Asthma Brochure flow plan.pptx
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Respiratory Portfolio Asthma Solution from A to Z Medical Data and Outline Asthma Facts Asthma is one of the most common chronic diseases.1 >300 million people have asthma, >100 million in 2025. 2 1. 2. 3. 4. 5. The incidence of physician-diagnosed asthma in Saudi Arabia was 11.3% From the tot...
Respiratory Portfolio Asthma Solution from A to Z Medical Data and Outline Asthma Facts Asthma is one of the most common chronic diseases.1 >300 million people have asthma, >100 million in 2025. 2 1. 2. 3. 4. 5. The incidence of physician-diagnosed asthma in Saudi Arabia was 11.3% From the total population.3 Adult females had 1.8 times greater asthma incidence than adult males. 2 250,000 deaths dur to asthma every year. 4 Asthma incidence rates of 4%–33.7% for asthma diagnosed by physicians among children in Saudi Arabia.5 Lammert, E., & M. Zeeb. Metabolism of human diseases. Springer, 2014. Nunes, C., et al. Asthma costs and social impact. Asthma research and practice, 2017; 3(1), 1. Saudi Med J 2018; Vol. 39 (2) Emergency department visits: CDC/NCHS. National Hospital Ambulatory Medical Care Survey (NHAMCS): 2010-2018. Mallol J., Crane J., von Mutius E., Odhiambo J., Keil U., Stewart A. ISAAC phase three study group. The International Study of Asthma and Allergies in Childhood (ISAAC) phase three: a global synthesis. Allergol Immunopathol. 2013 Mar 1;41(2):73–85. Asthmatic children with nocturnal attacks seen in ER (57%) vs (43%) not seen. 5 Asthma Diagnosis History of variable respiratory symptoms Evidence of variable expiratory airflow limitations Link each one with the GINA chart with animation 1. 2023 GINA MAIN report . Family History Occupational cause of asthma Asthma Severity and Control Assessment Assess of Asthma symptoms Control Assess risk factors for adverse outcomes Assess treatment factor Assess comorbiditi es Assess Lung Functions Link each one with the GINA chart with animation 1. 2023 GINA main report . Asthma Management Cycle for children (5 Years and Younger) Box 6-6 © Global Initiative for Asthma, www.ginasthma.org Asthma Management Children (6-11 years) Guidelines Box 3-13 © Global Initiative for Asthma, www.ginasthma.org Asthma Management Adults (>12 years) Guidelines *Anti-inflammatory reliever (AIR) Box 3-12 © Global Initiative for Asthma, www.ginasthma.org Seroflo Approved Indication is indicated in the regular treatment of asthma, where use of a combination (long-acting beta2-agonist and inhaled corticosteroid) has been found to be appropriate, and in patients with COPD Uncontrolled Asthmatic patients from age of 12 years and above. (starting from step 3) Maintenance treatment for well- controlled or partially controlled asthmatic patients. (starting from step 3) Add illustration here that can easily deliver the exact positioning of Seroflo approved indications 1. Seroflo Summary of Product Characteristics. Mechanism Of Action The High potent with highest selectivity • Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti‐inflammatory activity that is largely mediated via glucocorticoid receptors1 also inhibiting eosinophil activation and the subsequent release of inflammatory mediators.2 • Fluticasone propionate potently inhibit the formation of CYTOKINES, such as IL‐1, IL‐2, IL‐3, IL‐4, IL‐5, IL‐9, IL‐13, and TNF‐ α * and GM‐CSF by T LYMPHOCYTES and MACROPHAGES. 1 • Fluticasone propionate also decrease eosinophil survival by inducing apoptosis. They also inhibit the expression of multiple inflammatory genes in airway epithelial cells. 1 • Fluticasone propionate also have a direct inhibitory effect on mucus glycoprotein secretion from airway submucosal glands, as well as indirect inhibitory effects by down‐regulation of inflammatory stimuli that stimulate mucus secretion. 1 • It is a highly selective β2‐adrenoceptor (LABA) agonist with, long‐ acting bronchodilator activity, 3 • inhibition of the release of hypersensitivity mediators from mast cells. 4 • Salmeterol is at least 50times more selective for β2‐adrenoceptors than salbutamol (albuterol).3 • Binding of salmeterol to the β2‐adrenoceptor results in activation of intracellular adenyl cyclase, which catalyzes the conversion of adenosine triphosphate to cyclic adenosine monophosphate (cAMP).3 • Increased cAMP levels lead to bronchial smooth muscle relaxation.3 1. Barnes P.J. Drugs for the treatment of asthma and COPD. Principles of Immunopharmacology. Birkhäuser Basel, 2005 2. McKeage, K., & S. J.Keam. Salmeterol fluticasone propionate. Drugs, 2009; 69(13),1799‐1828 3. Keating, G. M., & P. L.McCormack. Salmeterol Fluticasone Propionate. Drugs, 2007; 67(16), 2383‐2405. 4. 2. McKeage, K., & S. J.Keam. Salmeterol fluticasone propionate. Drugs, 2009; 69(13),1799‐1828 Benefits of Seroflo Improve patients lives and help them lead healthier, happier, and more fulfilling lifestyles. Achieves the total control as defined by GINA guidelines Improves the lung function in asthmatic patient to enable them to engage in everyday activities without the limitations The Device make difference, Ciphaler ensure high complaint and dose delivery. The Device make difference, Inhaler is well known device for patients with the addition of dose counter to ensure compliance Goal Study A 1‐year, randomized, stratified, double‐blind, parallel‐group study of 3,421 patients with uncontrolled asthma compared fluticasone propionate and salmeterol/fluticasone in achieving two rigorous, composite, guideline‐based measures of control: totally and well‐controlled asthma Treatment was stepped‐up until total control was achieved (or maximum 500 μg corticosteroid twice a day). Study Design Stratified, randomized, double-blind, parallelgroup study Largest number of patients recruited in a trial on asthma ever N=5068 Use it as on the Reference Tab N=1647 excluded Patients achieving TC at any time during Phase I were placed into Phase II & Concept Study 1‐year, multi center, randomized, double‐blind, double‐dummy study in adult patients with symptomatic asthma that was not controlled by therapy with 200 to 500 pg/d inhaled corticosteroid (ICS) plus a long‐ acting beta2‐agonist, or with >500 to 1000 iag/d ICS alone Study Design This was a randomized, double-blind, double dummy, parallel-group study carried out at 91 centers in 15 countries. It consisted of 3 periods: 2-week run-in period 52-week double-blind treatment period 2-week follow-up period Use it as on the Reference Tab Concept Study 1‐year, multi center, randomized, double‐blind, double‐dummy study in adult patients with symptomatic asthma that was not controlled by therapy with 200 to 500 pg/d inhaled corticosteroid (ICS) plus a long‐ acting beta2‐agonist, or with >500 to 1000 iag/d ICS alone Study Design This was a randomized, double-blind, double dummy, parallel-group study carried out at 91 centers in 15 countries. The double-blind treatment period was split into 2 phases: weeks 1 through 4, during which the dose delivered from both devices was kept constant, and weeks 5 through 52, during which the dose delivered via Diskus remained unchanged but the dose delivered via Turbuhaler was initially reduced to 1 inhalation BID and subsequently adjusted according to the physician guided. Use it as on the Reference Tab Total Control Goal Study Achieves the total control as defined by GINA guidelines • Primary Outcome: Over all strata’s Total Control Achieved with SFC vs FP 31% vs 19% Over all strata’s Achieving GINA Guideline-Defined Well Controlled Asthma 63% VS 50% Based on Goal Study Total Control Goal Study Improve patients lives and help them lead healthier, happier, and more fulfilling lifestyles. Over all Maintenance of Control: Symptom-Free Daysstrata’s Over 1 Year in 75% vs 52% Over all strata’s Maintenance of Control: Improved Lung Function Over 1 Year 58% vs 17% Improves the lung function in asthmatic patient to enable them to engage in everyday activities without the limitations Based on Goal Study Concept Study Seroflo Offer more symptoms free day more than BUD/For over 58 weeks Improve patients lives and help them lead healthier, happier, and more fulfilling lifestyles. 58.8% Based on Concept Study Total Control Based on Concept Study Concept Study 48% more than BUD/FOR Improve patients lives and help them lead healthier, happier, and Seroflo decrease the Hospitalization by 20% more than BUD/FOR Seroflo reduce the rate of exacerbation by more fulfilling lifestyles. Seroflo Reduce the need of Oral Corticosteroids by 30% more than BUD/FOR Improves the lung function in asthmatic patient to enable them to engage in everyday activities without the limitations The Device make difference, Ciphaler ensure high complaint and dose delivery. Seroflo Ciphaler Pre-loaded 60 doses The Device make difference, Ciphaler ensure high complaint and dose delivery. Salmeterol / Fluticasone Propionate MOUTHPIECE LEVER CONTRACTING WHEEL Dose counter that counts every dose Differentiation Point/Edge over others THUMB GRIP COILED BLISTER STRIP Pre-loaded 60 doses BLISTER CONTAINING DRUG Double moisture protection OUTER CASE Data on file, Cipla Ltd. Differentiation Point/Edge over others The Device make difference, Inhaler is well known device for patients with the addition of dose counter to ensure compliance How to Read a Dose Counter Shows the total number of doses in the inhaler. The dose counter counts every dose but shows the number at interval of 20 doses. When there are 40 doses