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Memantine Hydrochloride (Memantine Hydrochloride)

Trade Name : Memantine Hydrochloride

Pharmaceutical Associates, Inc.

SOLUTION

Strength 10 mg/5mL

MEMANTINE HYDROCHLORIDE NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Memantine Hydrochloride (Memantine Hydrochloride) which is also known as Memantine Hydrochloride and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 10 mg/5mL per ml. Read more

Memantine Hydrochloride (Memantine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
  • 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. (n n n )n nn
  • The recommended starting dose of memantine hydrochloride is 5 mg (2.5 mL) once daily. The dose should be increased in 5 mg increments to 10 mg/day (2.5 mL twice daily), 15 mg/day (2.5 mL and 5 mL as separate doses), and 20 mg/day (5 mL 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 (5 mL twice daily).
  • Memantine hydrochloride can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be taken as scheduled.Memantine hydrochloride can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, 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 hydrochloride for several days, dosing may need to be resumed at lower doses and retitrated as described above.If a patient fails to take memantine hydrochloride for several days, dosing may need to be resumed at lower doses and retitrated as described above.
  • Do not mix memantine hydrochloride oral solution with any other liquid.Do not mix memantine hydrochloride oral solution with any other liquid.
  • Special Populations
  • May be taken with or without food (n n n )n n n
  • 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. (n n n )n n n
  • Severe renal impairment: recommended dose is 5 mg (2.5 mL) twice daily. (n n n )n n n
  • Memantine hydrochloride 2 mg/mL oral solution: clear, alcohol-free, sugar-free, and peppermint flavored.
  • Oral Solution: 2 mg/mL (n n n )n nn
  • Memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
  • Memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (n n n )n nn
  • Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [n n n ].n nn
  • Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. (n n n , n n n )n nn
  • Most common adverse reactions (u2265 5% and greater than placebo) are dizziness, headache, confusion and constipation. (n n n )n nn
  • No data
  • No data
  • Signs and symptoms most often accompanying memantine overdosage in clinical trials and from worldwide marketing experience, alone or in combination with other drugs and/or alcohol, include agitation, asthenia, bradycardia, confusion, coma, dizziness, ECG changes, increased blood pressure, lethargy, loss of consciousness, psychosis, restlessness, slowed movement, somnolence, stupor, unsteady gait, visual hallucinations, vertigo, vomiting, and weakness. The largest known ingestion of memantine worldwide was 2.0 grams in a patient who took memantine in conjunction with unspecified antidiabetic medications. The patient experienced coma, diplopia, and agitation, but subsequently recovered. Fatal outcome has been very rarely reported with memantine, and the relationship to memantine was unclear.
  • Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any cases of overdose, general supportive measures should be utilized, and treatment should be symptomatic. Elimination of memantine can be enhanced by acidification of urine.
  • Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:
  • The molecular formula is Cn n n Hn n n Nu2219HCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water.n nn
  • Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: sucralose, methylparaben, propylparaben, propylene glycol, glycerin, peppermint flavor PFC 9927, citric acid, sodium citrate, and purified water.
  • No data
  • No data
  • The clinical efficacy studies described below were conducted with memantine hydrochloride tablets and not with memantine hydrochloride oral solution; however, bioequivalence of memantine hydrochloride oral solution with memantine hydrochloride tablets has been demonstrated.
  • The effectiveness of memantine hydrochloride as a treatment for patients with moderate to severe Alzheimer's disease was demonstrated in 2 randomized, double-blind, placebo-controlled clinical studies (Studies 1 and 2) conducted in the United States that assessed both cognitive function and day to day function. The mean age of patients participating in these two trials was 76 with a range of 50-93 years. Approximately 66% of patients were female and 91% of patients were Caucasian. A third study (Study 3), carried out in Latvia, enrolled patients with severe dementia, but did not assess cognitive function as a planned endpoint. Study Outcome Measures: In each U.S. study, the effectiveness of memantine hydrochloride was determined using both an instrument designed to evaluate overall function through caregiver-related assessment, and an instrument that measures cognition. Both studies showed that patients on memantine hydrochloride experienced significant improvement on both measures compared to placebo.
