Finished product reference
Memantine Hydrochloride
Capsule, Extended Release · Oral · 14 mg
- List code
- 51380
What it is and how it works
Mechanism of Action Persistent activation of central nervous system N-methyl-D-aspartate (NMDA) receptors by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels. There is no evidence that memantine prevents or slows neurodegeneration in patients with Alzheimer's disease.
Indications
Memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride extended-release capsules is a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Dosage and administration (summary)
The recommended starting dose of memantine hydrochloride extended-release capsules is 7 mg once daily; the dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily; the minimum recommended interval between dose increases is one week. Patients with severe renal impairment: the recommended maintenance dose of memantine hydrochloride extended-release capsules is 14 mg once daily. Recommended Dosing The dosage of memantine hydrochloride extended-release capsules shown to be effective in a controlled clinical trial is 28 mg once daily. The recommended starting dose of memantine hydrochloride extended-release capsules is 7 mg once daily.
Contraindications
Memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation . Memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
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 ) Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine .
Pregnancy
Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women. Adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated…
Storage and supply
7 mg Capsule Opaque light green cap and opaque white body capsule, with "LPM" black imprint on the cap and "7 mg" black imprint on the body. Bottle of 30: NDC# 69680-161-30 14 mg Capsule Opaque blue cap and opaque white body capsule, with "LPM" black imprint on the cap and "14 mg" black imprint on the body.
Source: Memantine Hydrochloride (Memantine Hydrochloride) — US FDA prescribing information, 2024-02-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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