Rivastigmine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of rivastigmine.
Drugs List
Therapeutic Indications
Uses
Mild - moderate dementia in Alzheimer's disease
Mild - moderate dementia in idiopathic Parkinson's disease
Dosage
Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.
If treatment is interrupted for more than three days, it should be re-initiated at 1.5mg twice daily.
Adults
Initial: 1.5mg twice a day, increased (if tolerated) after at least 2 weeks to 3mg twice a day.
Maintenance: 3mg to 6mg twice a day. Dose increases to be made at intervals of 1.5mg at least every 2 weeks.
If intolerable adverse reactions occur (in particular gastrointestinal effects, weight loss or worsening of extrapyramidal symptoms) consider omitting one or more doses. If symptoms persist, reduce to the previous well tolerated dose or consider discontinuing treatment.
Monitor treatment response regularly, particularly in patients prescribed less than 3mg twice a day. Discontinue if no benefit is seen after 3 months of maintenance treatment or if effects diminish.
Contraindications
Children under 18 years
Breastfeeding
Precautions and Warnings
Predisposition to gastrointestinal ulceration
Predisposition to seizures
Predisposition towards electrolyte imbalance
Weight below 50kg
Bradyarrhythmia
Cardiac conduction defects
Decompensated cardiac failure
Duodenal ulcer
Gastric ulcer
Hepatic impairment
History of asthma
History of obstructive pulmonary disease
Pregnancy
Recent myocardial infarction
Renal impairment
Seizures
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
Oral solution contains sodium benzoate
Where treatment is interrupted for several days restart with initial dose
Monitor patient's weight
Monitor patients with hepatic impairment for adverse effects
Monitor patients with renal impairment for adverse effects
Review if an adequate response not obtained within 3 months
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
Adverse reactions including gastrointestinal disturbances, hypertension, hallucinations (in patients with Alzheimer's dementia) and worsening of extrapyramidal symptoms (in patients with Parkinson's disease) are more prevalent at high doses or following dose increments and may respond to dose adjustments (see Dosage; Adults). Potential complications include dehydration and oesophageal rupture (secondary to vomiting).
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.
Pregnancy and Lactation
Pregnancy
Rivastigmine should be used with caution during pregnancy.
The manufacturer advises that rivastigmine should not be used during pregnancy unless clearly necessary.
No clinical data on exposed human pregnancies is available. Animal data indicates rivastigmine crosses the placenta but has failed to show evidence of teratogenic effects. Based on the available animal data, Briggs (2015) suggests the potential risk during human pregnancy is low.
Lactation
Rivastigmine is contraindicated during breastfeeding.
The manufacturer advises that women on rivastigmine should not breastfeed.
Animal data has shown excretion of rivastigmine in breast milk. Presence in human breast milk is unknown but based on the drug's molecular weight, protein binding and ability to cross the blood brain barrier, transfer is possible. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Abnormal liver function tests
Aggression
Agitation
Allergic dermatitis
Angina pectoris
Anorexia
Anxiety
Asthenia
Atrial fibrillation
Atrioventricular block
Bradycardia
Bradykinesia
Cardiac arrhythmias
Cogwheel rigidity
Confusion
Cutaneous reactions
Decreased appetite
Dehydration
Depression
Diarrhoea
Dizziness
Duodenal ulcer
Dyskinesia
Dyspepsia
Dystonia
Extrapyramidal effects
Falls
Fatigue
Gait abnormality
Gastric ulceration
Gastro-intestinal haemorrhage
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersalivation
Hypertension
Hypokinesia
Hypotension
Insomnia
Loss of balance
Malaise
Motor disturbances
Movement disturbances
Muscle rigidity
Nausea
Nightmares
Oesophageal perforation
Pancreatitis
Parkinsonism
Pruritus
Rash
Restlessness
Rigors
Seizures
Sick-sinus syndrome
Somnolence
Stiffness
Syncope
Tachycardia
Tremor
Urinary obstruction
Urinary tract infections
Visual hallucinations
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: February 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Nimvastid 1.5mg hard capsules. Consilient Health Ltd. Revised December 2015.
Summary of Product Characteristics: Nimvastid 3mg hard capsules. Consilient Health Ltd. Revised December 2015.
Summary of Product Characteristics: Nimvastid 4.5mg hard capsules. Consilient Health Ltd. Revised December 2015.
Summary of Product Characteristics: Nimvastid 6mg hard capsules. Consilient Health Ltd. Revised December 2015.
Summary of Product Characteristics: Rivastigmine Dr. Reddy's 1.5mg hard Capsules. Dr Reddy's Laboratories (UK) Ltd. Revised February 2016.
Summary of Product Characteristics: Rivastigmine Dr. Reddy's 3mg hard Capsules. Dr Reddy's Laboratories (UK) Ltd. Revised February 2016.
Summary of Product Characteristics: Rivastigmine Dr. Reddy's 4.5mg hard Capsules. Dr Reddy's Laboratories (UK) Ltd. Revised February 2016.
Summary of Product Characteristics: Rivastigmine Rosemont 2mg/ml Oral Solution. Rosemont Pharmaceuticals Limited. Revised February 2016.
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