Drug Catalog - Product Detail
MEMANTINE HCL ORAL SOLUTION SUSP 2MG/ML 360ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00527-1943-13 | LANNETT | 360 | 2MG/ML | SOLUTION |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: sucralose, methylparaben, propylparaben, propylene glycol, glycerin, peppermint flavor PFC 9927, citric acid, sodium citrate, and purified water. molec-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 2 mg/mL Oral Solution 12 fl. oz. (360 mL) bottle NDC 0527-1943-13 Store memantine hydrochloride oral solution at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. 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
2 DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride is 5 mg (2.5 mL) once daily. The dose should be increased in 5 mg increments to 10 mg/day (2.5 mL twice daily), 15 mg/day (2.5 mL and 5 mL as separate doses), and 20 mg/day (5 mL twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day (5 mL twice daily). Dosing Titration Schedule Total daily dose Strength per dose (mg) Starting Dose 5mg 5mg Dose after week 1 10mg 5mg (first daily dose) 5mg (second daily dose) Dose after week 2 15mg 5mg (first daily dose) 10mg (second daily dose) Dose after week 3 20mg 10mg (first daily dose) 10mg (second daily dose) Memantine hydrochloride can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride for several days, dosing may need to be resumed at lower doses and retitrated as described above. Do not mix memantine hydrochloride oral solution with any other liquid. Memantine hydrochloride is administered with a dosing device that comes with the drug and consists of a syringe, press in bottle adaptor and other supplies a patient needs to administer the drug. The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient’s mouth. Special Populations Renal Impairment A target dose of 5 mg (2.5 mL) twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockcroft-Gault equation). Hepatic Impairment Memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology ( 12.3 )] . May be taken with or without food ( 2 ) Initial dose is 5 mg (2.5 mL) once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg (5 mL) 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 (2.5 mL) twice daily. ( 2 )