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Presentation

Tablets containing 10mg imipramine hydrochloride
Tablets containing 25mg imipramine hydrochloride
Oral solution containing 25mg/5ml imipramine hydrochloride

Drugs List

  • imipramine 10mg tablets
  • imipramine 25mg tablets
  • imipramine 25mg/5ml oral solution sugar-free
  • Therapeutic Indications

    Uses

    For the treatment of the symptoms of depressive illness

    For the relief of nocturnal enuresis in children

    Unlicensed Uses

    Attention deficit hyperactivity disorder in children (specialist supervision required)

    Dosage

    Adults

    Depression
    Initial dose: 25mg up to three times a day. Dose may be gradually increased up to 150mg to 200mg daily. Doses up to 150mg may be given as single dose at bedtime.
    The recommended maintenance dose is 50mg to 100mg a day, based on each individual patient response.

    Hospitalised patients may require daily doses of up to 300mg. This dose should be reached by the end of the first week of treatment and maintained until definite improvement has occurred.

    Elderly

    Depression
    Initial dose: 10mg a day. Doses may be increased gradually to 30mg to 50mg a day. The optimum dose should be achieved after about 10 days and then continued to the end of treatment.

    Cardiac function should be monitored in elderly patients.

    Children

    Nocturnal Enuresis
    Maximum dose should not exceed 75mg or 2.5mg/kg a day.
    Maximum period of treatment, including gradual withdrawal, should not exceed three months.
    Children aged 11 to 18 years (Bodyweight 35kg to 54kg)
    50mg to 75mg a day, just before bedtime.

    Children aged 8 to 11 years (Bodyweight 25kg to 35kg)
    25mg to 50mg a day, just before bedtime.

    Children aged 6 to 8 years (Bodyweight 20kg to 25kg)
    25mg a day, just before bedtime.

    Children under 6 years
    Not recommended

    If relapse should occur, full physical examination is required before further course.

    Attention Deficit Hyperactivity Disorder (Unlicensed)
    Children aged 6 to 18 years
    10mg to 30mg twice a day.

    Patients with Renal Impairment

    Use with caution in patients with severe renal disease.

    Patients with Hepatic Impairment

    Contraindicated in severe hepatic impairment.

    Monitor hepatic function in patients with mild to moderate hepatic impairment during treatment.

    Administration

    For oral administration

    Contraindications

    Severe hepatic impairment

    Recent myocardial infarction

    Atrioventricular block

    Cardiac arrhythmias

    Breastfeeding (see Lactation)

    Mania

    Porphyria

    Within 3 weeks of discontinuing treatment with an MAOI

    Children under 6 years of age

    Urinary retention

    Narrow angle glaucoma

    Precautions and Warnings

    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.

    Improvement in depression may take 2-4 weeks of treatment and so patients should be closely monitored during this period.

    Consider hyponatraemia in all patients developing symptoms such as drowsiness, confusion, or convulsions.

    Patients should be advised that treatment with imipramine may impair alertness and so they should avoid hazardous activities (such as driving) if affected.

    Where possible, imipramine should be discontinued several days before surgery. If this is not possible, caution should be observed as anaesthesia may increase the risk of hypotension and arrhythmias.

    Imipramine may cause anxiety and hyperexcitation in agitated patients and patients with schizophrenic symptoms.

    Imipramine may aggravate psychotic symptoms in schizophrenic patients.

    Imipramine may cause a shift toward mania in manic depressive patients: Consider to reduce the dosage or to withdrawn imipramine.

    Discontinue treatment with imipramine if severe neurological or psychiatric reactions occur.

    Monitor hepatic function and enzyme levels in patients with mild to moderate hepatic impairment.

    Severe renal disease

    Abrupt withdrawal should be avoided due to the risk of withdrawal symptoms.

    Elderly - Cardiac function should be monitored in elderly patients. Elderly patients may also require lower doses.

    Pregnancy (see Pregnancy)

    Use with caution in epilepsy and in patients predisposed to seizures as tricyclic antidepressants are known to lower the seizure threshold. The occurrence of seizures appears to be dose dependant.

    Concurrent electroconvulsive therapy - only under careful supervision.

    Tumours of the adrenal medulla (e.g. phaeochromocytoma, neuroblastoma) - hypertensive crises may be provoked.

    Patients with panic disorders may experience a paradoxical increase in anxiety during the initiation of therapy. This is most pronounced during the first few days of treatment and generally subsides within 2 weeks.

    Hyperthyroidism - aggravation of unwanted cardiac effects may occur.

    Monitor patients blood pressure before initiating therapy because those with hypotension or a labile circulation may be react to imipramine with a fall in blood pressure.

    Cardiovascular disease

    There have been isolated cases of changes in white blood cell counts with imipramine treatment, and so periodic blood cell counts and monitoring for symptoms such as fever and sore throat are called for, particularly during the first few months of treatment.

    Use with caution in patients with a history of raised intra-ocular pressure or urinary retention (e.g. prostatic hypertrophy) due to the anticholinergic effects of imipramine.