remaining the color changes from green to red, indicating fewer doses. Hence, you may need to consider getting a new inhaler. Shows no medication is left Seroflo Dosage Forms Inhaler Asthma Adults and Adolescents (12 years and older) SEROFLO 125 INHALER: Two inhalations twice daily SEROFLO 250 INHALER: Two inhalations twice daily Preloaded 120 Dose Put a picture of the device and the pack with the counter photo seen Ciphaler Asthma Adults and Adolescents (12 years and older) SEROFLO-250 CIPHALER: One inhalation twice daily SEROFLO-500 CIPHALER: One inhalation twice daily Preloaded 60 Dose Put a picture of the device and the pack Seroflo Use in Special Population Pregnant Women • Administration of SEROFLO CIPHALER to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women. Lactating Women • There are no available data on the presence of fluticasone propionate or salmeterol in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk. However, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SEROFLO CIPHALER and any potential adverse effects on the breastfed child. Pediatric Patients • The safety and effectiveness of salmeterol/fluticasone combination in children with asthma younger than 4 years have not been established. • ICS, including fluticasone propionate, a component of the formulation, may cause a reduction in growth velocity in children and adolescents. The growth of pediatric patients receiving orally inhaled corticosteroids, including fluticasone/salmeterol combination, should be monitored. • If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including fluticasone/salmeterol combination, each patient should be titrated to the lowest strength that effectively controls his/her asthma. Seroflo BI Seroflo Ciphaler Strength: 50 mcg Salmeterol Xinafoate / 100 mcg Fluticasone Propionate, 50 mcg Salmeterol Xinafoate / 250 mcg Fluticasone Propionate, 50 mcg Salmeterol Xinafoate / 500 mcg Fluticasone Propionate Dosage Form: Inhalation powder. DOSAGE AND ADMINSTRATION: • Seroflo Ciphaler is intended for inhalation use. Patients should be informed that it must be used daily for optimal benefits, even when asymptomatic. Regular reassessment by a doctor is necessary to ensure the appropriate strength of Seroflo Ciphaler and to make any changes based on medical advice. Patients should be prescribed the strength of Seroflo Ciphaler containing the suitable dosage of fluticasone propionate for the severity of their disease. If a patient requires dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed. • For asthma: Adults and adolescents aged 12 years and over: Seroflo Ciphaler 50/100 - One inhalation twice a day, Seroflo Ciphaler 50/250 - One inhalation twice a day, Seroflo Ciphaler 50/500 - One inhalation twice a day. Children 4 to 12 years of age: Seroflo Ciphaler 50/100 - One inhalation twice a day, Seroflo Ciphaler is not recommended for use in children below 4 years of age. • For adults with Chronic Obstructive Pulmonary Disease (COPD): Seroflo Ciphaler 50/500 - One inhalation twice a day." INDICATIONS: • Asthma in adults and adolescents aged 12 years and over • Chronic Obstructive Pulmonary Disease (COPD) in adults. INSTRUCTIONS FOR USE: Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Seroflo Ciphaler properly or as prescribed may mean that it will not help your asthma or COPD as it should. • The Ciphaler device holds blisters containing Seroflo as a powder. • There is a counter on top of the inhaler which tells you how many doses are left. It counts down to 0. The numbers 5 to 0 will appear in red to warn you when there are only a few doses left. Once the counter shows 0, your inhaler is empty. USING YOUR INHALER: 1. To open your Seroflo Ciphaler, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click. This will open a small hole in the mouthpiece. 2. Hold your inhaler with the mouthpiece towards you. You can hold it in either your right or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a dose of your medicine in the mouthpiece.3. Every time the lever is pulled back a blister is opened inside, and the powder made ready for you to inhale. Do not play with the lever as this opens the blisters and wastes medicine. Hold the inhaler away from your mouth, breathe out as far as is comfortable. Do not breathe into your inhaler.3. Put the mouthpiece to your lips; breathe in steadily and deeply through the inhaler, not through your nose. - Remove the inhaler from your mouth. - Hold your breath for about 10 seconds or for as long as is comfortable.- Breathe out slowly. 4. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help to stop you getting thrush and becoming hoarse. 