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Namenda

Namenda Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Namenda (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

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History

There is currently no drug history available for this drug.

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Other Information

Namenda® (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:

image of Namenda chemical structure

The molecular formula is C12H21N•HCl and the molecular weight is 215.76.

Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Namenda is available as tablets or as an oral solution. Namenda is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets). Namenda 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: sorbitol solution (70%), methyl paraben, propylparaben, propylene glycol, glycerin, natural peppermint flavor #104, citric acid, sodium citrate, and purified water.

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Namenda Manufacturers

  • Contract Pharmacy Services-pa
    Namenda | Contract Pharmacy Services-pa
    No Recall

    Namenda | Contract Pharmacy Services-pa

    Namenda | Contract Pharmacy Services-pa

    The dosage of Namenda (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

    The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

    Namenda can be taken with or without food.

    Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

    Doses in Special Populations

    A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

    For males: CLcr = [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

    For females: CLcr = 0.85 · [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

  • Rebel Distributors Corp
    Namenda | Rebel Distributors Corp
    No Recall

    Namenda | Rebel Distributors Corp

    Namenda | Rebel Distributors Corp

    The dosage of Namenda (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

    The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

    Namenda can be taken with or without food.

    Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

    Doses in Special Populations

    A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

    For males: CLcr = [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

    For females: CLcr = 0.85 · [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

  • Pd-rx Pharmaceuticals, Inc.
    Namenda | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Namenda | Pd-rx Pharmaceuticals, Inc.

    Namenda | Pd-rx Pharmaceuticals, Inc.

    The dosage of Namenda (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

    The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

    Namenda can be taken with or without food.

    Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

    Doses in Special Populations

    A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

    For males: CLcr = [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]
    For females: CLcr = 0.85 · [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]

  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Namenda | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    No Recall

    Namenda | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    Namenda | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    The dosage of Namenda (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

    The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

    Namenda can be taken with or without food.

    Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

    Doses in Special Populations

    A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

    For males: CLcr = [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]
    For females: CLcr = 0.85 · [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]

  • Bryant Ranch Prepack
    Namenda | Bryant Ranch Prepack
    No Recall

    Namenda | Bryant Ranch Prepack

    Namenda | Bryant Ranch Prepack

    The dosage of Namenda (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

    The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

    Namenda can be taken with or without food.

    Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

    Doses in Special Populations

    A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

    For males: CLcr = [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]
    For females: CLcr = 0.85 · [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]

  • Cardinal Health
    Namenda | Greenbrier International, Inc.
    No Recall

    Namenda | Greenbrier International, Inc.

    Namenda | Greenbrier International, Inc.

    • pump as needed into your palms and thoroughly spread on both hands.  • rub into skin until dry.  • not recommended for infants.

  • Forest Laboratories, Inc.
    Namenda |
    No Recall

    Namenda |

    Namenda |

    The recommended starting dose of NAMENDA is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg 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.

    NAMENDA can be taken with or without food. If a patient misses a single dose of NAMENDA, that patient should not double up on the next dose. The next dose should be taken as scheduled.If a patient fails to take NAMENDA for several days, dosing may need to be resumed at lower doses and retitrated as described above.

    Do not mix NAMENDA oral solution with any other liquid. The oral solution is administered with a dosing device that comes with the drug and consists of a syringe, syringe adaptor cap, tubing and other supplies a patient needs to administer the drug. The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient's mouth.

    Special Populations

    Renal Impairment

    A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation).

    Hepatic Impairment

    NAMENDA should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

  • Bryant Ranch Prepack
    Namenda | Bryant Ranch Prepack
    No Recall

    Namenda | Bryant Ranch Prepack

    Namenda | Bryant Ranch Prepack

    The recommended starting dose of NAMENDA is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg 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.

    NAMENDA can be taken with or without food. If a patient misses a single dose of NAMENDA, that patient should not double up on the next dose. The next dose should be taken as scheduled.If a patient fails to take NAMENDA for several days, dosing may need to be resumed at lower doses and retitrated as described above.

    Do not mix NAMENDA oral solution with any other liquid. The oral solution is administered with a dosing device that comes with the drug and consists of a syringe, syringe adaptor cap, tubing and other supplies a patient needs to administer the drug. The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient's mouth.

    Special Populations

    Renal Impairment

    A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation).

    Hepatic Impairment

    NAMENDA should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

  • Cardinal Health
    Namenda | Cardinal Health
    No Recall

    Namenda | Cardinal Health

    Namenda | Cardinal Health

    The recommended starting dose of NAMENDA is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg 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.

    NAMENDA can be taken with or without food. If a patient misses a single dose of NAMENDA, that patient should not double up on the next dose. The next dose should be taken as scheduled.If a patient fails to take NAMENDA for several days, dosing may need to be resumed at lower doses and retitrated as described above.

    Do not mix NAMENDA oral solution with any other liquid. The oral solution is administered with a dosing device that comes with the drug and consists of a syringe, syringe adaptor cap, tubing and other supplies a patient needs to administer the drug. The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient's mouth.

    Special Populations

    Renal Impairment

    A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation).

    Hepatic Impairment

    NAMENDA should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

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