Dermaflutisone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled Dermaflutisone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.
Dermaflutisone must be used with a short-acting medicine (eg, albuterol) for an asthma attack or asthma symptoms that need attention right away.
Dermaflutisone is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, Dermaflutisone propionate is used in certain patients with the following medical conditions:
Pulmonary disease, chronic obstructive
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Adult: As Dermaflutisone propionate spray: 100 mcg into each nostril once daily, increased to bid as necessary. As Dermaflutisone furoate spray: 55 mcg into each nostril once daily, may reduce to 27.5 mcg into each nostril once daily if symptoms are controlled.
Child: 4-11 yr As Dermaflutisone propionate spray: 50 mcg into each nostril once daily, increased to bid if necessary. 2-11 yr As Dermaflutisone furoate spray: 27.5 mcg into each nostril once daily, may be increased to 55 mcg into each nostril once daily if necessary.
Adult: As Dermaflutisone propionate drops: 200 mcg into each nostril 1-2 times daily for at least 4-6 wk.
Child: ≥16 yr Same as adult dose.
Adult: As Dermaflutisone propionate powd or aerosol inhaler: 100 mcg bid in mild asthma, up to 500-1,000 mcg bid in severe cases. As nebuliser soln: Severe chronic asthma: 500-2,000 mcg bid. As Dermaflutisone furoate dry powd inhaler: 100-200 mcg once daily.
Child: 4-16 yr As Dermaflutisone propionate powd or aerosol inhaler: 50-100 mcg bid, increased to 200 mcg bid if necessary. As nebuliser soln: 1,000 mcg bid.
Adult: 0.05% cream or 0.005% oint: Apply thinly and rub gently to affected area bid for up to 4 wk until improvement occurs.
Child: ≥3 mth Apply thinly to affected area bid, w/draw treatment and reassess diagnosis if no improvement is seen w/in 7-14 days.
How should I use Dermaflutisone?
Use Dermaflutisone spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Dermaflutisone spray. Talk to your pharmacist if you have questions about this information.
Shake gently before each use.
If needed, prime the spray pump according to the directions in the extra patient leaflet.
To use a nose spray, gently blow your nose. Sit down and tilt your head forward slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
Symptoms can start to improve as soon as 12 hours after you start using Dermaflutisone spray, and should improve within a couple of days. The full benefit may not be achieved until you have used Dermaflutisone spray for several days. If symptoms do not improve or if the condition worsens, contact your health care provider.
Use Dermaflutisone spray on a regular schedule to get the most benefit from it.
Using Dermaflutisone spray at the same time each day will help you remember to use it.
Continue to use Dermaflutisone spray even if you feel well. Do not miss any doses.
If you miss a dose of Dermaflutisone spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Dermaflutisone spray.
Uses of Dermaflutisone in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Dermaflutisone is used to control symptoms of asthma, allergies of nose, throat or chest that cause symptoms of stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, skin problems like itchy rash (eczema), redness and itchiness (psoriasis), inflammation (dermatitis), prickly heat or insect bites in adults or dermatitis in children.
Dermaflutisone propionate (Dermaflutisone) Nasal Spray 50 mcg is an aqueous suspension of microfine Dermaflutisone propionate for topical administration to the nasal mucosa by means of a metering atomizing spray pump.
It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (6 actuations), each actuation delivers 50 mcg of Dermaflutisone propionate in 100 mg of formulation through the nasal adapter. Each bottle contains a net fill of 10 mL and will provide 100 actuations.
The correct amount of medication in each spray cannot be assured after 100 sprays even though the bottle is completely empty. The bottle should be discarded when the labeled number of actuations has been used.
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Administer Dermaflutisone Nasal Spray by the intranasal route only. Prime Dermaflutisone Nasal Spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake Dermaflutisone Nasal Spray gently before each use.
Patients should use Dermaflutisone Nasal Spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief.
The recommended starting dosage in adults is 2 sprays (50 mcg of Dermaflutisone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.
Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.
Adolescents and Children (Aged 4 Years and Older)
The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is achieved, the dosage should be decreased to 1 spray in each nostril once daily.
The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day) There is no evidence that exceeding the recommended dose is more effective.
Under normal circumstances, low plasma concentrations of Dermaflutisone propionate are achieved after inhaled dosing, due to extensive first-pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 (CYP450 3A4) in the gut and liver. Hence, clinically significant drug interactions mediated by Dermaflutisone propionate are unlikely.
A drug interaction study in healthy subjects has shown that ritonavir (a highly potent CYP450 3A4 inhibitor) can greatly increase Dermaflutisone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving Dermaflutisone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of Dermaflutisone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Caution should be exercised when other potent CYP450 3A4 inhibitors are co-administered with Dermaflutisone propionate. In a drug interaction study, co-administration of orally inhaled Dermaflutisone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in increased plasma Dermaflutisone propionate exposure and reduced plasma cortisol area under the concentration-time curve (AUC), but had no effect on urinary excretion of cortisol. In another multiple-dose drug interaction study, co-administration of orally inhaled Dermaflutisone propionate (500 mcg twice daily) and erythromycin (333 mg 3 times daily) did not affect Dermaflutisone propionate pharmacokinetics.
Systemic and local corticosteroid use may result in the following:
Candida albicans infection
Hypercorticism and adrenal suppression
Reduction in bone mineral density
Growth effects in pediatrics
Glaucoma and cataracts
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The incidence of adverse reactions associated with Dermaflutisone in Table 1is based upon two placebo-controlled, 12-week, clinical studies (Study 1 and 2). A total of 822 adolescent and adult patients previously treated with inhaled corticosteroids were treated with twice daily Dermaflutisone 55 mcg, 113 mcg, 232 mcg or placebo. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 days in Dermaflutisone groups compared with 75 days in the placebo group.
Table 1: Adverse Reactions with ≥ 3% Incidence with Dermaflutisone, and More Common than Placebo in Subjects with Asthma
Dermaflutisone 55 mcg
Dermaflutisone 113 mcg
Dermaflutisone 232 mcg
Infections and infestations
Nervous system disorders
Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, oropharyngitis fungal
URTI = upper respiratory tract infection
Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on Dermaflutisone), whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with Dermaflutisone compared with patients treated with placebo include the following: Oropharyngeal pain, hypertension, rhinitis allergic, influenza, pyrexia, dizziness, respiratory tract infection, muscle spasms, rhinitis, epistaxis, ligament sprain, musculoskeletal pain, pain in extremity, throat irritation, and vomiting.
Long Term Safety Study: This was a 26-week, open label study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with Dermaflutisone 113 mcg, 232 mcg, AIRDUO RESPICLICK 113/14 mcg, 232/14 mcg, Dermaflutisone propionate aerosol 110 mcg, 220 mcg, Dermaflutisone propionate and salmeterol inhalation powder 250/50 mcg, 500/50 mcg. The types of adverse reactions among Dermaflutisone treatments were similar to those reported above in placebo controlled studies.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post‑approval use of Dermaflutisone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Dermaflutisone propionate or a combination of these factors.
Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, and throat soreness.
Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.
Immune System Disorders: Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.
Infections and Infestations: Esophageal candidiasis.
Psychiatry: Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
You should not use Dermaflutisone nasal if you are allergic to it, or if you are also taking ritonavir (Norvir, Kaletra).
Before using Dermaflutisone nasal, tell your doctor if you have glaucoma or cataracts, liver disease, diabetes, herpes simplex virus of your eyes, tuberculosis or any other infection, sores or ulcers inside your nose, or if you have recently had injury of or surgery on your nose.
It may take up to several days of using this medicine before your symptoms improve. Tell your doctor if your symptoms do not improve after a week of treatment.
Dermaflutisone nasal can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Dermaflutisone nasal.
Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.
Do not give this medicine to a child younger than 2 years old without medical advice. Steroid medication can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
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