    Tricyclic antidepressants may cause paralytic ileus and so should be used with caution in patients with chronic constipation.

    Tricyclic antidepressants may cause decreased lacrimation and accumulation of mucoid secretions which may cause damage to the corneal epithelium in wearers of contact lenses.

    Patients receiving SSRIs or TCAs, mainly those aged 50 years or older - a review of epidemiological studies shows an increased risk of bone fractures in these patients. The mechanism leading to this increased risk is unclear.

    Behavioural disturbances may occur in children receiving treatment for nocturnal enuresis.

    Patients should be advised to avoid alcohol during treatment.

    Regular dental check-ups are advisable during long-term treatment since an increase in dental caries has been reported.

    The oral solution contains sorbitol and is therefore unsuitable for patients with hereditary fructose intolerance.

    Use in Porphyria

    Contraindicated in porphyria

    Pregnancy and Lactation

    Pregnancy

    Use with caution in pregnancy.

    There is no evidence of safety in human pregnancy. There have been isolated reports of a connections between the use of tricyclic antidepressants and adverse effects on the development of the foetus.

    Neonates whose mothers had taken imipramine up until delivery have developed withdrawal symptoms such as respiratory depression, agitation, dyspnoea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms during the first few hours or days.

    If possible, imipramine should be withdrawn gradually at least 7 weeks before the calculated date of confinement.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Contraindicated in breastfeeding.

    Imipramine is excreted in breast milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Effects on Ability to Drive and Operate Machinery

    Patients should be advised that treatment with imipramine may impair alertness and so they should avoid hazardous activities (such as driving) if affected.

    Counselling

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

    Advise patients that treatment with imipramine may impair alertness and so they should avoid hazardous activities (such as driving) if affected.

    Advise patients to avoid alcohol during treatment.

    Side Effects

    Fatigue
    Drowsiness
    Restlessness
    Delirium
    Confusion
    Disorientation
    Hallucinations
    Anxiety
    Agitation
    Sleep disturbances
    Mania
    Hypomania
    Psychosis
    Paranoid delusions
    Aggression
    Paraesthesia
    Headache
    Dizziness
    Seizures
    EEG changes
    Myoclonus
    Weakness
    Extrapyramidal effects
    Ataxia
    Speech disturbances
    Drug fever
    Sinus tachycardia
    ECG changes
    Arrhythmias
    Hypotension
    Postural hypotension
    Conduction disturbances
    Palpitations
    Increased blood pressure
    Cardiac decompensation
    Peripheral vasospastic reactions
    Dry mouth
    Constipation
    Sweating
    Disturbances in accommodation
    Blurred vision
    Hot flushes
    Micturition disorders
    Mydriasis
    Glaucoma
    Paralytic ileus
    Nausea
    Vomiting
    Anorexia
    Stomatitis
    Tongue ulceration
    Abdominal disorders
    Increase of liver transaminases
    Liver function disturbances
    Hepatitis
    Jaundice
    Allergic reaction
    Urticaria
    Rash
    Oedema
    Photosensitivity
    Pruritus
    Petechiae
    Hair loss
    Weight gain
    Changes in libido
    Disturbances of potency
    Enlarged mammary glands
    Galactorrhoea
    Inappropriate secretion of antidiuretic hormone
    Blood sugar changes
    Weight loss
    Hyponatraemia
    Allergic alveolitis
    Pneumonitis
    Eosinophilia
    Anaphylactic reaction
    Agranulocytosis
    Bone marrow depression
    Leucopenia
    Thrombocytopenia
    Tinnitus
    Withdrawal symptoms
    Suicidal tendencies
    Tremor
    Hyperpigmentation
    Ejaculation disorders
    Purpura
    Irritability
    Dysarthria
    Urinary retention
    Gynaecomastia
    Sexual dysfunction
    Increased appetite
    Taste disturbances
    Neuroleptic malignant syndrome
    Hypertension
    Increased risk of fractures

    Withdrawal Symptoms and Signs

    Withdrawal symptoms may occur after abrupt cessation of therapy and include, nausea, vomiting, abdominal pain, diarrhoea, headache, insomnia, nervousness, anxiety, irritability and excessive perspiration.

    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 ).

    Shelf Life and Storage

    Store below 25 degrees C
    Store in a dry place

    Further Information

    Last full review date: May 2012

    Reference Sources

    Summary of Product Characteristics: Imipramine tablets 10mg. Actavis UK Ltd. Revised June 2017.
    Summary of Product Characteristics: Imipramine tablets 25mg. Actavis UK Ltd. Revised June 2017.
    Summary of Product Characteristics: Imipramine oral solution 25mg/5ml. Rosemont Pharmaceuticals Ltd. Revised May 2017.

    MHRA 4th February 2008
    https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
    Last accessed: February 11, 2008

    MHRA Drug Safety Update May 2010
    https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON081863
    Last accessed: July 14, 2010

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 August 2017

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