英文版 Namenda (memantine HCl) 药品使用说明书 用于中重度阿尔茨海默病 HAOEYOU ( 好医友 ) NAMENDA - memantine hydrochloride tablet NAMENDA - memantine hydrochloride solution NAMENDA - memantine hydrochloride Forest Laboratories, Inc. - HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NAMENDA safely and effectively. See full prescribing information for NAMENDA. NAMENDA (memantine HCl) tablets, for oral use NAMENDA (memantine HCl) solution, for oral use Initial U.S. Approval: 2003 INDICATIONS AND USAGE NAMENDA is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1) DOSAGE AND ADMINISTRATION May be taken with or without food (2) Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg 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 twice daily. (2) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg (3) Oral Solution: 2 mg/mL (3) CONTRAINDICATIONS NAMENDA is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (4) 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) ADVERSE REACTIONS Most common adverse reactions ( 5 % and greater than placebo) are dizziness, headache, confusion and constipation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories at 1-800-678-1605 or FDA at 1- 800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 10/2013 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Genitourinary Conditions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs that Make the Urine Alkaline 7.2 Use with Other N-methyl-D-aspartate (NMDA) Antagonists 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimers type. 2 DOSAGE AND ADMINISTRATION The recommended starting dose of NAMENDA is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg 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. NAMENDA can be taken with or without food. If a patient misses a single dose of NAMENDA, that patient should not double up on the next dose. The next dose should be taken as scheduled.If a patient fails to take NAMENDA for several days, dosing may need to be resumed at lower doses and retitrated as described above. Do not mix NAMENDA oral solution with any other liquid. The oral solution is administered with a dosing device that comes with the drug and consists of a syringe, syringe adaptor cap, tubing 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 patients mouth. Special Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 29 mL/min based on the Cockroft-Gault equation). Sections or subsections omitted from the full prescribing information are not listed. Hepatic Impairment NAMENDA should be administered with caution to patients with severe hepatic impairment see Clinical Pharmacology (12.3). 3 DOSAGE FORMS AND STRENGTHS NAMENDA 5 mg tablet: capsule-shaped, film-coated tablets are tan, with the strength (5) debossed on one side and FL on the other. NAMENDA 10 mg tablet: capsule-shaped, film-coated tablets are gray, with the strength (10) debossed on one side and FL on the other. NAMENDA 2 mg/mL oral solution: clear, alcohol-free, sugar-free, and peppermint flavored. 4 CONTRAINDICATIONS NAMENDA (memantine hydrochloride) is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipie