MEMANTINE HYDROCHLORIDE capsule, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride extended-release 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 extended-release 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 6 and 21 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 i

Tóm tắt sản phẩm:

7 mg Capsule Size '4' hard gelatin yellow capsule with yellow opaque cap and yellow opaque body, with black imprint "LU" on cap and "O61" on body. 14 mg Capsule Size '4' hard gelatin capsule with yellow opaque cap and dark green opaque body, with black imprint "LU" on cap and "O62" on body. 21 mg Capsule Size '4' hard gelatin capsule with white opaque cap and dark green opaque body, with black imprint "LU" on cap and "O63" on body. 28 mg Capsule Size '3' hard gelatin dark green capsule with black imprint "LU" on cap and "O64" on body. Blistercard of 30:                                                    NDC 0615-8264-39 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
PATIENT INFORMATION
Memantine Hydrochloride Extended-release Capsules
[me-MAN-teen HYE-droe-KLOR-ide]
Rx Only
Read this Patient Information that comes with memantine hydrochloride
extended-release capsules 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 extended-release capsules?
Memantine hydrochloride extended-release capsule is a prescription
medicine used for the treatment of
moderate to severe dementia in people with Alzheimer's disease.
Memantine hydrochloride extended-
release capsule belongs to a class of medicines called NMDA
(N-methyl-D-aspartate) inhibitors.
It is not known if memantine hydrochloride extended-release capsule is
safe and effective in children.
Who should not take memantine hydrochloride extended-release capsules?
Do not take memantine hydrochloride extended-release capsules if you
are allergic to memantine or any
of the other ingredients in memantine hydrochloride extended-release
capsules. See the end of this leaflet
for a complete list of ingredients in memantine hydrochloride
extended-release capsules.
What should I tell my doctor before taking memantine hydrochloride
extended-release capsules?
Before you take memantine hydrochloride extended-release capsules,
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 extended-
release will harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if memantine
hydrochloride extended-
release passes into your breast milk. You and your doctor should
decide if you w

Đặc tính sản phẩm

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MEMANTINE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULE, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosing (2.1) 9/2014
INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules contains memantine
hydrochloride, an NMDA receptor antagonist
indicated for the treatment of moderate to severe dementia of the
Alzheimer's type. (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose of memantine hydrochloride
extended-release capsules is 7 mg once daily; the dose
should be increased in 7 mg increments to the recommended maintenance
dose of 28 mg once daily; the minimum
recommended interval between dose increases is one week (2.1)
Patients with severe renal impairment: the recommended maintenance
dose of memantine hydrochloride extended-
release capsules is 14 mg once daily (2.3)
DOSAGE FORMS AND STRENGTHS
Memantine hydrochloride extended-release capsule is available as an
extended-release capsule (3.1) in the following
strengths: 7 mg, 14 mg, 21 mg and 28 mg (3.1, 3.2) (3)
CONTRAINDICATIONS
Memantine hydrochloride extended-release is contraindicated in
patients with known hypersensitivity to memantine
hydrochloride or to any excipients used in the formulation. (4) (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
The most commonly observed adverse reactions occurring at a frequency
of at least 5% and greater than placebo with
administration of memantine hydrochloride extended-release 28 mg/day
were headache, diarrhea and dizzin