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출처: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Macleods Pharmaceuticals Limited
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE 2 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Memantine hydrochloride solution is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride solution is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Teratogenic Effects Pregnancy Category B There are no adequate and well-controlled studies of memantine in pregnant women. Memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating and continuing through the postpartum period. Slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which rats were treated from day 15 of gestation through the postpartum period. The no-effect dose for these effects was 6 mg/kg, which is 3 times the MRHD on a mg/m2 basis. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when memantine hydrochloride is administered to a nursing mother. Safety and effectiveness in pediatric patients have not been established. The majority of people with Alzheimer's disease are 65 years and older. In the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. The efficacy and safety data presented in the clinical trial sections were obtained from these patients. There were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 year old. No dosage adjustment is needed in patients with mild or moderate renal impairment. A dosage reduction is recommended in patients with severe renal impairment [see Dosage and Administration (2) and Clinical Pharmacology (12.3)] . No dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].
Oral Solution: 2 mg/mL Oral Solution (10 mg = 5 mL) 240 mL, bottle NDC 33342-066-28 Store memantine hydrochloride oral solution at 20°C to 25°C (68°F to 77°F) ; excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE SOLUTION MACLEODS PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MEMANTINE HYDROCHLORIDE SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE HYDROCHLORIDE SOLUTION. MEMANTINE HYDROCHLORIDE SOLUTION, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES Dosage and Administration (2) 08/2014 INDICATIONS AND USAGE Memantine hydrochloride, USP 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 • 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) DOSAGE FORMS AND STRENGTHS Oral Solution: 2 mg/mL (3) CONTRAINDICATIONS Memantine hydrochloride solution 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 MACLEODS PHARMA USA, INC., AT 1-888- 943-3210 OR 1-855-926-3384 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS & USAGE 2 DOSAGE & ADMINISTRATION 3 DOSAGE FORMS & STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Genitourinary Conditions 6 ADVERSE REACTIONS 6.1 Clinical Trials 전체 문서 읽기