Page 25 - P4304.1-V91_PS-Magazine-November 2023 PRINT

Kentera® (oxybutynin)

3.9mg/24h Transdermal Patch

Stirlescent is the only effervescent naproxen
8 Patch available in the UK .
1
still want to prescribe
Naproxen Choice of NSAID: Naproxen is one of the first
choices because it combines good efficacy
Kentera® (oxybutynin) 3.9mg/24h Stirling Anglian -
Product Presentation with a low incidence of side-effects .
2
Transdermal patch
Contraindicated in patients with moderate or
Pack Size 8 Patch Stirlescent advert
Product Format Transdermal Patch severe renal impairment.
Legal Category POM Naproxen is the most widely prescribed NSAID
Can’t
3
Pack Dimensions (HxWxD) 108mm x 25mm x 95mm in England, Scotland and Wales .
swallow
Shelf Life 36 months BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • For the treatment of rheumatoid arthritis,
PIP Code 315-0018 . . . Don’t osteoarthritis, ankylosing spondylitis, acute
EAN Code 5012617001962 BACK IN give me musculoskeletal disorders, dysmenorrhoea and
Don’t syrup acute gout in patients aged 18 years or over with
STOCK a creatinine clearance of at least 30 ml/min.
. . . crush
Prescribing Information tablets Manufacturer Discount Scheme
Kentera® (oxybutynin) 3.9mg/24h Transdermal patch available to dispensing practices 30%
Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Don’t like offering a discount of
tablets
Presentation: Each transdermal patch contains 36mg of evidence there is no need for dose adjustment in elderly patients. When oxybutynin is used during breast-feeding, a small amount is
oxybutynin. The area of the patch is 39cm2, releasing a nominal Psychiatric and central nervous system (CNS) anticholinergic events excreted in the mother’s milk. Use of oxybutynin while breast-feeding Prefer to Product PIP NHS MDS Net Rebate
3.9 mg of oxybutynin per 24 hours. The patch is a clear plastic with an like sleep disorders (e.g. insomnia) and cognitive disorders have been is therefore not recommended. Code Price
adhesive backing, protected by a release liner that is to be removed prior associated with oxybutynin use, especially in elderly patients. Caution dissolve in
®
to application. should be exercised when oxybutynin is administrated concomitantly Adverse Events include: water Stirlescent 250 mg
Indications: Symptomatic treatment of urge incontinence and/or with other anticholinergic medicines. If patients experience such Adverse events which could be considered serious: Urinary tract infection, Effervescent tablets 4022232 £52.72 40% £31.63 £21.09
increased urinary frequency and urgency as may occur in adult patients events, drug discontinuation should be considered. Other psychiatric upper respiratory tract infection, fungal infection, delirium, hallucinations, x20
with unstable bladder. events implying an anticholinergic mechanism have been reported amnesia, rhinitis, urinary retention, tachycardia, arrhythmia, convulsion,
during post-marketing use. Gastrointestinal disorders: Anticholinergic intraocular hypertension, glaucoma, erectile dysfunction.
Dosage and Administration: The patch should be applied to dry, medicinal products may decrease gastrointestinal motility and should
intact skin on the abdomen, hip, or buttock immediately after removal be used with caution in patients with gastrointestinal obstructive Other Very Common adverse events: Application site pruritis. Stirlescent ® a clear solution
from the protective sachet. A new application site should be selected disorders because of the risk of gastric retention. Also in conditions Other Common adverse events: Headache, somnolence, blurred vision,
with each new patch to avoid reapplication to the same site within such as ulcerative colitis, and intestinal atony. Anticholinergic medicinal dizziness, dry mouth, constipation, diarrhoea, nausea, abdominal pain,
7 days. The recommended dose is one 3.9 mg transdermal patch applied products should be used with caution in patients who have hiatus application site erythema, application site reaction, application site rash. Stirlescent 250 mg Effervescent Tablets – such as oral corticosteroids, warfarin, low dose aspirin, other NSAIDs, antiplatelet
®
twice weekly (every 3 to 4 days). Elderly: No dose adjustment required. hernia/gastro-oesophageal reflux and/or who are concurrently taking Abbreviated Prescribing Information agents or selective serotonin-reuptake inhibitors. Stirlescent should be discontinued
Paediatric population: Safety and efficacy have not been established medicinal products (such as bisphosphonates) that can cause or See SmPC for details of other adverse events. at the first sign of a skin rash, mucosal lesion or any other sign of hypersensitivity.
Monitoring of renal function is recommended in patients with impaired renal
so not recommended. exacerbate oesophagitis. Anticholinergic medicinal products should Presentation and Price: 8 patches £27.20 Please refer to the appropriate Summary of Product Characteristics (SmPC) before function, cardiac impairment, liver dysfunction, those taking diuretics, angiotensin
prescribing naproxen 250 mg effervescent tablets.
Contraindications: Hypersensitivity to the active substance or to any be used with caution in patients who have autonomic neuropathy, Legal Category: POM Each tablet contains 250 mg of naproxen with 341.89 mg of sodium and the following converting enzyme inhibitors, angiotensin-II receptor antagonists and the elderly.
Interaction with other medicinal products Refer to the SmPC for detailed advice.
of the excipients. Contraindicated in patients with urinary retention, cognitive impairment or Parkinson’s disease. Patients should be excipients – anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium SmPC Use in pregnancy and lactation: Stirlescent is contraindicated in the third