5. To close the inhaler, slide the thumbgrip back towards you, as far as it will go. You will hear a click. The lever will return to its original position and is reset. Your inhaler is now ready for you to use again. As with all inhalers, caregivers should ensure that children prescribed Seroflo Ciphaler use correct inhalation technique, as described above. CLEANING YOUR INHALER: Wipe the mouthpiece of the Seroflo Ciphaler with a dry tissue to clean it. OVERDOSE & MISSED DOSES: • It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints. If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seroflo Ciphaler may reduce the amount of steroid hormones produced by the adrenal gland. • Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time. DO NOT TAKE SEROFLO: •If you are allergic to salmeterol, fluticasone propionate or to the other ingredient lactose monohydrate. SPECIAL WARNING AND PRECAUTIONS: Talk to your doctor before using Seroflo Ciphaler if you have: • Heart disease, including an irregular or fast heart beat • Overactive thyroid gland • High blood pressure • Diabetes mellitus (Seroflo may increase your blood sugar) • Low potassium in your blood • Tuberculosis (TB) now or in the past, or other lung infections. Contact your doctor if you experience blurred vision or other visual disturbances. OTHER MEDICINES AND SEROFLO CIPHALER: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including medicines for asthma or any medicines obtained without a prescription. This is because Seroflo Ciphaler may not be suitable to be taken with some other medicines. Tell your doctor if you are taking the following medicines, before starting to use Seroflo Ciphaler: - β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for high blood pressure or other heart conditions. - Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat containing products). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Seroflo Ciphaler, including irregular heart beats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines. - Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland. - Diuretics, also known as ‘water tablets’ used to treat high blood pressure. - Other bronchodilators (such as salbutamol) - Xanthine medicines. These are often used to treat asthma. DRIVING AND USING MACHINES: Seroflo Ciphaler is not likely to affect your ability to drive or use machines. LACTOSE INTOLERANCE: Seroflo Ciphaler contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. POSSIBLE SIDE EFFECTS: Like all medicines, Seroflo Ciphaler can cause side effects, although not everybody gets them. • Very common side effects Seroflo Inhaler Seroflo BI STRENGTH: Seroflo Inhaler 25 mcg/125 mcg (Salmeterol/Fluticasone Propionate) inhaler, Seroflo Inhaler 25 mcg/250 mcg (Salmeterol/Fluticasone Propionate) inhaler. DOSAGE AND ADMINSTRATION: Adults and adolescents 12 years and older: Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily or Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. Children 4 to 12 years of age: Seroflo inhaler is not recommended for use in children below 12 years of age. INDICATIONS: • Seroflo inhaler is indicated in the regular treatment of asthma. INSTRUCTIONS FOR USE: Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Seroflo Inhaler properly or as prescribed may mean that it will not help your asthma as it should. • The medicine is contained in a pressurized canister in a plastic casing with a mouthpiece. • There is a counter on the back of the inhaler which tells you how many doses are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one. • Take care not to drop the inhaler as this may cause the counter to count down. • Testing your inhaler: 1. When using your inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart. 2. To make sure that it works, shake it well, point the mouthpiece away from you and press the canister to release a puff into the air. Repeat these steps, shaking the inhaler before releasing each puff, until the counter reads 120. If you have not used your inhaler for a week or more, release two puffs of medicine into the air. USING YOUR INHALER: It is important to start to breathe as slowly as possible just before using your inhaler.1. Stand or sit upright when using your inhaler. 2. Remove the mouthpiece cover. Check inside and outside to make sure that the mouthpiece is clean and free of loose objects. 3. Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed. 4. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable. 5. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite. 6. Breathe in through your mouth slowly and deeply. Just after starting to breathe in, press firmly down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply. 7. Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable. 8. Wait about half a minute between taking each puff of medicine and then repeat steps 3 to 7. 9. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help to stop you getting thrush and becoming hoarse. 10. After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force. Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth, you should start again from step 3. As with all inhalers, caregivers should ensure that children prescribed Seroflo Inhaler use correct inhalation technique, as described above. If you or your child find it difficult to use the inhaler, either your doctor or nurse or other healthcare provider may recommend using a spacer device with your inhaler. CLEANING YOUR INHALER: To stop your inhaler blocking, it is important to clean it at least once a week. To clean your inhaler: • Remove the mouthpiece cover. • Do not remove the metal canister from the plastic casing at any time. • Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue. • Replace the mouthpiece cover. It will ‘click’ into place when fitted correctly. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force. Do not put the metal canister in water. OVERDOSE & MISSED DOSES: • It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints. If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seroflo Inhaler may reduce the amount of steroid hormones produced by the adrenal gland. • Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time. DO NOT TAKE SEROFLO INHALER: If you are allergic to salmeterol, fluticasone propionate or to the other ingredient Tetrafluoroethene (HFA-134a Propellant). SPECIAL WARNING AND PRECAUTIONS: Talk to your doctor or pharmacist before using Seroflo Inhaler if you have: • Heart disease, including an irregular or fast heart beat • Overactive thyroid gland • High blood pressure • Diabetes mellitus (Seroflo Inhaler may increase your blood sugar) • Low potassium in your blood • Tuberculosis (TB) now, or in the past, or other lung infections. Contact your doctor if you experience blurred vision or other visual disturbances. OTHER MEDICINES AND SEROFLO INHALER: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including medicines for asthma or any medicines obtained without a prescription. This is because Seroflo Inhaler may not be suitable to be taken with some other medicines. Tell your doctor if you are taking the following medicines, before starting to use Seroflo Inhaler: • β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for high blood pressure or other heart conditions.• Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat-containing products). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Seroflo Inhaler, including irregular heartbeats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines. • Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.• Diuretics, also known as ‘water tablets’ used to treat high blood pressure. • Other bronchodilators (such as salbutamol). • Xanthine medicines. PREGNANCY AND BREAST-FEEDING: If you are pregnant or breastfeeding, think you may be pregnant or are planning Flohale Approved Indication Is indicated for maintenance treatment in patients with mild to severe, persistent bronchial asthma. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Add illustration here that can easily deliver the exact positioning of Seroflo approved indications 1. Flohale Summary of Product Characteristics. Mechanism Of Action High Potent • Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti‐ inflammatory activity that is largely mediated via glucocorticoid receptors1 also inhibiting eosinophil activation and the subsequent release of inflammatory mediators.2 • Fluticasone propionate potently inhibit the formation of CYTOKINES, such as IL‐1, IL‐2, IL‐3, IL‐4, IL‐5, IL‐9, IL‐13, and TNF‐α * and GM‐CSF by T LYMPHOCYTES and MACROPHAGES. 1 • Fluticasone propionate also decrease eosinophil survival by inducing apoptosis. They also inhibit the expression of multiple inflammatory genes in airway epithelial cells. 1 • Fluticasone propionate also have a direct inhibitory effect on mucus glycoprotein secretion from airway submucosal glands, as well as indirect inhibitory effects by down‐ regulation of inflammatory stimuli that stimulate mucus secretion. 