MEMANTINE HYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Memantine Hydrochloride (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T)

Saadav alates:

Upsher-Smith Laboratories, LLC

INN (Rahvusvaheline Nimetus):

Memantine Hydrochloride

Koostis:

Memantine Hydrochloride 5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride tablets 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 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 [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. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal D

Toote kokkuvõte:

Memantine hydrochloride tablets, USP 5 mg are tan, capsule-shaped, film-coated tablets with "12" debossed on one side and "832" on the other side. They are supplied as follows: Memantine hydrochloride tablets, USP 10 mg are gray, capsule-shaped, film-coated tablets with "13" debossed on one side and "832" on the other side. They are supplied as follows: Store 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].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MEMANTINE HYDROCHLORIDE TABLETS.
MEMANTINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride is 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
May be taken with or without food. (2)
Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a
maintenance dose of 10 mg twice
daily. A minimum of 1 week of treatment with the previous dose should
be observed before increasing
the dose. (2)
Severe renal impairment: recommended dose is 5 mg twice daily. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3)
CONTRAINDICATIONS
Memantine hydrochloride tablets 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
Most common adverse reactions (≥ 5 % and greater than placebo) are
dizziness, headache, confusion,
and constipation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT UPSHER-SMITH
LABORATORIES, LLC AT 1-
855-899-9180 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Genitourinary Conditions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post marketing Experience
7 DRUG INTERACTIONS
7.1 D