Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Zydus Pharmaceuticals USA Inc.
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE 7 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Olvassa el a teljes dokumentumot