NAMENDA- memantine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. NAMENDA (memantine hydrochloride) is 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 NAMENDA 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 NAMENDA [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 of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Ora

Product summary:

Product: 63629-3383 NDC: 63629-3383-1 30 TABLET in a BOTTLE NDC: 63629-3383-2 60 TABLET in a BOTTLE NDC: 63629-3383-3 90 TABLET in a BOTTLE NDC: 63629-3383-4 180 TABLET in a BOTTLE

Authorization status:

New Drug Application

Summary of Product characteristics

NAMENDA- MEMANTINE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAMENDA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NAMENDA.
NAMENDA (MEMANTINE HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
NAMENDA 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
NAMENDA is 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 ALLERGAN AT 1 800
678-1605 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2019
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
7.1 DRUGS THAT MAKE THE URINE ALKALINE
7.2 USE WITH OTHER N-METHYL-D-ASPARTATE (NMDA) ANTAGONISTS
®
8 USE IN SPECIFIC POPULATIONS
8.1 PREGNANCY