Razadyne (galantamine HBr)

Dosage of galantamine hydrobromide is expressed in terms of galantamine.

The recommended initial adult dosage of galantamine for the management of mild to moderate Alzheimer's disease is 4 mg twice daily (as conventional tablets or oral solution) or 8 mg once daily (as extended-release capsules). Dosage may be increased after a minimum of 4 weeks to 8 mg twice daily (as conventional tablets or oral solution) or 16 mg once daily (as extended-release capsules). Subsequent increases to 12 mg twice daily (as conventional tablets or oral solution) or 24 mg once daily (as extended-release capsules) should be attempted after a minimum of 4 weeks of treatment at the previous dosage. Dosage increments should be based on clinical assessment of benefit and tolerance of the previous dosage. The recommended maintenance dosage is 8-12 mg twice daily (as conventional tablets or oral solution) or 16-24 mg once daily (as extended-release capsules). Higher dosages (e.g., 16 mg twice daily) do not result in greater efficacy and are less well tolerated than lower dosages.

If galantamine therapy has been interrupted for more than 3 days, therapy should be restarted using the lowest dosage and titrated upward to the prior dosage.

Galantamine hydrobromide conventional tablets and oral solution are administered orally twice daily, preferably with morning and evening meals. The extended-release capsules are administered orally once daily in the morning, preferably with food.

Slow dosage escalation is recommended to reduce the incidence of adverse cholinergic effects; a minimum of 4 weeks at the prior dosage is recommended before dosage is increased.

Patients should ensure adequate intake of fluids during treatment.

The oral solution should be administered using the dosing syringe provided by the manufacturer, referring to the accompanying patient information for instructions. The appropriate dose should be diluted in 100 mL of a nonalcoholic beverage just prior to administration; the mixture should be stirred well and consumed immediately.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to galantamine hydrobromide or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 5% or more of patients receiving galantamine hydrobromide include nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Most adverse effects associated with galantamine occurred during upward titration of dosages.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of galantamine have not been established in pediatric patients.

There are no adequate data to inform the developmental risks associated with the use of galantamine in pregnant women. Animal reproduction studies revealed some evidence of developmental toxicity when the drug was administered to pregnant rats and rabbits during the period of organogenesis at doses similar to or higher than those used clinically.

It is not known whether galantamine is distributed into milk of if the drug has any effects on the nursing infant or milk production. The known benefits of breast-feeding should be considered along with the mother's clinical need for galantamine and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

The mean age of patients receiving galantamine in clinical studies was 75 years; 78% of patients were 65-84 years of age and 10% were 85 years of age or older.