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Ventavis
Overview
What is Ventavis?
Ventavis (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing iloprost formulated for inhalation via the I-neb® AAD® (Adaptive Aerosol Delivery) System. Ventavis 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)-(3a, 4, 5, 6a)-hexahydro-5-hydroxy-4-[()-(3,4)-3-hydroxy-4-methyl-1-octen-6-ynyl]-Δ-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 CHO. Its relative molecular weight is 360.49. The structural formula is shown below:
What does Ventavis look like?
What are the available doses of Ventavis?
1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL ().
What should I talk to my health care provider before I take Ventavis?
How should I use Ventavis?
Ventavis® is a synthetic analog of prostacyclin indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%). ().
Ventavis is intended to be inhaled using the I-neb® AAD® System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing should be increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. Ventavis should be taken 6 to 9 times per day (no more than once every 2 hours) during waking hours, according to individual need and tolerability. The maximum daily dose evaluated in clinical studies was 45 mcg (5 mcg 9 times per day).
Direct mixing of Ventavis with other medications in the I-neb® AAD® System has not been evaluated; do not mix with other medications. To avoid potential interruptions in drug delivery due to equipment malfunctions, the patient should have easy access to a back-up I-neb®AAD® System.
Ventavis is supplied in 1 mL ampules in two concentrations: 10 mcg/mL and 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-nebAAD System will decrease treatment times to help maintain patient compliance.
For each inhalation session, the entire contents of each opened ampule of Ventavis should be transferred into the I-neb® AAD® System medication chamber immediately before use . After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-neb® AAD® System components after each dose administration.
What interacts with Ventavis?
Sorry No Records found
What are the warnings of Ventavis?
Sorry No Records found
What are the precautions of Ventavis?
Sorry No Records found
What are the side effects of Ventavis?
Sorry No records found
What should I look out for while using Ventavis?
None
What might happen if I take too much Ventavis?
Cases of overdose have been reported. Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain. Hypotension, vomiting, and diarrhea are possible. A specific antidote is not known. Interruption of the inhalation session, monitoring, and symptomatic measures are recommended.
How should I store and handle Ventavis?
The Sodium Iodide I-131 should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of sodium iodide I 131 in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all sodium iodide I 131solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of Sodium Iodide I-131 Solution.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.The Sodium Iodide I-131 should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of sodium iodide I 131 in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all sodium iodide I 131solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of Sodium Iodide I-131 Solution.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.The Sodium Iodide I-131 should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of sodium iodide I 131 in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all sodium iodide I 131solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of Sodium Iodide I-131 Solution.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.Ventavis (iloprost) Inhalation Solution is supplied in cartons of 30 x 1 mL clear glass single-use ampules as follows:1 mL ampule containing iloprost 10 mcg per mL, carton of 30 (NDC 66215-302-30)1 mL ampule containing iloprost 20 mcg per mL, carton of 30 (NDC 66215-303-30)Ventavis (iloprost) Inhalation Solution is supplied in cartons of 30 x 1 mL clear glass single-use ampules as follows:1 mL ampule containing iloprost 10 mcg per mL, carton of 30 (NDC 66215-302-30)1 mL ampule containing iloprost 20 mcg per mL, carton of 30 (NDC 66215-303-30)Ventavis (iloprost) Inhalation Solution is supplied in cartons of 30 x 1 mL clear glass single-use ampules as follows:1 mL ampule containing iloprost 10 mcg per mL, carton of 30 (NDC 66215-302-30)1 mL ampule containing iloprost 20 mcg per mL, carton of 30 (NDC 66215-303-30)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Iloprost is a synthetic analog of prostacyclin PGI. 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 diastereo- isomers of iloprost differ in their potency in dilating blood vessels, with the 4S isomer substantially more potent than the 4R isomer.
Non-Clinical Toxicology
NoneVentavis solution should not be allowed to come into contact with the skin or eyes; oral ingestion of Ventavis solution should be avoided.
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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