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April 23, 2014

Rivastigmine Sandoz

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Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Rivastigmine (as hydrogen tartrate) 1.5mg, 3mg, 4.5mg, 6mg.
Description: Yellow, orange, red or red/orange hard capsules respectively, marked with RIV and capsule strength.
Presentation: 1.5mg-56, €36.32; 3mg, 4.5mg and 6mg-56, €37.33.
Indications: Symptomatic treatment of mild to moderately severe Alzheimer’s dementia or mild to moderately severe dementia in patients with idiopathic Parkinson’s disease.
Pharmacology: Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’s disease and Parkinson’s disease.
Dosage: Adult: Initially 1.5mg morning and evening with meals; may be increased by 1.5mg twice daily at minimum 2 week intervals. Maintain patient on highest tolerated dose; up to maximum 6mg twice daily. If therapy interrupted for several days, re-initiate at 1.5mg twice daily. Children: Not recommended.
Contraindications: Hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients. Pregnancy (unless clearly necessary), lactation.
Special precautions: Reassess clinical benefit regularly; discontinue if rate of decline in symptoms not altered favourably after 3 months of maintenance treatment. Consider discontinuation when evidence of therapeutic effect no longer present. Not recommended: Severe dementia of Alzheimer’s or associated with Parkinson’s disease, other types of dementia or memory impairment (e.g. age-related cognitive decline). Caution: Renal/hepatic impairment, sick sinus syndrome, conduction defects, active gastric or duodenal ulcers, history of asthma or obstructive pulmonary disease, patients predisposed to urinary obstruction or seizures, body weight below 50kg. May exacerbate or induce extrapyramidal symptoms. Monitor patient’s weight. Monitor for dehydration in patients with prolonged vomiting or diarrhoea; oesophageal rupture reported. Severe hepatic impairment (monitor closely). Driving/using machines.
Drug interactions: Not recommended: Other cholinomimetics, anticholinergics. Caution: Anaesthetic agents, succinylcholine-type muscle relaxants. Drugs metabolised by butyrylcholinesterase.
Adverse drug reactions: Anorexia, anxiety, headache, somnolence, dizziness, GI upset, hyperhidrosis, fatigue. Alzheimer’s: Agitation, confusion, tremor, malaise, weight loss. Parkinson’s: Dehydration, insomnia, restlessness, tremor, worsening of Parkinson’s, bradykinesia, dyskinesia, bradycardia, muscle rigidity, abnormal gait.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie