Acute Bronchitis - An Overview
2
65 RESPIRATORY: BRONCHITIS HOSPITALPROFESSIONALNEWS.IE | HPN • MARCH - 2021 Introduction Acute bronchitis (AB) was originally described in 1808 as inflammation of the mucous membranes of the bronchi. 1 The definition has since evolved to an acute lower respiratory tract infection manifested predominantly by cough with or without sputum production, lasting less than 3 weeks, with no clinical or radiographic evidence to suggest an alternative explanation. 2 This review focuses on uncomplicated AB as opposed to bronchitis in patients with underlying pulmonary or cardiac conditions, immunosuppression or bacterial superinfection. Acute bronchitis in patients with documented emphysema, chronic bronchitis, or COPD for example, is usually considered a distinct clinical entity (acute exacerbation of chronic bronchitis or COPD) with unique aetiologic and treatment issues. AB is a common clinical condition responsible for both a significant number of primary care consultations and emergency department attendances. 3 The number of inpatient hospitalisations in Ireland for acute bronchitis is relatively low. In 2016, there were 236 such inpatient hospitalisations using a total of 539 bed days. 4 Aetiology and Pathogenesis Uncomplicated AB develops in sequential phases. The acute phase of infection results from direct inoculation of the tracheobronchial epithelium by the infectious agent, leading to cytokine release and inflammatory cell activation. The mucous membranes of the tracheobronchial tree become hyperemic and oedematous, with increased bronchial secretion and impaired mucociliary function. 5,6 The protracted phase of uncomplicated AB results from heightened airway reactivity and resistance not unlike in asthma, manifesting as a cough or signs of bronchial obstruction such as wheezing or dyspnoea on exertion. 5,6 However, unlike asthma the inflammatory changes are transient and resolve with clearance of the underlying infection. AB also differs from reactive airways dysfunction syndrome (RADS) in that the onset of symptoms in RADS manifests acutely after exposure to very high concentrations of gas, smoke, fumes or vapours with irritant properties and symptoms often last longer than three weeks. 7 AB in adults without underlying lung disease is usually caused by a viral pathogen, the most frequently identified agents include influenza A +B, parainfluenza, respiratory syncytial virus, coronavirus types 1-3, adenovirus and rhinoviruses. 8 Non-viral causes of acute bronchitis represent less than 10% of cases and include bacteria and inhaled lung irritants. Mycoplasma pneumoniae, Bordetella pertussis, and Chlamydia pneumoniae are the most common bacterial causes of acute bronchitis. 4,5 Among these bacteria, B.Pertussis is the most likely to cause prolonged cough. The overall incidence of pertussis and associated outbreaks are rising worldwide. (9) In patients with prolonged cough, reported rates of pertussis range from 1 to 12 percent. 10,11 Pertussis is one of the few bacterial causes of acute bronchitis that may respond to antibiotic therapy such as macrolide therapy. Clinical Features Presentation with cough due to suspected AB warrants a detailed review and exploration of pre-existing health conditions, exposure history to potential infectious contacts as well as any airway irritants, and consideration of differential diagnoses such as the common cold, cough variant asthma, acute exacerbation of chronic bronchitis in a smoker, acute exacerbation of bronchiectasis, and acute rhinosinusitis. 2 Cough is usually the predominant symptom in patients presenting with AB. The cough can last for 1-3 weeks with the median duration being 18 days 10,12,13 and can be associated with either purulent or non-purulent sputum. 12,14 Of note the presence of purulent sputum is non-specific and does not appear to be predictive of a bacterial infection. 15,16 Symptoms such as headache, nasal congestion and a sore throat can often precede the cough by a few days in keeping with a viral syndrome. 12,14 Wheeze and mild dyspnoea may accompany the cough. Certain clinical findings may suggest a specific cause for a cough or an alternate diagnosis that may warrant antibiotics. For example, bouts of coughing accompanied by an inspiratory whoop or post-tussive emesis may suggest pertussis. Fever, or other systemic symptoms are rare in patients with AB and their presence in addition to cough and sputum production should raise suspicion for influenza, COVID-19 or pneumonia. Physical exam is a pertinent component of assessing someone with suspected AB and any auscultatory signs of parenchymal consolidation (crackles) or pleural inflammation (a pleural rub) should prompt consideration for chest imaging. Investigations and Treatment Recent guidelines from the American College of Chest Physicians (ACCP) published in the journal Chest May 2020 advise that routine investigations such as chest x-ray, spirometry, peak flow measurement, sputum for microbial culture, respiratory tract samples for viral PCR, serum C-reactive protein (CRP) or procalcitonin need not be performed initially for immunocompetent adults with suspected AB in the outpatient setting. However, if the cough persists or worsens then the above investigations should be considered. 