MEMANTINE HYDROCHLORIDE liquid

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Patrin Pharma

INN (International ime):

Memantine Hydrochloride

Sastav:

Memantine Hydrochloride 2 mg in 1 mL

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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/m 2 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 ra

Proizvod sažetak:

2 mg/mL Oral Solution 12 fl. oz. (360 mL) bottle NDC #39328-551-12 Store Memantine Hydrochloride Oral Solution at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE LIQUID
PATRIN PHARMA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE
HYDROCHLORIDE ORAL 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 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 PATRIN PHARMA AT (800)
936 3088 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2018
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 Ex