MEMANTINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Nazwa):

MEMANTINE HYDROCHLORIDE

Skład:

MEMANTINE HYDROCHLORIDE 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. Pregnancy Category B  There are no adequate and well-controlled studies of memantine in pregnant women. Memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.   Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2  basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine

Podsumowanie produktu:

Memantine hydrochloride tablets USP, 5 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘596’ on other side. They are supplied in blistercards of 30. Blistercards of 30 NDC 0615-8192-39 Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side. They are supplied in blistercards of 15 and 30.  Blistercards of 15 NDC 0615-8100-05 Blistercards of 30 NDC 0615-8100-39 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.] 

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MEMANTINE- MEMANTINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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) (5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5 % and greater than placebo) are
dizziness, headache, confusion and constipation.
(6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S
LABORATORIES INC., AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2019
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 Postmarketing Experience
7 DRUG INTERACTIONS
7