FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older.
History
There is currently no drug history available for this drug.
Other Information
SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.
Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1α,3β,24-triol. The structural formula is represented below:
Molecular Formula: C27H40O3 Molecular Weight: 412.6
Calcipotriene is a white or off-white crystalline substance. SORILUX Foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. SORILUX Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.
Sources
Sorilux Manufacturers
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Stiefel Laboratories Inc
Sorilux | Ino Therapeutics
2.1 DosageTerm and near-term neonates with hypoxic respiratory failure
The recommended dose of INOmax is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.
Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)].
2.2 AdministrationTraining in Administration
The user of INOmax and Nitric Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of INOmax at 1-877-566-9466.
Nitric Oxide Delivery Systems
INOmax must be administered using a calibrated INOmax DSIR® Nitric Oxide Delivery System. Only validated ventilator systems should be used in conjunction with INOmax. Consult the Nitric Oxide Delivery System label or call 1-877-566-9466/visit inomax.com for a current list of validated systems.
Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures.
Monitoring
Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see Warnings and Precautions (5.2)].
Monitor for PaO2 and inspired NO2 during INOmax administration [see Warnings and Precautions 5.3)].
Weaning and Discontinuation
Avoid abrupt discontinuation of INOmax [see Warnings and Precautions (5.1)]. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.
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