Overview:
Fluticasone propionate is an FDA-approved drug that has been indicated for the treatment and management of non-allergic rhinitis, and its symptoms that include nasal as well as dermatological symptoms. Fluticasone propionate is sold under the brand name Flonase, and it received its approval from the Food and Drug Administration (FDA) in 1998. Flonase is manufactured and sold by the pharmaceutical company, GlaxoWellcome, Inc. Fluticasone propionate is a corticosteroid in the form of nasal spray that has been indicated for the treatment and correction of perennial non-allergic rhinitis, including the symptoms of the condition, in both adults as well as pediatric patients that are above the age of four years. The recommended dose that a patient is started on is 200 mcg in a day for adults, which equals two nasal sprays, and 100 mcg in a day for adolescents and pediatric patients above four years, which equals one spray in a day. Every 100 mg of a spray consists of 50 mcg of Fluticasone propionate.
Patients are warned against this medication if there is a known history of allergic reactions to Fluticasone propionate by the patient or the patient's family members. Patients must take precautionary measures in case they have a wound around the nasal cavity. Patients with nasal ulcerations, epistaxis, infection such as Candida albicans, nasal septal perforation, and nasal trauma must avoid Fluticasone propionate. Patients suffering from glaucoma and cataract additionally require clearance from the ophthalmologist since they may develop Fluticasone long-term usage symptoms. In case of any kind of hypersensitivity reaction, Fluticasone propionate must be immediately discontinued. The growth of pediatric patients must be observed carefully while they are on treatment with Fluticasone propionate. Headache, nasal irritation, asthma, pharyngitis, nausea, vomiting, and cough have been reported to be the most general adverse reactions to Fluticasone propionate. Fluticasone propionate must not be used in adjunct to another antiviral drug since this may lead to an enhanced effect of corticosteroids.
How Does Fluticasone Propionate Work?
Fluticasone propionate is a corticosteroid. It is a synthetic trifluorinated corticosteroid that has anti-inflammatory activities. In addition, Fluticasone propionate has shown, in several studies, to have a binding affinity to the human glucocorticoid receptor, which is 18 times more than the affinity of dexamethasone and twice the affinity of beclomethasone-17-monopropionate (BMP) which is the active metabolite of beclomethasone, and around three times relationship to Budesonide. The active ingredient of Fluticasone propionate is a corticosteroid that has the chemical name S- (fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3- oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate. The exact way how Fluticasone propionate works for the management of non-allergic rhinitis is not yet known. There have been several studies that have shown Fluticasone propionate to present with a massive range of alterations on mast cells, neutrophils, eosinophils, macrophages, lymphocytes, and other cell types, along with histamine, leukotrienes, eicosanoids, cytokines, and other mediators that are actively involved in the inflammatory response. The direct relationship between Fluticasone propionate and these findings is still not clear.
Uses:
Fluticasone propionate is a white-colored powder with a molecular weight of 500.6 g/mol. The formula of Fluticasone propionate is C25H31F3O5S. The drug is not soluble in water but is freely soluble in dimethyl sulfoxide as well as dimethylformamide. Fluticasone propionate is additionally soluble to some extent in 95 % ethanol and methanol. Fluticasone propionate is available in the form of a nasal spray that has been indicated for the treatment and management of the symptoms as well as the entire condition of non-allergic rhinitis. The age group of the patient for whom the drug is indicated is four years and above.
Dosage:
Fluticasone propionate nasal spray is an aqueous suspension of microfine ingredients and is used for topical administration onto the nasal mucosa. This administration is done by metering and atomizing the spray pump. The primary route of administration of Fluticasone propionate is the nasal route. The recommended dose for adult patients is two sprays of 50 mcg each per nostril per day. This equals 200 mcg of a daily dosage of Fluticasone propionate for adults. For pediatric patients and adolescents, the dosage is exactly half of the adults, that is, one spray per nostril per day, a total of 100 mcg per day. Doses must be administered at the same time every day. In case maintenance therapy is required, the dosage can be reduced to half for adults and children, respectively. It has not been recommended to exceed the dosage against the prescription for any particular reason.
Warning:
Mentioned below is the list of conditions and diseases that must be taken into consideration for precautionary measures when the treatment is initiated with Fluticasone propionate.
