Here in the United Snakes there are now available one or more generic formulations of fluticasone propionate, the active ingredient in Flonase. GSK's patent on this drug expired in May of 2004, but GSK was able to inhibit the marketing of generic formulations until the FDA approved, on the 20th of February, 2006, a generic formulation produced by Roxane Labs. The very next day GSK filed a court motion seeking to ban sales of the generic formulation. Miracle of miracles, GSK lost that case on the 7th of March, 2006. Later that same month I heard from a correspondent who was offered the generic formulation when refilling a prescription for Flonase. On the 4th of April, 2006, I bought my first bottle of generic fluticasone propionate. It was manufactured by Penn Laboratories (UK), which is owned by GSK.
My otorhinolaryngologist (hereafter "doc") prescribed Flonase spray. He explained that it should reduce my nasal congestion and retard the growth of polyps. I followed his advice and used this product, but I never noticed any benefit from it. Then a correspondent told me that his doc told him that there is a problem with the delivery system (a hand-actuated pump spray, hereafter "spray") for Flonase -- the active ingredient (fluticasone propionate, a steroid) is not delivered far enough up the nose to be effective against the sort of inflammation and polyps that he and I have. I assume that this product is effective for the sorts of nasal allergies that many people have (so called "hay fever"), because it sells well. My correspondent told me that his doc prescribed the Rhinocort Nasal Inhaler for him and that it worked well. I asked my doc to write me a prescription for this product. He first gave me Rhinocort Aqua, a water-based product that delivers a metered dose of the drug by spray. I noticed no effect of this product. After explaining that I wanted to try a "puffer," I obtained a prescription for the Rhinocort Nasal Inhaler. This is an aerosol that delivers a metered dose of the steroid (budesonide).
Unlike the steroid sprays, the Rhinocort Inhaler did help me somewhat (but not enough to keep my sense of smell without also using a systemic steroid, Kenalog by injection), so I used it on a regular basis until it was discontinued by the manufacturer. On the 31st of August, 2002, I got a letter from my pharmacy advising me that the Rhinocort Nasal Inhaler would become unavailable in early 2003, and it was. The propellant (chlorofluorocarbons) used in nasal inhalers can cause depletion of ozone, and the U.S. FDA has ruled that using CFCs in metered-dose steroid human drugs for nasal inhalation can no longer be considered to be essential, and thus these products must be discontinued. Of course, pharmaceutical firms could change to a different propellant -- at least one alternative propellant has been developed by 3M Corp., which has licensed its new technology to drug maker Schering-Plough -- but 3M wants to recoup the costs of developing this new propellant, and some of the pharmaceutical firms do not want to pay big bucks for using it -- see Glaxo Wellcome vs 3M.
A correspondent from Singapore advised me that his doctor prescribed for him the Rhinocort Turbuhaler. Like the discontinued Rhinocort Inhaler I have used, this product delivers budesonide powder. It is used both for asthma and the treatment of nasal polyposis, but appears not to be available in the US. It is available in Canada.
Another international correspondent, Matt from Australia, advised that he is successfully using the Pulmicort Turbohaler 400 which delivers 400 mcg of finely powdered budesonide into his nose. This product is intended for use by persons with asthma, who inhale it by mouth into their lungs. Matt presses the turbohaler against one nostril, tight enough to produce a seal, and inhales deeply and then exhales with mouth closed to distribute the powder through those troublesome nasal nooks and crannies. He reports that he started with two puffs in the morning and two in the evening but now is maintaining well with just one or two puffs a day. Do note that Matt is getting a lot more steroid from the Turbohaler than he would from the Rhinocort nasal spray, which delivers 32 mcg of budesonide per spray.
A Canadian correspondent advised that she was prescribed one ampule of Pulmicort daily, added to the saline rinse with which she irrigates.
After the Rhinocort Inhaler was discontinued, I switched to the Nasacort Inhaler. The steroid in Nasacort is Kenalog (triamcinolone acetonide), the same drug that gives me long-term relief when injected deep into muscle. Although the Nasacort inhaler did irritate my nose a bit (made it itch for a few minutes, stimulating sneezing), it was effective -- but it too was pulled off of the market. In June of 2003 I got a letter from my pharmacy advising me that the Nasacort Inhaler would no longer be available. Damn. I shifted back to Flonase, which may be better than nothing.
In June of 2004 correspondent Dale advised me that the Nasacort HFA Inhaler has been approved by the FDA. This new product uses hydrofluoroalkane (HFA), rather than chlorofluorocarbons (CFCs) to propel the dry steroid into the nasal chamber. I believe this is, in fact, the delivery system developed by 3M. I am hoping to be able to use this new product, if my health plan's drug Nazis will allow it. I wish budesonide (Rhinocort) would become available in an HFA inhaler. As of December of 2005, there is still no sign of the Nasacort HFA inhaler being on the market. Furthermore, my health plan's drug Nazis have announced that both Nasacort AQ and Rhinocort/Aqua have been removed from their preferred drugs list. They would rather save a few dollars on my prescriptions and then pay many thousands of dollars for the surgery that becomes necessary when my nasal polyps are not kept in check. Cognitive myopia strikes again. The Pulmicort Turbohaler is on their approved drug list, I wonder if I could get my doc to prescribe that?
