Ventavis

DRUG DESCRIPTION

Ventavis (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing iloprost formulated for inhalation via either of two pulmonary drug delivery devices: the I-neb® AAD® (Adaptive Aerosol Delivery) System or the Prodose® AAD® System. Ventavis (iloprost) is supplied in 1 mL single-use glass ampules containing either 10 mcg/mL or 20 mcg/mL.

For the 10 mcg/mL solution, one mL of the solution contains 0.01 mg iloprost, 0.81 mg ethanol, 0.121 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection.

For the 20 mcg/mL solution, one mL of the solution contains 0.02 mg iloprost, 1.62 mg ethanol, 0.242 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.76 mg hydrochloric acid (for pH adjustment to 8.4) in water for injection.

The solution contains no preservatives.

The chemical name for iloprost is (E)-(3aS, 4R, 5R, 6aS)-hexahydro-5-hydroxy-4-[(E)(3S,4RS)-3-hydroxy-4-methyl-1-octen-6-ynyl]-?2(1H),?-pentalenevaleric acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47. Iloprost is an oily substance, which is soluble in methanol, ethanol, ethyl acetate, acetone, and pH 7 buffer, sparingly soluble in buffer pH 9, and very slightly soluble in distilled water, buffer pH 3, and buffer pH 5. The molecular formula of iloprost is C22H32O4. Its relative molecular weight is 360.49. The structural formula is shown below:

VENTAVIS (iloprost) Structural Formula Illustration

What are the possible side effects of iloprost inhalation (Ventavis)?

Serious side effects from iloprost inhalation are not likely to occur. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat, swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may also occur. Continue to use iloprost inhalation and talk to your doctor if you experience

  • dry mouth, nose, or throat after use;
  • coughing or throat irritation;
  • hoarseness or deepening of the voice;
  • headache,...

Read All Potential Side Effects and See Pictures of Ventavis »

What are the precautions when taking iloprost (Ventavis)?

Before using iloprost, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, liver problems, kidney problems, bleeding problems, other breathing problems (such as asthma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your...

Read All Potential Precautions of Ventavis »


Ventavis Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, jaw pain, muscle spasms of the jaw, flushing, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: wheezing, sudden weight gain, worsening breathing, chest pain, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using iloprost, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, liver problems, kidney problems, bleeding problems, other breathing problems (such as asthma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Ventavis Patient Information Including Side Effects

Brand Names: Ventavis

Generic Name: iloprost (Pronunciation: ill O prost)

  • What is iloprost inhalation (Ventavis)?
  • What are the possible side effects of iloprost inhalation (Ventavis)?
  • What is the most important information I should know about iloprost inhalation (Ventavis)?
  • What should I discuss with my healthcare provider before taking iloprost inhalation (Ventavis)?
  • How should I use iloprost inhalation (Ventavis)?
  • What happens if I miss a dose (Ventavis)?
  • What happens if I overdose (Ventavis)?
  • What should I avoid while taking iloprost inhalation (Ventavis)?
  • What other drugs will affect iloprost inhalation (Ventavis)?
  • Where can I get more information?

What is iloprost inhalation (Ventavis)?

Iloprost is an synthetic prostacyclin. It works by opening blood vessels in the lungs.

Iloprost is used as an inhalant to treat pulmonary arterial hypertension.

Iloprost inhalation may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of iloprost inhalation (Ventavis)?

Serious side effects from iloprost inhalation are not likely to occur. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat, swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may also occur. Continue to use iloprost inhalation and talk to your doctor if you experience

  • dry mouth, nose, or throat after use;
  • coughing or throat irritation;
  • hoarseness or deepening of the voice;
  • headache, dizziness, or lightheadedness;
  • nausea;
  • flushing; or
  • jaw tightness or pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about iloprost inhalation (Ventavis)?

Use iloprost inhalation exactly as directed by your doctor. Iloprost inhalation should only be used with the Prodose AAD system. Do not use iloprost inhalation with other types of nebulizers. If you do not understand your instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Iloprost inhalation may lower blood pressure which can lead to dizziness or fainting. Stand up slowly when getting out of a chair or bed. If you experience fainting or if your dizziness gets worse contact your doctor.

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