-
Epistaxis:
Clinical trials have shown the presence of epistaxis in patients who were treated with Fluticasone propionate. The presence was reasonably frequent in nature.
-
Nasal Ulceration:
Post-marketing, there have been a few incidents of ulcerations in the nasal region with the use of Fluticasone propionate.
-
Candida Albicans Infection:
The presence of Candida albicans infection around the nose as well as the pharynx had been observed in clinical trials. In such cases, the infection is treated while putting the therapy with Fluticasone propionate on hold.
-
Nasal Septal Perforation:
Treatment with Fluticasone propionate has demonstrated a few cases of nasal septal perforations, but these were reported only after marketing the drug.
-
Impaired Wound Healing:
Corticosteroids have been known to lead to inhibitory effects of healing in the body. Due to the same reason, Fluticasone propionate leads to impaired wound healing of nasal trauma, nasal wound, nasal ulcers, etc.
-
Glaucoma and Cataracts:
The usage of Fluticasone propionate as a nasal spray may end up in the development or enhancement of cataracts and glaucoma. Any change in vision must be immediately reported.
-
Hypersensitivity Reactions:
There have been several reports of hypersensitivity to Fluticasone propionate.
-
Anaphylaxis:
In case of an anaphylactic reaction, the drug must be stopped entirely.
-
Hypercorticism:
In the event that intranasal corticosteroids are administered at a more remarkable than the recommended dose or administered in certain susceptible patients at recommended doses, systemic corticosteroid changes such as hypercorticism as well as adrenal suppression may develop. In this case, and if such changes do begin to occur, the dosage of Fluticasone propionate nasal spray should be discontinued according to the standard procedure of concluding a corticosteroid.
-
Adrenal Suppression:
The use of a systemic corticosteroid instead of a topical corticosteroid can be accompanied by several clinical manifestations and signs of adrenal insufficiency. A few patients may additionally experience particular symptoms of corticosteroid withdrawal, which include joint pain, muscular pain, depression, and lassitude.
-
Immunosuppression:
Individuals who are under therapy with certain drugs that are known to suppress the immune system of the patient are highly susceptible to several infections as compared to healthy individuals. Diseases such as chickenpox and measles may lead to a more serious and fatal outcome in children or adults under therapy with corticosteroids. In such patients, whether they may be children or adults who have not been exposed to such diseases or who have not been appropriately immunized, specific care is to be taken in order to avoid exposure. It is yet not clear how the dose, route, contribution to the underlying disease, and duration of corticosteroid administration may pose an increased risk of developing such disseminated infection.
For Patients:
What Do You Need to Know About Nonallergic Rhinitis?
Non-allergic rhinitis is the inflammation of the inner part of the nose that is not due to an allergic reaction. Non-allergic rhinitis involves several signs and symptoms, such as chronic sneezing and a congested and drippy nose without any particular identified allergic response. Other common terminologies for non-allergic rhinitis- are perennial rhinitis, non-allergic perennial rhinitis, and vasomotor rhinitis.
Non-allergic rhinitis is diagnosed after a thorough nose examination. The diagnosis reveals the nasal mucosa to be boggy and edematous with clear mucoid secretions. The turbinates are seen to be congested and hypertrophic. A pharynx examination is done as well that reveals the condition of the tongue, adenoids, and the base of the tongue. A mucosal injection is given that may reveal lymphoid hyperplasia. Other diagnostic tools to investigate the presence of non-allergic rhinitis include:
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Eosinophil count.
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Complete blood picture.
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Skin tests.
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Vitro allergy tests.
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Acoustic rhinometry.
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Nasal patency test.
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Smell test.
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Computerized tomography scan (CT).
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Magnetic resonance imaging (MRI).
The signs and symptoms of non-allergic rhinitis include sneezing in the morning, just after getting out of bed, excessive water discharge from the nose, water discharge if the patient moves forward, a nasal obstruction that is bilateral, and nasal stuffiness that is enhanced at night, and postnasal drip. Sinusitis and nasal polyps, along with turbine hypertrophy, are the most common subsequent complication of non-allergic rhinitis.
When Should We Use Fluticasone Propionate for Nonallergic Rhinitis?
