MEMANTINE HYDROCHLORIDE capsule, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

ANI Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 2-4% and 15-20%, respectively. The ba

Povzetek izdelek:

Memantine hydrochloride extended-release capsules 7 mg, are flesh opaque cap and body, hard gelatin capsules, printed “7MG” on the cap and “A242” on the body and are supplied as:           Bottles of 30     NDC 43975-242-03 Memantine hydrochloride extended-release capsules 14 mg, are flesh opaque cap and white opaque body, hard gelatin capsules, printed “14MG” on the cap and “A264” on the body and are supplied as:           Bottles of 30     NDC 43975-264-03           Bottles of 90     NDC 43975-264-09 Memantine hydrochloride extended-release capsules 21 mg, are pink opaque cap and body, hard gelatin capsules, printed “21MG” on the cap and “A243” on the body.           Bottles of 30     NDC 43975-243-03           Bottles of 90     NDC 43975-243-09 Memantine hydrochloride extended-release capsules 28 mg, are pink opaque cap and white opaque body, hard gelatin capsules, printed “28MG” on cap and “A266” on the body and are supplied as:           Bottles of 30     NDC 43975-266-03           Bottles of 90     NDC 43975-266-09 Store memantine hydrochloride extended-release capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ANI 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 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
•
•
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
•
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 ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2021
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
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
hydroc