Sign Out
Types of dementia other than Alzheimer's dementia: REMINYL is indicated for patients with mild to moderately severe dementia of the Alzheimer's type. The benefit of REMINYL in patients with other types of dementia or other types of memory impairment has not been demonstrated.
Serious skin reactions: Serious skin reactions (Steven-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving REMINYL (see Adverse Reactions). It is recommended that patients be informed about the signs of serious skin reactions, and that use of REMINYL be discontinued at the first appearance of skin rash.
Weight monitoring: Patients with Alzheimer's disease lose weight. Treatment with cholinesterase inhibitors, including galantamine, has been associated with weight loss in these patients. During therapy, patient's weight should be monitored.
Conditions requiring caution: As with other cholinomimetics, REMINYL should be given with caution in the following conditions: Cardiovascular Conditions: because of their pharmacological action, cholinomimetics may have vagotonic effects on heart rate, including bradycardia and all types of atrioventricular node block (see Adverse Reactions). The potential for this action may be particularly important to patients with 'sick sinus syndrome' or other supraventricular cardiac conduction disturbances or who use drugs that significantly reduce heart rate concomitantly, such as digoxin and beta-blockers. In clinical trials, use of REMINYL has been associated with syncope and rarely with severe bradycardia.
Gastrointestinal Conditions: patients at increased risk of developing peptic ulcers, e.g. those with a history of ulcer disease or those predisposed to these conditions, including those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDS), should be monitored for symptoms. However, clinical studies with REMINYL showed no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. The use of REMINYL is not recommended in patients with gastro-intestinal obstruction or recovering from gastro-intestinal surgery.
Neurological Conditions: convulsions have been reported with REMINYL (see Postmarketing data under Adverse Reactions). Seizure activity may also be a manifestation of Alzheimer's disease. An increase in cholinergic tone may worsen symptoms related to extrapyramidal disorders (see Postmarketing data under Adverse Reactions).
Pulmonary Conditions: because of their cholinomimetic actions, cholinomimetics should be prescribed with care for patients with a history of severe asthma or obstructive pulmonary disease.
Genitourinary: the use of REMINYL is not recommended in patients with urinary outflow obstruction or recovering from bladder surgery.
Safety in subjects with mild cognitive impairment (MCI): REMINYL is not indicated for individuals with mild cognitive impairment (MCI), i.e., those who demonstrate isolated memory impairment greater than expected for their age and education, but do not meet criteria for Alzheimer's disease.
Two, 2-year controlled trials in subjects with MCI did not meet dual primary efficacy outcomes. Although mortality in both treatment arms was low, more deaths were initially recorded in subjects randomized to galantamine than to placebo, but the incidence of serious adverse events was identical between treatment groups. The deaths were due to various causes that are not unexpected in an elderly population. When data retrieved from the large proportion of patients who discontinued prior to completion of the double-blind period was included, there was no evidence of an increasing risk of death in REMINYL-treated subjects over time. More subjects from the placebo than the galantamine group discontinued prior to death, which may account for the difference in mortality initially recorded.
The MCI study results are discrepant from those observed in studies of Alzheimer's disease. In pooled studies in Alzheimer's disease (n=4614), the mortality rate was numerically higher in the placebo than the REMINYL group.
Effects on Ability to Drive and Use Machines: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery. Furthermore, like other cholinomimetics, REMINYL may cause adverse reactions (such as dizziness and somnolence), which could affect the ability to drive or use machines, especially during the first weeks after initiation of treatment (see Adverse Reactions).
