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FLUTINAP

Quick Overview

The pedigree of SAVA Medica Ltd stands tall as our Nasal spray and Dry powder inhaler technology, and expertise.


Our aim is to reach out to the globe with in shortest possible time frame


To promote this objective, not only we distribute and market our respiratory range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Flutinap/Flutiair  nasal Spray which Contains Fluticasone propionate 0.05% w/v.


This Flutinap contains same active ingredients as Flonas nasal spray  from GSK(Glaxosmithkline)

FLUTINAP

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Details

 

Each Spray Delivers:

Fluticasone Propionate BP…..50 mcg

Composition:

Fluticasone Propionate BP….0.05%w/v

Preservatives:

Benzalkonium Chloride BP ….0.01%w/v

Phenyl Ethyl Alcohol USP ….0.25%w/v

Excipients..q.s.

Chemistry - 6 α , 9 - D i f l u o r o - 1 7 - [[(fluoromethyl)sulphanyl]carbonyl]-11β- hydroxy-16α-methyl-3- oxoandrosta-1,4-dien- 17α-yl propanoate.

Category

Corticosteroid with anti-inflammatory.

Pharmacology

 Phrmacodynamic

Fluticasone propionate causes little or no hypothalamic-pituitary-adrenal axis suppression following intranasal administration.

Following intranasal dosing of fluticasone propionate, (200mcg/day) no significant change in 24h serum cortisol AUC was found compared to placebo (ratio1.01, 90%CI 0.9-1.14).

In a 1-year randomized, double-blind, placebo controlled, Parallel group growth study in prepubescent children aged 3 to 9 years (56 patients receiving intranasal fluticasone propionate and 52 receiving placebo,) no statistically significant difference in growth velocity was observed in patients receiving intranasal fluticasone propionate (200micrograms per day nasal spray) compared to placebo. The estimated growth velocity over one year of treatment was 6.20cm/year (SE=0.23) in the placebo group and 5.99cm/year (SE=0.23) in the fluticasone propionate group; the mean difference between treatments in growth velocity after one year was 0.20cm/year (SE=0.28, 95% CI=-0.35, 0.76). No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cor tisol excretion and dual-energy x-ray absorptiometry, respectively.

Pharmacokinetic Actions

Absorption: Following intranasal dosing of fluticasone propionate, (200mcg/day) steadystate

maximum plasma concentrations were not quantifiable in most subjects (<0.01ng/mL).

Distribution: Fluticasone propionate has a large volume of distribution at steady-state (approximately 318L). Plasma protein binding is moderately high (91%).

Metabolism: Fluticasone propionate is cleared rapidly from the systemic circulation, principally by hepatic metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.

Elimination: The elimination rate of intravenous administered fluticasone propionate is linear over the 250 1000mcg dose range and are characterized by a high plasma clearance CL=1.1L/min).

Indications

The prophylaxis and treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis.

Dosage and Administration

Fluticasone Nasal Spray is for administration by the intranasal route only. Each actuation delivers 50mcg of fluticasone propionate in 100mg of formulation through the nasal adapter It is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. When you prime the pump for the first time, press down and release the pump 6 times. The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.

Adults and children over 12 years of age:

For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis - Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used.

Elderly patients: The normal adult dosage is applicable.

Children under 12 years of age: For the prophylaxis and treatment of seasonal allergic rhinitis and perennal rhinitis in children aged 4-11 years a dose of one spray into each nostril once daily preferably in the morning is recommended. In some cases one spray into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays into each nostril.

Contraindications

Hypersensitivity to any of its ingredients.

Special warning and Precaution

Local infections: infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with Fluticasone Nasal Spray.

The full benefit of Fluticasone Nasal Spray may not be achieved until treatment has been administered for several days.

Care must be taken while transferring patients from systemic steroid treatment to Fluticasone Nasal Spray if there is any reason to suppose that their adrenal function is impaired.

Although Fluticasone Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.

Systemic effects of nasal corticosteroids may occur particularly at high doses prescribed for prolonged periods. These effects vary between patients and different corticosteroids.

Interactions

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.

In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. Cases of Cushing's syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.

In a small study using inhaled fluticasone propionate in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. Co-treatment with other potent CYP3A inhibitors, such as itraconazole, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side-effects. Caution is recommended and long-term treatment with such drugs should if possible be avoided.

Pregnancy and Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. It should be noted, however, that the foetal changes in animals occur after relatively high systemic exposure; direct intranasal application ensures minimal systemic exposure. As with other drugs the use of Fluticasone Nasal Spray during human pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.

The secretion of fluticasone propionate in human breast milk has not been investigated.

Subcutaneous administration of fluticasone propionate to lactating laboratory rats produced measurable plasma levels and evidence of fluticasone propionate in the milk. However, following intranasal administration to primates, no drug was detected in the plasma, and it is therefore unlikely that the drug would be detectable in milk. When Fluticasone Nasal Spray is used in breast feeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby.

Effect to Drive and use the machine

None reported.

Adverse Reactions

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports.

Very common: Epistaxis

Common: Nasal dryness, nasal irritation, throat dryness, throat irritation, Headache, unpleasant taste and smell.

Very rare: Cutaneous hypersensitivity reactions, Angioedema, Respiratory symptoms, Anaphylactic reactions, laucoma, raised intraocular pressure, cataract, Nasal septal perforation. Systemic effects of some nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

Overdosage

There are no data available on the effects of acute or chronic over dosage with Fluticasone Nasal Spray. Intranasal administration of 2mg fluticasone propionate twice daily for seven days to healthy human volunteers has no effect on hypothalamo-pituitary-adrenal (HPA) axis function.

Inhalation or oral administration of high doses of corticosteroids over a long period may lead to suppression of HPA axis function.

Packing

Fluticasone Nasal Spray 50mcg is supplied in an amber glass vial fitted with a silver metering atomizing pump, transparent nasal adapter, and white dust cover in a box with patient's instructions for use.

Presentation

Each 10 ml vial with spray pump delivering 100 sprays of 50 mcg.

Each 12 ml vial with spray pump delivering 120 sprays of 50 mcg.

Each actuation delivers 50mcg of Fluticasone Propionate through the nasal adapter.

Storage

Store in a dry place, below 30°C.

Protect from light. Do not freeze.

Keep out of reach of children.

 
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