MEMANTINE HYDROCHLORIDE- memantine hydrochloride capsule, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Major Pharmaceuticals

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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. Available: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6734-61 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. Available: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6736-61 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. Available: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6737-61 28 mg Capsule Size '3' hard gelatin dark green capsule with black imprint "LU" on cap and "O64" on body. Available: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6735-61 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Major Pharmaceuticals
----------
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
will take memantine
hydrochloride extended-release or breastfeed.
Tell your doctor about all the med

Produkta apraksts

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MAJOR PHARMACEUTICALS
----------
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
•
•
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)
CONTRAINDICATIONS
Memantine hydrochloride extended-release 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
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 dizziness (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 6/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Switching from Memantine hydrochloride Tablets to Memantine
hydrochloride Extended-
Release Capsules
2.