Most Patients Happy With Their New Salamol Inhaler

Media Statement
9th May 2005

Survey Reveals Most Patients Happy With Their New Salamol Inhaler

A survey for the world’s biggest cooperative pharmacy group* has found that two weeks after switching from their old inhaler to Salamol, 76 per cent of patients were happy with their new inhaler. Slighty more, 77 per cent, were happy to continue using Salamol, while 66 per cent reported that they preferred Salamol to their old inhaler.

The major findings of the Ventolin Replacement Study, carried out for the UK’s Cooperative Pharmacy Group showed that some patients had initial concerns about efficacy, different taste, the smaller sized container and differences in pressure, and just over half (58 per cent) discussed these with their pharmacist.

However, two weeks after switching to Salamol, three quarters of patients were happy to continue to take their new inhaler longer term. When asked if the Co-Op were only to supply Salamol, would you change pharmacy, 79 per cent of patients said they would stay with their Co-Op pharmacy.

Professor Julian Crane, Medical School, Wellington commented: `This survey shows that the majority of respondents had no concerns about a replacement with Salamol. Two weeks after switching there was a high level of satisfaction with the Salamol replacement, with well over half of respondents preferring Salamol to Ventolin. This survey reaffirms previous research into the generic substitution of branded salbutamol. A randomised double-blind study in Scotland1 found that while doctors could find no objective clinical differences between Ventolin and a generic salbutamol, almost half the patients studied reported differences between labelled Ventolin and unlabelled Ventolin. This shows that patients’ own assessment of their relief inhaler seems to be influenced by factors other than efficacy. It highlights the need for careful encouragement and education rather than alarmist headlines when changing to a generic product.’

In 1995 Salamol was approved by the US Food and Drug Administration (FDA) based on what were then newly developed methods to assess bioequivalence. It was found to be equivalent to the brand name product, Ventolin MDI. The FDA determined that the generic version is bioequivalent to the brand name product based upon a series of laboratory tests and clinical studies in humans. The generic version was, therefore, considered as safe and effective as the brand name product2. CFC-free Salamol was approved by the FDA in 2004.

All CFC-free salbutamol inhalers can clog if not cared for by careful washing3,4,5. Washing each week with warm running water for at least 30 seconds prevents possible clogging. If an inhaler is blocked and is needed immediately, rinse it, shake, test spray by firing twice and then use, then rinse again and allow to dry. Full directions are inside each pack.

In common with a number of pharmaceutical products, including other MDIs, Salamol contains ethanol. The amount used in MDIs is insufficient to have a pharmacological effect6 or affect their driving7.

*http://www.co-oppharmacy.co.uk/coop/first.asp

1. Williamson I J et al. Generic inhaled salbutamol. A randomised double-blind study. Postgrad Med 1997; 73:156-158

2. http://www.fda.gov/bbs/topics/answers/ans00701.html

3. Data Sheets for Salamol CFC-Free Inhaler, Ventolin® Inhaler (CFC-Free) and Airomir® Inhaler, available at www.medsafe.govt.nz/profs.htm

4. Gilchrist E et al. Remind patients to wash their MDI devices (letter). Pharm J 2003; 270: 792

5. Reminder: Blockage of CFC-free inhalers, Current Problems in Pharmacovigilance, Volume 27, February 2001.

6 Harrison L I. et al. Twenty-eight-day double-blind safety study of an HFA-134g Inhalation Aerosol System in Healthy Subjects. J.Pharm. Pharmacol 1996; 48:596-600

7. Barry, PW. Metered dose inhaler increases breath alcohol levels. Resp Med 1999, 93: 167-168

SalamolTM CFC-Free Inhaler contains 100mcg Salbutamol (as sulphate) per metered dose. Also contains the CFC-free propellant Norflurane (HFA134a) and Ethanol (anhydrous). 200 metered doses. Salbutamol makes it easier to breathe when airways (breathing tubes in your lungs) get tight due to asthma, chronic bronchitis and emphysema. It is suitable for use in the relief of asthmatic symptoms. Many asthmatics also require a preventer inhaler. Check with your doctor that SalamolTM is right for you. Precautions: Use strictly as directed. Your doctor may need to adjust your dose from time-to-time depending on the severity of your asthma. Do not stop using your inhaler without your doctor's advice. See your doctor if a previously effective dose fails to give relief for at least three hours or if you need your inhaler more often than usual. Do not use if you are allergic to Salbutamol or any of the inhaler components. Side effects may include Trembling, headache, fast heart beat. Mouth and throat irritation may occur. See your doctor if you have side effects. Normal doctor's visit fees will apply. PRESCRIPTION MEDICINE. This medicine is fully funded on prescription. See your doctor or pharmacist for further information. Made in Ireland. Air Flow Products Ltd, PO Box 1485, Wellington. www.air-flow.co.nz. Phone 0800 AIRFLOW (0800 247 3569) or email: afp@air-flow.co.nz. Salamol is a trademark. TAPS NA9547

Ventolin® is a trademark of the GlaxoSmithKline group of companies, Airomir® is a trademark of 3M. Ventolin® and Airomir® both contain 100mcg Salbutamol (as sulphate) per metered dose. 200 metered doses. PRESCRIPTION MEDICINES

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