1 1. Barnes P.J. Drugs for the treatment of asthma and COPD. Principles of Immunopharmacology. Birkhäuser Basel, 2005 2. McKeage, K., & S. J.Keam. Salmeterol fluticasone propionate. Drugs, 2009; 69(13),1799‐1828 Add illustration here that can easily shows mechanism of action. Benefits of Flohale Flohale improves the quality of life for individuals, especially those with respiratory conditions like asthma, by effectively managing symptoms and promoting better respiratory health. Flohale significantly enhances lung function, empowering individuals, especially those with respiratory conditions, to breathe easier and lead more active lives.. Based on EUR JR EUR JR Study Study Fluticasone propionate was evaluated in a double-blind, placebo-controlled, randomized study performed in 12 countries at 32 centers, involving 258 children.6 Fluticasone propionate (50 mcg) significantly improved morning and evening PEFR rate compared with placebo (adjusted mean difference over days 1–28, 17 l/min (95% CI: 10, 24): p<0.001) and evening PEFR (adjusted mean difference over days 1–28, 16 l/min (95% CI: 9, 23); p<0.001). Improvement in lung function with fluticasone propionate was rapid, with patients experiencing a benefit within the first week of treatment. Total Control Flohale significantly enhances lung function, empowering individuals, especially those with respiratory conditions, to breathe easier and lead more active lives.. 1. Fluticasone Propionate increase the Morning PEFR by 17L/Min vs Placebo over the 28 days of study 2. Fluticasone Propionate increase the Evening PEFR by 16L/Min vs Placebo over the 28 days of study Total Control Meta Analysis of Seven Studies Based Meta Analysis of 7 studies A meta-analysis of all studies comparing fluticasone propionate with budesonide in adults and children involving 1,980 patients (1,000 treated with fluticasone propionate 200–800 mcg/day and 980 with budesonide 400–1600 mcg/day) was performed. Flohale significantly enhances lung function, empowering individuals, especially those with respiratory conditions, to breathe easier and lead more active lives.. Across all seven studies significantly, favored fluticasone propionate, with a mean difference in Morning PEFR of 11 L/Min between fluticasone propionate and budesonide. Safety Meta Analysis of Seven Studies Based Meta Analysis of 7 studies A meta-analysis of all studies comparing fluticasone propionate with budesonide in adults and children involving 1,980 patients (1,000 treated with fluticasone propionate 200–800 mcg/day and 980 with budesonide 400–1600 mcg/day) was performed. Flohale improves the quality of life for individuals, especially those with respiratory conditions like asthma, by effectively managing symptoms and promoting better respiratory health. Across all studies fluticasone propionate at half the dose is more effective than budesonide and similar in safety, indicating an improved efficacy to safety ratio compared with budesonide. Flohale Dosage Forms Inhaler Asthma Dosage forms FLOHALE 125 INHALER: Two inhalations twice daily FLOHALE 250 INHALER: Two inhalations twice daily Preloaded 120 Dose Put a picture of the device and the pack Flohale Advices There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment. FLOHALE Inhaler may be used with a Zero stat/Zero stat VT spacer/MiniZerostat device by patients who find it difficult to synchronize aerosol actuation with inspiration of breath. Put a picture of the device while being used with Spacer Flohale BI Make the description of each indication as tab Pulmirema Approved Indication Bronchial asthma When treatment is started, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the recommended dose of Pulmirema respules is: Adults (including the elderly): Usually 1-2 mg twice daily. In very severe cases the dosage may be further increased. Pediatric population Children 12 years and older: Dosage as for adults. Children 3 months to 12 years: 0.5-1 mg twice daily. 1. Pulmirema product characteristic summary. Maintenance The maintenance dose should be individualized and be the lowest dose which keeps the patient symptom-free. Adults (including the elderly and children 12 years and older): 0.5-1 mg twice daily. Pediatric population Children 3 months to 12 years: 0.25-0.5 mg twice daily. Patients maintained on oral glucocorticosteroids When patients face acute asthma attacks taking oral glucocorticoid they gradually step to nebulized glucocorticoid BUDECORT respules can be mixed with solutions for nebulization of ASTHALIN, LEVOLIN, IPRAVENT, MUCINAC and INHALEX respules. The admixture should be used within 30 minutes. Croup Croup can be caused by a number of viruses, some of the more common being respiratory syncytial virus (RSA), influenza virus, adenovirus and enteroviruses. Croup can also be caused by allergies or a bacterial infection, which is easily spread through coughing and In infants and children with sneezing. croup: The usual dose is 2 mg of nebulized budesonide. This dose is given as a single administration, or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hour for a maximum of 36 hours or until clinical improvement. Mechanism Of Action Fast onset with safety • Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. • Budesonide is liposoluble molecules that freely diffuse