2 For the majority of patients with AB, the symptoms are self-limiting. Reassurance and symptomatic management are the cornerstone of treatment. A Cochrane review in 2017 confirmed that antibiotics have limited, if any, beneficial effects in AB. Any benefits that were identified were minimal such as reduction in mean duration of cough of less than one day and may be of questionable clinical significance. 17 In line with the above the ACCP advise against routine prescription of antibiotic therapy, antiviral therapy, antitussives, inhaled beta agonists, inhaled anticholinergics, inhaled corticosteroids, oral corticosteroids, oral NSAIDs, or other therapies for suspected AB. 2 Acute Bronchitis - An Overview Written by Dr Rachel Mulpeter, Respiratory SpR, Tallaght University Hospital, Dublin & Professor Eddie Moloney, Consultant Respiratory Physician, Tallaght University Hospital, Dublin Dr Rachel Mulpeter is a first year Specialist Registrar in Respiratory Medicine currently working in Tallaght University Hospital. She is a graduate of Trinity College Dublin and completed her basic specialist training in St James’s Hospital Professor Eddie Moloney, Consultant Respiratory Physician, Tallaght University Hospital
Transcript of Acute Bronchitis - An Overview
65RESPIRATORY: BRONCHITIS
HOSPITALPROFESSIONALNEWS.IE | HPN • MARCH - 2021
Introduction
Acute bronchitis (AB) was originally described in 1808 as inflammation of the mucous membranes of the bronchi.1 The definition has since evolved to an acute lower respiratory tract infection manifested predominantly by cough with or without sputum production, lasting less than 3 weeks, with no clinical or radiographic evidence to suggest an alternative explanation.2 This review focuses on uncomplicated AB as opposed to bronchitis in patients with underlying pulmonary or cardiac conditions, immunosuppression or bacterial superinfection. Acute bronchitis in patients with documented emphysema, chronic bronchitis, or COPD for example, is usually considered a distinct clinical entity (acute exacerbation of chronic bronchitis or COPD) with unique aetiologic and treatment issues.
AB is a common clinical condition responsible for both a significant number of primary care consultations and emergency department attendances.3 The number of inpatient hospitalisations in Ireland for acute bronchitis is relatively low. In 2016, there were 236 such inpatient hospitalisations using a total of 539 bed days.4
Aetiology and Pathogenesis
Uncomplicated AB develops in sequential phases. The acute phase of infection results from direct inoculation of the tracheobronchial epithelium by the infectious agent, leading to cytokine release and inflammatory cell activation. The mucous membranes of the tracheobronchial tree become hyperemic and oedematous, with increased bronchial secretion and impaired mucociliary function.5,6 The protracted phase of uncomplicated AB results from heightened airway reactivity and resistance not unlike in asthma, manifesting as a cough or signs of bronchial obstruction such as wheezing or dyspnoea on exertion.5,6 However, unlike asthma the inflammatory changes are transient and resolve with clearance of the underlying infection. AB also differs from reactive airways dysfunction
syndrome (RADS) in that the onset of symptoms in RADS manifests acutely after exposure to very high concentrations of gas, smoke, fumes or vapours with irritant properties and symptoms often last longer than three weeks.7
AB in adults without underlying lung disease is usually caused by a viral pathogen, the most frequently identified agents include influenza A +B, parainfluenza, respiratory syncytial virus, coronavirus types 1-3, adenovirus and rhinoviruses.8
Non-viral causes of acute bronchitis represent less than 10% of cases and include bacteria and inhaled lung irritants. Mycoplasma pneumoniae, Bordetella pertussis, and Chlamydia pneumoniae are the most common bacterial causes of acute bronchitis.4,5
Among these bacteria, B.Pertussis is the most likely to cause prolonged cough. The overall incidence of pertussis and associated outbreaks are rising worldwide. (9) In patients with prolonged cough, reported rates of pertussis range from 1 to 12 percent.10,11 Pertussis is one of the few bacterial causes of acute bronchitis that may respond to antibiotic therapy such as macrolide therapy.
Clinical Features
Presentation with cough due to suspected AB warrants a detailed review and exploration of pre-existing health conditions, exposure history to potential infectious contacts as well as any airway irritants, and consideration of differential diagnoses such as the common cold, cough variant asthma, acute exacerbation of chronic bronchitis in a smoker, acute exacerbation of bronchiectasis, and acute rhinosinusitis.2
Cough is usually the predominant symptom in patients presenting with AB. The cough can last for 1-3 weeks with the median duration being 18 days10,12,13 and can be associated with either purulent or non-purulent sputum.12,14 Of note the presence of purulent sputum is non-specific and does not appear to be predictive of a bacterial infection.15,16 Symptoms such as headache, nasal congestion and a sore throat can often precede the cough by a few days in
keeping with a viral syndrome.12,14 Wheeze and mild dyspnoea may accompany the cough.
