MEMANTINE HYDROCHLORIDE- 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:

Camber Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablet 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 memantine hydrochloride 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 [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 mi

Product summary:

5 mg Tablets: Tan colored, modified capsule shaped, biconvex, film coated tablets debossed with 'J' on one side and '47' on the other side. Bottles of 60                                                               NDC 31722-807-60 Bottles of 200                                                             NDC 31722-807-02 Carton of 100 (10 x 10) Unit dose tablets                  NDC 31722-807-32 10 mg Tablets: Gray colored, modified capsule shaped, biconvex, film coated tablets debossed with 'J' on one side and '48' on the other side. Bottles of 60                                                               NDC 31722-808-60 Bottles of 200                                                             NDC 31722-808-02 Carton of 100 (10 x 10) Unit dose tablets                  NDC 31722-808-32 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET
CAMBER PHARMACEUTICALS, INC.
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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 tablets 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
• 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 ANNORA PHARMA PRIVATE
LIMITED AT 1-
866-495-1995 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2022
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 Drug