  • Day-to-day function was assessed in both studies using the modified Alzheimer's disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL). The ADCS-ADL consists of a comprehensive battery of ADL questions used to measure the functional capabilities of patients. Each ADL item is rated from the highest level of independent performance to complete loss. The investigator performs the inventory by interviewing a caregiver familiar with the behavior of the patient. A subset of 19 items, including ratings of the patient's ability to eat, dress, bathe, telephone, travel, shop, and perform other household chores has been validated for the assessment of patients with moderate to severe dementia. This is the modified ADCS-ADL, which has a scoring range of 0 to 54, with the lower scores indicating greater functional impairment.
  • The ability of memantine hydrochloride to improve cognitive performance was assessed in both studies with the Severe Impairment Battery (SIB), a multi-item instrument that has been validated for the evaluation of cognitive function in patients with moderate to severe dementia. The SIB examines selected aspects of cognitive performance, including elements of attention, orientation, language, memory, visuospatial ability, construction, praxis, and social interaction. The SIB scoring range is from 0 to 100, with lower scores indicating greater cognitive impairment.
  • 2 mg/mL Oral Solution
  • STORAGE
  • Store memantine hydrochloride oral solution at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • See n n n .n n n
  • To assure safe and effective use of memantine hydrochloride, the following information and instructions provided in the patient information section should be discussed with patients and caregivers.
  • Patients/caregivers should be instructed to follow the dose titration schedule provided by their physician or healthcare professional for memantine hydrochloride.
  • If a patient misses a single dose of memantine hydrochloride, 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 hydrochloride for several days, dosing should not be resumed without consulting that patient's healthcare professional.
  • Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.
  • MANUFACTURED BY
  • Silarx Pharmaceuticals, Inc.n n n Carmel, NY 10512n nn
  • PACKAGED BYn n n n n
  • R03/18
  • Memantine Hydrochloride Oral Solution
  • Read this Patient Information that comes with memantine hydrochloride oral solution 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 is memantine hydrochloride oral solution?
  • Memantine hydrochloride oral solution is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer's disease. Memantine hydrochloride oral solution belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.
  • It is not known if memantine hydrochloride oral solution is safe and effective in children.
  • Arrayn- Who should not take memantine hydrochloride oral solution?
  • Do not take memantine hydrochloride oral solution if you
  • What should I tell my doctor before taking memantine hydrochloride oral solution?
  • Before you take memantine hydrochloride oral solution, tell your doctor if you:
  • Tell your doctor about all the medicines you take
  • Taking memantine hydrochloride oral solution with certain other medicines may affect each other. Taking memantine hydrochloride oral solution with other medicines can cause serious side effects.
  • Especially tell your doctor if you take:
  • Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take memantine hydrochloride oral solution?
  • What are the possible side effects of memantine hydrochloride oral solution?
  • Arrayn- Memantine hydrochloride oral solution may cause side effects, including:
  • The most common side effects of memantine hydrochloride oral solution include:
  • These are not all the possible side effects of memantine hydrochloride oral solution. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store memantine hydrochloride oral solution?
  • Store memantine hydrochloride oral solution at room temperature between 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F).
  • What are the ingredients in memantine hydrochloride oral solution?
  • Active ingredients: memantine hydrochloride
  • Inactive ingredients: sucralose, methylparaben, propylparaben, propylene glycol, glycerin, peppermint flavor PFC 9927, citric acid, sodium citrate, and purified water
  • Keep memantine hydrochloride oral solution and all medicines out of the reach of children.
  • General information about the safe and effective use of memantine hydrochloride oral solution.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take memantine hydrochloride oral solution for a condition for which it was not prescribed. Do not give memantine hydrochloride oral solution to other people, even if they have the same condition. It may harm them.
  • This Patient Information leaflet summarizes the most important information about memantine hydrochloride oral solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about memantine hydrochloride oral solution that was written for healthcare professionals.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • MANUFACTURED BY
  • Silarx Pharmaceuticals, Inc.n n n Carmel, NY 10512n nn
  • PACKAGED BYn n n n n
  • R03/18
  • Delivers 5 mLn n n NDC 0121-0850-05n nn
  • MEMANTINEn n n HYDROCHLORIDEn n n ORAL SOLUTIONn nn
  • 10 mg/5 mL
  • Alcohol Free / Sugar Free
  • Rx ONLYn n n FOR INSTITUTIONAL USE ONLYn nn
  • Pkg. by: Pharmaceutical Associates, Inc.n n n Greenville, SC 29605n nn
  • SEE INSERT
  • A0850050318

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