EXELON

Generic Name/API: Rivastigmin (as the hydrogen tartrate salt).

Manufacturer: Novartis

Dosage Forms & Strength & Pack Size:
Exelon hard capsules contain 1.5, 3.0, 4.5 or 6.0 mg

Storage:
KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.

Store at 20° to 25°C.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer’s Disease or Alzheimer’s Disease.
Treatment of patients with mild to moderately severe dementia associated with Parkinson’s disease.

CONTRAINDICATIONS
The use of Exelon is contraindicated in patients with:
 Known hypersensitivity to rivastigmine, to other carbamate derivatives or to the
excipients of the formulation (see section DESCRIPTION AND COMPOSITIONExcipients)
 previous history of application site reactions suggestive of allergic contact dermatitis with
rivastigmine transdermal patch (see section WARNINGS AND PRECAUTIONS – Skin
reactions)
WARNINGS AND PRECAUTIONS
Treatment should always be started at a dose of 1.5 mg twice daily and titrated to the patient’s
maintenance dose. If treatment is interrupted for longer than three days, treatment should be
re-initiated with the lowest daily dose to reduce the possibility of adverse reactions (e.g.
severe vomiting) (see section DOSAGE AND ADMINISTRATION).
Gastrointestinal disorders such as nausea, vomiting and diarrhoea may occur when initiating
treatment and/or increasing the dose. They may respond to a dose reduction. In other cases,
use of Exelon has been discontinued. Patients who show signs or symptoms of dehydration
resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and
dose reduction or discontinuation if recognized and treated promptly. Dehydration can be
associated with serious outcomes (see section ADVERSE DRUG REACTIONS).
Patients with Alzheimer’s disease may lose weight whilst taking cholinesterase inhibitors,
including rivastigmine. The patient’s weight should be monitored during therapy with Exelon.
Patients with body weight below 50 kg may experience more adverse events and may be more
likely to discontinue due to adverse events.

As with other cholinomimetics, care must be taken when using Exelon in patients with sick
sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section
ADVERSE DRUG REACTIONS).
Cholinergic stimulation may cause increased gastric acid secretion and may exacerbate
urinary obstruction and seizures. Caution is recommended in treating patients predisposed to
such conditions.
Like other cholinomimetics, Exelon should be used with caution in patients with a history of
asthma or obstructive pulmonary disease.
Like other cholinomimetics, rivastigmine may induce or exacerbate extrapyramidal
symptoms. In patients with dementia associated with Parkinson’s disease who were treated
with Exelon capsules, worsening of parkinsonian symptoms, particularly tremor, has been
observed (see section ADVERSE DRUG REACTIONS).
Skin reactions
In patients who develop application site reactions suggestive of allergic contact dermatitis to
Exelon Patch and who still require rivastigmine, treatment should be switched to oral
rivastigmine only after negative allergy testing and under close medical supervision. It is
possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may
not be able to take rivastigmine in any form.
Allergic contact dermatitis should be suspected if application site reactions spread beyond the
patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema,
edema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after
patch removal. In these cases, treatment should be discontinued (see section
CONTRAINDICATIONS).
There have been isolated post-marketing reports of patients experiencing allergic dermatitis
(disseminated) when administered rivastigmine irrespective of the route of administration
(oral, transdermal). In these cases, treatment should be discontinued (see section
CONTRAINDICATIONS). Patients and caregivers should be instructed accordingly.
Special population
Patients with clinically significant renal or hepatic impairment may experience more adverse
reactions. Dosing recommendations to titrate according to individual tolerability should be
closely followed (see section DOSAGE AND ADMINISTRATION). Patients with severe
hepatic impairment have not been studied, however, Exelon capsules may be used in this
patient population provided close monitoring is exercised.
Driving and using machines
Alzheimer’s and Parkinson’s disease dementia may cause gradual impairment of driving
performance or compromise the ability to use machinery. Rivastigmine may induce dizziness
and somnolence, mainly when initiating treatment or increasing the dose. Therefore, in patients
with dementia treated with Exelon, the ability to continue driving or operating complex
machines should be routinely evaluated by the treating physician.

 

 

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