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LOFEPRAMINE is a brand name for Lofepramine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The treatment of symptoms of depressive illness.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The usual dose is 70 mg twice daily (140 mg) or three times daily (210 mg) depending upon patient response. Elderly Elderly patients may respond to lower doses in some cases. Paediatric population Lofepramine is not recommended in children.
Method of administration For oral use.
The following side effects have been reported with lofepramine:
Blood and lymphatic system disorders: Rarely, bone marrow depression including isolated reports of: agranulocytosis, eosinophilia, granulocytopenia, leucopenia, pancytopenia, thrombocytopenia.
Endocrine disorders:
Rarely, inappropriate secretion of antidiuretic hormone leading to hyponatraemia.
Psychiatric disorders:
Sleep disturbances, agitation, confusion, nightmares, hallucinations, mania, psychoses, delirium; rarely, hypomania.
Nervous system disorders:
Dizziness, headache, paraesthesia, tremor; rarely, drowsiness, convulsions, impairment of sense of taste; very rarely, uncoordinated movement.
Eye disorders:
Visual disturbances including blurred vision, mydriasis, disturbances of accommodation, induction of glaucoma.
Ear and labyrinth disorders:
Very rarely, tinnitus.
Cardiac disorders:
Tachycardia, cardiac conduction disorders, increase in cardiac insufficiency, QT- prolongation, arrhythmias (including ventricular arrhythmias or Torsades de Pointes).
Vascular:
Hypotension.
Gastrointestinal disorders:
Gastrointestinal disturbance including nausea, vomiting, diarrhoea, constipation, dryness of mouth.
Suicide/suicidal thoughts or clinical worsening 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 suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
It should be remembered that severely depressed patients are at risk of suicide. An improvement in depression may not occur immediately upon initiation of treatment; therefore the patient should be closely monitored until symptoms improve.
Other warnings and precautions Lofepramine may lower the convulsion threshold, it should therefore be used with extreme caution in patients with a history of epilepsy or recent convulsions or other predisposing factors, or during withdrawal from alcohol or other drugs with anticonvulsant properties.
1 or dibenzazepines. 5). Lofepramine must not be administered in patients with acute alcoholic, hypnotic, analgesic and psychotropic drug poisoning and acute deliria. 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatobiliary disorders:
Increases in liver enzymes, sometimes progressing to clinical hepatitis and jaundice, have been reported in some patients, usually occurring within the first 3 months of starting therapy.
Skin and subcutaneous tissue disorders:
Skin rash, allergic skin reactions, photosensitivity reactions; rarely, cutaneous bleeding, sweating.
Renal and urinary disorders:
Urinary hesitancy, urinary retention. g. testicular pain); rarely, interference with sexual function, gynaecomastia, galactorrhoea.
General disorders and administration site conditions:
Malaise, facial oedema; rarely, inflammation of mucosal membranes.
Investigations:
Rarely, changes of blood sugar level. The following adverse effects have been encountered in patients under treatment with tricyclic antidepressants and should therefore be considered as theoretical hazards of lofepramine even in the absence of substantiation: psychotic manifestations, including mania and paranoid delusions may be exacerbated during treatment with tricyclic antidepressants.
4). It should be remembered that severely depressed patients are at risk of suicide until there is a complete remission of symptomatology. Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.
The mechanism leading to this risk is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Concurrent electroconvulsive therapy should only be undertaken with careful supervision. Caution is needed in patients with hyperthyroidism, or during concomitant treatment with thyroid preparations, since aggravation of unwanted cardiac effects may occur.
Lofepramine should be used with caution in patients with cardiovascular disease, because it is associated with a risk of cardiovascular adverse reactions in all age groups. Lofepramine should be used with caution in patients with impaired liver function, impaired renal function, blood dyscrasias or porphyria.
Caution is called for where there is a history of prostatic hypertrophy, narrow angle glaucoma or increased intra-ocular pressure, because of lofepramine’s anticholinergic properties. In patients with narrow angle glaucoma, lofepramine may only be used if adequate glaucoma treatment is given.
3). g. phaeochromocytoma, neuroblastoma) in whom tricyclic antidepressants may provoke antihypertensive crises. Blood pressure should be checked before initiating treatment because individuals with hypertension, or an unstable circulation, may react to lofepramine with a fall in blood pressure.
5), therefore before local or general anaesthesia the anaesthetist should be informed that the patient has been taking lofepramine. Lofepramine should be used with caution where there is a history of mania. Psychotic symptoms may be aggravated.
There have also been reports of hypomania or manic episodes during a depressive phase in patients with cyclic affective disorders receiving antidepressants. It is recommended that abrupt withdrawal of lofepramine be avoided unless essential, because withdrawal symptoms may occur on abrupt cessation of therapy.
Withdrawal symptoms may include insomnia, irritability and excessive perspiration. Lofepramine can prolong the QT-interval in the ECG and may lead to Torsades de Pointes. Lofepramine may only be used with particular caution when other risk factors for Torsades de Pointes are present, such as: • congenital long QT syndrome • other clinically significant cardiac disorders • parallel treatment with medicinal products, • patients with a family history of QT prolongation which also prolong the QT interval in the ECG or can cause hypokalaemia.
If Torsades de Pointes occur the treatment with lofepramine has to be stopped. Overall, lofepramine has a low risk to induce a QT interval prolongation at therapeutic doses. g. g. fluoxetine, sertraline, paroxetine) may increase the plasma concentrations of lofepramine.
Therefore, concomitant use of these drugs might have an impact on the QT interval. 8). Monitoring of full blood count should be considered before start of treatment and periodically during treatment, particularly in patients with a history of blood dyscrasias.
The film-coated tablets contain ponceau 4R (E124), which may cause allergic reactions. These tablets also contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.