Namenda

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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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

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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:

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.

Sources

Namenda Manufacturers

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)]

No Recall
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)]

No Recall
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)]

No Recall
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)]

No Recall
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)]

No Recall
Cardinal Health

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.

No Recall
Forest Laboratories, Inc.

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)].

No Recall
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)].

No Recall
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)].

No Recall