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IMIPRAMINE is a brand name for Imipramine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of depressive illness in adults. For the treatment of nocturnal enuresis in children.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
In depressive illness, initially 75 mg daily given in divided doses and increased gradually to 150-200 mg daily. This dose to be reached by the end of the first week of treatment. Once improvement has occurred a maintenance dose should be calculated, on an individual basis and the dose gradually reduced (normally to approx.
50 – 100 mg daily). For hospitalized patients the dose can be increased to 100 mg three times daily, until significant improvement occurs. Again a maintenance dose should then be calculated, on an individual basis and the dose reduced (normally to approx.
100 mg daily).
Special populations:
Elderly: Patients over 60 years of age may be responsive to lower doses than those detailed above. Initially 10 mg daily and gradually increasing the dose to 30 – 50 mg daily. This dose should be reached approximately 10 days after starting treatment and continued for the length of treatment.
3). 6-7 years (weight 20-25 kg or 44-55 lbs): 25 mg at bedtime. 8-11 years (weight 25-35 kg or 55-77 lbs): 25 – 50 mg at bedtime. 11 years and over (weight 35-45 kg or 77-119 lbs): 50 – 75 mg at bedtime. 5 mg/kg. Treatment should not exceed three months and the dose should be gradually withdrawn.
Should a relapse occur, no further treatment with imipramine should be started until a full physical examination has been made. Method of administration For oral administration.
Imipramine should be withdrawn if severe neurological and psychiatric reactions occur. Elderly patients are particularly sensitive to the anticholinergic, cardiovascular, neurological or psychiatric effects. Their ability to metabolise and eliminate drugs may be reduced, leading to a risk of elevated plasma concentrations at therapeutic doses.
The following undesirable effects have been reported with tricyclic antidepressant drugs, not necessarily reported with imipramine: Very common (≥1/10), common (≥1/100 - <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 - <1/100), very rare (<1/10,000), frequency not known (cannot be estimated from the available data): Blood and the lymphatic system disorders: Very rarely: agranulocytosis, bone marrow depression including eosinophilia, leucopenia and thrombocytopenia have been reported.
It is advisable to perform blood counts during treatment with tri/tetracyclic antidepressants, especially if the patient develops fever, sore throat or other signs of infection. 4) Endrocrine disorders: Very common: weight gain. Common: changes to libido & potency.
Very rarely: enlarged mammary glands, galactorrhoea, increase/decrease in blood sugar, SIADH (syndrome of inappropriate antidiuretic hormone secretion) and weight loss. 4).
Psychiatric disorders:
Common: fatigue, drowsiness, sleep disturbance, increased anxiety, restlessness/agitation, delirium, confusion, swings from depression to hypomania/mania, disorientation and hallucinations (mainly in geriatric patients or those suffering from Parkinson’s disease).
Rarely psychotic symptoms have been activated. Very rarely aggressiveness. Paranoid delusion may be exacerbated during treatment with tricyclic antidepressants. These are more frequently seen in elderly patients or those on high doses.
Improvement in depression may not occur during the first two to four weeks of treatment and hence patients should be closely monitored during this period. Hyponatraemia (usually in the elderly) has been associated with all types of antidepressants and should be considered in all patients who develop symptoms such as drowsiness, confusion or convulsions.
As tricyclic antidepressants are known to lower the convulsion threshold, imipramine should be used with extreme caution in patients with epilepsy and other predisposing factors eg. brain damage of varying aetiology, concomitant use of neuroleptics, withdrawal from alcohol or drugs with anti-convulsive properties (eg benzodiazepines).
Occurrence of seizures appears to be dose dependant. Concomitant treatment with imipramine and electro-convulsive therapy should only be resorted to under careful supervision. Caution is required when giving tricyclic antidepressants to: • patients with severe renal disease.
g. phaeochromocytoma, neuroblastoma), as hypertensive crisis may be provoked. • patients with hyperthyroidism or during concomitant treatment with thyroid preparations as aggravation of unwanted cardiac effects may occur. Many patients with panic disorders experience intensified anxiety symptoms at the start of treatment with antidepressants.
This paradoxical initial increase in anxiety is most pronounced during the first few days of treatment and generally subsides within 2 weeks. Before starting treatment it is advisable to check the patient’s blood pressure because patients with hypotension or a labile circulation may react to the drug with a fall in blood pressure.
