Memantine 10 mg Tablets — Generic For Namenda — Upsher-Smith

These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS.

MEMANTINE HYDROCHLORIDE Tablets, for oral use

Initial U.S. Approval: 2003

Indications And Usage

Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (

1)

Dosage And Administration

May be taken with or without food. (

2)

Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg twice daily. A minimum of 1 week of treatment with the previous dose should be observed before increasing the dose. (

2)

Severe renal impairment: recommended dose is 5 mg twice daily. (

2)

Dosage Forms And Strengths

Tablets: 5 mg and 10 mg (

3)

Contraindications

Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (

4)

Warnings And Precautions

• Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1, 7.1)

• Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1, 7.1)

Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. (

5.1,

7.1)

Adverse Reactions

Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion, and constipation. (

6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2022