Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Bryant Ranch Prepack
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. NAMENDA (memantine hydrochloride) is 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 NAMENDA 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 NAMENDA [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 unknown. Data Animal Data Ora
Product: 63629-3383 NDC: 63629-3383-1 30 TABLET in a BOTTLE NDC: 63629-3383-2 60 TABLET in a BOTTLE NDC: 63629-3383-3 90 TABLET in a BOTTLE NDC: 63629-3383-4 180 TABLET in a BOTTLE
New Drug Application
NAMENDA- MEMANTINE HYDROCHLORIDE TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NAMENDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAMENDA. NAMENDA (MEMANTINE HYDROCHLORIDE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE NAMENDA is an 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 May be taken with or without food. (2) Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg twice daily. A minimum of 1 week of treatment with the previous dose should be observed before increasing the dose. (2) Severe renal impairment: recommended dose is 5 mg twice daily. (2) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg (3) CONTRAINDICATIONS NAMENDA is 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 Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT 1 800 678-1605 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 9/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 GENITOURINARY CONDITIONS 6 ADVERSE REACTIONS 6.1 CLINICAL TRIALS EXPERIENCE 6.2 POSTMARKETING EXPERIENCE 7 DRUG INTERACTIONS 7.1 DRUGS THAT MAKE THE URINE ALKALINE 7.2 USE WITH OTHER N-METHYL-D-ASPARTATE (NMDA) ANTAGONISTS ® 8 USE IN SPECIFIC POPULATIONS 8.1 PREGNANCY Izlasiet visu dokumentu