Another of my correspondents, JY from South Africa, told me in May of 2002 that his physician had started him on a new product, Flixonase Nasules. The active ingredient is the same as in Flonase spray, but it is delivered as a nose drop rather than as a spray. A device called a "nasule" is used to deliver a metered dose of the drug. Each nasule contains 400 mcg of fluticasone propionate. A single spray of Flonase contains only 50 mcg. JY administers this drug by hanging his head over the side of the bed and squeezing 200 mcg into one nostril and then the remaining 200 mcg into the other -- this is twice the dose you get with two sprays of Flonase. According to the manufacturer, this method of delivery places the drug well into the nasal cavity rather than just at the front of the nose like sprays do. Although Flonase spray did not help JY, he reported to me that Flixonase Nasules worked marvelously for him. JY told me that use of these nasules restored his sense of smell and that after using these nasules "I went to see the doc for a checkup and he said he can see parts of my sinuses he has never seen before (I've been going to this doc for about four years)." Regretfully this product is not available in the United States. When I search for it on the web, most of the pages on which I find it mentioned are "pharmacy benefit exclusion pages," that is, pages that list the drugs that the Health Insurance Nazis disallow.
I did find mention of Flixonase nasules in the Primary Care Journal Watch (1999, May), issue 32, page 3. Here it said "Another formulation of fluticasone - it is now available in a new drop formulation specifically designed for the treatment of nasal polyps. The company claims that by using Nasules(tm) a controlled dose of steroid is delivered into the nasal cavity, unlike sprays which mainly deposit the drug at the front of the nose. In the promotional material the company cite a placebo-controlled study which showed that the active drug was associated with a statistically significant increase in morning peak nasal inspiratory flow over a 12-week period. The contents of one nasule (400mcg fluticasone) should be instilled once or twice daily: which means that it costs between £13.48 and £26.96 to treat one patient for a month."
I also found online a patient leaflet for these nasules.
In the Journal of Allergy and Clinical Immunology (2005, 115, 1017-1023) A. A. C. Aukema, P. G. M. Mulder, & W. J. Fokkens reported "Treatment of nasal polyposis and chronic rhinosinusitis with fluticasone propionate nasal drops reduces need for sinus surgery." In other words, these nasules were effective in providing relief and reducing the need for sinus surgery.
Another correspondent, ER from the UK, told me that her doc advised that a spray formulation was of little use and put her on fluticasone nasules. She added that another alternative was the use of betamethasone nose drops, which are available in the UK. Of course, these too are not available in the USA. Another of my correspondents told me that her doctor put her on dexamethasone drops that were designed for use in the eyes or ears. She reported that this treatment was successful in restoring her sense of smell.
A correspondent from Pennsylvania told me that his doc had modified a nasal inhaler so that it could be fitted with a canister of Flovent 110. Flovent 110 is designed to be used for oral inhalation (for asthma), not nasal inhalation. It delivers a metered dose of 110 mcg of fluticasone. The propellants used in this inhaler are chlorofluorocarbon propellants (trichlorofluoromethane and dichlorodifluoromethane), like those in the nasal inhalers that have been phased out. I wrote the doctor asking for details or a reference, but he never replied.
A member of the Smell Disorders Group at Yahoo got her ENT to prescribe an asthma inhaler which she then adapted for nasal use. See her post and the beclomethasone inhaler that she used.
Several correspondents also noted that the effect of any of the nasal steroids waned with time, but if they switched to a different nasal steroid then it would be effective for a while.
In the Spring of 2003 a new subscriber to the anosmia group at Yahoo reported that the steroid nasal sprays Flonase and Nasonex did not help her, but that the Nasacort Inhaler did restore her sense of smell. She then lamented that the Nasacort Inhaler was no longer available in Canada, pulled from the shelves because it contains CFC's. She is trying the Rhinocort Turbohaler now, which she said delivers the powdery drug by the power of one's inhalation, with no propellant, CFC or otherwise.