across the cell membrane, thus binding to a cytoplasmic glucocorticoid receptor (GR) existing as a predominant GRα isoform or as a less common, alternatively spliced and non-functional GRβ isoform • Budesonide has a high receptor-binding affinity. Indeed, when compared to an arbitrary reference value of 100 assigned to dexamethasone, budesonide displays a relative GR affinity of 935. • In the airways, budesonide effectively reduces the numbers and inhibits the functions of several immune-inflammatory cells involved in asthma pathobiology, including T lymphocytes, eosinophils, mast cells, and dendritic cells • In allergic asthmatics, budesonide enhanced the apoptosis of peripheral blood total lymphocytes, and also decreased antigen-induced proliferation of T cells. Moreover, in these subjects budesonide significantly reduced the percentage of T lymphocyte Add illustration here that can easily shows mechanism of action. Benefits of Pulmirema Pulmirema is both safe and enabling rapid response and effective management for acute asthma. Empowers patients to take control of their condition, ensuring timely relief and improved outcomes. Pulmirema Marketing Messages & Patients benefits Nebulized Budesonide vs Oral Prednisolone Cuddalore Cuddalore 67L/Min in the Morning PEF with Budesonide vs 57L/Min with oral prednisolone Nebulized Budesonide offer fitness for discharge at less 2h when compared to oral prednisolone in children between 5 and 12 y with acute severe asthma. Cuddalore Study 7 days , randomized, double‐blind, double‐dummy study To compare the efficacy of nebulized budesonide with that of oral prednisone in the treatment of acute severe asthma in children. 1. 2. 3. 4. 5. Chest. 2006 Nov;130(5):1301-11 N Engl J Med. 2000 Sep 7;343(10):689-94 Am Rev Respir Dis. 1991 Jun;143(6):1317-21 Chest. 2003 Sep;124(3):790-4 Allergy. 1991 Oct;46(7):547-53 Cuddalo re study Cuddalore Study Children aged 5-12 y with acute exacerbation of bronchial asthma were included. The study (budesonide) group received budesonide respirator solution (800 μg) at intervals of 20 min and a single dose of placebo tablets. The control (prednisolone) group received placebo solution at intervals of 20 min and a single dose of oral prednisolone (2 mg/kg). Both groups received three doses of nebulized salbutamol (0.15 mg/kg). Heart rate, respiratory rate, oxygen saturation, PEFR (Peak Expiratory Flow Rate) and fitness for discharge were assessed. Pulmirema is both safe and enabling rapid response and effective management for acute asthma. Empowers patients to take control of their condition, ensuring timely relief and improved outcomes. 67L/Min in the Morning PEF with Budesonide vs 57L/Min with oral prednisolone And Safer than oral glucocorticoid Nebulized Budesonide offer fitness for discharge at 2 h less when compared to oral prednisolone in children between 5 and 12 y with acute severe asthma. Put a picture of the device and the pack Pulmirema Doses Asthma Dosage forms 0.25 mg and 0.5 mg respules Each 1 ml contains Budesonide 0.25 mg Each 1 ml contains Budesonide 0.5 mg The right dose for the right Patients Pediatrics (put pedia art) Put the photo of the Pulmirema pediatrics dose Adults (put adult art) Pulmirema Instruction for use 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Break off a respule from the strip. Leave the rest in the foil envelope. Shake the respule gently. Hold upright. Twist off the top of the respule to open. Place the open end of the respule firmly inside the nebulizer cup. Squeeze slowly to put the liquid in the cup. Throw the empty respule away. Put the top back on the nebulizer cup. Connect one end of the cup to the face mask or mouthpiece. Connect the other end of the cup to the air pump. Gently shake the cup. Turn on the nebulizer and breathe in the mist calmly and deeply using the face mask or mouthpiece. If you are using a face mask, make sure the face mask fits tightly. You will know when your treatment is complete because the fine mist will stop coming out of your mask or mouthpiece. How long it takes to nebulize all the medicine depends on the type of equipment you use. It will also depend on the amount of medicine to be used. Rinse your mouth with water. Spit out the water. Do not swallow it. If you have used a face mask, wash your face as well. After each use, you must wash the nebulizer cup and mouthpiece (or face mask) in warm soapy water and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and blow air through them.. Note: Do not use an ultrasonic nebulizer with Pulmirema respules. Put illustration for the steps Pulmirema BI PULMIREMA nebulizer suspension STRENGTH: Budesonide 0.125 mg/ml nebulizer suspension, Budesonide 0.25 mg/ml nebulizer suspension, Budesonide 