Rivastigmine transdermal
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Transdermal patches containing rivastigmine.
Drugs List
Therapeutic Indications
Uses
Mild - moderate dementia in Alzheimer's disease
Dosage
Adults
Initiate treatment with the 4.6mg/24 hours patch.
This dose should be increased to 9.5mg/24 hours after a minimum of 4 weeks of treatment and if the drug is well tolerated. 9.5mg/24 hours is the recommended effective maintenance dose and should be continued for as long as the patient continues to demonstrate therapeutic benefit.
If well tolerated and only after a minimum of six months of treatment at 9.5mg/24 hours, the dose may be increased to 13.3mg/24 hours in patients who have demonstrated a meaningful cognitive deterioration and/or functional decline while on the recommended effective maintenance dose.
Patients with body weight below 50kg
Particular caution should be exercised in titrating patients with body weight below 50kg above the recommended effective dose of 9.5mg/24 hours. They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Additional Dosage Information
Temporarily interrupt treatment if gastrointestinal adverse reactions are observed until they 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 4.6mg/24 hour.
Switching from oral therapy to transdermal patches
The first patch should be applied the day after the last oral dose.
Oral dose of 3mg/day - switch to 4.6mg/24 hour patch
Oral dose of 6mg/day - switch to 4.6mg/24 hour patch
Stable and well tolerated oral dose of 9mg/day - switch to 9.5mg/24 hour patch
Oral dose of 9mg/day that is not stable and not well tolerated - switch to 4.6mg/24 hour patch
Oral dose of 12mg/day - switch to 9.5mg/24 hour patch
After switching from oral therapy to the 4.6mg/24 hour patch, this dose should be increased to 9.5mg/24 hours after a minimum of 4 weeks of treatment if the patch is well tolerated.
Contraindications
Children under 18 years
Breastfeeding
Precautions and Warnings
Predisposition to gastrointestinal ulceration
Predisposition to hypokalaemia
Predisposition to hypomagnesaemia
Predisposition to seizures
Weight below 50kg
Atrioventricular block
Bradyarrhythmia
Cardiac conduction defects
Decompensated cardiac failure
Duodenal ulcer
Gastric ulcer
Hepatic impairment
History of asthma
History of obstructive pulmonary disease
Non-paced sinus node dysfunction
Pregnancy
Recent myocardial infarction
Urinary obstruction
Adverse effects more likely in patients weighing less than 50kg
Advise ability to drive/operate machinery may be affected by side effects
Do not start treatment unless a carer is available to monitor drug intake
Evaluate patient's ability to drive/operate machinery regularly
Treatment to be initiated and supervised by a specialist
Advise patient to wash hands after use
Advise patients and caregivers on the correct administration of patches
Avoid broken or inflamed skin
Avoid contact with eyes
Avoid exposing application site to direct external heat
Avoid the use of creams, oils or lotions as they may reduce patch adhesion
Discard used patches safely - fold with adhesive edges together
Do not apply more than one patch at a time
If accidental contact with the eyes occurs, rinse thoroughly with water
Rotate application sites - avoid applying patch to the same site
Where treatment is interrupted for several days restart with initial dose
Discontinue drug at the first occurrence of gastrointestinal symptoms
Monitor patient's weight
Monitor patients with hepatic impairment for adverse effects
Reassess need for continued treatment at regular intervals
Advise patient to report skin reaction, pain, erythema, pruritus
May cause or exacerbate extrapyramidal symptoms
Modify dose if adverse effects occur
Consider dose reduction or interrupting treatment if dehydration occurs
Discontinue if severe skin reaction occurs
Discontinue if therapeutic effect is no longer present
If patients who discontinue treatment with rivastigmine patches due to allergic contact dermatitis still require rivastigmine treatment, they should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision. Allergic contact dermatitis is observed when the skin reaction spreads beyond the patch size, after patch removal if symptoms do not improve after 48 hours treatment should be discontinued.
Signs and symptoms of dehydration can be managed with intravenous fluids and dose reduction or discontinuation if observed promptly.
Pregnancy and Lactation
Pregnancy
Use rivastigmine with caution during pregnancy.
The manufacturer advises that rivastigmine should not be used during pregnancy unless clearly necessary.
No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity. In peri/postnatal studies in rats, an increased gestation time was observed. Reproduction studies in rats (at two times the maximum recommended human dose) and rabbits (four times the maximum recommended human dose) did not find any teratogenic effects.
There are no clinical data available on exposed pregnancies. Rivastigmine crosses the rabbit placenta, but it is not known if it crosses the human placenta. It does cross the human blood brain barrier, and has a low molecular weight and moderate protein binding, all of which suggest it will cross to the foetal compartment. However, it is extensively metabolised to inactive metabolites and has a very short plasma elimination half life of 1.5 hours, which limits the amount available for foetal transfer. Briggs (2015) concludes that animal data suggests the risk is low and that inadvertent exposure is not a reason for termination of pregnancy.
