MEMANTINE HYDROCHLORIDE- memantine capsule, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mylan Pharmaceuticals Inc.

INN (Международно Name):

MEMANTINE HYDROCHLORIDE

Композиция:

MEMANTINE HYDROCHLORIDE 7 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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. 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 2-4% and 15-20%, respectively. The background risk

Каталог на резюме:

Memantine Hydrochloride Extended-Release Capsules are available containing 7 mg, 14 mg, 21 mg or 28 mg of memantine hydrochloride, USP. The 7 mg capsules are hard shell gelatin capsules with a light peach opaque cap and light peach opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over MT 7 in black ink on the cap and body. They are available as follows: NDC 0378-5435-93 bottles of 30 capsules The 14 mg capsules are hard shell gelatin capsules with a light peach opaque cap and light green opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over MT 14 in black ink on the cap and body. They are available as follows: NDC 0378-5436-93 bottles of 30 capsules NDC 0378-5436-77 bottles of 90 capsules The 21 mg capsules are hard shell gelatin capsules with a white opaque cap and light green opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over MT 21 in black ink on the cap and body. They are available as follows: NDC 0378-5437-93 bottles of 30 capsules The 28 mg capsules are hard shell gelatin capsules with a light green opaque cap and light green opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over MT 28 in black ink on the cap and body. They are available as follows: NDC 0378-5438-93 bottles of 30 capsules NDC 0378-5438-77 bottles of 90 capsules Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container using a child-resistant closure.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

MEMANTINE HYDROCHLORIDE- MEMANTINE CAPSULE, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
----------
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 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
•
•
DOSAGE FORMS AND STRENGTHS
Memantine hydrochloride is available as an extended-release capsule in
the following strengths: 7 mg, 14 mg, 21 mg, 28
mg (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2019
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
2.3 Dosing in Patients with Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
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 re