Although changes in the white blood cell count have been reported with imipramine only in isolated cases, periodic blood cell counts and monitoring for symptoms such as fever and sore throat are called for, particularly during the first few months of therapy.
1 • Cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group • Children under 6 years of age • Concurrent use in patients receiving or within 3 weeks of stopping treatment with MAO inhibitors • Concomitant treatment with selective, reversible MAO-A inhibitors such as moclobemide.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4).
Nervous system disorders:
Very common: tremor. Common: dizziness, headache and paraesthesiae. Rarely epileptic seizures. Very rarely ataxia, drug fever, EEG changes, extrapyramidal symptoms, myoclonus, problems with speech and weakness.
Ear and labyrinth disorders:
Tinnitus has been reported.
Cardiac disorders:
Very common: sinus tachycardia and clinically irrelevant ECG changes (T and ST changes) in patients with normal cardiac status, postural hypotension. Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage.
They may also occur in patients with pre- existing heart disease taking normal dosage. Common: arrhythmias, conduction disorders (widening of QRS complex and PR interval, bundle-branch block) and palpitations. Very rarely increases in blood pressure, cardiac decompensation and peripheral vasospastic reactions.
Gastrointestinal disorders:
Common: anorexia, nausea, vomiting. Very rarely abdominal disorders, tongue lesions and stomatitis.
Hepato-biliary disorders:
Common: elevated transaminases. Rarely impaired liver function. Very rarely hepatitis (with or without jaundice).
Skin and subcutaneous tissue disorders:
Common: allergic skin reactions such as rash and urticaria. Very rarely oedema (local or generalised), hair loss, photosensitivity, pruritus and petechiae.
Hypersensitivity:
Very rarely allergic alveolitis (pneumonitis) with or without eosinophilia, systemic anaphylactic/anaphylactoid reactions including hypotension.
Anticholinergic effects:
Very commonly (due the anticholinergic action of tricyclic antidepressant drugs) may cause constipation, dry mouth, sweating, hot flushes, blurred vision or disorders of visual accommodation. Commonly micturition disturbances. Very rarely glaucoma, mydriasis and paralytic ileus.
4). Respiratory depression, agitation and withdrawal symptoms have been reported in neonates whose mothers received imipramine during the last trimester of pregnancy. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
8). Periodic monitoring of hepatic enzyme levels is recommended in those with liver disease. Monitoring of cardiac function is indicated in elderly patients. g. diseases of the prostate). Caution is required in patients with chronic constipation.
Tricyclic antidepressants may cause paralytic ileus (especially in elderly or bedridden patients). Before general or local anaesthesia, the anaesthetist should be aware that the patient has been receiving imipramine. Anaesthetics given during tri/tetracyclic anti-depressants therapy may increase the risk of arrhythmias and hypotension.
5). An increase in dental caries has been reported during long-term treatment with tricyclic antidepressants. Regular dental check-ups are therefore advisable during long-term treatment. Decreased lacrimation and accumulation of mucoid secretions due to the anticholinergic properties of tricyclic antidepressants may cause damage to the corneal epithelium in patients with contact lenses Imipramine may cause anxiety, feelings of unrest and hyperexcitation in agitated patients and patients with accompanying schizophrenic symptoms.
Activation of psychosis has been observed occasionally in schizophrenic patients receiving tricyclic antidepressants. Hypomanic or manic episodes have also been reported during a depressive phase in patients with cyclic affective disorders receiving treatment with a tricyclic antidepressant.
In such cases it may be necessary to reduce the dosage of imipramine or to withdraw it and administer an antipsychotic agent. After such episodes have subsided, low dose therapy with imipramine may be resumed if required. In predisposed and elderly patients, imipramine may, particularly at night, provoke pharmacogenic (delirious) psychoses, which disappear without treatment within a few days of withdrawing the drug.
Agitation, confusion and postural hypotension may occur. Abrupt withdrawal of this drug should be avoided because of possible adverse Reactions. 8). Behavioural disturbances may occur in children receiving treatment with imipramine for the treatment of nocturnal enuresis Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of 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 anti- depressants 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.
5). If concomitant treatment with buprenorphine containing medicinal products is clinically warranted, careful observation of […]