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CNASHighly Regulated (List I)

FLOHALE HFA

125µG/DOSE/Buccal Inhalation Spray Suspension/FLUTICASONE PROPIONATE
CIPLA
ManufacturerVerified lab

CIPLA

Public retail price
N/ADZD

Identification

Active ingredient (INN)
FLUTICASONE PROPIONATE
Internal code
20 A 078
Country of Origin
India
Pharmaceutical form
Buccal Inhalation Spray Suspension
Prescription List
Highly Regulated (List I)
Packaging
flacon./120doses
FLOHALE HFA
Clinical View
CNAS
Highly Regulated (List I)

DAWA Clinical Workbench v2.0

Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.

Description

Fluticasone propionate is a synthetic glucocorticoid 9, 10 Label.

These drugs are available as inhalers, nasal, sprays, and topical treatments for various inflammatory indications 9, 10 Label.

Fluticasone propionate was first approved in 1990 7.

Indications

Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxis Label as well as inflammatory and pruritic dermatoses 9.

Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis 8, 10.

Pharmacodynamics

Systemically, fluticasone propionate activates glucocorticoid receptors, and inhibits lung eosinophilia in rats 10 Label.

Fluticasone propionate as a topical formulation is also associated with vasoconstriction in the skin 9, 3.

Absorption

Intranasal bioavailability of fluticasone propionate is <2%, and oral bioavailability is <1% 10 Label.

Intranasal exposure results in the majority of the dose being swallowed 3.

Topical absorption of fluticasone propionate is very low but can change depending on a number of factors including integrity of the skin and the presence of inflammation or disease 9.

A study of 24 healthy Caucasian males showed an inhaled bioavailability of 9.0% 1.

Volume of Distribution

The volume of distribution of intravenous fluticasone propionate is 4.2 L/kg 10 Label.

A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 577 L following intravenous administration 1.

Metabolism

Fluticasone propionate is cleared from hepatic metabolism by cytochrome P450 3A4 10, 4 Label.

Fluticasone propionate is hydrolysed at the

FIVE-S-fluoromethyl carbothioate group, forming an inactive metabolite 9, 3 Label.

Hover over products below to view reaction partners Fluticasone propionate fluticasone 17beta-carboxylic acid.

Route of Elimination

Fluticasone propionate is mainly eliminated in the feces with <5% eliminated in the urine 10, 5 Label.

Half-life

hours for intravenous fluticasone propionate 10 Label.

A study of 24 healthy Caucasian males shows a half life of 14.0 hours following intravenous administration and 10.8 hours following inhalation 1.

Clearance

mL/min for fluticasone propionate 10.

A study of 24 healthy Caucasian males showed a clearance of 63.9 L/h following intravenous administration 1.

Adverse Effects

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Toxicity

Fluticasone propionate's use in specific populations has not been well studied 10.

Fluticasone propionate is not carcinogenic, mutagenic, or clastogenic, nor did it affect fertility in animal studies 10 Label.

Subcutaneous fluticasone propionate has been shown to produce teratogenic effects in rats though oral administration does not 9 Label.

Generally, there are no reported adverse effects with fluticasone in pregnancy 6.

Fluticasone propionate in human milk may cause growth suppression, effects on endogenous corticosteroid production, or other effects 9, 2.

Pediatric patients treated with fluticasone propionate ointment experienced adrenal suppression 9.

Geriatric patients treated with fluticasone propionate did not show any difference in safety or efficacy compared to other patient groups, though older patients may be more sensitive to adverse effects 9.

There is no difference in the clearance of fluticasone propionate across genders or race Label.

Patients with hepatic impairment should be closely monitored due to the elimination mechanism Label 5.

Warnings

Only for use in the nose.

Do not spray into your eyes or mouth.

Dosage & Administration

Directions read the Quick Start

Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1.

  • use 2 sprays in each nostril once daily Week 2 through 6 months.
  • use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – ask your doctor if you can keep using CHILDREN TO 11 YEARS OF AGE the growth rate of some children may be slower while using this product.

Children should use for the shortest amount of time necessary to achieve symptom relief.

Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE do not use.

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