FLUTIZAL Salmeterol Xinafoate / Fluticasone Propionate 25mcg / 125 mcg Metered-Dose Inhaler (Suspension) 120actuations
RXDRUG-DR-XY44488
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Fluticasone propionate + Salmeterol xinafoate Inhaler is indicated in the regular treatment of asthma where use of a combination (long acting beta-2 agonist and inhaled corticosteroid) is appropriate: Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short acting beta-2 agonist or; patients already adequately controlled on both inhaled corticosteroids and long acting beta-2 agonist.
Dosage/Direction for Use
Adults and adolescents aged 12 years and older: Fluticasone propionate + Salmeterol xinafoate 125/25 Inhaler: 2 inhalations (puffs) twice a day.
Fluticasone propionate + Salmeterol xinafoate 250/25 Inhaler: 2 inhalations (puffs) twice a day or, as directed by the physician.
Fluticasone propionate + Salmeterol xinafoate 250/25 Inhaler: 2 inhalations (puffs) twice a day or, as directed by the physician.
Overdosage
No human overdosage data has been reported for this combination inhaler; however data on overdose with both drugs are given as follows.
Salmeterol: The signs and symptoms of Salmeterol overdose are seizures, angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.
Other signs of overdosage may include hypokalemia and hyperglycemia. Treatment consists of discontinuation of Salmeterol together with appropriate cardio selective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Fluticasone propionate: Acute inhalation of Fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements. Chronic overdose of inhaled Fluticasone propionate may lead to adrenal suppression. Monitoring of adrenal reserve may be necessary. In cases of Fluticasone propionate overdose this combination inhaler therapy may still be continued at a suitable dosage for symptom control.
Salmeterol: The signs and symptoms of Salmeterol overdose are seizures, angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.
Other signs of overdosage may include hypokalemia and hyperglycemia. Treatment consists of discontinuation of Salmeterol together with appropriate cardio selective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Fluticasone propionate: Acute inhalation of Fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements. Chronic overdose of inhaled Fluticasone propionate may lead to adrenal suppression. Monitoring of adrenal reserve may be necessary. In cases of Fluticasone propionate overdose this combination inhaler therapy may still be continued at a suitable dosage for symptom control.
Contraindications
This combination inhaler is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
Special Precautions
Consideration should be given to additional corticosteroid therapies and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this combination inhaler should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This combination inhaler should be administered with caution in patients with thyrotoxicosis. Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The long term effects of this reduction including the impact of final adult height are unknown.
Use In Pregnancy & Lactation
There is insufficient experience of the use of Salmeterol xinafoate and Fluticasone propionate in human pregnancy and lactation.
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus or child.
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus or child.
Adverse Reactions
As the combination inhaler contains Salmeterol xinafoate and Fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.
Adverse events, which have been associated with Salmeterol or Fluticasone propionate are given as follows: Salmeterol: The pharmacological side effects of beta-2 agonist treatment, such as tremor, subjective palpitations and headache have been reported but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions including rash, oedema and angioedema. There have been also reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/Fluticasone propionate Inhaler. Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing.
Adverse events, which have been associated with Salmeterol or Fluticasone propionate are given as follows: Salmeterol: The pharmacological side effects of beta-2 agonist treatment, such as tremor, subjective palpitations and headache have been reported but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions including rash, oedema and angioedema. There have been also reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/Fluticasone propionate Inhaler. Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing.
Drug Interactions
Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. Ketoconazole, Ritonavir), as there is potential for increased systemic exposure to Fluticasone propionate.
Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely.
Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely.
Caution For Usage
How to use the inhaler correctly: 1. Remove the mouthpiece cover and check the mouthpiece thoroughly to see that it is clean. Then shake the inhaler vigorously.
2. Hold the inhaler between index finger and thumb. Breathe out gently through the mouth and immediately place the mouthpiece between the teeth (Do not bite it).
3. Grip the mouthpiece firmly with the lips. Tilt the head slightly backwards, start breathing in slowly through the mouth. At the same time press the canister to release one dose while continuing to breathe in steadily and deeply.
4. Remove the inhaler from the mouth. Hold the breath at least for 10 seconds or as long as it is comfortable. Breathe out slowly.
If another dose is required, wait for at least 1 minute and repeat the whole process. After use, place the cover to close the mouthpiece.
How to clean the Inhaler: 1. Gently pull the metal canister out of the plastic body of the inhaler, remove the mouthpiece cover.
2. Rinse the plastic body and the mouthpiece cover in warm water but do not put the metal canister into water.
3. Leave to dry in warm place, avoid excessive heat.
4. Replace the canister and the mouthpiece cover correctly.
2. Hold the inhaler between index finger and thumb. Breathe out gently through the mouth and immediately place the mouthpiece between the teeth (Do not bite it).
3. Grip the mouthpiece firmly with the lips. Tilt the head slightly backwards, start breathing in slowly through the mouth. At the same time press the canister to release one dose while continuing to breathe in steadily and deeply.
4. Remove the inhaler from the mouth. Hold the breath at least for 10 seconds or as long as it is comfortable. Breathe out slowly.
If another dose is required, wait for at least 1 minute and repeat the whole process. After use, place the cover to close the mouthpiece.
How to clean the Inhaler: 1. Gently pull the metal canister out of the plastic body of the inhaler, remove the mouthpiece cover.
2. Rinse the plastic body and the mouthpiece cover in warm water but do not put the metal canister into water.
3. Leave to dry in warm place, avoid excessive heat.
4. Replace the canister and the mouthpiece cover correctly.
Storage
Store at temperatures not exceeding 30°C.
Do not puncture, break or incinerate pressurized canister even when apparently empty. Avoid direct sunlight or heat.
Do not puncture, break or incinerate pressurized canister even when apparently empty. Avoid direct sunlight or heat.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Flutizal
Full Details
Dosage Strength
25 mcg / 125 mcg
Drug Ingredients
- Fluticasone
- Salmeterol
Drug Packaging
Metered-Dose Inhaler (Suspension) 120 act.
Generic Name
Salmeterol Xinafoate / Fluticasone Propionate
Dosage Form
Metered-Dose Inhaler (Suspension)
Registration Number
DR-XY44488
Drug Classification
Prescription Drug (RX)
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