Fluticasone Propionate (Fluticasone Propionate)

Trade Name : Fluticasone Propionate

West-Ward Pharmaceuticals Corp.

SPRAY, METERED

Strength 50 ug/1

FLUTICASONE PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Propionate (Fluticasone Propionate) which is also known as Fluticasone Propionate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 50 ug/1 per ml. Read more

Fluticasone Propionate (Fluticasone Propionate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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5.2

Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older.
Fluticasone propionate nasal spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. ()

Administer fluticasone propionate nasal spray by the intranasal route only. Prime fluticasone propionate 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 fluticasone propionate nasal spray gently before each use.
Patients should use fluticasone propionate 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.
For intranasal use only. Recommended starting dosages:

Fluticasone propionate nasal spray USP is an aqueous suspension. Each 100 mg spray delivers 50 mcg of fluticasone propionate USP.
Nasal spray: 50 mcg of fluticasone propionate USP in each 100 mg spray. ()

Fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients , .
Hypersensitivity to any ingredient. ()

No data

Candida albicans

Systemic and local corticosteroid use may result in the following:
The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, and cough. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur.
Ritonavir
Ketoconazole
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ()

Hepatic impairment: Monitor patients for signs of increased drug exposure. ()

Chronic overdosage may result in signs/symptoms of hypercorticism Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days was administered to healthy human volunteers. Adverse events reported with fluticasone propionate were similar to placebo, and no clinically significant abnormalities in laboratory safety tests were observed. Single oral doses up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups. Acute overdosage with this dosage form is unlikely since one bottle of fluticasone propionate nasal spray contains approximately 8 mg of fluticasone propionate.

The active component of fluticasone propionate nasal spray USP is fluticasone propionate USP, a corticosteroid having the chemical name -(fluoromethyl)6u03b1,9-difluoro-11u03b2-17-dihydroxy-16u03b1-methyl-3-oxoandrosta-1,4-diene-17u03b2-carbothioate, 17-propionate and the following chemical structure:
Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6 and the molecular formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
Fluticasone propionate nasal spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone propionate nasal spray also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80 and has a pH between 5 and 7.
After initial priming, each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter.

No data

Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 25 and 20 times the MRHDID in adults and children, respectively, on a mcg/m basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately 3 and 2 times the MRHDID in adults and children, respectively, on a mcg/mu00a0basis) for 104 weeks.
Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells . No significant clastogenic effect was seen in cultured human peripheral lymphocytes or in the mouse micronucleus test.
Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 2 times the MRHDID in adults on a mcg/m basis).

Perennial Nonallergic Rhinitis

Fluticasone Propionate Nasal Spray USP, 50 mcg
Store between 4u00b0 and 30u00b0C (39u00b0 and 86u00b0F).

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Local Nasal Effectsn- Candidan- Array
Glaucoma and Cataractsn- Array
Hypersensitivity Reactions, including Anaphylaxisn- Array
Immunosuppressionn- Array
Reduced Growth Velocityn- Array
Use Daily for Best Effect
Keep Spray Out of Eyes and Mouth
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10002064/09
Revised January 2019

Fluticasone Propionate Nasal Spray USP, 50 mcg
(FLOO-tih-kah-sone)
What is fluticasone propionate nasal spray?
Fluticasone propionate nasal spray is a prescription medicine used to treat non-allergy nasal symptoms such as runny nose, stuffy nose, sneezing, and nasal itching in adults and children aged 4 years and older.
It is not known if fluticasone propionate nasal spray is safe and effective in children younger than 4 years of age.
Do not use fluticasone propionate nasal spray
Before using fluticasone propionate nasal spray, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take,
Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use fluticasone propionate nasal spray?
Read the step-by-step instructions for using fluticasone propionate nasal spray at the end of this Patient Information.
What are the possible side effects of fluticasone propionate nasal spray?
Fluticasone propionate nasal spray may cause serious side effects, including:
The most common side effects of fluticasone propionate nasal spray include:
These are not all the possible side effects with fluticasone propionate nasal spray.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store Fluticasone Propionate Nasal Spray?
Keep fluticasone propionate nasal spray and all medicines out of the reach of children.
General information about the safe and effective use of fluticasone propionate nasal spray.
Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use fluticasone propionate nasal spray for a condition for which it was not prescribed. Do not give your fluticasone propionate nasal spray to other people, even if they have the same condition that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about fluticasone propionate nasal spray that was written for healthcare professionals.
What are the ingredients in fluticasone propionate nasal spray?
Active ingredient: fluticasone propionate USP.
Inactive ingredients: 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80.
For more information about fluticasone propionate nasal spray, call 1-800-962-8364.
Instructions for Use
Fluticasone Propionate Nasal Spray USP, 50 mcg
(FLOO-tih-kah-sone)
Fluticasone propionate nasal spray is for use in your nose only.
Read this information before you start using your fluticasone propionate nasal spray.
Your fluticasone propionate nasal spray must be primed before you use it for the first time and when you have not used it for a week or more.
How to prime your fluticasone propionate nasal spray:
Figure 1
Figure 2
Using your fluticasone propionate nasal spray:
Step 1:
Step 2:n- 1
Figure 3
Step 3n- 1
Figure 4
Step 4
Step 5n- 2n- 4
Step 6n- 2n- 5
Step 7
Figure 5
Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. Before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed. Do not take extra doses or stop taking fluticasone propionate nasal spray without talking to your healthcare provider.
Cleaning your fluticasone propionate nasal spray:
Your nasal spray should be cleaned at least time each week.
1. Remove the dust cap and then gently pull upwards to free the nasal applicator.
2. Wash the applicator and dust cap under warm tap water. Allow to dry at room temperature.
3. Place the applicator and dust cap back on the bottle.
4. If the nasal applicator becomes blocked, it can be removed and left to soak in warm water. Rinse the nasal applicator with cold tap water. Dry the nasal applicator and place it back on the bottle. n
Storing your fluticasone propionate nasal spray:
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10002064/09
Revised January 2019

No data

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Fluticasone Propionate (Fluticasone Propionate)

Trade Name : Fluticasone Propionate

SPRAY, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fluticasone Propionate (Fluticasone Propionate)

Trade Name : Fluticasone Propionate

SPRAY, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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