Certain clinical findings may suggest a specific cause for a cough or an alternate diagnosis that may warrant antibiotics. For example, bouts of coughing accompanied by an inspiratory whoop or post-tussive emesis may suggest pertussis. Fever, or other systemic symptoms are rare in patients with AB and their presence in addition to cough and sputum production should raise suspicion for influenza, COVID-19 or pneumonia. Physical exam is a pertinent component of assessing someone with suspected AB and any auscultatory signs of parenchymal consolidation (crackles) or pleural inflammation (a pleural rub) should prompt consideration for chest imaging.
Investigations and Treatment
Recent guidelines from the American College of Chest Physicians (ACCP) published in the journal Chest May 2020 advise that routine investigations such as chest x-ray, spirometry, peak flow measurement,
sputum for microbial culture, respiratory tract samples for viral PCR, serum C-reactive protein (CRP) or procalcitonin need not be performed initially for immunocompetent adults with suspected AB in the outpatient setting. However, if the cough persists or worsens then the above investigations should be considered.2
For the majority of patients with AB, the symptoms are self-limiting. Reassurance and symptomatic management are the cornerstone of treatment. A Cochrane review in 2017 confirmed that antibiotics have limited, if any, beneficial effects in AB. Any benefits that were identified were minimal such as reduction in mean duration of cough of less than one day and may be of questionable clinical significance.17
In line with the above the ACCP advise against routine prescription of antibiotic therapy, antiviral therapy, antitussives, inhaled beta agonists, inhaled anticholinergics, inhaled corticosteroids, oral corticosteroids, oral NSAIDs, or other therapies for suspected AB.2
Acute Bronchitis - An OverviewWritten by Dr Rachel Mulpeter, Respiratory SpR, Tallaght University Hospital, Dublin & Professor Eddie Moloney, Consultant Respiratory Physician, Tallaght University Hospital, Dublin
Dr Rachel Mulpeter is a first year Specialist Registrar in Respiratory Medicine currently working in Tallaght University Hospital. She is a graduate of Trinity College Dublin and completed her basic specialist training in St James’s Hospital
Professor Eddie Moloney, Consultant Respiratory Physician, Tallaght University Hospital
HOSPITALPROFESSIONALNEWS.IE | HPN • MARCH - 2021
67BRONCHITIS
Subsequent presentations with Acute Bronchitis
The review to date has focussed on assessing a patient who presents with suspected AB for the first time. However it is often the case that patients can present with un-resolving symptoms or recurrence of symptoms after a period of resolution. Consideration, should be given at this time to alternative diagnoses such as pneumonia, acute rhinosinusitis, acute exacerbation of chronic bronchitis, asthma or gastro-reflux disease and arranging investigations accordingly. Previous retrospective cohort studies including patients with a diagnosis of acute bronchitis have found that at initial presentation just over one-third would also meet the criteria for a diagnosis of asthma and that 3 years after a diagnosis of acute bronchitis 34% of the cohort fulfilled criteria for either asthma or chronic bronchitis.18 Large prospective studies are needed to firmly establish or reject a causal link between uncomplicated acute bronchitis and asthma and to identify specific risk factors (such as microbial infection, atopic history, or sex) for development of subsequent asthma.
COVID19 and Acute Bronchitis
The COVID-19 pandemic has adversely impacted almost every aspect of life since it emerged in late 2019. It has had a crippling effect on our healthcare provision and resources. Early data, however suggests that it
may be inadvertently reducing the number of patient visits and antibiotic prescriptions for acute uncomplicated AB. Recent correspondence published in Infection Control and Hospital Epidemiology highlights a profound reduction in both the overall number of patients seen and discharged with a primary diagnosis of bronchitis and the number of antibiotic prescriptions written for these encounters when compared over a period as far back as April 2017 in the US.19 The reasons for this are multi-fold. Moreover, in addition to patients not seeking healthcare due to the pandemic, it is thought that stay-at-home orders, hand hygiene and the wearing of face-masks and social distancing has resulted in a reduced burden of common respiratory viruses in the community, leading to fewer cases of acute, uncomplicated bronchitis.20,21
Summary
In conclusion, AB is a common clinical presentation both in the primary and secondary care setting. Respiratory viruses appear to cause the large majority of cases. Identifying influenza and pertussis as possible causative agents may be relevant as treatment options for these differ to standard care. Routine investigations and antibiotics are not indicated for uncomplicated AB in an otherwise well adult. Although robust data is awaited, the lifestyle restrictions imposed by COVID-19 are likely to have led to a reduction in the number
of patients presenting with uncomplicated AB over the past 12 months.
