Galantamine

Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine Tables are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )

• Galantamine tablets: Recommended starting dosage is 4 mg twice daily; increase to initial maintenance dosage of 8 mg twice daily after a minimum of 4 weeks
• Based on clinical benefit and tolerability, dosage may be increased to 12 mg twice daily after a minimum of 4 weeks at 8 mg twice daily
• Take with meals; ensure adequate fluid intake during treatment Hepatic impairment: should not exceed 16 mg/day for moderate hepatic impairment; do not use in patients with severe hepatic impairment Renal impairment: should not exceed 16 mg/day for creatinine clearance 9 to 59 mL/min; do not use in patients with creatinine clearance less than 9 mL/min Galantamine Immediate-Release Tablets The dosage of galantamine tablets shown to be effective in controlled clinical trials is 16 - 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 - 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 tablets might provide additional benefit for some patients
• The recommended starting dosage of galantamine tablets is 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. …

Galantamine Tablets, USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.253 mg, and 15.379 mg of galantamine hydrobromide, respectively. Galantamine Tablets, USP are available in the following strengths: 4 mg white color film coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side. …

• The safety and effectiveness
• In pediatric patients have not been established

Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine tablets in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions (6.1) and Clinical Studies (14) ] . …

• Serious Skin Reactions Advise patients and caregivers to discontinue galantamine tablets and seek immediate medical attention at the first appearance of skin rash [see Warnings and Precautions ]
• General Dosing Guidance Instruct caregivers about the recommended dosage and administration of galantamine tablets
• Galantamine tablets should be administered twice per day, preferably with the morning and evening meals
• Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. …

• Galantamine tablets are 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

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) ] . …

Serious skin reactions: discontinue at first appearance of skin rash ( 5.1 ) All patients should be considered at risk for adverse effects on cardiac conduction, including bradycardia and AV block, due to vagotonic effects on sinoatrial and atrioventricular nodes ( 5.3 ) Active or occult gastrointestinal bleeding: monitor, especially those with an increased risk for developing ulcers ( 5.4 ) Cholinomimetics may cause bladder outflow obstruction ( 5.5 ) Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease ( 5.7 ) 5.1 Serious Skin Reactions Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulo …

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, decreased appetite, and weight decreas …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine tablets in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. …

Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. …

Galantamine Tablets, USP should be stored at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.