MEMANTINE HYDROCHLORIDE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Aphena Pharma Solutions - Tennessee, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 HCl 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 continu

Sommarju tal-prodott:

5 mg Tablet: Tan, capsule-shaped, film-coated tablets with “5” debossed on one side and FL on the other. Bottle of 60                       NDC #0591-3870-60 10 x 10 Unit Dose           NDC #0591-3870-44 10 mg Tablet: Gray, capsule-shaped, film-coated tablets with “10” debossed on one side and FL on the other. Bottle of 60                       NDC #0591-3875-60 10 x 10 Unit Dose           NDC #0591-3875-44 Titration Pack:                  NDC #0591-3900-87 Blister package containing 49 tablets (28 x 5 mg and 21 x 10 mg tablets). Oral Solution: 2 mg/mL Oral Solution (10 mg = 5 mL) 12 fl. oz. (360 mL) bottle           NDC #0591-3011-07 Store Memantine HCl tablets and oral solution at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HCL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR MEMANTINE HCL.
MEMANTINE HCL TABLETS, FOR ORAL USE
MEMANTINE HCL SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine HCl 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 once daily. Increase dose in 5 mg increments to a
maintenance dose of 10 mg 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 twice daily. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3)
Oral Solution: 2 mg/mL (3)
CONTRAINDICATIONS
Memantine HCl 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 ACTAVIS AT
1-800-272-5525 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2015
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 Experience
7 DRUG INTERACTIONS
7.1 Drugs that Make the Urine Alkaline
7.2 Us