MEMANTINE HYDROCHLORIDE solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)

Διαθέσιμο από:

Macleods Pharmaceuticals Limited

INN (Διεθνής Όνομα):

MEMANTINE HYDROCHLORIDE

Σύνθεση:

MEMANTINE HYDROCHLORIDE 2 mg in 1 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)].

Περίληψη προϊόντος:

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].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

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