Fluticasone propionate is available in the form of a nasal spray that has been indicated for the treatment and management of the symptoms as well as the entire condition of non-allergic rhinitis. The age group of the patient for whom the drug is indicated is four years and above.
Things to Inform Your Respective Healthcare Provider Before Being Prescribed Fluticasone Propionate:
There are certain conditions that must be informed to the healthcare provider before the patient begins any therapy and is prescribed any kind of medication. In addition, family, personal, drug history, as well as recent admission to hospitals, must be additionally informed to the healthcare professional.
Mentioned below are the few conditions and situations that the patient is advised to notify their respective healthcare provider before being prescribed Fluticasone propionate.
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Known allergy to Fluticasone propionate.
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Known allergy to any ingredient mentioned in Fluticasone propionate nasal spray.
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Nasal surgery.
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Nasal trauma.
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Existing tuberculosis.
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Fungal, Bacterial, Viral, or Parasitic Infection.
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Glaucoma.
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Cataract.
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Family history of allergic reaction to Fluticasone propionate.
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Hepatic impairment.
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Renal insufficiency.
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Angioedema.
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Urticaria.
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Contact Dermatitis.
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Ocular Herpes Simplex.
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Chickenpox.
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Nasal perforation.
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Presence of Candida albicans infection.
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Measles.
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Hyperthyroidism.
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Autoimmune diseases.
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Undergoing conjunct corticosteroid therapy.
How to Use Fluticasone Propionate Nasal Spray for Nonallergic Rhinitis?
Fluticasone propionate nasal spray is an aqueous suspension of microfine ingredients and is used for topical administration onto the nasal mucosa. This administration is done by metering and atomizing the spray pump. The primary route of administration of Fluticasone propionate is the nasal route. The recommended dose for adult patients is two sprays of 50 mcg each per nostril per day. This equals 200 mcg of a daily dosage of Fluticasone propionate for adults. For pediatric patients and adolescents, the dosage is exactly half of the adults, that is, one spray per nostril per day, a total of 100 mcg per day. Doses must be administered at the same time every day. In case maintenance therapy is required, the dosage can be reduced to half for adults and children, respectively. It has not been recommended to exceed the dosage against the prescription for any particular reason.
Keep Track of the Changes After the Nasal Administration of Fluticasone Propionate:
There are specific reactions that may occur after the nasal administration of Fluticasone propionate. Such changes must be noted down and informed to the respective healthcare provider.
Mentioned below are the changes that may occur after the nasal administration of Fluticasone propionate that must be immediately reported to the healthcare professional.
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Rashes.
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Redness around the nose.
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Swelling of the nose.
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Nausea.
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Vomiting.
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Dizziness.
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Fever.
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Weakness.
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Headache.
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Pain around the eyes.
-
Tinnitus.
-
Skin irritation.
-
Acne.
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Burning sensation.
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Asthma symptoms.
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Cough.
-
Sore throat.
-
Pain in the ears.
Avoid Self-Medication:
Fluticasone propionate is a corticosteroid drug that is indicated for the treatment of non-allergic rhinitis. Only a healthcare provider gives the prescription. Fluticasone propionate is to be used only for the patient for whom the drug was prescribed and nobody else. Licensed pharmacists, nurses, or any other medical representative must not prescribe Fluticasone propionate. An experienced healthcare professional, after diagnosing the condition and understanding the medical history, drug history, and personal history of the patient, makes a decision to prescribe Fluticasone propionate. Thus, self-medication of Fluticasone propionate must be strictly avoided.
What Should Be Done in Case of an Overdosage of Fluticasone Propionate?
A chronic overdose of Fluticasone propionate may result in signs and symptoms similar to hypercorticism. In clinical studies, intranasal administration of around 2 mg Fluticasone propionate, which is approximately ten times the recommended dosage, was administered twice daily for seven days to healthy volunteers.
The adverse reactions reported with Fluticasone propionate were similar to placebo, and there were no clinically significant alterations and abnormalities in the laboratory safety tests. Headache, burning sensation, and vomiting are the clinical manifestations of an overdose of Fluticasone propionate. In such cases, the drug must not be imminently stopped.