severe gastro-intestinal condition, myasthenia gravis or narrow-angle informed that heat prostration (fever and heat stroke due to decreased Further information is available from: carbonate, sodium cyclamate, saccharin sodium, sodium citrate, povidone K30, trimester. Do not use naproxen during labour or breastfeeding. Do not use during
glaucoma and in patients who are at risk for these conditions. sweating) can occur when anticholinergics such as oxybutynin are Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS. macrogol 6000, mannitol, simeticone, docusate sodium and flavour Cassis ‘NAP’, the first two trimesters unless the benefits outweigh the perceived risks. Ability
code 410. Indications: For the treatment of rheumatoid arthritis, osteoarthritis,
to drive and use machinery: If affected by dizziness, drowsiness do not drive or
Warnings and Precautions: Kentera should be used with caution used in a hot environment. Oxybutynin may exacerbate the symptoms Marketing Authorisation Numbers: PLGB 0142/1151 ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute operate machinery. Overdose: Refer to the SmPC for detailed advice.
gout in patients aged 18 years or over with a creatinine clearance of at least 30
in patients with hepatic or renal impairment, and patients with of hyperthyroidism, coronary heart disease, congestive heart ml/min. Dosage and administration: Rheumatoid arthritis, osteoarthritis and Legal category: POM
failure, cardiac arrhythmias, tachycardia, hypertension and prostatic Date of PI Preparation: February 2022
hepatic impairment should be carefully monitored. Other causes of ankylosing spondylitis: Initially 250 mg twice daily, increasing if necessary to 500 Pack size: 20 effervescent tablets in polypropylene tubes with desiccant included in
mg twice daily. Acute musculoskeletal conditions and dysmenorrhoea: Initial
the stopper. Shelf life: 36 months. NHS list price: 20 effervescent tablets = £52.72
frequent urination (heart failure or renal disease) should be assessed hypertrophy. Oxybutynin may lead to suppressed salivary secretions Document number: UK-03757 dose of 500 mg followed by 250 mg every 6–8 hours. Maximum dose after the first Marketing Authorisation Holder: Stirling Anglian Pharmaceuticals Ltd, Hillington
before treatment with Kentera. If urinary tract infection is present, which could result in dental caries, parodontosis or oral candidiasis. day is 5 tablets daily. Acute gout: Initial dose of 750 mg followed by 250 mg every Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United
appropriate antibacterial therapy should be started. Urinary retention: Effects on ability to drive and use machines: Kentera may produce Adverse events should be reported. 8 hours until the attack has passed. Elderly patients: Use the lowest effective dose Kingdom.
for the shortest possible duration. Renal/Hepatic impairment: Consider lowering
Anticholinergic products should be administered with caution to drowsiness, somnolence, or blurred vision, therefore patients should be Reporting forms and information can be found at the dose in patients with renal or hepatic impairment. Method of administration: Marketing Authorisation Number: PL42582/0009
patients with clinically significant bladder outflow obstruction because advised to exercise caution when driving or using machinery. www.mhra.gov.uk/yellowcard Doses of 1 to 2 tablets must be dissolved in at least 150 ml (a glass) of water and Further information is available at medinfo@stirlinganglianpharmaceuticals.com
doses of 3 to 4 tablets must be dissolved in 300 ml of water. Preferably to be taken
of the risk of urinary retention. Use with caution in elderly patients, who Fertility, Pregnancy & Lactation: There are no adequate data with or after food. Contraindications: Hypersensitivity to the active drug or any of or via the office number 0141 585 6352
may be more sensitive to the effects of centrally acting anticholinergics on the use of oxybutynin transdermal patch in pregnant women. Adverse events should also be reported to Accord-UK LTD on the other excipients, Active peptic ulcer or GI haemorrhage, History of recurrent Date of preparation: November 2017
01271 385257 or email medinfo@accord-healthcare.com.
Unique Code: STIPI 171101 Stirlescent
and exhibit differences in pharmacokinetics. Based on current clinical Kentera should not be used during pregnancy unless clearly necessary. peptic ulceration, perforation or GI haemorrhage, previous hypersensitivity
reactions to aspirin, ibuprofen or other NSAIDs, Severe hepatic, renal or cardiac
failure. Stirlescent should not be administered at the same time as any other NSAID.
Use with caution in patients with asthma or allergic disorders hypertension or mild Adverse events should be reported. Reporting forms and information can 0030030017 v 1.0 | Date of preparation: May 2023
UK-04230 | Date of Preparation: July 2022 to moderate congestive heart failure. Patients at high risk of GI bleeding, ulceration be found at http://yellowcard.mhra.gov.uk or downloaded from Google Play
or perforation should be considered for co-prescribing of a gastroprotective agent or the Apple App store. Adverse events should also be reported to JensonR+
such as misoprostol or a proton pump inhibitor. Caution is necessary in patients on 01271 314 320 or Stirling Anglian Pharmaceuticals on 0141 585 6352.
receiving other medication that could increase the risk of ulceration or bleeding
References
1. BNF Naproxen products available at https://bnf.nice.org.uk/drugs/naproxen/medicinal-forms/#effervescent-tablet. Date accessed May 2023
25
5
2. BNF. Choice of NSAID available at https://bnf.nice.org.uk/treatment-summaries/non-steroidal-anti-inflammatory-drugs/. Date accessed May 2023
0
MDS Terms Information | PS Magazine
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3. Haymarket Medical Media. MIMS. Available at: http://www.mims.co.uk/. Date accessed May 2023
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