References:
1. Oeffinger KC, Snell LM, Foster BM, et al. Diagnosis of acute bronchitis in adults: a national survey of family physicians. J Fam Pract 1997;45: 402–9.
2. Smith MP, Lown M, Singh S, Ireland B, Hill AT, Linder JA, Irwin RS; CHEST Expert Cough Panel. Acute Cough Due to Acute Bronchitis in Immunocompetent Adult Outpatients: CHEST Expert Panel Report. Chest. 2020 May;157(5):1256-1265.
3. Woodhead M, Blasi F, Ewig S, et al. Guidelines for the management of adult lower respiratory tract infections. Clin Microbiol Infect. 2011;17(suppl 6): E1-E59.
4. Respiratory Health of the Nation Report 2018. Irish Thoracic Society.
5. Niroumand M, Grossman RF. Airway infection. Infect Dis Clin N Am 1998;12:671–88.
6. Hueston WJ, Mainous AG III. Acute bronchitis. Am Fam Physician 1998;57:1270–6.
7. Brooks SM, Weiss MA, Bernstein IL Reactive airways dysfunction syndrome (RADS). Persistent asthma syndrome after high level irritant exposures. Chest 1985;88(3):376–384
8. Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med. 2000;133:981–91.
9. CDC Final Pertussis Surveillance Report 2017.
10. Ward JI, Cherry JD, Chang SJ, et al. Efficacy of an acellular pertussis vaccine among adolescents and adults. N Engl J Med 2005; 353:1555.
11. Nennig ME, Shinefield HR, Edwards KM, et al. Prevalence and incidence of adult pertussis in an urban population. JAMA 1996; 275:1672.
12. Wenzel RP, Fowler AA 3rd. Clinical practice. Acute bronchitis. N Engl J Med 2006; 355:2125.
13. Ebell MH, Lundgren J, Youngpairoj S. How long does a cough last? Comparing patients' expectations with data from a systematic review of the literature. Ann Fam Med 2013; 11:5.
14. Kinkade S, Long NA. Acute Bronchitis. Am Fam Physician 2016; 94:560.
15. McKay R, Mah A, Law MR, et al. Systematic Review of Factors Associated with Antibiotic Prescribing for Respiratory Tract Infections. Antimicrob Agents Chemother 2016; 60:4106.
16. Altiner A, Wilm S, Däubener W, et al. Sputum colour for diagnosis of a bacterial infection in patients with acute cough. Scand J Prim Health Care 2009; 27:70.
17. Smith SM, Fahey T, Smucny J, Becker LA. Antibiotics for acute bronchitis. Cochrane Database Syst Rev. 2017 Jun 19;6(6).
18. Jonsson JS, Gislason T, Gislason D, Sigurdsson JA. Acute bronchitis and clinical outcome three years later: prospective cohort study. BMJ. 1998;317(7170):1433.
19. Dilworth, T., & Brummitt, C. (2020). Reduction in ambulatory visits for acute, uncomplicated bronchitis: An unintended but welcome result of the coronavirus disease 2019 (COVID-19) pandemic. Infection Control & Hospital Epidemiology, 1-2.
20. Nolen LD, Seeman S, Bruden D, et al. Impact of social distancing and travel restrictions on non–COVID-19 respiratory hospital admissions in young children in rural Alaska. Clin Infect Dis 2020.
21. Hatoun J, Correa ET, Donahue SMA, Vernacchio L. Social Distancing for COVID-19 and Diagnoses of Other Infectious Diseases in Children Paediatrics. 2020 Sep 2.
RESPIRATORY NEWS
A growing body of evidence points to the health risks of using e-cigarettes (or "vaping"). But because e-cigarettes are marketed as a less harmful alternative to traditional cigarettes, it has been difficult to tell whether the association between vaping and disease is just a matter of smokers switching to vaping when they start experiencing health issues.
Now, a study by researchers from the Boston University School of Public Health (BUSPH) and School of Medicine (BUSM) is one of the first to look at vaping in a large, healthy sample of the population over time, independently from other tobacco product use.
Published in JAMA Network Open, the study found that participants who had used e-cigarettes in the past were 21% more likely to develop a respiratory disease, and those who were current e-cigarette users had a 43% increased risk.
Most previous research on the respiratory health effects of vaping have used animal or cell models, or, in humans, only short-term clinical studies of acute conditions.
For this study, the researchers used data on 21,618 healthy adult participants from the first four waves (2013-2018) of the nationally-representative Population Assessment of Tobacco and Health (PATH), which is the most
comprehensive national survey of tobacco and e-cigarette-related information to date.
