MEMANTINE HYDROCHLORIDE capsule, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Amneal Pharmaceuticals LLC

INN (שם בינלאומי):

MEMANTINE HYDROCHLORIDE

הרכב:

MEMANTINE HYDROCHLORIDE 7 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride extended-release capsules are 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 memantine hydrochloride extended-release capsules 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 memantine hydrochloride extended-release capsules [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

leaflet_short:

Memantine hydrochloride extended-release capsules, 7 mg, are supplied as a two-piece hard gelatin capsule with standard yellow opaque cap and standard yellow opaque body filled with white to off-white pellets. Imprinted in black ink “AN” on the cap and imprinted in black ink “782” on the body. They are available as follows: Bottles of 30:                          NDC 65162-782-03 Bottles of 90:                          NDC 65162-782-09 Bottles of 500:                        NDC 65162-782-50 Memantine hydrochloride extended-release capsules, 14 mg, are supplied as a two-piece hard gelatin capsule with standard yellow opaque cap and dark green opaque body filled with white to off-white pellets. Imprinted in black ink “AN” on the cap and imprinted in black ink “783”on the body. They are available as follows: Bottles of 30:                          NDC 65162-783-03 Bottles of 90:                          NDC 65162-783-09 Bottles of 500:                        NDC 65162-783-50 Memantine hydrochloride extended-release capsules, 21 mg, are supplied as a two-piece hard gelatin capsule with white opaque cap and dark green opaque body filled with white to off-white pellets. Imprinted in black ink “AN” on the cap and imprinted in black ink “784” on the body. They are available as follows: Bottles of 30:                          NDC 65162-784-03 Bottles of 90:                          NDC 65162-784-09 Bottles of 500:                        NDC 65162-784-50 Memantine hydrochloride extended-release capsules, 28 mg, are supplied as a two-piece hard gelatin capsule with dark green opaque cap and dark green opaque body filled with white to off-white pellets. Imprinted in white ink “AN” on the cap and imprinted in white ink “785” on the body. They are available as follows: Bottles of 30:                          NDC 65162-785-03 Bottles of 90:                          NDC 65162-785-09 Bottles of 500:                        NDC 65162-785-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
AMNEAL PHARMACEUTICALS LLC
----------
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 CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules are 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 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 capsules are available as an
extended-release capsule in the
following strengths: 7 mg, 14 mg, 21 mg, 28 mg. (3)
CONTRAINDICATIONS
Memantine hydrochloride extended-release capsules are 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 capsules 28 mg/day were
headache, diarrhea and dizziness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMNEAL PHARMACEUTICALS
AT 1-877-835-
5472 O