Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
NCS HealthCare of KY, Inc dba Vangard Labs
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 is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Pregnancy Category B There are no adequate and well-controlled studies of memantine in pregnant women. Memantine hydrochloride extended-release should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 6 and 21 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study i
7 mg Capsule Size '4' hard gelatin yellow capsule with yellow opaque cap and yellow opaque body, with black imprint "LU" on cap and "O61" on body. 14 mg Capsule Size '4' hard gelatin capsule with yellow opaque cap and dark green opaque body, with black imprint "LU" on cap and "O62" on body. 21 mg Capsule Size '4' hard gelatin capsule with white opaque cap and dark green opaque body, with black imprint "LU" on cap and "O63" on body. 28 mg Capsule Size '3' hard gelatin dark green capsule with black imprint "LU" on cap and "O64" on body. Blistercard of 30: NDC 0615-8264-39 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE NCS HealthCare of KY, Inc dba Vangard Labs ---------- PATIENT INFORMATION Memantine Hydrochloride Extended-release Capsules [me-MAN-teen HYE-droe-KLOR-ide] Rx Only Read this Patient Information that comes with memantine hydrochloride extended-release capsules before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What are memantine hydrochloride extended-release capsules? Memantine hydrochloride extended-release capsule is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer's disease. Memantine hydrochloride extended- release capsule belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors. It is not known if memantine hydrochloride extended-release capsule is safe and effective in children. Who should not take memantine hydrochloride extended-release capsules? Do not take memantine hydrochloride extended-release capsules if you are allergic to memantine or any of the other ingredients in memantine hydrochloride extended-release capsules. See the end of this leaflet for a complete list of ingredients in memantine hydrochloride extended-release capsules. What should I tell my doctor before taking memantine hydrochloride extended-release capsules? Before you take memantine hydrochloride extended-release capsules, tell your doctor if you: • have or have had seizures • have or have had problems passing urine • have or have had bladder or kidney problems • have liver problems • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if memantine hydrochloride extended- release will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if memantine hydrochloride extended- release passes into your breast milk. You and your doctor should decide if you w Lue koko asiakirja
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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 CAPSULE, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES Dosage and Administration, Recommended Dosing (2.1) 9/2014 INDICATIONS AND USAGE Memantine hydrochloride extended-release capsules contains memantine hydrochloride, an 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 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 capsule is available as an extended-release capsule (3.1) in the following strengths: 7 mg, 14 mg, 21 mg and 28 mg (3.1, 3.2) (3) CONTRAINDICATIONS Memantine hydrochloride extended-release is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (4) (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 28 mg/day were headache, diarrhea and dizzin Lue koko asiakirja