Memantine extended-release

FDA label, Lupin Pharmaceuticals, Inc., oral, effective 2026-01-15. Full label on DailyMed

Other products: Memantine

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Dosing in Patients with Renal Impairment In patients with severe renal impairment (creatinine clearance of 5 to 29 mL/min, based on the Cockcroft-Gault equation), the recommended maintenance dose (and maximum recommended dose) is 14 mg/day [see CLINICAL PHARMACOLOGY].

Dosing in liver impairment

Hepatic Impairment No dosage adjustment is needed in patients with mild or moderate hepatic impairment. Memantine hydrochloride extended-release was not studied in patients with severe hepatic impairment [see Clinical Pharmacology].

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  • Memantine extended-release
Label text (3 paragraphs)

7 DRUG INTERACTIONS

7.1 Drugs That Make Urine Alkaline The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse effects. Urine pH is altered by diet, drugs (e.g. carbonic anhydrase inhibitors, sodium bicarbonate) and clinical state of the patient (e.g. renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions.

7.2 Use with Other N-methyl-D-aspartate (NMDA) Antagonists The combined use of memantine hydrochloride extended-release with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.

Contraindications

Memantine hydrochloride extended-release is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. ( 4 ) Memantine hydrochloride extended-release is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

Safety data

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

D

Likelihood score D: Possible rare cause of clinically apparent liver injury.

Memantine is an oral N-methyl-D-aspartate glutamate receptor antagonist used in the therapy of Alzheimer disease and dementia. Memantine is associated with a minimal rate of serum enzyme elevations during therapy and has only rarely been implicated as a cause of clinically apparent acute liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Memantine (NIDDK, public domain)Chapter updated Jan 28, 2020

Pregnancy and lactation

Breastfeeding (LactMed)

Little information is available on the clinical use of memantine during breastfeeding. One case report implicates memantine as the possible cause of cholestatic jaundice in a 6-week-old infant. If memantine is used during breastfeeding, monitor the infant closely for signs of jaundice.

Source: LactMed: Memantine (NICHD, public domain)Revised Oct 15, 2026

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