In general, with doses of argatroban up to 2 gkgmin, argatroban can be discontinued when the inr is 4. Desferal deferoxamine mesylate for injection usp vials rx only prescribing information description desferal, deferoxamine mesylate usp, is an ironchelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Argatroban order set for heparininduced thrombocytopenia hit atn. Jan 20, 2020 reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose approximately 60 mg mupirocin per day on a mgm 2 basis and revealed no evidence of harm to the fetus due to mupirocin. In these patients, a mean steady state bivalirudin concentration of 12. Heparin induced thrombocytopenia hit treatment page 1.
Arixtra injection is provided in a singledose, prefilled syringe affixed with an automatic needle protection system. There are, however, no adequate and wellcontrolled. Prozac fluoxetine hydrochloride capsules label fda. Argatroban argatroban injection, solution this product information is intended only for residents of the united states. Argatroban fda prescribing information, side effects and.
Acova argatroban dosing, indications, interactions, adverse. Information for the user bactroban 2% nasal ointment mupirocin calcium read all of this leaflet carefully before you start using this medicine because it contains important information for you. A healthcare provider will give you this injection. The 149 clinical efficacy rate for bactroban ointment n 27 was 96%, and for erythromycin it was. The investigation focused on predictors for the maintenance doses of argatroban with ef. The 149 clinical efficacy rate for bactroban ointment n. Us 4258192, us 4201863 argatroban is an anticoagulant that is a small molecule direct thrombin inhibitor. List of approved drug products containing argatroban in the fda orange book on.
Argatroban definition of argatroban by medical dictionary. Prescribing information argatroban injection description argatroban is a synthetic direct thrombin inhibitor derived from larginine. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Hemorrhage can occur, especially in patients with disease states associated with a risk of bleeding. If you have any further questions, ask your doctor, nurse or pharmacist. Argatrobanacova generic is an anticoagulant thrombin inhibitor agent prescribed for thrombosis treatment in patients with heparininduced thrombocytopenia low platelet levels.
Pdf argatroban in extracorporeal membrane oxygenation. Labeling package insert, labelingcontainercarton labels. For use in hit, therapy with argatroban injection is monitored using the aptt with a target range of 1. Argatroban indications, dosage, side effects and precautions. Nov 01, 2018 argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Argatroban side effects, dosage, interactions drugs. Argatroban fda orange book approved drug product list. The chemical name for argatroban is 15aminoiminomethylamino1oxo21,2,3,4tetrahydro3methyl8quinolinylsulfonylaminopentyl4methyl2piperidinecarboxylic acid, monohydrate.
Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose approximately 60 mg mupirocin per day on a mgm 2 basis and revealed no evidence of harm to the fetus due to mupirocin. It is not a substitute for appropriate clinical evaluation and does not supersede clinical judgment. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication. Nitrogen containing heterobicycles as factor xa inhibitors download pdf. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Argatroban for anticoagulation in continuous renal. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and.
Argatroban fda prescribing information, side effects and uses. Argatroban is a synthetic dti derived from larginine that selectively and reversibly binds to the thrombin active site, inhibiting its catalytic activity. Nov 09, 2018 argatroban blocks the activity of certain clotting substances in the blood. Prozac fluoxetine hydrochloride pulvules for oral use. Bivalirudin exhibits linear pharmacokinetics following iv administration to patients undergoing ptca. Argatroban blocks the activity of certain clotting substances in the blood. Quinolones have been shown to cause arthropathy in immature animals. Wo20000391a1 nitrogen containing heterobicycles as factor xa. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease.
Sep 05, 2019 argatroban injection is supplied in 2. Adult argatroban drip protocol this protocol reflects current evidence based clinical practice. Argatroban package insert pdf store in original package until time of use. Highlights of prescribing information these highlights do not. Argatroban injection is a clear, colorless to pale yellow solution. The concomitant use of argatroban with warfarin results in prolongation of inr beyond that produced by warfarin alone.