To make sure they weren't simply seeing cigarette smokers switching to e-cigarettes specifically because of health issues (rather than vaping itself causing these issues), the researchers only included people with no reported respiratory issues when they entered PATH, and adjusted for a comprehensive set of health conditions. They also adjusted for having ever used other tobacco products (including cigarettes, cigars, hookah, snus, and dissolvable tobacco) and for marijuana use, as well as childhood and current secondhand smoking exposure. They repeated the
Study: E-cigarette users have 43% increased risk of developing respiratory disease
analyses among subgroups of healthy respondents who had no self-reported chronic conditions, and whose self-rated overall health was good, great, or excellent.
Adjusting for all of these variables and for demographic factors, the researchers found that former e-cigarette use was associated with a 21% increase in the risk of respiratory disease, while current e-cigarette use was associated with a 43% increase. Current e-cigarette use was associated with a 33% increase in chronic bronchitis risk, 69% increase in emphysema risk, 57% increase in chronic obstructive pulmonary disease (COPD) risk, and 31% percent increase in asthma risk.
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Preservative free corticosteroid- Have anti-in�ammatory priorities
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TREAHALOSE• O�ers osmoprotection©
HYPOTONIC• Restores the osmotic balance
INFLAMMATIONNeurogenic
in�ammation Lacrimal gland
stimulaton
PRESERVATIVE - FREE• Avoids further cell damage2
TREAHALOSE• Protects proteins and lipids from denaturation2
• Renews cellular materials by inducing autophagy210
TREAHALOSE• Protects cells from desiccation11
TEAR FILMINSTABILITY
TearHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
INFLAMMATION
TEAR FILMINSTABILITY
Tear/CellHYPEROSMOLARITY
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TheaPamex Ltd. 14 Moneen Business Park,Castlebar, Co. Mayo. Ireland Phone: 094 925 0290 Website: www.theapharma.ie
Zoftacot® 3.35mg/ml eye drops, solution in single-dose container. Please refer to the Summary of Product Characteristics for full prescribing information. Additional information is available on request. Active Ingredients: Hydrocortisone sodium phosphate. Presentation: 3 sachets each containing 10 single-dose units of 0.4ml. A single-dose container contains enough to treat both eyes.Indications(s): Treatment of mild non-infectious allergic or inflammatory conjunctival disease.Posology and method of administration: Adults & the Elderly: 2 drops 2-4 times per day in the affected eye. Treatment will generally vary from a few days up to a maximum of 14 days. Consider gradual tapering off down to one drop every other day to avoid relapse. Children: safety and efficacy is not established. Contraindications: Hypersensitivity to active substance or excipients. Ocular hypertension including that caused by known glucocorticosteroids. Herpes simplex and other corneal viral infections at acute stage of ulceration, unless combined with specific therapeutic agents. Conjunctivitis with ulcerative keratitis even at the initial stage. Ocular tuberculosis, ocular mycosis, acute ocular purulent infection, purulent conjunctivitis, and purulent blepharitis, stye and herpes infection that may be masked or aggravated by anti-inflammatory drugs. Warnings and precautions: Red eye: Do not prescribe for undiagnosed red eye. Ocular hypertension & cataracts: Monitor patients at regular intervals during treatment – prolonged use of corticosteroids has been shown to cause ocular hypertensions especially for patients with previous IOP increase induced by steroids, and also cataract formation especially in children and the elderly. In children the ocular hypertensive response can happen more often, frequently and severely than in adults. Immuno suppression: Use of corticosteroids can result in opportunistic ocular infections due to delay or suppression or healing delay; and to the masking of symptoms. Viral keratitis: Not recommended but may be used if required only with a combined antiviral treatment and under close supervision. Perforations and thinning of cornea / sclera: Thinning of cornea and sclera (caused by diseases) may increase risk of perforations with use of topical steroids. Suspect a fungal infection with corneal ulcerations where a steroid has been used for a long time.
