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Iloprost

 
Drug Info: Iloprost
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Brand names: Ilomedin®, Ventavis™

Chemical formula:



Iloprost inhalation solution

What is Iloprost inhalation solution?

ILOPROST (Ventavis®) is used to treat a serious heart and lung disorder called pulmonary arterial hypertension. While iloprost inhalation solution will not cure this disorder, it is designed to improve symptoms and the quality of life. Generic iloprost inhalation solution is not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• bleeding problems
• infection
• low blood pressure
• lung or breathing problem such as asthma or chronic obstructive pulmonary disease (COPD)
• an unusual reaction to Iloprost, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Iloprost inhalation solution is for use in the Prodose® AAD® or I-neb AAD® nebulizer only.

Iloprost inhalation is breathed (inhaled) into your lungs with the help of a special nebulizer. Nebulizers convert a solution of iloprost into an aerosol for inhalation through the mouth and into the lungs. The amount of drug you receive will be determined by your doctor. You will be provided a special device that is to be used with the Prodose® AAD® or I-neb AAD® nebulizer. This device will deliver the correct dose to you. Follow the instructions provided with the product to prepare and inhale the iloprost inhalation solution. Follow the directions that come with the Prodose® AAD® or I-neb AAD® system for proper use of the nebulizer. Take precautions to avoid bacterial contamination of the iloprost inhalation solution dose or nebulizer system.

Take your prescribed doses at regular intervals. Your doctor will tell you how to space out your doses. Do not use more often than directed.

Do not let iloprost solution come into contact with your skin or eyes. If it does, rinse the skin or your eyes right away with water.

Do not allow other people to be exposed to iloprost inhalation while you are breathing it, especially babies and pregnant women.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What drug(s) may interact with Iloprost?

• alcohol
• aspirin and aspirin-like medicines
• blood thinners such as warfarin (your prescriber or health care professional, however, is likely to want you to take blood thinners while you are using iloprost; this can be done safely)
• cilostazol
• clopidogrel
• dipyridamole
• ephedrine or pseudoephedrine
• medicines for colds and breathing difficulties
• herbal stimulants or weight loss products, like ephedra, ma huang
• medicines for chest pain or heart disease
• medicines for high blood pressure
• monoamine oxidase inhibitors (Azilect®, Eldepryl®, Emsam®, Marplan®, Nardil®, Parnate®, Zelapar™)
• ticlopidine
• water pills (diuretics)

Tell your prescriber or health care professional: about all other medicines you are taking including non-prescription medicines; if you are a frequent user of drinks with caffeine or alcohol; if you smoke; or if you use illegal drugs. These may effect the way your medicine works. Check before starting or stopping any of your medicines.

What should I watch for while taking Iloprost?

Visit your prescriber or health care professional for checks on your progress. You will need to be seen regularly. Report any unusual or severe side effects promptly.

You may get dizzy. Do not drive or use machinery until you know how iloprost affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks. Alcohol can make you more dizzy and increase flushing of the face.

If you take too much of this medicine, you may get a severe headache, chest pain, reddening of the face, jaw pain, dizziness, nausea, vomiting, and diarrhea. If this happens, stop taking iloprost inhalation and call your health care provider promptly.

Despite receiving iloprost inhalation solution, your condition may worsen and you may need your dose adjusted. Call your prescriber or health care professional if you experience any worsening of your condition.

What side effects may I notice from receiving Iloprost?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• chest pain
• change in the amount of urine passed
• dark yellow or brown urine
• difficulty breathing
• dizziness or faintness
• fever
• pain or difficulty passing urine
• swelling in your arms, legs, hands, or feet
• slow, fast, or irregular heart beat
• unusual tiredness or weakness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• chills or flu-like symptoms
• cough
• diarrhea
• difficulty sleeping
• flushing
• headache
• jaw pain
• muscle ache or pain
• nausea/vomiting
• stomach pain

Where can I keep my medicine?

Ampules of unopened iloprost inhalation solution are good until the date printed on the package when stored between 68 and 77 degrees F (20 and 25 degrees C) and protected from light in the package.

An opened ampule should be used immediately and any solution remaining in the Prodose® AAD® or I-neb AAD® medication chamber should be discarded. Use of the remaining solution will result in unpredictable dosing.

Keep out of the reach of children in a container that small children cannot open.

Last updated: 1/7/2005 10:36:00 AM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Wikipedia: Iloprost
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Home > Library > Miscellaneous > Wikipedia
Iloprost
Systematic (IUPAC) name
(E)-[(3aS,4R,5R,6aS)-5-hydroxy-4-((3S,E)-3-hydroxy-4-methyloct-1-en-6-ynyl)hexahydropentalen-2(1H)-ylidene]pentanoic 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 20-30 minutes
Excretion  ?
Therapeutic considerations
Licence data

EU EMEA:(inhalation) or Ilomedine (intravenous)/Ventavis (inhalation) or Ilomedine (intravenous).htm link, US FDA:link
Pregnancy cat.

C
Legal status

℞ Prescription only
Routes Inhaled Intravenous
 Yes check.svgY(what is this?)  (verify)

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 Bayer Schering Pharma AG in Europe and Actelion Pharmaceuticals in the USA.

Contents

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 inhaled specifically using the I-Neb AAD or Prodose AAD delivery systems. In Europe Iloprost has been approved for use with two compresse air nebuliozers with AAD delivery systems (Halolite and Prodose) as well as with two ultrasonic nebulizers Ventaneb and I-Neb.

Ventavis is supplied in 1 mL single-use glass ampules containing either 10 mcg/mL or 20 mcg/mL. The 20 mcg/mL concentration is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Transitioning patients to the 20 mcg/mL concentration using the I-neb® AAD® System will decrease treatment times to help maintain patient compliance. [2]

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

Iloprost is also available in an intravenous form, developed and marketed by Schering AG under the trade name Ilomedine [3]. 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:

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

References

  1. ^ a b "Iloprost Information". http://raynauds.chicanes.net/potioncms/articlefiles/102-Iloprost.pdf. Retrieved 2009-02-05. 
  2. ^ Ventavis Prescribing Information 2009 http://www.pahpathways.com/pdfs/ventavis_prescribing_info.pdf
  3. ^ "BIJSLUITER: INFORMATIE VOOR DE GEBRUIK(ST)ER". http://www.bayer.nl/ebbsc/export/sites/nl_bc_internet/nl/_galleries/documents/products/bayer_schering_pharma/20070611_ILOMEDINE_1B2.pdf. Retrieved 2009-02-05.  (in Dutch)
  • 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

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platelets: induce (TXA2) inhibit (PGD2, PGI2) · leukocytes: induce (TXA2, LTB4) inhibit (PGD2, PGE2)

labor stimulation: (PGE2 (Dinoprostone), PGF2α (Dinoprost))
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This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer)

 
 
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Iloprost inhalation solution
Iloprost Inhalation vapour, solution
Iloprost, Inhalación del vapor, solución

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