Memantine: uses, appearance and warnings

Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine Hydrochloride Extended-Release Capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. ( 1 )

Each capsule contains 7 mg, 14 mg, 21 mg, or 28 mg of memantine hydrochloride, USP. The 7 mg capsules are an opaque buff capsule, with “YH” black imprint on the cap and “123” black imprint on the body. The 14 mg capsules are an opaque buff cap and opaque dark green body capsule, with “YH” black imprint on the cap and “124” black imprint on the body. The 21 mg capsules are an opaque white cap and opaque dark green body capsule, with “YH” black imprint on the cap and “125” black imprint on the body. The 28 mg capsules are a dark green opaque capsule, with “YH” white imprint on the cap and “126” white imprint on the body. Memantine hydrochloride extended-release capsules are available as an extended-release capsule in the following strengths: 7 mg, 14 mg, 21 mg, 28 mg. ( 3 )

Memantine Hydrochloride Extended-Release Capsules contain 7 mg, 14 mg, 21 mg or 28 mg of memantine hydrochloride, USP. 7 mg Capsule Opaque buff capsule, with “YH” black imprint on the cap and “123” black imprint on the body. Bottle of 30 capsules with a child-resistant closure: NDC 70436-054-04 14 mg Capsule Opaque buff cap and opaque dark green body capsule, with “YH” black imprint on the cap and “124” black imprint on the body. Bottle of 30 capsules with a child-resistant closure: NDC 70436-055-04 Bottle of 90 capsules with a child-resistant closure: NDC 70436-055-06 21 mg Capsule Opaque white cap and opaque dark green body capsule, with “YH” black imprint on the cap and “125” black imprint on the body. Bottle of 30 capsules with a child-resistant closure: NDC 70436-056-04 28 mg Capsule Dark green opaque capsule, with “YH” white imprint on the cap and “126” white imprint on the body. Bottle of 30 capsules with a child-resistant closure: NDC 70436-057-04 Bottle of 90 capsules with a child-resistant closure: NDC 70436-057-06 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container as defined in the USP with a child-resistant closure. Keep Memantine Hydrochloride Extended-Release Capsules and all medicines out of the reach of children.

Memantine Hydrochloride Extended-Release Capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation . Memantine Hydrochloride Extended-Release Capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. ( 4 )

Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine. ( 5.1 , 7.1 ) 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1 )] .

The most commonly observed adverse reactions occurring at a frequency of at least 5% and greater than placebo with administration of memantine hydrochloride extended-release capsules 28 mg/day were headache, diarrhea and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s Experience Memantine hydrochloride extended-release capsules were evaluated in a double-blind placebo-controlled trial in which a total of 676 patients with moderate to severe dementia of the Alzheimer’s type (341 patients on memantine hydrochloride extended-release capsules 28 mg/day and 335 patients on placebo) were treated for up to 24 weeks. …

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 O th er N-methyl-D-aspartate (NMDA) A ntagonists The combined use of memantine hydrochloride extended-release capsules with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.