Flixocort Metered-Dose Inhaler (MDI)

Fluticasone Propionate inhaler is a pressurized metered dose inhaler. It is intended for oral inhalation only. It contains Fluticasone Propionate BP as an active ingredient. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systemic effect of usual dose.

Adults and children over 16 years of age: 100 to 1000 mcg twice daily. Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease:

Mild asthma: 100 to 250 mcg twice daily; Moderate asthma: 250 to 500 mcg twice daily,

Severe asthma: 500 to 1000 mcg twice daily.

Children over 4 years of age: 50 to 200 mcg twice daily.

Children aged 1 to 4 years: 100 mcg twice daily administered via a paediatric spacer device with a face mask.

Special patient groups: There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Under normal circumstances, due to low plasma concentrations of Flixocort are achieved after inhaled dosing, clinically significant drug interactions mediated by Flixocort are unlikely. Care should be taken when co-administering known strong cytochrome P450 3A4 inhibitors like ritonavir, ketoconazole and erythromycin.

Fluticasone Propionate is contraindicated in patient with a history of hypersensitivity to any ingredient of the preparation.

Infections and infestations: Very common: Candidiasis of mouth and throat. Rare: Oesophageal candidiasis.

Immune system disorders: Uncommon: Cutaneous hypersensitivity reactions. Very rare: Angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm) and anaphylactic reactions.

Endocrine disorders: Very rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density, cataract and glaucoma.

Metabolism and nutrition disorders: Very rare: Hyperglycaemia

Psychiatric disorders: Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).

Respiratory, thoracic and mediastinal disorders: Common: Hoarseness. Very rare: Paradoxical bronchospasm.

Skin and subcutaneous tissue disorders: Common: Contusions

Fertility: There are no data on human fertility. Animal studies indicate no effects of fluticasone propionate on male or female fertility.

Pregnancy: There are limited data in pregnant women. Administration of Fluticasone Propionate inhaler during pregnancy should only be considered if the expected benefit on the mother is greater than any possible risk to the foetus. Results from the retrospective epidemiological study did not find any increased risk of major congenital malformations (MCMs) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy.

Lactation: The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the breast milk. However, plasma levels in patients following inhaled application of fluticasone propionate at recommended doses are likely to be low. Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Increasing use of short-acting inhaled B2-agonists to control asthma symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to increasing corticosteroid dosage. In patients considered at risk, daily peak flow monitoring may be instituted. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods; these effects are much less likely to occur than with oral corticosteroids. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained. Treatment with Flixocort Inhaler should not be stopped abruptly. As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.

Acute inhalation of Flixocort doses in excess of those approved may lead to temporary suppression the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days. If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved doses (typically 1000mcg daily and above), over prolonged periods (several months or years); observed features included hypoglycaemia and sequelae of decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in dosage. Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.

Fluocinolone & Combined Preparations, Respiratory corticosteroids

Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage of direct sunlight and heat. Store below 30°C. Keep away from eyes. Keep away from children.