MEMANTINE HYDROCHLORIDE capsule, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals USA Inc.

INN (Medzinárodný Name):

MEMANTINE HYDROCHLORIDE

Zloženie:

MEMANTINE HYDROCHLORIDE 7 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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% to 4% and 15% to 20%, respectively

Prehľad produktov:

Memantine hydrochloride extended-release capsules, 7 mg are white to off-white pellets filled in size '4' hard gelatin capsules with white opaque cap imprinted with '546' in black ink and white opaque body and are supplied as follows: NDC 68382-546-06 in bottle of 30 capsules with child-resistant closure NDC 68382-546-16 in bottle of 90 capsules with child-resistant closure NDC 68382-546-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 14 mg are white to off-white pellets filled in size '4' hard gelatin capsules with light blue opaque cap imprinted with '547' in black ink and green opaque body and are supplied as follows: NDC 68382-547-06 in bottle of 30 capsules with child-resistant closure NDC 68382-547-16 in bottle of 90 capsules with child-resistant closure NDC 68382-547-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 21 mg are white to off-white pellets filled in size '4' hard gelatin capsules with white opaque cap imprinted with '548' in black ink and green opaque body and are supplied as follows: NDC 68382-548-06 in bottle of 30 capsules with child-resistant closure NDC 68382-548-16 in bottle of 90 capsules with child-resistant closure NDC 68382-548-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 28 mg are white to off-white pellets filled in size '3' hard gelatin capsules with light green opaque cap imprinted with '549' in black ink and light green opaque body and are supplied as follows: NDC 68382-549-06 in bottle of 30 capsules with child-resistant closure NDC 68382-549-16 in bottle of 90 capsules with child-resistant closure NDC 68382-549-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tightly closed container.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ZYDUS PHARMACEUTICALS USA 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
The recommended starting dose of memantine hydrochloride
extended-release capsules are 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
hydrochloride extended-release capsules are 14 mg once daily (2.3)
DOSAGE FORMS AND STRENGTHS
Memantine hydrochloride is available as an extended-release capsule in
the following strengths: 7 mg, 14
mg, 21 mg, 28 mg (3)
CONTRAINDICATIONS
Memantine hydrochloride extended-release capsules 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
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 ZYDUS PHARMACEUTICALS
(USA) INC. AT 1-
877-993-8779 OR FDA AT 1-800-F