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RECOTHROM
Overview
What is RECOTHROM?
RECOTHROM Thrombin topical (Recombinant), is a human coagulation protein produced via recombinant DNA technology from a genetically modified CHO cell line. RECOTHROM is identical in amino acid sequence and structurally similar to naturally occurring human thrombin. RECOTHROM precursor is secreted to culture medium as single chain form that is proteolytically converted to a two-chain active form (using a protein derived from snakes) and is purified by a chromatographic process that yields a product having hemostatic activities similar to native human thrombin. The cell line used to manufacture RECOTHROM has been tested and shown to be free of known infectious agents. The cell culture process used in the manufacture of RECOTHROM employs no additives of human or animal origin. The purification process includes solvent-detergent treatment and nano-filtration steps dedicated to viral clearance.
RECOTHROM is provided as a sterile, white to off-white, preservative-free, lyophilized powder in vials for reconstitution with diluent (sterile 0.9% sodium chloride, USP). Reconstitution with the provided diluent, as described
yields a solution with a pH of 6.0 containing 1000 units/mL of recombinant thrombin for topical use. The formulated product is a clear, colorless solution upon reconstitution and contains the following excipients: histidine, mannitol, sucrose, polyethylene glycol 3350, sodium chloride, and calcium chloride dihydrate, USP.
What does RECOTHROM look like?
What are the available doses of RECOTHROM?
RECOTHROM is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL of RECOTHROM. ()
What should I talk to my health care provider before I take RECOTHROM?
Pregnancy: No human or animal data. Use only if clearly needed. ()
How should I use RECOTHROM?
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
For topical use only.
What interacts with RECOTHROM?
Sorry No Records found
What are the warnings of RECOTHROM?
Sorry No Records found
What are the precautions of RECOTHROM?
Sorry No Records found
What are the side effects of RECOTHROM?
Sorry No records found
What should I look out for while using RECOTHROM?
Do not inject directly into the circulatory system. ()
Do not use for the treatment of massive or brisk arterial bleeding. ()
Do not administer to patients with a history of hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins. ()
What might happen if I take too much RECOTHROM?
Sorry No Records found
How should I store and handle RECOTHROM?
One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:NDC 43825-606-41A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-41A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.NDC 43825-707-50The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.No RECOTHROM kit components contain latex.Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze.Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Do not inject directly into the circulatory system. ()Do not use for the treatment of massive or brisk arterial bleeding. ()
Do not administer to patients with a history of hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins. ()
Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine.
Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative.
An interaction study between gentamicin and cytarabine showed a cytarabine related antagonism for the susceptibility of strains. This study suggests that in patients on cytarabine being treated with gentamicin for a infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy.
Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine injection. This may be due to potential competitive inhibition of its uptake.
RECOTHROM may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT.
Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM in all completed clinical trials (N=644)
Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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