البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
DirectRx
ORAL
PRESCRIPTION DRUG
Memantine hydrochloride tablets, USP 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. 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine 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 [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 unknow
Memantine Hydrochloride Tablets USP, 5 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF' on one side and '41' on other side and are supplied as below. NDC in bottle of 60 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NDC in bottle of 1000 tablets NDC in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Memantine Hydrochloride Tablets USP, 10 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF 40' on one side and other side is plain and are supplied as below. NDC in bottle of 60 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NCD in bottle of 1000 tablets NDC 72578-004-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET DIRECTRX ---------- MEMANTINE HCL Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The recommended starting dose of memantine hydrochloride is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day. Memantine hydrochloride tablets can be taken with or without food. If a patient misses a single dose of memantine hydrochloride tablets, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloridetablets for several days, dosing may need to be resumed at lower doses and retitrated as described above. Specific Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 to 29 mL/min based on the Cockcroft-Gault equation). Hepatic Impairment Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)]. Memantine Hydrochloride Tablets USP, 5 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF' on one side and '41' on other side. Memantine Hydrochloride Tablets USP, 10 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF 40' on one side and other side is plain. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions اقرأ الوثيقة كاملة