MEMANTINE HYDROCHLORIDE- memantine hydrochloride tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Memantine Hydrochloride (UNII: JY0WD0UA60) (Memantine - UNII:W8O17SJF3T)

Доступно од:

Jubilant Cadista Pharmaceuticals Inc.

INN (Међународно име):

Memantine Hydrochloride

Састав:

Memantine Hydrochloride 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are 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

Резиме производа:

Memantine hydrochloride tablets, USP 5 mg: Orange, capsule-shaped, film-coated tablets debossed with ‘C’ on one side and ‘331’ on other side. Bottle of 60                       NDC 59746-331-60 Bottle of 500                     NDC 59746-331-05 Bottle of 1000                   NDC 59746-331-10 Memantine hydrochloride tablets, USP 10 mg: Grey, capsule-shaped, film-coated tablets debossed with ‘C’ on one side and ‘332’ on other side. Bottle of 60                       NDC 59746-332-60 Bottle of 500                     NDC 59746-332-05 Bottle of 1000                   NDC 59746-332-10 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
Jubilant Cadista Pharmaceuticals Inc.
----------
PATIENT INFORMATION
Memantine Hydrochloride Tablets, USP
(me-MAN-teen HYE-droe-KLOR-ide)
Read this Patient Information that comes with memantine hydrochloride
tablets before you start taking it
and each time you get a refill. There may be new information. This
information does not take the place of
talking to your doctor about your medical condition or your treatment.
What are memantine hydrochloride tablets?
Memantine hydrochloride tablets are prescription medicine used for the
treatment of moderate to severe
dementia in people with Alzheimer's disease. Memantine hydrochloride
tablets belong to a class of
medicines called NMDA (N-methyl-D-aspartate) inhibitors.
It is not known if memantine hydrochloride tablets are safe and
effective in children.
Who should not take memantine hydrochloride tablets?
Do not take memantine hydrochloride tablets if you are allergic to
memantine or any of the ingredients in
memantine hydrochloride tablets. See the end of this leaflet for a
complete list of ingredients in
memantine hydrochloride tablets.
What should I tell my doctor before taking memantine hydrochloride
tablets?
Before you take memantine hydrochloride tablets, tell your doctor if
you:
•
have or have had seizures
•
have or have had problems passing urine
•
have or have had bladder or kidney problems
•
have liver problems
•
have any other medical conditions
•
are pregnant or plan to become pregnant. It is not known if memantine
hydrochloride will harm
your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if memantine
hydrochloride passes into
your breast milk. You and your doctor should decide if you will take
memantine hydrochloride or
breastfeed.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
Taking memantine hydrochloride tablets with certain other medicines
may affect eac

Карактеристике производа

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MEMANTINE HYDROCHLORIDE TABLETS, USP.
MEMANTINE HYDROCHLORIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride tablets, USP are 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)
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 JUBILANT CADISTA
PHARMACEUTICALS INC., AT 1-800-313-
4623 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 8/2016
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 D