Nine in 10 children experience at least 1 episode of middle ear infection by school entry and could benefit from a new formulation of a gold standard antibiotic, according to national research released today.(1)
Maxamox Suspension (500mg/5mL) is the first and only amoxycillin antibiotic designed for twice-daily (as opposed to three-times-daily) treatment of middle ear infection or acute otitis media (AOM). [Amoxycillin is used to treat various infections and twice-daily usage is recommended by health professionals as the treatment of choice for AOM].2 The sugar, gluten and lactose-free formulation, which is available on the Pharmaceutical Benefits Scheme (PBS), does not require refrigeration, even after mixing.(3)
According to Dr John Gullotta, Sydney General Practitioner, a simpler dosing regimen of amoxycillin can help a child achieve the best possible health outcome.
"Playgroups and schools are often reluctant to administer medications to children and it can be very difficult for parents to arrange administration of three doses of medication during the school day," he said.
"Also, if a patient does not complete the full course of treatment, this reduces the chance of the antibiotic working and increases the possibility of antibiotic resistant bugs developing, making it more likely for the infection to recur and less likely that the antibiotic will work next time.
"Because Maxamox Suspension only needs to be given twice a day - before and after school - this increases a child's chance of completing the full course to achieve the best result," said Dr Gullotta.
According to the Galaxy research revealing parents' understanding of, and attitude towards managing and treating childhood ear infections, more than half of those surveyed have experienced some problems when administering medication which required a 3 times per day regimen. The most common problem is forgetting to dose at the right time and only remembering later on. One in four parents has completely missed one or more doses in a day.(1)
Parents also have concerns about administering medication to their child while at school or playgroup. Of those parents surveyed, 81 per cent are concerned about ensuring that their child receives the correct dosage at the correct time. Furthermore, 71 per cent of parents are also concerned about keeping the medication refrigerated, while 66 per cent are concerned about remembering to take the medication to school or playgroup.
Childhood ear infections can significantly disrupt family life. The research suggests that, of those parents surveyed with children aged 9 years or younger, around 8 in 10 acknowledge some form of disruption to their paid work or daily activities when they are called upon to care for a child with an ear infection.
"The convenient, twice-daily dosing regimen of Maxamox Suspension allows parents to return to their work or other daily commitments without having to dose during the day," said Dr Gullotta.
The research also suggests that there is much confusion about the true risk factors associated with ear infections. Only 12 per cent of parents consider the risk posed by children mixing with others at playgroup and school to be a risk factor. According to Dr Gullotta, however, this represents the most common form of transmission.
"Many parents do not realise that their child's attendance at playgroup, school or any environment in which children play close together, puts them most at risk of developing AOM".
Parents are also not certain about the complications that can result if ear infections are not treated when appropriate. While 42 per cent are aware that middle ear infections can lead to hearing loss, 1 in 3 parents are not aware of any complications that can result. Interestingly, those who have had a child experience an ear infection are no more aware of the potential complications than those who have not experienced it.
According to Perth primary school teacher, Anna Sinclair, without appropriate treatment, AOM can result in severe complications such as hearing loss and learning and behavioural difficulties at school.
"There is a lot of research that shows a strong correlation between hearing loss and academic achievement. Recurrent hearing loss can lead to a number of problems for children including speech, language, intellectual, social, psychological and learning problems both inside the classroom, to name a few," she said.
"But until a parent or teacher is actually confronted with a situation in which a child has an identified hearing loss, they are probably not aware of the significant impact that it can have on the child's learning and social development".
According to Dr Gullotta, due to the high prevalence of AOM among young infants and children, recognising and treating the infection when appropriate is very important.
"Parents who suspect that their child has acute otitis media should see their doctor to ensure that the right approach to treatment and medication is undertaken as quickly as possible. "
"However the use of antibiotics is not always necessary, as in the case of a viral infection, and it's important that antibiotics are not over-used or used inappropriately," he said.
About acute otitis media (AOM)
AOM is an infection (bacterial or viral) that produces pus, fluid and inflammation in the middle ear. It is usually associated with upper respiratory tract infections such as colds and coughs. The infection blocks the eustachian tube, stopping the airflow that maintains a healthy middle ear. The pressure and inflammation prevent the eardrum from vibrating, often causing temporary hearing loss. Severe ear infections may cause the eardrum to tear.(4,5)
Common signs and symptoms of AOM include intense ear pain in babies and toddlers, unusual irritability or behavioural problems and difficulty hearing.(4,5,6,7) The infection is most common among children aged 6 to 12 months. Although its incidence declines after 6 to 7 years of age, 1 out of every 3 primary school age children will have some form of conductive hearing loss at any given time.(2,6)
Maxamox Suspension - adverse reactions and contraindications
Maxamox Suspension should not be taken by patients who have allergies to amoxycillin or any other penicillins, or who have had a serious allergic reaction to any cephalosporins (a group of similar antibiotics). The following side effects may occur but are usually mild: thrush - oral or vaginal, diarrhoea, nausea, vomiting. As with all amoxycillins, serious side effects are rare, but if patients notice any of the following they should inform their doctor immediately, or go to the nearest hospital: skin rash, itching, hives, blistering / peeling of the skin, wheezing, difficulty breathing, swelling of the face, lips or tongue, severe stomach cramps, watery, severe diarrhoea. Other side effects may occur and patients should see their doctor if they notice anything making them feel unwell. Patients should also mention any medical conditions or current illnesses including kidney problems, a history of allergy or any other medicines they may be using.(3)
The recommended dosage of Maxamox Suspension for treating AOM in children (6 months to 12 years old) is 30mg/kg twice-daily (up to a maximum dose of 1g twice-daily). Treatment should continue for 48 to 72 hours after the child's symptoms disappear.(3)
(1) Acute otitis media (AOM) study, Australia. Galaxy Research. 6-22 August 2004.
(2) www.rch.unimelb.edu.au. Acute Otitis Media. Clinical Practice Guidelines - Australia. The Royal Children's Hospital, Division of Medicine, Melbourne. 27 May, 2004.
(3) MAXAMOX Powder for Oral Suspension Product Information (PI). Sandoz Pty Ltd. September 2003.
(4) www.nidcd.nih.gov. Otitis Media (Ear Infection) technical fact sheet (2002). National Institute on Deafness and Other Communication Disorders (NIDCD). NIH Pub. No. 97-4216. July 2002.
(5) www.chw.edu.au. Aboriginal Otitis Media - fact sheet. Westmead Children's Hospital. 28 Feb, 2002.
(6) www.myDr.com.au. Acute Otitis Media. Guidelines on the management of paediatric middle ear disease. The Medical Journal of Australia. Supplement 4, October 1993.
(7) www.aap.org. New guidelines outline appropriate treatment of ear infections. American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). March 98, 2004.