memantine/donepezil (Rx)

Brand and Other Names:Namzaric
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

memantine extended-release/donepezil

capsule

  • 7mg/10mg
  • 14mg/10mg
  • 21mg/10mg
  • 28mg/10mg

Alzheimer Disease

Fixed dose combination product for patients with moderate-to-severe Alzheimer disease currently stabilized on donepezil 10 mg once daily

Recommended dose is 28 mg/10 mg PO qDay

Stabilized on donepezil and not currently on memantine

  • Starting dose is 7 mg/10 mg PO, taken once a day in the evening
  • Increase dose in 7 mg increments based on the memantine component to the recommended maintenance dose of 28 mg/10 mg once daily
  • The minimum recommended interval between dose increases is 1 week
  • Only increase if the previous dose is well tolerated
  • Maximum dose: 28 mg/10 mg qDay

Stabilized on both donepezil and memantine

  • Patients on memantine (10 mg BID or 28 mg extended-release qDay) and donepezil 10 mg/day can be switched to Namzaric 28 mg/10 mg PO, taken once a day in the evening
  • Initiate the day following the last dose of memantine and donepezil administered separately

Dosage Modifications

Severe renal impairment

  • Severe renal impairment (CrCl 5-29 mL/min, based on the Cockcroft-Gault equation)
  • Stabilized on donepezil 10 mg/day and not currently on memantine
    • Recommended starting dose: 7 mg/10 mg PO taken once daily in the evening
    • The dose should be increased to the recommended maintenance dose of 14 mg/10 mg once daily in the evening after a minimum of 1 week
  • Stabilized on both donepezil and memantine
    • Patients on memantine (5 mg BID or 14 mg extended-release qDay) and donepezil 10 mg/day can be switched to Namzaric 14 mg/10 mg, taken once a day in the evening

Not indicated

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Interactions

Interaction Checker

and memantine/donepezil

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            Adverse Effects

            >10% (donepezil)

            Nausea (5-19%)

            Diarrhea (8-15%)

            Insomnia (5-14%)

            Accident (7-13%)

            Infection (11%)

            1-10% (memantine)

            Dizziness (7%)

            Confusion (6%)

            Headache (6%)

            Constipation (5%)

            Cough (4%)

            Hypertension (4%)

            Backache (3%)

            Pain (3%)

            Somnolence (3%)

            Syncope (3%)

            Vomiting (3%)

            Dyspnea (2%)

            Fatigue (2%)

            1-10% (donepezil)

            Headache (4-10%)

            Vomiting (3-8%)

            Cramping (3-8%)

            Fatigue (3-8%)

            Anorexia (3-7%)

            Hypertension (3% )

            Abnormal dreams (3%)

            Hallucinations (3%)

            Confusion (2%)

            Syncope (2%)

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            Warnings

            Contraindications

            Hypersensitivity to memantine, donepezil, or piperidine derivatives

            Cautions

            Memantine

            • Conditions that raise urine pH may decrease urinary elimination and increase plasma levels of memantine
            • Use caution in cardiovascular disease, seizure disorder, ophthalmic disease, hepatic and/or renal impairment

            Donepezil

            • Risk of GI bleed, especially in patients with history of gastric ulcer or those at increased risk of developing ulcers
            • Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia
            • Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block
            • May cause diarrhea, nausea, and vomiting
            • May cause anorexia and/or weight loss (dose dependent)
            • Cholinomimetics may cause bladder outflow obstructions
            • Cholinomimetics are believed to have some potential to cause generalized convulsions
            • Cholinesterase inhibitors should be prescribed with care with history of asthma or obstructive
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            Pregnancy & Lactation

            Pregnancy Category: B (memantine); C (donepezil)

            Lactation: Unknown if distributed in human breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Memantine: Low- to moderate-affinity uncompetitive N-methyl-D-aspartate (NMDA) receptor (NMDAR) antagonist that binds preferentially to NMDAR-operated cation channels, blocking receptor only under conditions of excessive stimulation, with no effect on normal neurotransmission

            Donepezil: Acetylcholinesterase inhibitor that causes an increase in concentrations of acetylcholine, which in turn enhances cholinergic neurotransmission

            Absorption

            Peak plasma time (memantine ER): 18 hr (with food); 25 hr (fasting)

            Distribution

            Protein bound (memantine ER): 45%

            Vd (memantine ER): 9-11 L/kg

            Metabolism

            Memantine: Undergoes partial hepatic metabolism; CYP450 enzyme system does not play a significant role

            Elimination

            Half-life (memantine): 60-80 hr

            Excretion (memantine): Predominantly in urine (48% unchanged); renal clearance involves active tubular secretion moderated by pH dependent tubular reabsorption

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            Administration

            Oral Administration

            May take with or without food

            Capsules can be taken intact or may be opened, sprinkled on applesauce, and swallowed without chewing

            The entire contents of each capsule should be consumed; the dose should not be divided

            Except when opened and sprinkled on applesauce, the capsule should be swallowed capsule whole; do not divide, chew, or crush

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.