MEMANTINE HYDROCHLORIDE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lannett Company, Inc.

INN (International Name):

MEMANTINE HYDROCHLORIDE

Sammensetning:

MEMANTINE HYDROCHLORIDE 2 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. 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 a

Produkt oppsummering:

2 mg/mL Oral Solution 12 fl. oz. (360 mL) bottle NDC 0527-1943-13 Store memantine hydrochloride oral solution at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE SOLUTION
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MEMANTINE
HYDROCHLORIDE ORAL SOLUTION. MEMANTINE HYDROCHLORIDE ORAL SOLUTION,
FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration (2) 08/2014
INDICATIONS AND USAGE
Memantine hydrochloride 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 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 LANNETT COMPANY, INC.
AT 1-844-834-
0530 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2021
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 Experie