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Mianserin oral

Presentation

Oral formulations of mianserin hydrochloride

Drugs List

  • mianserin 10mg tablets
  • mianserin 30mg tablets
  • Therapeutic Indications

    Uses

    Symptoms of depressive illness especially if sedation required

    Dosage

    It is often advantageous to maintain antidepressant treatment for several months after clinical improvement is seen. To ensure optimal antidepressant effect, dosage of mianserin should not be reduced.

    Adults

    For adults under 65

    Initially 30 to 40 mg daily, in divided doses or as a single dose at bedtime. This dose can be gradually increased as necessary. The usual daily dosage is within the range 30 to 90 mg. The manufacturer states that divided doses up to 200 mg are well tolerated.

    For adults over 65

    The use of mianserin is restricted to those who do not respond to other antidepressant drugs. Patients with narrow angle glaucoma or prostatic disorders should be monitored due to possible anticholinergic side effects. The manufacturer states that anticholinergic side effects are not anticipated with mianserin therapy.

    The initial dose should not be more than 30 mg daily. Any further increases should be performed under close supervision.

    A single night time dose should be preferable to the divided dose in older people. A lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response.

    Contraindications

    Children under 18 years
    Within 2 weeks of discontinuing MAOIs
    Breastfeeding
    Mania
    Pregnancy
    Severe hepatic impairment

    Precautions and Warnings

    Anaesthesia
    Patients over 65 years
    Suicidal ideation
    Atrioventricular block
    Bipolar disorder
    Cardiac arrhythmias
    Diabetes mellitus
    Hepatic impairment
    Narrow angle glaucoma
    Phaeochromocytoma
    Porphyria
    Prostate disorder
    Recent myocardial infarction
    Renal impairment
    Seizures

    Patients at risk of suicide should be closely supervised
    Advise patient drowsiness may affect ability to drive or operate machinery
    Full blood count recommended every 4 weeks during first 3 months
    Monitor for depressive disorders/suicidal ideation-consider discontinuation
    Monitor for mental changes, suicidal depression and antisocial behaviour
    Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
    Monitor patient initially- response may take 2 or more weeks
    Advise patient to report any new or worsening depression/suicidal ideation
    Advise patients/carers to seek medical advice if suicidal intent develops
    Consider hyponatraemia in all patients with drowsiness/confusion/seizures
    Patient should report worrying psychological changes esp. suicidal thoughts
    Discontinue at first signs of jaundice
    Discontinue if blood dyscrasia develops
    Discontinue if convulsions occur
    Discontinue if patient enters a manic phase
    Advise patient concurrent alcohol will increase drowsiness

    Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.

    Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

    Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.

    Pregnancy and Lactation

    Pregnancy

    Mianserin is contraindicated during pregnancy.

    Use of mianserin during pregnancy is contraindicated by the manufacturer.

    At the time of writing, there is insufficient data available to assess the safety of mianserin in pregnant women.

    Animal studies have not shown mianserin to be a hazard.

    Lactation

    Mianserin is contraindicated during breastfeeding.

    The manufacturer advises that breastfeeding should be discontinued if treatment with mianserin is considered essential.

    A study on two breastfeeding women has found that mianserin can be excreted in breast milk (Schaefer 2015).

    When drug treatment for depression is urgently needed, monotherapy with amitriptyline, clomipramine, nortriptyline, imipramine, desipramine or dosulepin is the treatment of choice during breastfeeding (Schaefer 2007).

    Side Effects

    Agranulocytosis
    Aplastic anaemia
    Arthralgia
    Arthritis
    Blood dyscrasias
    Bone marrow depression
    Convulsions
    Dizziness
    Granulocytopenia
    Gynaecomastia
    Hypomania
    Hyponatraemia
    Jaundice
    Leucopenia
    Liver function disturbances
    Mania
    Nipple discomfort
    Non-puerperal lactation
    Oedema
    Paranoid delusions
    Polyarthropathy
    Postural hypotension
    Psychotic disorder
    Rash
    Suicidal tendencies
    Sweating
    Tremor

    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: November 2019

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Mianserin tablets 10mg. Generics UK Ltd. Revised May 2017.
    Summary of Product Characteristics: Mianserin tablets 30mg. Generics UK Ltd. Revised January 2014.

    MHRA 4th February 2008
    https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
    Last accessed: July 25, 2013

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