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desirudin
Overview
What is Iprivask?
Iprivask (desirudin for injection) is a direct inhibitor of human thrombin. It has a protein structure that is similar to that of hirudin, the naturally occurring anticoagulant present in the peripharyngeal glands in the medicinal leech, Hirudin is a single polypeptide chain of 65 amino acids residues and contains three disulfide bridges. Desirudin has a chemical formula of C H N O S with a molecular weight of 6963.52. Desirudin, which is expressed in yeast strain TR 1456) by recombinant DNA technology differs from the natural hirudin by lack of a sulfate group on Tyr-63. The biological activity of desirudin is determined through a chromogenic assay which measures the ability of desirudin to inhibit the hydrolysis of a chromogenic peptidic substrate by thrombin in comparison to a desirudin standard. One vial of desirudin contains 15.75 mg desirudin corresponding to approximately 315,000 antithrombin units (ATU) or 20,000 ATU per milligram of desirudin with reference to the WHO International Standard (prepared 1991) for alphathrombin.
Iprivask 15 mg is supplied as a sterile, white, freeze dried powder for injection. Each contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each prefilled syringe of diluent for Iprivask contains 0.6 mL sterile Mannitol USP (3%) in Water for Injection and is preservative free. The reconstituted solution has a pH of 7.4.
STRUCTURAL FORMULA
What does Iprivask look like?
What are the available doses of Iprivask?
Single use vials containing (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection (3)]. Reconstituted solution delivers 15 mg of Iprivask.
What should I talk to my health care provider before I take Iprivask?
How should I use Iprivask?
Iprivask is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.
All patients should be evaluated for bleeding disorder risk before prophylactic administration of Iprivask [ ]
Initial Dosage:
15 mg every 12 hours
after
see Warnings and Precautions (5.1
.
What interacts with Iprivask?
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What are the warnings of Iprivask?
Sorry No Records found
What are the precautions of Iprivask?
Sorry No Records found
What are the side effects of Iprivask?
Sorry No records found
What should I look out for while using Iprivask?
Iprivask is contraindicated in patients with known hypersensitivity to natural or recombinant hirudins due to risk of anaphylaxis, and in patients with active bleeding and/or irreversible coagulation disorders due to risk of hemorrhage.
What might happen if I take too much Iprivask?
In case of overdose, most likely reflected in hemorrhagic complications or suggested by excessively high aPTT values, Iprivask therapy should be discontinued. Emergency procedures should be instituted as appropriate (for example, determination of aPTT and other coagulation levels, hemoglobin, the use of blood transfusion or plasma expanders).
No specific antidote for Iprivask is available; however, the anticoagulant effect of desirudin may be partially reversible using thrombin-rich plasma concentrates while aPTT levels can be reduced by the intravenous administration of 0.3 μg/kg DDAVP (desmopressin). The clinical effectiveness of DDAVP in treating bleeding due to desirudin overdose has not been studied. In an open, pilot, dose-ascending study to assess safety, the highest dose of desirudin (40 mg every 12 hours) caused excessive hemorrhage.
How should I store and handle Iprivask?
Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes: Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray. Each tray of Iprivask (desirudin for injection) contains: Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder. Storage: Unopened vials or prefilled syringes:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Desirudin is a direct inhibitor of free circulating and clot-bound thrombin. The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human plasma. One molecule of desirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin. As a result, all thrombin-dependent coagulation assays are affected. Activated partial thromboplastin time (aPTT) is a measure of the anticoagulant activity of desirudin and increases in a dose-dependent fashion.
Non-Clinical Toxicology
Iprivask is contraindicated in patients with known hypersensitivity to natural or recombinant hirudins due to risk of anaphylaxis, and in patients with active bleeding and/or irreversible coagulation disorders due to risk of hemorrhage.Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure [see ], as well as to assure diuretic efficacy.
Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.
This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
There is a risk of neuraxial hematoma formation with the concurrent use of desirudin and spinal/epidural anesthesia, which has the potential to result in long term or permanent paralysis. The risk may be greater with the use of post-operative indwelling catheters or the concomitant use of additional drugs affecting hemostasis such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), platelet inhibitors or other anticoagulants [ ]. The risk may also be increased by traumatic or repeated neuraxial puncture.
To reduce the potential risk of bleeding associated with the concurrent use of desirudin and epidural or spinal anesthesia/analgesia, the pharmacokinetic profile of the drug should be considered [ ] when scheduling or using epidural or spinal anesthesia in proximity to desirudin administration. The physician should consider placement of the catheter prior to initiating desirudin and removal of the catheter when the anticoagulant effect of desirudin is low [see ].
Should the physician decide to administer anticoagulation in the context of epidural/spinal anesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction. Patients should be instructed to inform their physician immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.
The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
Iprivask cannot be used interchangeably with other hirudins as they differ in manufacturing process and specific biological activity (ATUs). Each of these medicines has its own instructions for use.
The following serious reactions are described further in other sections of the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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