Galantamine Hydrobromide Oral Solution Solution
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Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
Galantamine hydrobromide oral solution is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
History
There is currently no drug history available for this drug.
Other Information
Galantamine hydrobromide oral solution contains galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3•HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:
Galantamine hydrobromide oral solution contains 4 mg (as 5.13 mg galantamine hydrobromide) per mL. The inactive ingredients are methylparaben, propylparaben, purified water and saccharin sodium. Galantamine Hydrobromide Oral Solution may contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Sources
Galantamine Hydrobromide Oral Solution Solution Manufacturers
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Roxane Laboratories, Inc
![Galantamine Hydrobromide Oral Solution Solution [Roxane Laboratories, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Galantamine Hydrobromide Oral Solution Solution | Roxane Laboratories, Inc
2.2 Galantamine Hydrobromide Oral SolutionThe recommended starting dosage of Galantamine hydrobromide oral solutionis 4 mg twice a day (8 mg/day). The dosage should be increased to the initial maintenance dosage of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day).
Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
Galantamine hydrobromide oral solutionshould be administered twice a day, preferably with morning and evening meals.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose.
The abrupt withdrawal of galantamine in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. The beneficial effects of galantamine hydrobromide oral solution are lost, however, when the drug is discontinued.
2.3 Dosage in Patients with Hepatic ImpairmentIn patients with moderate hepatic impairment (Child-Pugh score of 7 to 9), the dosage should generally not exceed 16 mg/day. The use of galantamine hydrobromide oral solution in patients with severe hepatic impairment (Child-Pugh score of 10 to15) is not recommended.
2.4 Dosage in Patients with Renal ImpairmentIn patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of galantamine hydrobromide oral solution is not recommended [see Clinical Pharmacology (12.3)].
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