This is because Fluticasone propionate is a corticosteroid, and a corticosteroid has a specific protocol that is to be followed in case a corticosteroid needs to be stopped. The healthcare provider must be informed about the overdose as well as the symptoms experienced by the patient. A professional will examine the dose and clinical manifestations to follow the required protocol of stopping a strong corticosteroid drug.
How to Store Fluticasone Propionate?
Fluticasone propionate nasal spray, 50 mcg, is supplied in an amber-colored glass bottle that is fitted with white-colored metering atomizing pump along with a white nasal adapter and a green dust cover in an FDA-approved box with patient labeling. The bottle is to be discarded when it is empty. The storage of Fluticasone propionate should be between 4 degrees Celsius and 30 degrees Celsius which is equivalent to 39 degrees Fahrenheit and 86 degrees Fahrenheit.
For Doctors:
Indications:
Fluticasone propionate is a corticosteroid that is indicated in the treatment and management of non-allergic rhinitis in the form of a nasal spray.
Contraindications:
Fluticasone propionate is contraindicated in patients who are known to have a hypersensitivity reaction to the below-mentioned ingredients of Fluticasone propionate nasal spray.
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Fluticasone propionate.
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Microcrystalline cellulose.
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Carboxymethylcellulose sodium.
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Dextrose.
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0.02 % w/w benzalkonium chloride.
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Polysorbate 80.
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0.25 % w/w phenyl ethyl alcohol.
Pharmacology:
Mechanism of Action:
The active component of the nasal spray is Fluticasone propionate, which is a corticosteroid of the chemical name S- (fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3- oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate. Fluticasone propionate is a white-colored powder that has a molecular weight of 500.6 g/mol, and the formula is C25H31F3O5S. Fluticasone propionate is insoluble in water and soluble in dimethyl sulfoxide and dimethylformamide, methanol, and 95 % ethanol.
Fluticasone propionate is a synthetic trifluorinated corticosteroid that has vigorous anti-inflammatory activity, and it exhibits a strong binding affinity to the human glucocorticoid receptor, which is 18 times more than that of Dexamethasone, twice that of beclomethasone-17-monopropionate or BMP- the active metabolite of beclomethasone dipropionate, and approximately three times that of Budesonide. Fluticasone propionate nasal spray comes in a 50 mcg aqueous suspension of microfine ingredients for topical use to the nasal mucosa with the help of a metering, atomizing spray pump. Fluticasone propionate nasal spray additionally consists of microcrystalline cellulose, carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25 % w/w phenyl ethyl alcohol. Fluticasone propionate has a pH that is between 5 and 7. Each actuation of the nasal spray delivers 50 mcg of Fluticasone propionate in 100 mg of formulation with the help of the nasal adapter.
The precise mechanism of action by which Fluticasone propionate corrects non-allergic rhinitis symptoms is not very well known. However, corticosteroids have shown effects on multiple cell types and inflammatory mediators that include the following mentioned below.
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Mast cells.
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Eosinophils.
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Neutrophils.
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Macrophages.
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Lymphocytes.
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Histamine.
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Eicosanoids.
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Leukotrienes.
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Cytokines.
Ingredients:
1. Active Ingredient:
Fluticasone propionate
2. Inactive Ingredient:
-
Microcrystalline cellulose.
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Carboxymethylcellulose sodium.
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Dextrose.
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0.02 % w/w benzalkonium chloride.
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Polysorbate 80.
-
0.25 % w/w phenyl ethyl alcohol.
Pharmacodynamics:
The potential systemic changes of Fluticasone propionate nasal spray, such as 200 mcg once daily or 400 mcg twice daily, do not alter the adrenal response up to six hours of cosyntropin stimulation. There have not been any studies on the cardiac electrophysiology of Fluticasone propionate.
Pharmacokinetics:
The activity of the nasal spray is due to the parent drug within the spray- Fluticasone propionate. However, because of the low bioavailability through the intranasal route, the majority of the pharmacokinetic data have been obtained through other routes of administration.
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Absorption:
Indirect calculations have shown that Fluticasone propionate, when given by the intranasal route, has an absolute bioavailability that is less than 2 %. After intranasal administration of Fluticasone propionate in patients with rhinitis for around three weeks, the plasma concentration of Fluticasone propionate was 50 pg/ml, which is above the level of detection.
