Galantamine Hydrobromide

GALANTAMINE HYDROBROMIDE- galantamine hydrobromide tablet, film coated
GALANTAMINE HYDROBROMIDE- galantamine hydrobromide capsule, extended release
Patriot Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

GALANTAMINE ER is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Administration

Administer GALANTAMINE ER extended-release capsules once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment.

The recommended starting dosage of GALANTAMINE ER is 8 mg/day. Increase to the initial maintenance dosage of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day may be attempted after a minimum of 4 weeks at 16 mg/day. Increase dosage based upon assessment of clinical benefit and tolerability of the previous dosage.

The dosage of GALANTAMINE ER shown to be effective in a controlled clinical trial is 16–24 mg/day.

2.2 Dosage in Patients with Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh score of 7–9), the dosage should generally not exceed 16 mg/day. The use of GALANTAMINE ER in patients with severe hepatic impairment (Child-Pugh score of 10–15) is not recommended [see Clinical Pharmacology (12.3)].

2.3 Dosage in Patients with Renal Impairment

In 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 ER is not recommended [see Clinical Pharmacology (12.3)].

2.4 Treatment Interruption

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 ER 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.

2.5 Switching to GALANTAMINE ER from Galantamine Tablets

Patients currently being treated with galantamine tablets can convert to GALANTAMINE ER (extended-release capsules) by taking their last dose of galantamine tablets in the evening and starting GALANTAMINE ER once daily treatment the next morning. Converting from galantamine tablets to GALANTAMINE ER should occur at the same total daily dosage.

3 DOSAGE FORMS AND STRENGTHS

GALANTAMINE ER extended-release capsules contain white to off-white pellets and are available in the following strengths:

  • 8 mg white opaque, size 4 hard gelatin capsule with the inscription “GAL 8”
  • 16 mg pink opaque, size 2 hard gelatin capsule with the inscription “GAL 16”
  • 24 mg caramel opaque, size 1 hard gelatin capsule with the inscription “GAL 24”

4 CONTRAINDICATIONS

GALANTAMINE ER is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.

5 WARNINGS AND PRECAUTIONS

5.1 Serious Skin Reactions

Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving GALANTAMINE ER and galantamine tablets. Inform patients and caregivers that the use of GALANTAMINE ER should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.

5.2 Anesthesia

Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

5.3 Cardiovascular Conditions

Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities [see Adverse Reactions (6.1, 6.2)]. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.

Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope (placebo 0.7% [2/286]; 4 mg twice daily 0.4% [3/692]; 8 mg twice daily 1.3% [7/552]; 12 mg twice daily 2.2% [6/273]).

5.4 Gastrointestinal Conditions

Through their primary action, cholinomimetics may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk for developing ulcers, e.g., those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

Galantamine, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. During therapy with GALANTAMINE ER, the patient’s weight should be monitored.

5.5 Genitourinary Conditions

Although this was not observed in clinical trials with galantamine, cholinomimetics may cause bladder outflow obstruction.

5.6 Neurological Conditions

Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions [see Adverse Reactions (6.2)]. Seizure activity may also be a manifestation of Alzheimer’s disease. Patients with Alzheimer’s disease should be monitored closely for seizures while taking GALANTAMINE ER.

An increase in cholinergic tone may worsen symptoms related to extrapyramidal disorders [see Adverse Reactions (6.2)].

5.7 Pulmonary Conditions

Because of its cholinomimetic action, GALANTAMINE ER should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Respiratory function should be monitored closely for the occurrence of respiratory adverse effects.

5.8 Deaths in Patients with Mild Cognitive Impairment (MCI)

In two randomized placebo-controlled trials of 2 years duration in patients with mild cognitive impairment (MCI), a total of 13 patients on galantamine (n=1026) and 1 patient on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population; about half of the galantamine deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death).

Although the difference in mortality between galantamine- and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of galantamine. Specifically, in these two MCI studies, the mortality rate in the placebo-treated patients was markedly lower than the rate in placebo-treated patients in trials of galantamine in Alzheimer’s disease or other dementias (0.7 per 1000 person years compared to 22–61 per 1000 person years, respectively). Although the mortality rate in the galantamine-treated MCI patients was also lower than that observed in galantamine-treated patients in Alzheimer’s disease and other dementia trials (10.2 per 1000 person years compared to 23–31 per 1000 person years, respectively), the relative difference was much less. When the Alzheimer’s disease and other dementia studies were pooled (n=6000), the mortality rate in the placebo group numerically exceeded that in the galantamine group. Furthermore, in the MCI studies, no patients in the placebo group died after 6 months, a highly unexpected finding in this population.

Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer’s disease.

6 ADVERSE REACTIONS

Serious adverse reactions are discussed in more detail in the following sections of the labeling:

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