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Memantine oral

Updated 2 Feb 2023 | Other anti-dementia drugs

Presentation

Oral formulations of memantine hydrochloride.

Drugs List

  • EBIXA 10mg tablets
  • EBIXA 20mg tablets
  • EBIXA 5mg/actuation oral solution
  • EBIXA INITIATION PACK tablets
  • MARIXINO 10mg tablets
  • MARIXINO 20mg tablets
  • memantine 10mg orodispersible tablets sugar-free
  • memantine 10mg soluble tablet sugar-free
  • memantine 10mg tablets
  • memantine 10mg/ml oral solution sugar-free
  • memantine 20mg orodispersible tablets sugar-free
  • memantine 20mg soluble tablet sugar-free
  • memantine 20mg tablets
  • memantine 5mg tablets and 10mg tablets and 15mg tablets and 20mg tablets
  • memantine 5mg and 10mg and 15mg and 20mg orodispersible sugar-free tablets
  • VALIOS 10mg orodispersible tablets sugar-free
  • VALIOS 20mg orodispersible tablets sugar-free
  • VALIOS INITIATION PACK 5mg and 10mg and 15mg and 20mg orodispersible tablets
  • Therapeutic Indications

    Uses

    Moderate to severe Alzheimer's disease

    Dosage

    Adults

    The maximum daily dose is 20mg per day. In order to reduce the risk of side effects the maintenance dose is achieved by upward titration of 5mg per week over the first 3 weeks as follows:

    Treatment should be started with 5mg daily (0.5ml equivalent to one pump actuation of oral solution) during the first week.
    In the second week 10mg daily (1ml equivalent to two pump actuations of oral solution) is recommended.
    In the third week 15mg daily (1.5ml equivalent to three pump actuations of oral solution) is recommended.
    From the fourth week on, treatment can be continued with the recommended maintenance dose of 20mg daily (2ml equivalent to four pump actuations of oral solution).

    Patients with Renal Impairment

    Creatinine clearance 30 to 49ml/minute
    10mg a day (1ml equivalent to two pump actuations of oral solution). After at least 7 days, if the dose is well tolerated, it can be titrated up to 20mg a day (2ml equivalent to four pump actuations of oral solution).

    Creatinine clearance 5 to 29ml/minute
    10mg a day (1ml equivalent to two pump actuations of oral solution).

    Additional Dosage Information

    0.5ml (equivalent to one pump actuation) oral solution contains 5mg memantine hydrochloride.

    Contraindications

    Children under 18 years
    Breastfeeding
    Renal impairment - creatinine clearance below 5ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Predisposition to epileptic disorder
    Restricted sodium intake
    Epileptic disorder
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    History of seizures
    Lactose intolerance
    Phenylketonuria
    Pregnancy
    Recent myocardial infarction
    Renal impairment - creatinine clearance 5-49 ml/minute
    Renal tubular acidosis
    Severe decompensated cardiac failure
    Uncontrolled hypertension
    Urinary tract infection

    Reduce dose in patients with creatinine clearance 5-29ml/minute
    Reduce dose initially in patients with creatinine clearance 30-49 ml/min
    Sodium content of effervescent preparation may be significant
    Some formulations contain aspartame - caution in phenylketonuria
    Advise ability to drive/operate machinery may be affected by side effects
    Do not start treatment unless a carer is available to monitor drug intake
    Treatment to be initiated and supervised by a specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Assess benefit within 3 months and evaluate continued need regularly
    Assess patient's tolerance to treatment
    Monitor patients with elevated urine pH
    Monitor prothrombin times closely in patients on anticoagulant therapy
    Discontinue if therapeutic effect is no longer present

    Some factors which may raise urine pH may necessitate careful monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivorous to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by states of renal tubular acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.

    Pregnancy and Lactation

    Pregnancy

    Use memantine with caution in pregnancy.

    The manufacturer does not recommend use of memantine during pregnancy unless clearly necessary. At the time of writing, there is limited published information regarding the use of memantine during pregnancy.

    Animal studies indicate a potential for reducing intrauterine growth at exposure levels which are identical or slightly higher than at human exposure. Memantine was not found to be teratogenic in rats and rabbits at maternally toxic doses. The potential risk for humans is unknown.

    Lactation

    Memantine is contraindicated in breastfeeding.

    It is not known whether memantine is excreted in human breast milk. At the time of writing there is limited published information regarding the use of memantine during breastfeeding. It is likely memantine is excreted into breast milk due to the lipophilicity.

    Counselling

    Advise patient that memantine should be taken once a day, at the same time each day.

    Advise patient that the oral drop solution should be discarded three months after first opening.

    Advise outpatients to take special care as moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery. Furthermore, memantine has minor or moderate influence on the ability to drive and operate machinery.

    Side Effects

    Altered liver function tests
    Cardiac failure
    Confusion
    Constipation
    Depression
    Dizziness
    Dyspnoea
    Fatigue
    Fungal infection
    Gait abnormality
    Hallucinations
    Headache
    Hepatitis
    Hypersensitivity reactions
    Hypertension
    Loss of balance
    Pancreatitis
    Psychotic reactions
    Seizures
    Somnolence
    Suicidal tendencies
    Thromboembolism
    Venous thrombosis
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: April 2018

    Reference Sources

    Summary of Product Characteristics: Alzhok 10mg Soluble Tablets. Glenmark Pharmaceuticals Europe Limited. Revised December 2016.
    Summary of Product Characteristics: Alzhok 20mg Soluble Tablets. Glenmark Pharmaceuticals Europe Limited. Revised December 2016.
    Summary of Product Characteristics: Alzhok 5mg+10mg+15mg+20mg Soluble Tablets. Glenmark Pharmaceuticals Europe Limited. Revised January 2018.

    Summary of Product Characteristics: Ebixa 5mg/pump actuation oral solution, 20mg and 10mg tablets and treatment initiation pack. Lundbeck Ltd. Revised October 2016.

    Summary of Product Characteristics: Memantine 10mg soluble tablets. Zentiva. Revised July 2021.
    Summary of Product Characteristics: Memantine 20mg soluble tablets. Zentiva. Revised July 2021.

    Summary of Product Characteristics: Nemdatine 10mg tablets. Actavis UK Ltd. Revised July 2015.
    Summary of Product Characteristics: Nemdatine 20mg tablets. Actavis UK Ltd. Revised July 2016.
    Summary of Product Characteristics: Nemdatine tablets treatment initiation pack. Actavis UK Ltd. Revised July 2015.

    Summary of Product Characteristics: Valios 10mg and 20mg orodispersible tablets. Dr Reddys Laboratories (UK) Ltd. Revised July 2015.

    Summary of Product Characteristics: Valios 5mg/ 10mg/15mg/20mg orodispersible tablets (initiation pack). Dr Reddys Laboratories (UK) Ltd. Revised July 2015.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 January 2022

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