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Distribution:
The amount of Fluticasone propionate linked to human plasma proteins is around 99 %. Fluticasone propionate is reversibly and weakly bound to erythrocytes. Fluticasone propionate is not attached to human transcortin at an expected level.
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Metabolism:
After administration of nasal Fluticasone propionate, the circulating metabolite detected was the 17β-carboxylic acid derivative of Fluticasone propionate. This is formed via the CYP3A4 pathway, and it has a lower amount of affinity than the parent drug for the glucocorticoid receptor of human lung cytosol. It additionally has negligible pharmacological activity.
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Drug Interactions Inhibitors of Cytochrome P450 3A4:
Fluticasone propionate is known to be a substrate of CYP3A4. It is not recommended to co-administer Fluticasone propionate and the potent CYP3A4 inhibitor, such as Ritonavir and Ketoconazole. This result has been derived after a multiple-dose, crossover drug interaction trial in 18 healthy individuals. Fluticasone propionate nasal spray of the dose of 200 mcg, once daily, was co-administered for a week with Ritonavir of the dose of 100 mg, twice daily. This resulted in an 86 % increase in serum cortisol levels.
Dosage and Administration:
Each 100-mg spray delivers 50 mcg of Fluticasone propionate. Fluticasone propionate nasal spray is an aqueous suspension of microfine ingredients. It is used for topical administration onto the nasal mucosa. This administration is done by metering and atomizing the spray pump. The primary route of administration of Fluticasone propionate is the nasal route. The recommended dose for adult patients is two sprays of 50 mcg each per nostril per day. This equals to 200 mcg of a daily dosage of Fluticasone propionate for adults. For pediatric patients and adolescents, the dosage is exactly half of the adults, that is, one spray per nostril per day, a total of 100 mcg per day.
Doses must be administered at the same time every day. In case maintenance therapy is required, the dosage can be reduced to half for adults and children, respectively. It has not been recommended to exceed the dosage against the prescription for any particular reason.
Warning and Precautions:
-
Epistaxis:
Clinical trials have shown the presence of epistaxis in patients who were treated with Fluticasone propionate. The presence was reasonably frequent in nature.
-
Nasal Ulceration:
Post-marketing, there have been a few incidents of ulcerations in the nasal region with the use of Fluticasone propionate.
-
Candida Albicans Infection:
The presence of Candida albicans infection around the nose as well as the pharynx had been observed in clinical trials. In such cases, the infection is treated while putting the therapy with Fluticasone propionate on hold.
-
Nasal Septal Perforation:
Treatment with Fluticasone propionate has demonstrated a few cases of nasal septal perforations, but these were reported only after marketing the drug.
-
Impaired Wound Healing:
Corticosteroids have been known to lead to inhibitory effects of healing in the body. Due to the same reason, Fluticasone propionate leads to impaired wound healing of nasal trauma, nasal wound, nasal ulcers, etc.
-
Glaucoma and Cataracts:
The usage of Fluticasone propionate as a nasal spray may end up in the development or enhancement of cataracts and glaucoma. Any change in vision must be immediately reported.
-
Hypersensitivity Reactions:
There have been several reports of hypersensitivity to Fluticasone propionate.
-
Anaphylaxis:
If Anaphylactic reactions occur, the drug must be stopped entirely.
-
Hypercorticism:
In the event that intranasal corticosteroids are administered at a more considerable than the recommended dose or administered in certain susceptible patients at recommended doses, systemic corticosteroid changes such as hypercorticism as well as adrenal suppression may develop. In this case, and if such changes do begin to occur, the dosage of Fluticasone propionate nasal spray should be discontinued according to the usual procedure of concluding a corticosteroid.
-
Adrenal Suppression:
The use of a systemic corticosteroid instead of a topical corticosteroid can be accompanied by several clinical manifestations and signs of adrenal insufficiency. A few patients may additionally experience corticosteroid withdrawal symptoms, including joint pain, muscular pain, depression, and lassitude.
-
Immunosuppression:
Individuals under therapy with certain drugs known to suppress the patient's immune system are highly susceptible to several infections compared to healthy individuals. Diseases such as chickenpox and measles may lead to a more severe and fatal outcome in children or adults under therapy with corticosteroids. In such patients, whether they may be children or adults who have not been exposed to such diseases or who have not been adequately immunized, specific care is to be taken in order to avoid exposure. It is yet not clear how the dose, route, contribution to the underlying disease, and duration of corticosteroid administration may pose an increased risk of developing such disseminated infection.
