2010年6月，美国FDA批准了Forest和Merz两制药公司联合开发的盐酸美金刚（memantine hydrochloride）28mg缓释胶囊NamendaXR，用于一日1次口服治疗中至重度阿尔茨海默病患者
NAMENDA XR CAP TITRATION PACK
里面含 Contains 28 capsules (7粒 x 7 mg, 7粒 x 14 mg, 粒7 x 21 mg, 7粒 x 28 mg)
NAMENDA XR CAP 7MG 30
NAMENDA XR CAP 14MG 30
NAMENDA XR CAP 21MG 30
Recommended Dosing
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The dosage of NAMENDA XR shown to be effective in a controlled clinical trial is 28 mg once daily.
The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week, and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
NAMENDA XR can be taken with or without food. NAMENDA XR capsules can be taken intact or may be opened, sprinkled on applesauce, and thereby swallowed. The entire contents of each NAMENDA XR capsule should be consumed; the dose should not be divided.
Except when opened and sprinkled on applesauce, as described above, NAMENDA XR should be swallowed whole. NAMENDA XR capsules should not be divided, chewed, or crushed.
Switching from NAMENDA Tablets to NAMENDA XR Capsules:
Patients treated with NAMENDA tablets may be switched to NAMENDA XR capsules as follows:
It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
In a patient with severe renal impairment, it is recommended that a patient who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once daily capsules the day following the last dose of a 5 mg NAMENDA tablet.
Special Populations:
Hepatic Impairment
No dosage adjustment is recommended in patients with mild or moderate hepatic impairment. NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
Renal Impairment
No dosage adjustment is recommended in patients with mild or moderate renal impairment.
A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min, based on the Cockroft-Gault equation).