Remove contact lenses when using Zoftacot. With blurred vision or other visual disturbances, consider referring patients for evaluating possible causes which may include cataract, glaucoma or rare diseases like central serous chorioretinopathy (CSR). Zoftacot contains phosphates. Children: Long-term continuous corticosteroid therapy may produce adrenal suppression. Pregnancy: Not recommended unless clearly necessary.Lactation: Risk to newborns/infants cannot be excluded. It is unknown if Zoftacot is excreted in human milk. Driving & using machines: Temporary blurred vision or other visual disturbances may affect ability to drive or use machines. Wait until vision clears before driving or operating machinery. Undesirable effects: Mild and transient burning and stinging immediately after instillation. Unseen with hydrocortisone, but have been observed with other topical corticosteroids: allergic and hypersensitivity reactions, delayed wound healing, posterior capsular cataract, opportunistic infections, herpes simplex infection, fungal infection, glaucoma, mydriasis, ptosis, corticosteroid induced uveitis, changes in corneal thickness, crystalline keratopathy, blurred vision. Very rarely, corneal calcification in patients with significantly damaged corneas. Prolonged use of corticosteroids has shown to cause ocular hypertension, especially with pre-existing or family history of increased IOP, and cataract formation. Children / elderly are more susceptible to IOP rise. Diabetics are more prone to sub capsular cataracts following topical steroids. In diseases causing thinning of the cornea, topical steroids could lead to perforation. Adverse events should be reported. Reporting forms and information can be found at http://www.hpra.ie. Overdose: Rinse with sterile water. Discontinue treatment where prolonged overdosage causes ocular hypertension. Symptoms from accidental ingestion are unknown, however, consider gastric lavage or emesis.Legal category: POM. PA Number: PA1107/13/1. PA Holder: Laboratoires THEA, 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France. Date of preparation: May 2019. Item Code: TP/19/033/Zoftacot API/V1.
let’s open our eyes
ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.HPRA.IE/HOMEPAGE/ MEDICINES/SAFETY-INFORMATION/REPORTING-SUSPECTED-SIDE-EFFECTS.
ADVERSE EVENTS SHOULD ALSO BE REPORTED TO THEAPAMEX LIMITED 094 9250290 OR MEDICAL INFORMATION ON +44 345 521 1290
TP/21/004 Ocular Surface Advert V1
References
1) L. Jones et al. The Ocular Surface 15 (2017) 575-628 2) Chiambaretta, F. et al. Eur J Ophthalmol 2017; 27(1): 1-9
Take control of Ocular SurfaceInflammation with Zoftacot
Relieve the symptoms of Dry Eye Disease with Thealoz Duo2
Break the vicious cycle of Dry Eye Disease
with Théa
1
Supported By
TREAHALOSE• O�ers osmoprotection©
HYPOTONIC• Restores the osmotic balance
INFLAMMATION
SODIUM HYALURONATE• Enhances hydration and lubrication
of the corneal surface 12
• Improves residence time 14
• Reduces tear evaporation 14
Preservative free corticosteroid- Have anti-in�ammatory priorities
PRESERVATIVE - FREE• Avoids further cell damage2
TREAHALOSE• Protects proteins and lipids from denaturation2
• Renews cellular materials by inducing autophagy210
TREAHALOSE• Protects cells from desiccation11
TEAR FILMINSTABILITY
Tear/CellHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
TREAHALOSE• O�ers osmoprotection©
HYPOTONIC• Restores the osmotic balance
INFLAMMATIONNeurogenic
in�ammation Lacrimal gland
stimulaton
PRESERVATIVE - FREE• Avoids further cell damage2
TREAHALOSE• Protects proteins and lipids from denaturation2
• Renews cellular materials by inducing autophagy210
TREAHALOSE• Protects cells from desiccation11
TEAR FILMINSTABILITY
TearHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
INFLAMMATION
TEAR FILMINSTABILITY
Tear/CellHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
TheaPamex Ltd. 14 Moneen Business Park,Castlebar, Co. Mayo. Ireland Phone: 094 925 0290 Website: www.theapharma.ie
Zoftacot® 3.35mg/ml eye drops, solution in single-dose container. Please refer to the Summary of Product Characteristics for full prescribing information. Additional information is available on request. Active Ingredients: Hydrocortisone sodium phosphate. Presentation: 3 sachets each containing 10 single-dose units of 0.4ml. A single-dose container contains enough to treat both eyes.Indications(s): Treatment of mild non-infectious allergic or inflammatory conjunctival disease.Posology and method of administration: Adults & the Elderly: 2 drops 2-4 times per day in the affected eye. Treatment will generally vary from a few days up to a maximum of 14 days. Consider gradual tapering off down to one drop every other day to avoid relapse. Children: safety and efficacy is not established. Contraindications: Hypersensitivity to active substance or excipients. Ocular hypertension including that caused by known glucocorticosteroids. Herpes simplex and other corneal viral infections at acute stage of ulceration, unless combined with specific therapeutic agents. Conjunctivitis with ulcerative keratitis even at the initial stage. Ocular tuberculosis, ocular mycosis, acute ocular purulent infection, purulent conjunctivitis, and purulent blepharitis, stye and herpes infection that may be masked or aggravated by anti-inflammatory drugs. Warnings and precautions: Red eye: Do not prescribe for undiagnosed red eye. Ocular hypertension & cataracts: Monitor patients at regular intervals during treatment – prolonged use of corticosteroids has been shown to cause ocular hypertensions especially for patients with previous IOP increase induced by steroids, and also cataract formation especially in children and the elderly. In children the ocular hypertensive response can happen more often, frequently and severely than in adults. Immuno suppression: Use of corticosteroids can result in opportunistic ocular infections due to delay or suppression or healing delay; and to the masking of symptoms. Viral keratitis: Not recommended but may be used if required only with a combined antiviral treatment and under close supervision. Perforations and thinning of cornea / sclera: Thinning of cornea and sclera (caused by diseases) may increase risk of perforations with use of topical steroids. Suspect a fungal infection with corneal ulcerations where a steroid has been used for a long time.
