Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1701
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Cyklokapron (Injection, Solution)
|
| dailymed-instance:dosage |
Immediately before dental extraction in patients with hemophilia, administer 10 mg per kg body weight of CYKLOKAPRON intravenously together with replacement therapy . Following surgery, parenteral therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days. Note: For patients with moderate to severe impaired renal function, the following dosages are recommended: For intravenous infusion, CYKLOKAPRON Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to CYKLOKAPRON Injection. CYKLOKAPRON Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
|
| dailymed-instance:descripti... |
Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL.<br/>FORMULATION: Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid. Structural Formula: Tranexamic acid is a white crystalline powder. The aqueous solution for injection has a pH of 6.5 to 8.0.
|
| dailymed-instance:clinicalP... |
Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. Tranexamic acid in a concentration of 1 mg per mL does not aggregate platelets in vitro. Tranexamic acid in concentrations up to 10 mg per mL blood has no influence on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood from normal subjects. On the other hand, tranexamic acid in concentrations of 10 mg and 1 mg per mL blood prolongs the thrombin time. The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind to serum albumin. After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase. The initial volume of distribution is about 9 to 12 liters. Urinary excretion is the main route of elimination via glomerular filtration. Overall renal clearance is equal to overall plasma clearance (110 to 116 mL/min) and more than 95% of the dose is excreted in the urine as the unchanged drug. Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg per kg body weight. An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up to seven or eight hours. Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg per kg to pregnant women is about 30 mg per L, as high as in the maternal blood. Tranexamic acid diffuses rapidly into joint fluid and the synovial membrane. In the joint fluid the same concentration is obtained as in the serum. The biological half-life of tranexamic acid in the joint fluid is about three hours. The concentration of tranexamic acid in a number of other tissues is lower than in blood. In breast milk the concentration is about one hundredth of the serum peak concentration. Tranexamic acid concentration in cerebrospinal fluid is about one tenth of that of the plasma. The drug passes into the aqueous humor, the concentration being about one tenth of the plasma concentration. Tranexamic acid has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
CYKLOKAPRON Injection is contraindicated:
|
| dailymed-instance:supply |
CYKLOKAPRON Injection 100 mg/mL NDC 0013-1114-10 10��10 mL ampules<br/>STORAGE: Store at 25��C (77��F); excursions permitted to 15�����30��C (59�����86��F) [see USP Controlled Room Temperature].
|
| dailymed-instance:genericDr... | |
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:possibleD... | |
| dailymed-instance:overdosag... |
There is no known case of overdosage of CYKLOKAPRON Injection. Symptoms of overdosage may be nausea, vomiting, orthostatic symptoms and/or hypotension.
|
| dailymed-instance:genericMe... |
tranexamic acid
|
| dailymed-instance:fullName |
Cyklokapron (Injection, Solution)
|
| dailymed-instance:adverseRe... |
Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur but disappear when the dosage is reduced. Giddiness and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. To avoid this response, the solution should not be injected more rapidly than 1 mL per minute.<br/>Worldwide Postmarketing Reports: Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined.
|
| dailymed-instance:indicatio... |
CYKLOKAPRON Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Cyklokapron
|