ing the period of organogenesis.
There are no adequate and well-controlled studies of galantamine hydrobromide in pregnant women. Galantamine hydrobromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether galantamine is excreted in human breast milk. Galantamine hydrobromide has no indication for use in nursing mothers.
Pediatric Us
There are no adequate and well-controlled trials documenting the safety and efficacy of galantamine in any illness occurring in children. Therefore, use of galantamine hydrobromide in children is not recommended.
ADVERSE REACTIONS
Pre-Marketing Clinical Trial Experience:
The specific adverse event data described in this section are based on studies of the immediate-release tablet formulation. In clinical trials, once-daily treatment with galantamine hydrobromide extended-release capsules was well tolerated and adverse events were similar to those seen with galantamine hydrobromide tablets.
Adverse Events Leading to Discontinuation:
In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5-month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, galantamine 16 mg/day, and galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principle reason for discontinuing galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study.Table 1: Most Frequent Adverse Events Leading to Discontinuation in a Placebo-Controlled, Double-Blind Trial With a 4-Week Dose Escalation Schedule 4-Week Escalation
Placebo 16 mg/day 24 mg/day
Adverse Event
N=286
N=279
N=273
Nausea
<1%
2%
4%
Vomiting
0%
1%
3%
Anorexia
<1%
1%
<1%
Dizziness
<1%
2%
1%
Syncope
0%
0%
1%
Adverse Events Reported in Controlled Trials:
The reported adverse events in trials using galantamine hydrobromide tablets reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ.
The majority of these adverse events occurred during the dose-escalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5 to 7 days.
Administration of galantamine hydrobromide with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events.
The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of galantamine hydrobromide under conditions of every 4-week dose-escalation for each dose increment of 8 mg/day, are shown in Table 2. These events were primari |