Mentioned below are some of the lesser-known warning and precautionary conditions that must be taken into consideration when undergoing treatment with Fluticasone propionate.
-
Angioedema.
-
Urticaria.
-
Contact dermatitis.
-
Rash.
-
Potential worsening of infections.
-
Existing tuberculosis.
-
Fungal, bacterial, viral, or parasitic infection.
-
Ocular herpes simplex.
-
Chickenpox.
-
Measles.
-
Adverse effects on the nasal mucosa.
-
Nasal ulcers.
-
Nasal surgery.
-
Nasal trauma.
Results from Clinical Trials:
Three randomized, double-blind, parallel-group, vehicle, placebo-controlled trials were conducted on 1,191 individuals in order to investigate the regular use of Fluticasone propionate nasal spray in those suffering from non-allergic rhinitis. The study resulted in statistically significant depression of nasal obstruction, rhinorrhea, postnasal drip, and nasal congestion.
Overdosage:
In case of overdosage, the drug must not be stopped immediately. Being a corticosteroid, the tapering of Fluticasone propionate must be done after following the exact protocol of stopping a corticosteroid in between therapy.
Adverse Effects:
-
Rashes.
-
Redness around the nose.
-
Swelling of the nose.
-
Nausea.
-
Vomiting.
-
Dizziness.
-
Fever.
-
Weakness.
-
Headache.
-
Pain around the eyes.
-
Tinnitus.
-
Skin irritation.
-
Acne.
-
Burning sensation.
-
Asthma symptoms.
-
Cough.
-
Sore throat.
-
Pain in the ears.
Other Specifications:
-
Pregnancy:
There is no sufficient data on the use of Fluticasone propionate in pregnant individuals. When inhaled Fluticasone propionate, lab rats decreased the fetus's body weight but not any presence of gene mutation. In humans, the neonatal cord blood, after delivery, had traces of Fluticasone propionate.
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Lactation:
There is data available on the presence of Fluticasone propionate in human milk. It is known that low amounts concentrations of several other corticosteroids have been detected on multiple occasions in human milk.
-
Pediatric Use:
The safety and effectiveness of Fluticasone propionate nasal spray in children younger than four years have not been established. Therefore, the physical and mental growth of pediatric patients above four years who are under inhalation of corticosteroid therapy such as Fluticasone nasal spray should regularly undergo stadiometry.
-
Geriatric Use:
Only a small number of individuals above 65 years had been studied with Fluticasone propionate nasal spray in clinical trials, which is too small to permit an analysis of the efficacy and safety as well as the adverse reactions of Fluticasone propionate in the geriatric age group.
-
Hepatic Impairment:
There have not been any specific studies or research on patients suffering from hepatic impairment. Thus there is no sufficient data to analyze the changes in the liver of patients with hepatic impairment who are undergoing Fluticasone propionate therapy. However, such patients must be closely monitored since corticosteroids are known to eliminate in the liver.
-
Renal Impairment:
There has not been any formal study or research on patients who are known to have an underlying renal impairment. Thus, there is no data to establish the safety of Fluticasone propionate in such patients.
- Carcinogenesis, Mutagenesis, Impairment of Fertility:
Fluticasone propionate had demonstrated no tumorigenic changes, no gene mutation changes, and no alterations in the fertility as well as the reproductive strengths of both genders in lab mice when at inhalation doses that were approximately three times the recommended dosage in adults and children, respectively.
Storage and Supply:
Fluticasone propionate nasal spray, 50 mcg, is supplied in an amber-colored glass bottle that is fitted with white-colored metering atomizing pump along with a white nasal adapter and a green dust cover in an FDA-approved box with patient labeling. Each bottle consists of a fill weight of 16 g and will be able to provide 120 actions where each actuation delivers 50 mcg of Fluticasone propionate with 100 mg of formulation via the nasal adapter. The bottle is to be discarded when it is empty. The storage of Fluticasone propionate should be between 4 degrees Celsius and 30 degrees Celsius which is equivalent to 39 degrees Fahrenheit and 86 degrees Fahrenheit.