If you have any questions about bactroban nasal ointment and how to use it, please ask your doctor or pharmacist. Generic argatroban is available in one strength 1 mg per ml and is sold in 125ml and 50ml vials. The volatiles were removed under reduced pressure and the product purified by. Bactroban nasal ointment is usually applied two or three times a day. Argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Argatroban is highly selective for thrombin with an inhibitory constant k. Us 4258192, us 4201863 argatroban is an anticoagulant. Pdf to renew the pharmacology, pharmacokinetics, efficacy adverse events, and. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Turn the package over and insert the clear plastic spike through the diluent stopper by pressing straight down fig.
Mcmaster university department of medicine division of. Argatroban injection side effects, medical uses, and drug. Bactroban ointment is not for intranasal, ophthalmic, or other mucosal use. Inr should be measured daily while argatroban and warfarin are coadministered. Argatroban is made by several different manufacturers, including glaxosmithkline, sandoz, inc.
Kxnpvxpopuzygbxyvmcahjsan argatroban chemical compound. Tecoland corporation 4 venture, suite 310 irvine, ca 92618, usa phone. The product catalog provides you with a full listing of tevas brand and generic product lines. Bactroban cream mupirocin calcium cream, 2% contains the dihydrate crystalline. Argatroban is a type of blood thinner used instead of heparin to prevent blood clots during certain procedures to open up the blood vessels in the heart e. Labelingpackage insert, labelingcontainercarton labels. Jan 22, 2020 unit dose package ndc 0049389028 5 mgml, 60 ml, 300 mg unit dose package ndc 0049390028 storage. Reevaluate patients not showing a clinical response within 3 to 5 days. Attach vial adapter to vial by using the outer package to handle adapter. Store the vials in original cartons at room temperature 25 c 77f, with excursions permitted to 1530 c 5986f. See full prescribing information for complete boxed warning.
This faq is provided for informational purposes only and is not intended as medical advice. Bactroban nasal ointment 2% patient information leaflet. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow solution. Argatroban is given until your blood coagulates properly.
Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Argatroban acova generic is an anticoagulant thrombin inhibitor agent prescribed for thrombosis treatment in patients with heparininduced thrombocytopenia low platelet levels. Use bactroban nasal ointment as directed by your doctor or pharmacist. Argatroban is not approved for use by anyone younger than 18 years old. Your doctor will test your blood often to determine how long to treat you with argatroban. The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze protect from. Jun 28, 2019 bivalirudin exhibits linear pharmacokinetics following iv administration to patients undergoing ptca. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for altabax retapamulin. Update on argatroban for the prophylaxis and treatment of. Do not use if the solution is cloudy, contains precipitates, or if the flipoff seal is not intact.
Argatroban reversibly inhibits the catalytic site of thrombin, neutralizing the actions of thrombin, including thrombin entrapped within established clots. Argatroban is capable of inhibiting the action of both free and clotassociated thrombin. Argatroban argatroban for injection product monograph page 4 of 30 warnings and precautions general argatroban is intended for use as an anticoagulant in patients with heparininduced thrombocytopenia hit syndrome. Department of health and human services silver spring md 20993. Indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparininduced thrombocytopenia. The molecular formula of argatroban is c 23 h 36 n 6 o 5 sh 2 o. Healthcare professionals argatroban injection in % sodium chloride mg ml 1 mg1 ml. Place the diluents vial on a flat and solid surface. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Prozac fluoxetine hydrochloride oral solution for oral. Argatroban is a selective direct thrombin inhibitor similar to bivalirudin, desirudin, and lepirudin, recombinant forms of the natural anticoagulant hirudin. Bactroban nasal ointment 2% patient information leaflet pil by glaxosmithkline uk. Sep 05, 2019 argatroban is not approved for use by anyone younger than 18 years old. Push adapter down onto vial until spike pierces rubber stopper and snaps into place.
The age range of the pediatric subjects was 7 months to years. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for bactroban mupirocin. Desferal is supplied as vials containing 500 mg of deferoxamine mesylate usp in sterile. Argatroban argatroban injection side effects, images, uses.
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