Lactation
Rivastigmine is contraindicated during breastfeeding.
The manufacturer advises that women on rivastigmine should not breastfeed. At the time of writing, no reports on use in human lactation have been located, which is not surprising given the indication.
In animals, rivastigmine is excreted into milk. It is not known if it is excreted in human milk, but the molecular weight, moderate protein binding and crossing the blood brain barrier all suggest that it will. However the short plasma elimination half life will limit the amount available for excretion. The effect of exposure on the neonate is unknown.
Counselling
The previous patch must be removed before applying a new one every day. The patch should be replaced after 24 hours. Only one patch should be worn at a time.
The patch should be pressed down firmly for at least 30 seconds, using the palm of the hand, until the edges stick well. If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
The patch should not be applied to skin that is red, irritated or cut. Reapplication to the exact same skin location within 14 days should be avoided to reduce the potential risk of skin irritation.
To avoid interference with the adhesive properties of the patch, no cream, lotion or powder should be applied to the skin area where the patch is to be applied.
The patch should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, or another place that will not be rubbed by tight clothing.
The patch should not be applied to the thigh or abdomen as these areas can cause decreased bioavailability of rivastigmine.
The patch can be worn in everyday situations, including during bathing or in hot weather.
The patch should not be exposed to any external heat sources for long periods of time.
The patch should only be applied whole. Do not cut into pieces.
Advise patients and caregivers that skin application site reactions may occur.
Advise patients not to drive or operate machinery if they experience syncope or delirium.
Side Effects
Abdominal pain
Aggression
Agitation
Allergic dermatitis
Altered liver function tests
Anorexia
Anxiety
Application site reaction
Asthenia
Atrial fibrillation
Atrioventricular block
Bradycardia
Cutaneous reactions
Decreased appetite
Dehydration
Delirium
Depression
Diarrhoea
Dizziness
Dyspepsia
Erythema
Extrapyramidal effects
Falls
Fatigue
Gastric ulceration
Hallucinations
Headache
Hepatitis
Hypertension
Irritation at application site
Nausea
Nightmares
Oedema at application site
Pancreatitis
Pruritus
Psychomotor hyperactivity
Pyrexia
Rash
Restlessness
Seizures
Sick-sinus syndrome
Somnolence
Syncope
Tachycardia
Tremor
Urinary incontinence
Urinary tract infections
Urticaria
Vesicles
Vomiting
Weight loss
Worsening of Parkinson's disease
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2016
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Almuriva 4.6 mg/24 h transdermal patch. Sandoz Limited. Revised February 2016.
Summary of Product Characteristics: Almuriva 9.5 mg/24 h transdermal patch. Sandoz Limited. Revised February 2016.
Summary of Product Characteristics: Almuriva 13.3 mg/24 h transdermal patch. Sandoz Limited. Revised October 2020.
Summary of Product Characteristics: Alzest 4.6 mg/24 h transdermal patch. Dr. Reddy's Laboratories UK Ltd. Revised September 2020.
Summary of Product Characteristics: Alzest 9.5 mg/24 h transdermal patch. Dr. Reddy's Laboratories UK Ltd. Revised September 2020.
Summary of Product Characteristics: Alzest 13.3 mg/24 h transdermal patch. Dr. Reddy's Laboratories UK Ltd. Revised September 2020.
Summary of Product Characteristics: Eluden 4.6 mg/24 h transdermal patch. Generics UK Ltd. Revised January 2014.
Summary of Product Characteristics: Eluden 9.5 mg/24 h transdermal patch. Generics UK Ltd. Revised January 2014.
Summary of Product Characteristics: Erastig 4.6 mg/24 h transdermal patch. Generics UK Ltd. Revised June 2015.
Summary of Product Characteristics: Erastig 9.5 mg/24 h transdermal patch. Generics UK Ltd. Revised June 2015.
Summary of Product Characteristics: Erastig 13.3 mg/24 h transdermal patch. Generics UK Ltd. Revised June 2015.
Summary of Product Characteristics: Exelon patches. Novartis Pharmaceuticals UK Ltd. Revised March 2013.
Summary of Product Characteristics: Prometax 4.6 mg/24 h transdermal patch. Novartis Pharmaceuticals UK Ltd. Revised October 2019.
Summary of Product Characteristics: Prometax 9.5 mg/24 h transdermal patch. Novartis Pharmaceuticals UK Ltd. Revised October 2019.
Summary of Product Characteristics: Somniton patches. Zentiva Ltd. Revised January 2014.
Summary of Product Characteristics: Voleze patches 4.6 mg/24 h, 9.5 mg/24 h and 13.3 mg/24 h transdermal patch. Focus Pharmaceuticals Ltd. Revised October 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 June 2021
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