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Lofepramine oral


Oral formulations containing lofepramine

Drugs List

  • lofepramine 70mg tablets
  • lofepramine 70mg/5ml suspension sugar-free
  • Therapeutic Indications


    Depressive illness



    The usual dosage is 70 mg twice daily (140 mg) or three times daily (210 mg) depending upon the patient response.


    (See Dosage; Adult)
    Elderly patients may respond to lower doses in some cases.

    Patients with Renal Impairment

    The manufacturer contraindicates use in severe renal impairment, but the Renal Drug Handbook states the following:
    GFR less than 10 ml/minute - start with a small dose and titrate slowly
    GFR more than 10 ml/minute - dose as in normal renal function.


    Acute alcohol intoxication
    Children under 18 years
    Drug intoxication
    Risk of paralytic ileus
    Within 2 weeks of discontinuing MAOIs
    Within 2 weeks of discontinuing selegiline
    Acute porphyria
    Atrioventricular block
    Cardiac arrhythmias
    Delirium tremens
    Long QT syndrome
    Recent myocardial infarction
    Severe hepatic impairment
    Torsade de pointes
    Uncontrolled narrow angle glaucoma

    Precautions and Warnings

    Electroconvulsive therapy
    Family history of long QT syndrome
    Recent seizure
    Suicidal ideation
    Alcohol withdrawal syndrome
    Benign prostatic hyperplasia
    Cardiac disorder
    Cardiovascular disorder
    Chronic constipation
    Congenital long QT syndrome
    Diabetes mellitus
    Electrolyte imbalance
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    Hereditary fructose intolerance
    History of mania
    History of torsade de pointes
    Lactose intolerance
    Narrow angle glaucoma
    Renal impairment
    Urinary retention

    Correct electrolyte disorders before treatment
    Patients at risk of suicide should be closely supervised
    Advise impaired alertness may affect ability to drive or operate machinery
    May reduce seizure threshold
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Some formulations may contain alcohol
    Monitor blood pressure before starting treatment
    Perform full blood count before treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor blood pressure in hypertensive patients
    Monitor full blood count regularly
    Monitor serum electrolytes
    Advise patients/carers to seek medical advice if suicidal intent develops
    Consider hyponatraemia in all patients with drowsiness/confusion/seizures
    Increased risk of fractures in patients over 50 years
    Life threatening arrhythmias may occur during anaesthesia and surgery
    May cause activation of latent psychosis
    Do not withdraw this drug suddenly
    Dosage reduction should be done gradually over about 4 weeks
    Discontinue if patient enters a manic phase
    Discontinue if Torsade de Pointes should occur during treatment
    Consider reducing initial dose in the elderly
    Advise patient not to take St John's wort concurrently
    Advise patient that the effects of alcohol may be potentiated
    Advise patient to avoid alcohol during treatment

    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 antidepressants may increase the risk of suicidal thoughts and self harm in children and adolescents.

    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


    Use lofepramine with caution in pregnancy.

    The manufacturers advise that lofepramine should not be used during pregnancy unless there are compelling medical reasons to do so.

    At the time of writing, there are no or very limited data available on the use of lofepramine guidance has been derived from the general knowledge on tricyclic antidepressants:

    Maternal exposure to tricyclic antidepressants may be associated with risks for spontaneous abortions, preterm births and low birth weights. Also, gestational orthostatic hypotension may be exacerbated.

    Schaefer recommends monitoring of maternal serum levels, due to altered pharmacokinetics during pregnancy, especially in the second and third trimesters.

    Tricyclic antidepressants used during pregnancy may also elicit adverse reactions in the neonate: withdrawal symptoms, respiratory depression, irritability, myoclonus and convulsions have been reported.

    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 to 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 ( ) or if this is unavailable at the backup site ( ).


    Use lofepramine with caution in breastfeeding.

    Lofepramine is excreted into breast milk. The manufacturers advise against using lofepramine during breastfeeding.

    At the time of writing, there is highly limited data describing the use of lofepramine during breastfeeding.

    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

    Side Effects

    Allergic skin reactions
    Behavioural disturbances
    Blood sugar changes
    Blurred vision
    Bone marrow depression
    Cardiac conduction disturbances
    Cardiac insufficiency
    Cutaneous bleeding disorders
    Dermatological and photosensitivity reactions
    Disturbances in accommodation
    Dry mouth
    ECG changes
    Exacerbation of psychoses
    Extrapyramidal effects
    Facial oedema
    Hepatic impairment
    Impaired co-ordination
    Inappropriate secretion of antidiuretic hormone
    Increased appetite
    Increased risk of fractures
    Increases in hepatic enzymes
    Mucosal inflammation
    Neuroleptic malignant syndrome
    Paralytic ileus
    Peripheral neuropathy
    Postural hypotension
    Prolongation of QT interval
    Sexual dysfunction
    Sleep disturbances
    Suicidal tendencies
    Testicular disorders
    Urinary hesitancy
    Urinary retention
    Visual disturbances
    Weight gain
    Weight loss
    Withdrawal symptoms


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2016

    Reference Sources

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

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 09 November 2016.

    Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Lofepramine Oral Suspension 70mg/5ml. Rosemont Pharmaceuticals Ltd. Revised January 2016.

    Summary of Product Characteristics: Lofepramine 70 mg tablets. Merck Sorono. Revised November 2010.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    MHRA 4th February 2008
    Accessed 11th February 2008

    MHRA Drug Safety Update May 2010
    Last accessed: 14th July 2010

    Antenatal and postnatal mental health. Clinical management and service guidance (Dated April 2007, review of new evidence: 2 years after this date).
    Available at
    Accessed 09 November 2016

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