0.5 mg/ml nebulizer suspension. DOSAGE AND ADMINSTRATION: The recommended starting dose and highest recommended dose of PULMIREMA, based on prior asthma therapy: • Bronchodilators alone: 0.5 mg total daily dose administered either once daily or twice daily in divided doses. • Inhaled corticosteroids: 0.5 mg total daily dose administered either once daily or twice daily in divided doses. • Oral corticosteroids: 1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily. INDICATIONS: PULMIREMA Nebulizer Suspension are used to control and prevent asthma symptoms in children ages 12 months to 8 years. INSTRUCTIONS FOR USE: PULMIREMA Nebulizer Suspension is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses PULMIREMA Nebulizer Suspension. PULMIREMA Nebulizer Suspension is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs. The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask. 1. PULMIREMA Nebulizer Suspension come in a sealed protective aluminum foil envelope. • Do not open the sealed pouch until you are ready to use a dose of PULMIREMA Nebulizer Suspension. • Open the sealed foil envelope along the dotted line and take out 1 single-dose ampule from the strip. • Record the date that you opened the foil on the back of the envelope in the space provided. Return the unopened PULMIREMA ampules on the strip back into the foil envelope before storing. 2. Gently shake the PULMIREMA ampule using a circular motion. 3. Hold the PULMIREMA ampule upright without squeezing the ampule and open by twisting off the top. 4. Place the open end of the PULMIREMA ampule into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the ampule into the nebulizer medicine cup. 5. Use your jet nebulizer as directed. OVERDOSE & MISSED DOSES: It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice. If you use more PULMIREMA Nebulizer Suspension than you should, contact your doctor or pharmacist for advice. If you forget to take a dose, skip the missed dose and take the next dose as usual. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. SPECIAL WARNING AND PRECAUTIONS: Talk to your doctor or pharmacist before using PULMIREMA Nebulizer Suspension, tell your doctor or pharmacist if you or your child: • has or recently had chicken pox or measles, or has recently been near anyone with chicken pox or measles. • has or had tuberculosis of the respiratory tract.• has certain kinds of infections that have not been treated, including: - fungal infections - bacterial infections - viral infections - parasitic infections - herpes simplex infection of the eye (ocular herpes simplex). PULMIREMA Nebulizer Suspension may not be right for children who have had any of these types of infections. • has decreased bone mineral density (bone strength). Your child is at risk for decreased bone mineral density if he or she: - is inactive for a long period of time - has a family history of osteoporosis - does not eat well (poor nutrition) - takes bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time. • has an eye problem such as increased pressure in the eye, glaucoma or cataracts. • has liver problems • is planning to have surgery. OTHER MEDICINES AND PULMIREMA NEBULISER SUSPENSION: Tell your doctor or pharmacist if you or your child are taking, recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you or your child are taking of the following medicines: • Corticosteroids • Anti-seizure medicine (anticonvulsants) • Medicines that suppress the immune system (immunosuppressant) • Medicines to treat fungal infections (such as ketoconazole) • Certain medicines that can affect how your liver breaks down medicine. Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines your child takes. Keep a list of them and show it to your doctor and pharmacist when your child gets a new medicine. PREGNANCY AND BREAST-FEEDING: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine - do not use PULMIREMA Nebulizer Suspension unless your doctor tells you to. PULMIREMA Nebulizer Suspension may not be right for women who is pregnant or plans to become pregnant. It is not known if PULMIREMA Nebulizer Suspension will harm your unborn baby. PULMIREMA Nebulizer Suspension may not be right for women who is breast-feeding or plans to breast-feed. PULMIREMA Nebulizer Suspension can pass into breast milk. You and your doctor should decide if you will use PULMIREMA Nebulizer Suspension or breast-feed. DRIVING AND USING MACHINES: PULMIREMA Nebulizer Suspension are not likely to affect you being able to drive or use any tools or machines. STORAGE: Do not store above 30°C, protect from light, do not freeze. • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. • Do not throw away any medicines via wastewater or household waste. Ask your
