Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Par Pharmaceutical, 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
The 7 mg, capsule is available as a Size 4CS hard gelatin capsule with a yellow opaque cap and yellow opaque body, imprinted with “par” on the cap and “C346” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30.……..…NDC# 10370-346-11 The 14 mg, capsule is available as a Size 4CS hard gelatin capsule with a green opaque cap and yellow opaque body, imprinted with “par” on the cap and “C347” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30.………..NDC# 10370-347-11 Bottle of 90.………..NDC# 10370-347-09 The 21 mg, capsule is available as a Size 3CS hard gelatin capsule with a green opaque cap and white opaque body, imprinted with “par” on the cap and “C348” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30………...NDC# 10370-348-11 The 28 mg, capsule is available as a Size 2CS hard gelatin capsule with green opaque cap and green opaque body, imprinted with “par” on the cap and “C349” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30………...NDC# 10370-349-11 Bottle of 90…….......NDC# 10370-349-09 Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature]
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE PAR PHARMACEUTICAL, 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 N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type (1) (1) DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride extended-release capsules is 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 is 14 mg once daily (2.3) DOSAGE FORMS AND STRENGTHS Memantine hydrochloride extended-release capsules are available as an extended-release capsules 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 PAR PHARMACEUTICAL AT 1-800-828-9393 OR FDA AT 1- Przeczytaj cały dokument