Drugplain

Galantamine Hydrobromide 24 mg/1

Galantamine Hydrobromide · CAPSULE, EXTENDED RELEASE · Sun Pharmaceutical Industries, Inc.

No Recall History
Plain English

Galantamine Hydrobromide is a capsule, extended release containing galantamine hydrobromide at 24 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Galantamine Hydrobromide
Generic Name
Galantamine Hydrobromide
NDC Code (Product)
47335-837
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
24 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA090178
Marketing Start
02/09/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fall494 reports
constipation417 reports
cognitive disorder414 reports
hypotension405 reports
orthostatic hypotension403 reports
balance disorder402 reports
sedation380 reports
depressed level of consciousness374 reports
pain364 reports
creatinine renal clearance decreased359 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended starting dosage is 8 mg/day in morning; increase to initial maintenance dose of 16 mg/day after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 24 mg/day after a minimum of 4 weeks at 16 mg/day. ( 2.1 ) Take with food; ensure adequate fluid intake during treatment ( 2.1 ) Hepatic impairment: should not exceed 16 mg/day for moderate hepatic impairment; do not use in patients with severe hepatic impairment ( 2.2 ) 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. ( 2.3 ) Conversion from galantamine tablets to galantamine hydrobromide extended-release capsules should occur at the same daily dosage with the last dose of galantamine tablets taken in evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. (2.5) 2.1 Recommended Dosage and Administration Administer galantamine hydrobromide extended-release capsules once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. The recommended starting dosage of gala…

Contraindications

4 CONTRAINDICATIONS Galantamine hydrobromide extended-release capsules 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 ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 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 )] .

Adverse Reactions

6 ADVERSE REACTIONS 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 Patients 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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 …

Frequently Asked Questions

What is Galantamine Hydrobromide used for?

Galantamine Hydrobromide contains Galantamine Hydrobromide. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Galantamine Hydrobromide a controlled substance?

Galantamine Hydrobromide is not classified as a controlled substance by the DEA.

What is the generic name for Galantamine Hydrobromide?

The generic name for Galantamine Hydrobromide is Galantamine Hydrobromide. There are no other listed brand versions of Galantamine Hydrobromide.

What is the NDC code for Galantamine Hydrobromide 24 mg/1?

The NDC (National Drug Code) for Galantamine Hydrobromide 24 mg/1 is 47335-837, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

47335-837

Package NDC

47335-837-08

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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