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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: Adults For the treatment of depressive illness. Children and adolescents: For the treatment of nocturnal enuresis in children over 6 years.
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).
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, 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 Treatment should not exceed three months and the dose should be gradually withdrawn.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.
Treatment with imipramine should be withdrawn if severe neurological and psychiatric reactions occur. Elderly patients are particularly sensitive to the anticholinergic, neurological, psychiatric and cardiovascular 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. The adverse reactions are presented according to the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).
Blood and the lymphatic system disorders:
Very rare: bone marrow depression including eosinophilia, with leucopenia, agranulocytosis, thrombocytopenia. 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).
Immune system disorders:
Very rare: allergic alveolitis (pneumonitis) with or without eosinophilia, systemic anaphylactic/anaphylactoid reactions including hypotension.
Endocrine disorders:
Very common: weight gain. Common: changes to libido & potency. Very rare: 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, confusion, delirium, swings from depression to hypomania/mania, hallucinations and disorientation (mainly in geriatric patients or those suffering from Parkinson’s disease).
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.
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 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.
Other psychiatric effects Many patients with panic disorders experience intensified anxiety symptoms at the start of treatment with tricyclic antidepressants. This paradoxical initial increase in anxiety is most pronounced during the first few days of treatment, usually subsiding within two weeks.
1 • Cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group. • 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.
• Patients with any degree of heart block or other cardiac arrhythmias; recent myocardial infarction. • Mania • Severe liver disease • Porphyria. • Narrow angle glaucoma • Urine retention • Children under 6 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rare: psychotic symptoms have been activated. Very rare: aggressiveness.
Not known:
Paranoid delusion may be exacerbated during treatment with tricyclic antidepressants. These are more frequently seen in elderly patients or those on high doses. 4).
Nervous system disorders:
Very common: tremor. Common: dizziness, headache and paresthesias. Rare: epileptic seizures. Very rare: ataxia, drug fever, EEG changes, extrapyramidal symptoms, myoclonus, problems with speech and weakness.
Eye disorders:
Very common: blurred vision, disorders of visual accommodation. Very rare: glaucoma, mydriasis.
Ear and labyrinth disorders:
Not knowns: tinnitus.
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 the QRS complex, and PR interval, bundle-branch block) and palpitations. Very rare: increases in blood pressure, cardiac decompensation and peripheral vasospastic reactions.
Vascular disorders:
Very common: hot flushes.
Gastrointestinal disorders:
Very common: dry mouth, constipation. Common: anorexia, nausea, vomiting. Very rare: paralytic ileus, stomatitis, tongue lesions, abdominal disorders.
Hepato-biliary disorders:
Common: elevated transaminases Rare: impaired liver function. Very rare: hepatitis (with or without jaundice).
Skin and subcutaneous tissue disorders:
Very common: sweating. Common: allergic reactions such as skin rash and urticaria. Very rare: oedema (local or generalised), petechiae, pruritus, photosensitivity, alopecia.
Renal and urinary disorders:
Common: disturbances of micturition. 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 data, particularly from studies conducted in patients 50 years and over, show an increased risk of bone fractures in patients taking selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants. The mechanism underlying this risk is still 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.
Activation of psychosis has occasionally been observed in schizophrenic patients taking tricyclic antidepressants. Hypomanic and 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 or elderly patients, tricyclic antidepressants can cause pharmacogenic (delirious) psychoses, particularly at night which disappear without treatment within a few days of withdrawing the drug.
Imipramine may cause anxiety, feelings of unrest and hyperexcitation in agitated patients and patients with accompanying schizophrenic symptoms. Behavioural disturbances may occur in children receiving treatment with imipramine for the treatment of nocturnal enuresis.
Monitoring of cardiac function is indicated in the elderly. Before starting treatment with Imipramine, it is advisable to check the patients’ blood pressure, as patients with hypotension or a labile circulation may react to the drug with a fall in blood pressure.
5). If concomitant treatment with buprenorphine containing medicinal products is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. g. g. benzodiazepines). Occurrence of seizures appears to be dose dependant. As with related tricyclic antidepressants, concomitant treatment of imipramine and electroconvulsive therapy should only be resorted to under careful supervision.
g. prostate disease). Decreased lacrimation (tear production) 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.
g. phaeochromocytoma, neuroblastoma), as hypertensive crisis may be provoked. - hyperthyroidism or during concomitant treatment with thyroid preparations which may aggravate unwanted cardiac effects. Periodic monitoring of liver enzyme levels is recommended in individuals with liver disease.
Caution is needed in patients with chronic constipation. Tricyclic antidepressants can cause paralytic ileus especially in elderly or bedridden patients. An increase in the number of dental caries has been reported during long-term treatment with tricyclic antidepressants.
It is therefore recommended to carry out regular dental checks during long-term therapy. Monitoring of cardiac function is indicated in elderly patients. White blood cell count Although changes in the white blood cell count have been reported with […]