Several correspondents have noted that the hand-pump sprays work better for them if they apply them after getting into a head-down position, better to allow gravity to bring the spray to where it is needed. One approach is to lie on the bed on one's back with the head hanging over the side of the bed and instill the steroid solution. Another approach is to get on your knees on the floor, spray your nostrils, and then assume the Mecca position (head down). For more details on this method of administering nasal steroids, please see Dr. Robert McGinnis' letter in the American Family Physician, 1997, Administering Topical Steroids in Sinusitis with Head Inverted, 56(5), 1301-1302. Elsewhere Dr. McGinnis explained how to do this with Flonase -- carefully open the bottle, being sure not to break it -- you don't want slivers of glass in the fluid. He suggested using a pair of wire cutters repeatedly to crease the metal collar until it releases. He then transfers the fluid into a different container and uses a TB or insulin syringe (without the needle) to administer the medicine as drops. This seems likes a technique that should approximate that provided by using Flixonase Nasules. Of course, you need to know what dose to use. Dr. McGinnis suggested doing a search (National Library of Medicine; Grateful Med; Medline) of the literature for the latest information on steroid drop treatment of nasal polyps and sinusitis (most of which will likely come from outside of the US) and then consulting with your personal physician. Dr. McGinnis does not have a doctor-patient relationship with me or with you (and I don't have one with you either), so anybody who wishes to use the head-inverted method of administering steroids is doing so at his or her own risk -- that is, Dr. McGinnis is assuming no personal liability (nor am I) in explaining how he has used this method. In these litigious days, physicians have to watch out for themselves!
Dr. McGinnis reported that he was currently treating himself with 0.4 ml of Flonase in each nostril at bedtime. By his calculations that is 200 mcg per nostril, which is twice the amount recommended in the literature that comes with Flonase nasal spray. Dr. McGinnis also suggested that the product within Flixonase nasules may well be more concentrated than is that in Flonase nasal spray.
Dr. McGinnis also noted that Fluticasone (Flonase, Flixonase) seems to be considerably more powerful than Dexamethasone, but that some doctors use Dexamethasone for initial treatment of polyps, before using the newer, more powerful steroids for long term control. It may be that Dexamethasone solution is more water soluble than Fluticasone (especially some formuations of Fluticasone such as the microcrystalline suspensions). For this reason, some or all forms of Dexamethasone may penetrate polyps better than some or all forms of Fluticasone -- of course, it could just be that the dexamethasone is available for use as drops but the fluticasone not. He added that there is as yet probably no formal FDA approval in this country for the use of the head inverted technique for nasal polyps or sinusitis. There may not even be formal FDA approval for using topical steroids for sinusitis in a conventional upright position -- the only formal approval may be for allergic and perennial rhinitis or runny nose, but topical steroids like Flonase are still used widely by ENTs and other doctors for sinusitis. It is probably just too expensive (reducing profits) to do the research (necessary to gain FDA approval) establishing effectiveness of nasal steroids for treating polyposis -- that is, the market is not large enough to justify the expense, especially if doctors are already prescribing it for that purpose.
Dr. McGinnis also suggested that interested persons see if they can get the Flixonase nasule drops from outside the country and avoid any potential problems that could occur from modifying/adapting Flonase Nasal Spray for use as drops. Such problems could include getting bits of metal, glass, plastic or other material into the medication and then into your nose, getting infections from re-using syringes and container without sterilizing them, and so on. I really wish the Flixonase nasules were available in the US. I'm too cheap to buy medicines that my insurance provider won't pay for.
Karagama, Lancaster, Karkanevatos, and Sullivan (Delivery of Nasal Drops to the Middle Meatus: Which is the Best Head Position, Rhinology, 2001, 39, 226-229) researched effectiveness of four different head positions. They found that the Mygind (head dangling back) and the Ragan (lie on side, head turned towards opposite shoulder, no pillow, instill into lower nostril) positions were more effective at delivering the medication to the middle meatus than were the Mecca (kneeling, vertex touching the floor) and the Head Back (sit or stand, tilt head back)positions. These positions are illustrated in their article. Since sinusitis and nasal polyposis most often involve the maxillary and the anterior ethmoid sinuses, it is thought that medication will be most effective if it is delivered to the ostiometal complex through which these sinuses drain. The ostiometal complex opens into the middle meatus (see Anatomy of the Sinuses and Sinus and Nasal Anatomy). With the Mecca position no medication was delivered to the middle meatus -- rather it pooled in the roof of the nose -- but the authors also suggested that placing the medication in the roof of the nose may be exactly what is desired when the intranasal steroid is intended to treat anosmia/hyposmia or nasal polyps in the roof of the nose.
Kayarkar, Clifton, and Woolford (An evaluation of the best head position for instillation of steroid nose drops, Clin Otolaryngol. 2002, 27, 18-21) found the Lying Head Back (LHB) position (very similar to the Mygind position described by Karagama et al.) best for delivering drops to the middle meatus. Check the figures in their article, available online, and linked above. It is the LHB position that I employ, largely because I find it convenient and comfortable. Thanks to Dr. McGinnis for pointing me to this article.
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Benzalkonium Chloride -- this preservative, used in many nasal sprays, may interfere with nasal clearance
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