Rivastigmine Patch Dexcel 4.6 mg / 24h, 9.5 mg / 24h

/ Dexcel

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to current guidelines. Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.
Mild to moderate dementia of the Alzheimer’s type
Initial dose and dose titration to the effective dose:
Treatment is started with Rivastigmine patch Dexcel 4.6mg/24h once a day.
After a minimum of four weeks of treatment and if well tolerated this dose should be increased to Rivastigmine patch Dexcel 9.5mg/24h, the daily recommended effective dose, which can be continued for as long therapeutic benefit for the patient exists.
Individual responses to rivastigmine may vary and some patients may derive additional benefit from higher doses.
Interruption of treatment:
Treatment should be temporarily interrupted if gastrointestinal adverse effects and/or worsening of existing extrapyramidal symptoms (e.g. tremor) are observed until these adverse effects resolve. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise treatment should be re-initiated with Rivastigmine patch Dexcel 6mg/24h.
If adverse effects persist on re-initiation of therapy, the dose should be temporarily reduced to the previous well-tolerated dose.
Switching from capsules to transdermal patches:
Patients treated with Rivastigmine capsules or oral solution can be switched to Rivastigmine patches as follows.
A patient who is on a dose < 6 mg per day oral rivastigmine can be switched to Rivastigmine patch Dexcel 4.6mg/24h.
A patient on a dose of 6 mg or 12 mg per day oral rivastigmine may be directly switched to Rivastigmine patch Dexcel 9.5mg/24h.
It is recommended to apply the first transdermal patch on the day following the last oral dose.
Patients with body weight below 50 kg
Caution should be exercised in titrating these patients may experience more adverse reactions.
Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop.
Hepatic impairment
Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions. Patients with severe hepatic impairment have not been studied. Particular caution should be exercised in titrating these patients.
Renal impairment
No dose adjustment is necessary for patients with renal impairment.
Paediatric population
Children and adolescents (age below 18 years): rivastigmine is not recommended for use in children.
Method of administration
Rivastigmine transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing. The patch should be replaced by a new one after 24 hours.
Please refer to the license holder for further details.

Treatment of mild to moderate dementia of the Alzheimer’s type.

Hypersensitivity to rivastigmine, to other carbamate derivatives or to any of the excipients.
Previous history of application site reactions suggestive of allergic contact dermatitis with  rivastigmine transdermal patch.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.