Remove contact lenses when using Zoftacot. With blurred vision or other visual disturbances, consider referring patients for evaluating possible causes which may include cataract, glaucoma or rare diseases like central serous chorioretinopathy (CSR). Zoftacot contains phosphates. Children: Long-term continuous corticosteroid therapy may produce adrenal suppression. Pregnancy: Not recommended unless clearly necessary.Lactation: Risk to newborns/infants cannot be excluded. It is unknown if Zoftacot is excreted in human milk. Driving & using machines: Temporary blurred vision or other visual disturbances may affect ability to drive or use machines. Wait until vision clears before driving or operating machinery. Undesirable effects: Mild and transient burning and stinging immediately after instillation. Unseen with hydrocortisone, but have been observed with other topical corticosteroids: allergic and hypersensitivity reactions, delayed wound healing, posterior capsular cataract, opportunistic infections, herpes simplex infection, fungal infection, glaucoma, mydriasis, ptosis, corticosteroid induced uveitis, changes in corneal thickness, crystalline keratopathy, blurred vision. Very rarely, corneal calcification in patients with significantly damaged corneas. Prolonged use of corticosteroids has shown to cause ocular hypertension, especially with pre-existing or family history of increased IOP, and cataract formation. Children / elderly are more susceptible to IOP rise. Diabetics are more prone to sub capsular cataracts following topical steroids. In diseases causing thinning of the cornea, topical steroids could lead to perforation. Adverse events should be reported. Reporting forms and information can be found at http://www.hpra.ie. Overdose: Rinse with sterile water. Discontinue treatment where prolonged overdosage causes ocular hypertension. Symptoms from accidental ingestion are unknown, however, consider gastric lavage or emesis.Legal category: POM. PA Number: PA1107/13/1. PA Holder: Laboratoires THEA, 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France. Date of preparation: May 2019. Item Code: TP/19/033/Zoftacot API/V1.
let’s open our eyes
ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.HPRA.IE/HOMEPAGE/ MEDICINES/SAFETY-INFORMATION/REPORTING-SUSPECTED-SIDE-EFFECTS.
ADVERSE EVENTS SHOULD ALSO BE REPORTED TO THEAPAMEX LIMITED 094 9250290 OR MEDICAL INFORMATION ON +44 345 521 1290
TP/21/004 Ocular Surface Advert V1
References
1) L. Jones et al. The Ocular Surface 15 (2017) 575-628 2) Chiambaretta, F. et al. Eur J Ophthalmol 2017; 27(1): 1-9
Take control of Ocular SurfaceInflammation with Zoftacot
Relieve the symptoms of Dry Eye Disease with Thealoz Duo2
Break the vicious cycle of Dry Eye Disease
with Théa
1
Supported By
TREAHALOSE• O�ers osmoprotection©
HYPOTONIC• Restores the osmotic balance
INFLAMMATION
SODIUM HYALURONATE• Enhances hydration and lubrication
of the corneal surface 12
• Improves residence time 14
• Reduces tear evaporation 14
Preservative free corticosteroid- Have anti-in�ammatory priorities
PRESERVATIVE - FREE• Avoids further cell damage2
TREAHALOSE• Protects proteins and lipids from denaturation2
• Renews cellular materials by inducing autophagy210
TREAHALOSE• Protects cells from desiccation11
TEAR FILMINSTABILITY
Tear/CellHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
TREAHALOSE• O�ers osmoprotection©
HYPOTONIC• Restores the osmotic balance
INFLAMMATIONNeurogenic
in�ammation Lacrimal gland
stimulaton
PRESERVATIVE - FREE• Avoids further cell damage2
TREAHALOSE• Protects proteins and lipids from denaturation2
• Renews cellular materials by inducing autophagy210
TREAHALOSE• Protects cells from desiccation11
TEAR FILMINSTABILITY
TearHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
INFLAMMATION
TEAR FILMINSTABILITY
Tear/CellHYPEROSMOLARITY
APOPTOSIS
CELL DAMAGE
TheaPamex Ltd. 14 Moneen Business Park,Castlebar, Co. Mayo. Ireland Phone: 094 925 0290 Website: www.theapharma.ie
