Galantamine is a cholinesterase inhibitor sold in the U.S. under 3 brand and generic names, for alzheimer disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Razadyne (application NDA021169). Other galantamine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Galantamine Oral Solution: Recommended starting dosage is 4 mg (1 mL) twice daily; increase dose to initial maintenance dosage of 8 mg (2 mL) twice daily after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 12 mg (3 mL) twice daily after a minimum of 4 weeks at 8 mg (2 mL) twice daily. ( 2.2 ) • Take with meals; ensure adequate fluid intake during treatment. ( 2.2 ) • Hepatic Impairment: should not exceed 16 mg (4 mL)/day for moderate hepatic impairment; do not use in patients with severe hepatic impairment. ( 2.3 ) • Renal Impairment: should not exceed 16 mg (4 mL)/day for creatinine clearance 9 mL to 59 mL/min; do not use in patients with creatinine clearance less than 9 mL/min. ( 2.4 ) 2.2 Galantamine Oral Solution The dosage of galantamine tablets shown to be effective in controlled clinical trials is 16 mg to 32 mg/day given as twice daily dosing. As the dosage of 32 mg/day is less well tolerated than lower dosages and does not provide increased effectiveness, the recommended dosage range is 16 mg to 24 mg/day given twice daily. The dosage of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dosage of 24 mg of galantamine might provide additional benefit for some patients. The recommended starting dosage of…
Serious adverse reactions are discussed in more detail in the following sections of the labeling: • Serious Skin Reactions [see Warnings and Precautions (5.1) ] • Cardiovascular Conditions [see Warnings and Precautions (5.3) ] • Gastrointestinal Conditions [see Warnings and Precautions (5.4) ] • Genitourinary Conditions [see Warnings and Precautions (5.5) ] • Neurological Conditions [see Warnings and Precautions (5.6) ] • Pulmonary Conditions [see Warnings and Precautions (5.7) ] • Deaths in Subjects with Mild cognitive impairment (MCI) [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions in galantamine-treated patients from double-blind clinical trials (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. The most common adverse reactions associated with discontinuation…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $27 | View → | |
| 2 | 72/100 | Prescription | Capsule | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 837;837 | 24 mg | brown | capsule | — |
| 836;836 | 16 mg | pink | capsule | — |
| 837;837 | 24 mg | brown | capsule | — |
| 835;835 | 8 mg | white | capsule | — |
| 836;836 | 16 mg | pink | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Known hypersensitivity to galantamine hydrobromide or any excipients. ( 4 )
Potential to interfere with the activity of anticholinergic medications. ( 7.1 ) • Synergistic effect expected when given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents, or cholinergic agonists. ( 7.2 ) 7.1 Use with Anticholinergics Galantamine has the potential to interfere with the activity of anticholinergic medications [see Clinical Pharmacology (12.3) ] . 7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol [see Clinical Pharmacology (12.3) ] .
| $27 |
| View → |
| 3 | 58/100 | Prescription | Capsule | Generic | $27 | View → |