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20-September-2008 09:55:48 - Iloprost Iloprost Systematic IUPAC name E-3aS,4R,5R,6aS-hexahydro-5-hydroxy-4- E-3S,4RS-3-hydroxy-4-methyl-1-octen-6-ynyl- Δ21H,Δ-pentalenevaleric acid Identifiers CAS number 78919-13-8 73873-87-7 ATC code B01AC11 PubChem 54313 Chemical data Formula C22H32O4 Mol. mass 360.49 g/mol Pharmacokinetic data Bioavailability The absolute bioavailability of inhaled iloprost has not been determined. Metabolism Iloprost is metabolized principally via β-oxidation of the carboxyl side chain. The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form. In animal experiments, tetranor-iloprost was pharmacologically inactive. Half life ? Excretion ? Therapeutic considerations Licence data inhalation or Ilomedine intravenous/Ventavis inhalation or Ilomedine intravenous.htm EU, US Pregnancy cat. C Legal status â„ž Prescription only Routes Inhaled Intravenous Iloprost is a drug used to treat pulmonary arterial hypertension PAH, scleroderma, Raynaud's phenomenon and ischaemia 1. It was developed by the pharmaceutical company Schering AG and is marketed by Schering AG in Europe and Actelion Pharmaceuticals in the USA. Contents 1 Clinical pharmacology 2 Dosage and administration 2.1 Inhaled Iloprost 2.2 Intravenous Iloprost 3 Important safety information 4 See also 5 References 6 External links Clinical pharmacology Iloprost is a synthetic analogue of prostacyclin PGI2. Iloprost dilates systemic and pulmonary arterial vascular beds. It also affects platelet aggregation but the relevance of this effect to the treatment of pulmonary hypertension is unknown. The two diastereoisomers of iloprost differ in their potency in dilating blood vessels, with the 4S isomer substantially more potent than the 4R isomer. Dosage and administration Inhaled Iloprost In the U.S., iloprost is intended to be inhaled specifically using the I-Neb AAD or Prodose AAD delivery systems. Iloprost has not been approved for use with other brands of nebulizers. The approved dosing regimen for iloprost is 6 to 9 times daily no more than every 2 hours during waking hours, according to individual need and tolerability. The significant clinical effects observed in the pivotal study of patients with PAH were achieved with a median dose of 30 mcg per day range: 12.5 to 45 mcg delivered at the mouthpiece, corresponding to 6 daily inhalations of 5 mcg. The majority of patients 80% in the pivotal study used this median dose or a higher dose with an excellent treatment compliance after 12 weeks. The first inhaled dose of iloprost should be 2.5 mcg as delivered at the mouthpiece. If this dose is well tolerated, dosing should be increased to 5 mcg and maintained at that dose. Any patient who cannot tolerate the 5 mcg dose should be maintained at 2.5 mcg. Each inhalation treatment requires one entire single-use ampule. Each single-use ampule delivers a concentration of 10 mcg/mL to the medication chamber of either the I-Neb AAD or Prodose AAD System, and delivers a nominal dose of either 2.5 mcg or 5.0 mcg to the mouthpiece. After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution, even if the reservoir is topped off with fresh medication, will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-Neb AAD or Prodose AAD System components after each dose administration. Complete information regarding use of iloprost in specific populations e.g. nursing mothers, pediatrics, patients with hepatic or renal impairment, drug interactions, and overdosage can be found in full prescribing information. Intravenous Iloprost Vial and box of IV Iloprost Vial and box of IV Iloprost Iloprost is also available in an intravenous form, developed and marketed by Schering AG under the trade name Ilomedine 2. IV Iloprost is usually administer, diluted, via a peripheral vein or central venous catheter. The diluted Iloprost should be delivered by an accurate rate delivery system such as a syringe driver. Doses vary with individuals as side effects are more tolerated in some patients than others. The duration of the treatment is typically 3 days. This is usually repeated every 8 to 12 weeks 1 Important safety information Contraindications: There are no known contraindications. Common side effects: In clinical studies, common adverse reactions due to inhaled iloprost included: vasodilation flushing, 27%, cough 39%, headache 30%, flu syndrome 14%, nausea 13%, neck spasms 12%, hypotension 11%, insomnia 8%, and fainting syncope 8%; other serious adverse events reported with the use of Ventavis included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, swelling of the limbs especially around the ankles and feet, and kidney failure. Serious adverse events reported with the use of inhaled iloprost include congestive heart failure, chest pain, supraventricular tachycardia, shortness of breath, peripheral edema, and kidney failure. Warnings: Iloprost as Ventavis is intended for inhalation administration only via the I-Neb AAD or Prodose AAD Systems, pulmonary drug delivery devices. It has not been studied with any other nebulizers. Vital signs should be monitored while initiating inhaled iloprost therapy. Dose adjustments or a change in therapy should be considered if exertional syncope occurs. Inhaled Iloprost should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Iloprost should be stopped immediately if signs of pulmonary edema occur. This may be a sign of pulmonary venous hypertension. Iloprost has not been evaluated in patients with chronic obstructive pulmonary disease COPD, severe asthma, or with acute pulmonary infections. Should signs of pulmonary edema occur when inhaled iloprost is administered in patients with pulmonary hypertension, the treatment should be stopped immediately. This may be a sign of pulmonary venous hypertension. See also pulmonary arterial hypertension PAH Raynaud's Scleroderma References ^ a b http://raynauds.chicanes.net/potioncms/articlefiles/102-Iloprost.pdf ^ http://www.bayer.nl/ebbsc/export/sites/nl_bc_internet/nl/_galleries/documents/products/bayer_schering_pharma/20070611_ILOMEDINE_1B2.pdf Ventavis Package insert prescribing information available in PDF format. H. Olschewski et al, Inhaled Iloprost for Severe Pulmonary Hypertension., NEJM, Volume 347:322-329, August 1, 2002, Number 5 1 ATS 2005. The International Conference of the American Thoracic Society. 20 May - 25 May 2005. San Diego, CA. External links Home page for Ventavis in the U.S. Home page for Ventavis in the EU Cotherix, Inc. Company website - marketer of Ventavis; prescribing information available in PDF format. FDA Web Site for Ventavis Consumer Information v d e Antithrombotics thrombolytics, anticoagulants and antiplatelet drugs B01 Antiplatelet drugs Glycoprotein IIb/IIIa inhibitors Abciximab Eptifibatide Tirofiban ADP receptor/P2Y12 inhibitors Clopidogrel Ticlopidine Prasugrel Prostaglandin analogue PGI2 Beraprost Prostacyclin Iloprost Treprostinil COX inhibitors Acetylsalicylic acid/Aspirin Aloxiprin Carbasalate calcium Other Ditazole Cloricromen Dipyridamole Indobufen Picotamide Triflusal Anticoagulants Vitamin K antagonists inhibit II, VII, IX, X Acenocoumarol Clorindione Coumatetralyl Dicoumarol Dicumarol Diphenadione Ethyl biscoumacetate Phenprocoumon Phenindione Tioclomarol Warfarin Heparin group Antithrombin III Danaparoid Sulodexide low molecular weight heparin Bemiparin, Dalteparin, Enoxaparin, Nadroparin, Parnaparin, Reviparin, Tinzaparin Direct thrombin II inhibitors Argatroban Bivalirudin Dabigatran Desirudin Hirudin Lepirudin Melagatran Ximelagatran Factor Xa inhibitors Apixaban Otamixaban Rivaroxaban oligosaccharides Fondaparinux, Idraparinux Other Defibrotide Dermatan sulfate Ramatroban Thrombolytic drugs/ fibrinolytics plasminogen activators: TPA Alteplase, Reteplase, Tenecteplase UPA Urokinase, Saruplase Streptokinase Anistreplase Monteplase other serine endopeptidases: Ancrod Drotrecogin alfa/Protein C Fibrinolysin Brinase Non-medicinal Citrate EDTA Oxalate v d e Medications used in the management of pulmonary arterial hypertension B01, C02 Prostacyclin analogues Beraprost, Epoprostenol, Iloprost, Treprostinil Endothelin receptor antagonists Ambrisentan, Bosentan, Sitaxsentan PDE5 inhibitors Sildenafil, Tadalafil Adjunctive therapy Calcium channel blockers, Diuretics, Digoxin, Oxygen therapy, Warfarin v d e Eicosanoids: prostaglandins Endogenous/series 2 D2 - E2 Dinoprostone - F2 Dinoprost - H2 - I2 Prostacyclin Prostaglandin analogues E: Alprostadil - Enprostil - Misoprostol F: Bimatoprost - Carboprost - Latanoprost - Travoprost I: Beraprost - Epoprostenol - Iloprost - Treprostinil Retrieved from http://en..org/wiki/Iloprost Categories: Orphan drugs | Prostaglandins | Alkynes Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages Español Italiano УкраїнÑ?ька This page was last modified on 11 August 2008, at 13:26
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