MEMANTINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/m 2 basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical verte

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE SOLUTION
MACLEODS PHARMACEUTICALS LIMITED
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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 FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2015
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 Experience