NAMENDA XR- memantine hydrochloride capsule, extended release NAMENDA XR- memantine hydrochloride kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Allergan, Inc.

INN (Международно Name):

MEMANTINE HYDROCHLORIDE

Композиция:

MEMANTINE HYDROCHLORIDE 7 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

NAMENDA XR®  is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Risk   Summary   There are no adequate data on the developmental risk associated with the use of NAMENDA XR in pregnant women.  Adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of NAMENDA XR [see   Data].    In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal   Data Oral administration of memantine 

Каталог на резюме:

7 mg Capsule Yellow opaque capsule, with “FLI 7 mg” black imprint. Bottle of 30:       NDC# 0456-3407-33 14  mg   Capsule Yellow cap and dark green opaque capsule with “FLI 14 mg” black imprint on the yellow cap. Bottle of 30:       NDC# 0456-3414-33 Bottle of 90:       NDC# 0456-3414-90 21 mg Capsule White to off-white cap and dark green opaque capsule, with “FLI 21 mg” black imprint on the white to off-white cap. Bottle of 30:       NDC# 0456-3421-33 28  mg   Capsule Dark green opaque capsule, with “FLI 28 mg” white imprint. Bottle of 30:       NDC# 0456-3428-33 Bottle of 90:       NDC# 0456-3428-90 Titration Pack       NDC# 0456-3400-29  Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg) Store NAMENDA XR at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Статус Оторизация:

New Drug Application

Данни за продукта

NAMENDA XR- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
NAMENDA XR- MEMANTINE HYDROCHLORIDE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAMENDA XR CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAMENDA XR CAPSULES.
NAMENDA XR (MEMANTINE HYDROCHLORIDE) EXTENDED-RELEASE CAPSULES, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
NAMENDA XR is a 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
The recommended starting dose of NAMENDA XR 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 NAMENDA XR is 14 mg once daily.
(2.3)
DOSAGE FORMS AND STRENGTHS
NAMENDA XR is available as an extended-release capsule in the
following strengths: 7 mg, 14 mg, 21 mg, 28 mg (3)
CONTRAINDICATIONS
NAMENDA XR 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 NAMENDA XR 28 mg/day were headache, diarrhea and
dizziness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED DOSING
2.2 SWITCHING FROM NAMENDA TO N