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
NAMENDA XR™ (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Important Safety Information
Contraindications
•NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
Warnings and Precautions
•NAMENDA XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels and a possible increase in adverse effects.
•NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.
Adverse Reactions
•The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
Drug Interactions
•No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Dosage and Administration
•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.
•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.
•It is recommended that a patient with severe renal impairment 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
•NAMENDA XR should be administered with caution to patients with severe hepatic 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 Cockcroft-Gault equation).