Zoftacot® 3.35mg/ml eye drops, solution in single-dose container. Please refer to the Summary of Product Characteristics for full prescribing information. Additional information is available on request. Active Ingredients: Hydrocortisone sodium phosphate. Presentation: 3 sachets each containing 10 single-dose units of 0.4ml. A single-dose container contains enough to treat both eyes.Indications(s): Treatment of mild non-infectious allergic or inflammatory conjunctival disease.Posology and method of administration: Adults & the Elderly: 2 drops 2-4 times per day in the affected eye. Treatment will generally vary from a few days up to a maximum of 14 days. Consider gradual tapering off down to one drop every other day to avoid relapse. Children: safety and efficacy is not established. Contraindications: Hypersensitivity to active substance or excipients. Ocular hypertension including that caused by known glucocorticosteroids. Herpes simplex and other corneal viral infections at acute stage of ulceration, unless combined with specific therapeutic agents. Conjunctivitis with ulcerative keratitis even at the initial stage. Ocular tuberculosis, ocular mycosis, acute ocular purulent infection, purulent conjunctivitis, and purulent blepharitis, stye and herpes infection that may be masked or aggravated by anti-inflammatory drugs. Warnings and precautions: Red eye: Do not prescribe for undiagnosed red eye. Ocular hypertension & cataracts: Monitor patients at regular intervals during treatment – prolonged use of corticosteroids has been shown to cause ocular hypertensions especially for patients with previous IOP increase induced by steroids, and also cataract formation especially in children and the elderly. In children the ocular hypertensive response can happen more often, frequently and severely than in adults. Immuno suppression: Use of corticosteroids can result in opportunistic ocular infections due to delay or suppression or healing delay; and to the masking of symptoms. Viral keratitis: Not recommended but may be used if required only with a combined antiviral treatment and under close supervision. Perforations and thinning of cornea / sclera: Thinning of cornea and sclera (caused by diseases) may increase risk of perforations with use of topical steroids. Suspect a fungal infection with corneal ulcerations where a steroid has been used for a long time.
Remove contact lenses when using Zoftacot. With blurred vision or other visual disturbances, consider referring patients for evaluating possible causes which may include cataract, glaucoma or rare diseases like central serous chorioretinopathy (CSR). Zoftacot contains phosphates. Children: Long-term continuous corticosteroid therapy may produce adrenal suppression. Pregnancy: Not recommended unless clearly necessary.Lactation: Risk to newborns/infants cannot be excluded. It is unknown if Zoftacot is excreted in human milk. Driving & using machines: Temporary blurred vision or other visual disturbances may affect ability to drive or use machines. Wait until vision clears before driving or operating machinery. Undesirable effects: Mild and transient burning and stinging immediately after instillation. Unseen with hydrocortisone, but have been observed with other topical corticosteroids: allergic and hypersensitivity reactions, delayed wound healing, posterior capsular cataract, opportunistic infections, herpes simplex infection, fungal infection, glaucoma, mydriasis, ptosis, corticosteroid induced uveitis, changes in corneal thickness, crystalline keratopathy, blurred vision. Very rarely, corneal calcification in patients with significantly damaged corneas. Prolonged use of corticosteroids has shown to cause ocular hypertension, especially with pre-existing or family history of increased IOP, and cataract formation. Children / elderly are more susceptible to IOP rise. Diabetics are more prone to sub capsular cataracts following topical steroids. In diseases causing thinning of the cornea, topical steroids could lead to perforation. Adverse events should be reported. Reporting forms and information can be found at http://www.hpra.ie. Overdose: Rinse with sterile water. Discontinue treatment where prolonged overdosage causes ocular hypertension. Symptoms from accidental ingestion are unknown, however, consider gastric lavage or emesis.Legal category: POM. PA Number: PA1107/13/1. PA Holder: Laboratoires THEA, 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France. Date of preparation: May 2019. Item Code: TP/19/033/Zoftacot API/V1.
let’s open our eyes
ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.HPRA.IE/HOMEPAGE/ MEDICINES/SAFETY-INFORMATION/REPORTING-SUSPECTED-SIDE-EFFECTS.
ADVERSE EVENTS SHOULD ALSO BE REPORTED TO THEAPAMEX LIMITED 094 9250290 OR MEDICAL INFORMATION ON +44 345 521 1290
TP/21/004 Ocular Surface Advert V1
References
1) L. Jones et al. The Ocular Surface 15 (2017) 575-628 2) Chiambaretta, F. et al. Eur J Ophthalmol 2017; 27(1): 1-9
Take control of Ocular SurfaceInflammation with Zoftacot
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