Memorex

Each 10-mg tablet contains Memantine HCl 10 mg (equivalent to Memorex 8.31 mg). It also contains the following excipients: Tablet Core: Croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate. Tablet Coat: Hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172).

Each tablet contains Memantine HCl 20 mg (equivalent to Memorex 16.62 mg). It also contains the following excipients: Tablet Core: Microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. Tablet Coat: Hypromellose, macrogol 400, titanium dioxide (E171), yellow and red iron oxide (E172).

Each activation of the pump (1 downward stroke) delivers 0.5 mL (0.5 g) of solution containing Memorex HCl 5 mg equivalent to Memorex 4.16 mg.

Each g of solution also contains sorbitol (E420) 100 mg and potassium 0.5 mg as excipients.

Memorex is used for the treatment of moderate to severe dementia of the Alzheimer’s type. Dementia can be categorized into three levels of severity. Mild: Patients are alert and sociable, but forgetfulness begins to interfere with daily living. Moderate: This is often the longest stage of the disease with deterioration of intellect, logic, behavior, and function. Severe: Loss of long-term memory and language skills. Patients may require 24-hour care and can no longer complete basic self-care tasks including washing, eating, and using the bathroom.

Treating moderate to severe Alzheimer-type dementia. It may also be used for other conditions as determined by your doctor.

Memorex extended-release capsules is an N-methyl-D-aspartate (NMDA)-receptor antagonist. It works by blocking excess activity of a substance in the brain called glutamate, which may reduce the symptoms associated with Alzheimer disease. Memorex extended-release capsules is not a cure for Alzheimer disease.

Recommended Dosing

The dosage of Memorex shown to be effective in a controlled clinical trial is 28 mg once daily.

The recommended starting dose of Memorex is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week, and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.

Memorex can be taken with or without food. Memorex capsules can be taken intact or may be opened, sprinkled on applesauce, and thereby swallowed. The entire contents of each Memorex capsule should be consumed; the dose should not be divided.

Except when opened and sprinkled on applesauce, as described above, Memorex should be swallowed whole. Memorex capsules should not be divided, chewed, or crushed.

Switching from NAMENDA Tablets to Memorex Capsules:

Patients treated with NAMENDA tablets may be switched to Memorex capsules as follows:

It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to Memorex 28 mg once daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.

In a patient with severe renal impairment, it is recommended that a patient who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to Memorex 14 mg once daily capsules the day following the last dose of a 5 mg NAMENDA tablet.

Special Populations:

Hepatic Impairment

No dosage adjustment is recommended in patients with mild or moderate hepatic impairment. Memorex should be administered with caution to patients with severe hepatic impairment.

Renal Impairment

No dosage adjustment is recommended in patients with mild or moderate renal impairment.

A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min, based on the Cockroft-Gault equation).

See also:
What is the most important information I should know about Memorex?

Before using Memorex, tell your doctor if you are allergic to any drugs, or if you have a seizure disorder, cataracts, liver or kidney disease, or a bladder or kidney infection.

Memorex can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Use Memorex extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Memorex extended-release capsules. Talk to your pharmacist if you have questions about this information.
• Take Memorex extended-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Memorex extended-release capsules whole. Do not break, crush, or chew before swallowing.
• Do not take any capsules that do not look normal or are damaged.
• If you cannot swallow Memorex extended-release capsules whole, the capsule may be opened and the contents sprinkled on applesauce. Swallow the entire mixture right away. Do not store the mixture for use at a later time.
• If you miss a dose of Memorex extended-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss several doses of Memorex extended-release capsules, check with your doctor before you take another dose.

Ask your health care provider any questions you may have about how to use Memorex extended-release capsules.

Memorex is used to treat moderate to severe confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by blocking the action of a certain natural substance in the brain (glutamate) that is believed to be linked to symptoms of Alzheimer's disease.

How to use Memorex

Read the Patient Information Leaflet if available from your pharmacist before you start taking Memorex and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. If you have trouble swallowing the capsules whole, the capsule may be opened and the contents may be sprinkled on applesauce. Swallow all of the drug/food mixture right away without chewing. Do not prepare a supply in advance.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

If switching from another form of Memorex to the extended-release form, follow your doctor's instructions carefully. Do not switch forms of Memorex without talking to your doctor first.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition worsens.

See also:
What other drugs will affect Memorex?

Due to the pharmacological effects and the mechanism of action of Memorex, the following interactions may occur: The mode of action suggests that the effects of L-dopa, dopaminergic agonists and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists eg, Memorex. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of Memorex with the antispasmodic agents, dantrolene or baclofen, can modify their effects, and a dosage adjustment may be necessary.

Concomitant use of Memorex and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis. Both compounds are chemically related NMDA-antagonists. The same may be true for ketamine and dextromethorphan. There is one published case report on a possible risk also for the combination of Memorex and phenytoin.

Other drugs eg, cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with Memorex leading to a potential risk of increased plasma levels.

There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when Memorex is co-administered with HCT or any combination with HCT.

In post-marketing experience, isolated cases with international normalized ration (INR) increases have been reported in patients concomitantly treated with warfarin. Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.

In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant effect of Memorex on the pharmacokinetics of galantamine was observed.

In a clinical study in young healthy subjects, no relevant effect of Memorex on the pharmacokinetics of galantamine was observed.

Memorex did not inhibit CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase and sulphation in vitro.

Incompatibilities: Not applicable.

See also:
What are the possible side effects of Memorex?

Clinical Trials Experience

Memorex was evaluated in a double-blind placebo-controlled trial in which a total of 676 patients with moderate to severe dementia of the Alzheimer's type (341 patients on Memorex 28 mg/day and 335 patients on placebo) were treated for up to 24 weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions Leading to Discontinuation

In the placebo-controlled clinical trial of Memorex, the proportion of patients in the Memorex group and the placebo group who discontinued treatment due to adverse reactions was 10% and 6%, respectively. The most common adverse reaction that led to treatment discontinuation in the Memorex group was dizziness, at a rate of 1.5%.

Most Common Adverse Reactions

The most commonly observed adverse reactions seen in patients administered Memorex in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the Memorex group and at a frequency higher than placebo, were headache, diarrhea and dizziness.

Table 1 lists adverse reactions that were observed at an incidence of ≥ 2% in the Memorex group and occurred at a rate greater than placebo.

Table 1: Adverse reactions observed with a frequency of ≥ 2% in the Memorex group and at a rate greater than placebo

Seizure

Memorex has not been systematically evaluated in patients with a seizure disorder. In clinical trials of Memorex, seizures occurred in 0.3% of patients treated with Memorex and 0.6% of patients treated with placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Memorex.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include:

Blood and Lymphatic System Disorders: agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura.

Cardiac Disorders: cardiac failure congestive.

Gastrointestinal disorders: pancreatitis.

Hepatobiliary Disorders: hepatitis.

Psychiatric Disorders: suicidal ideation.

Renal and Urinary Disorders: acute renal failure (including increased creatinine and renal insufficiency).

Skin Disorders: Stevens Johnson syndrome.