Indications and Usage

AMICAR 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. ...

4. Contraindications

AMICAR should not be used when there is evidence of an active intravascular clotting process. When there is uncertainty as to whether the cause of bleeding is primary fibrinolysis or disseminated intravascular ...

5. Warnings

In patients with upper urinary tract bleeding, AMICAR administration has been known to cause intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis and ureters. ...

6.1. General

AMICAR inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The drug should NOT be administered without a definite diagnosis and/or laboratory finding indicative ...

6.3. Laboratory Tests

The use of AMICAR should be accompanied by tests designed to determine the amount of fibrinolysis present. There are presently available: (a) general tests such as those for the determination of the lysis ...

6.5. Drug/Laboratory Test Interactions

Prolongation of the template bleeding time has been reported during continuous intravenous infusion of AMICAR at dosages exceeding 24 g/day. Platelet function studies in these patients have not demonstrated ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of AMICAR and studies to evaluate its mutagenic potential have not been conducted. Dietary administration of an equivalent of the maximum ...

6.7. Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with AMICAR. It is also not known whether AMICAR can cause fetal harm when administered to a pregnant woman or can affect reproduction ...

6.9. 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 AMICAR is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

7. Adverse Reactions

AMICAR is generally well tolerated. The following adverse experiences have been reported: General: Edema, headache, malaise. Hypersensitivity Reactions: Allergic and anaphylactoid reactions, ...

9. Overdosage

A few cases of acute overdosage with AMICAR administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal failure leading to death. ...

10. Dosage and Administration

An identical dosage regimen may be followed by administering AMICAR Tablets or AMICAR Oral Solution as follows: For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is ...

11. How Supplied

AMICAR Oral Solution, 0.25 g/mL: Each mL of raspberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid. 8 Fl. Oz. (236.5 mL) Bottle NDC 49411-052-08 Store at 20°-25°C (68°-77°F) ...

14. References

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