MEMANTINE HYDROCHLORIDE- memantine hydrochloride oral solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)

থেকে পাওয়া:

Seton Pharmaceuticals

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride 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 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 9 and 30 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 in which rats were given oral memantine beginning pre-mating and continuing through the postpartum period. Slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which rats were treated from day 15 of gestation through the postpartum period. The no-effect dose for these effects was 6 mg/kg, which is 3 times the MRHD on a mg/m2 basis. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when memantine hydrochloride is administered to a nursing mother. Safety and effectiveness in pediatric patients have not been established. The majority of people with Alzheimer’s disease are 65 years and older. In the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. The efficacy and safety data presented in the clinical trial sections were obtained from these patients. There were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 year old. No dosage adjustment is needed in patients with mild or moderate renal impairment. A dosage reduction is recommended in patients with severe renal impairment [see Dosage and Administration (2) and Clinical Pharmacology (12.3)] . No dosage adjustment is needed in patients with mild or moderate hepatic impairment. Memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see Dosage and Administration (2) and Clinical Pharmacology (12.3)] . INSTRUCTIONS FOR USE Memantine Hydrochloride (me-MAN-teen HYE-droe-KLOR-ide) Oral Solution Directions for Using your Memantine Hydrochloride Oral Solution Read these instructions before taking memantine hydrochloride oral solution 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. Preparing your dose of Memantine Hydrochloride Oral Solution. You will need the following supplies: - Memantine Hydrochloride Oral Solution bottle with Child-resistant cap - Press-in bottle adaptor - Oral dosing syringe - Prescribing Information ​INSTRUCTIONS This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured for: Seton Pharmaceuticals, Wall, NJ 07719 1 [phone] Manufactured by: Medley Pharmaceuticals Ltd. Plot No. 18 & 19, Zari Causeway Road Kachigram, Daman 396210, INDIA Revised 02/2021

পণ্য সারাংশ:

Memantine Hydrochloride Oral Solution 2 mg/mL (10 mg = 5 mL) 12 fl. oz. (360 mL) bottle                       NDC #13925-540-12 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59°to 86°F). [see USP Controlled Room Temperature.] Dispense in tightly closed containers.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE ORAL SOLUTION
SETON PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MEMANTINE
HYDROCHLORIDE ORAL SOLUTION.MEMANTINE HYDROCHLORIDE ORAL SOLUTION, FOR
ORAL USE. INITIAL U.S.
APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride is an 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
May be taken with or without food (2) (2)
Initial dose is 5 mg (2.5 mL) once daily. Increase dose in 5 mg
increments to a maintenance dose of 10
mg (5 mL) twice daily. A minimum of 1 week of treatment with the
previous dose should be observed
before increasing the dose. (2) (2)
Severe renal impairment: recommended dose is 5 mg (2.5 mL) twice
daily. (2) (2)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 2 mg/mL (3) (3)
CONTRAINDICATIONS
Memantine hydrochloride 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) (5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5 % and greater than placebo) are
dizziness, headache, confusion
and constipation. (6.1) (6)
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088
or www.fda.gov/medwatch
(6)
REVISED: 6/2021
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-asparta