IMIPRAMINE is a brand name for Imipramine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1. Treatment of depressive illness 2. Treatment of nocturnal enuresis in children
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults: 1 x 25mg up to three times daily, increasing stepwise to 150-200mg. This should be reached by the end of the first week and maintained until definite improvement has occurred. The subsequent maintenance dose should be individually determined by gradually reducing the dosage, usually to about 50-100mg daily.
e. severe cases, the dose may be increased to 100mg three times daily until a distinct improvement is seen. Again, the subsequent maintenance dose should be determined individually by reducing the dosage, usually to about 100mg daily.
Elderly:
Patients over 60 years may respond to lower doses of imipramine than those recommended above. Treatment should be initiated with 10mg daily, gradually increasing to 30-50mg daily. The optimum dose should be reached after about 10 days and then continued until the end of treatment.
Paediatric population Children: (In the treatment of nocturnal enuresis only). The tablets should be administered just before bedtime. 6-7 years (weight 20-25kg or 44-55lbs): 25 mg daily 8-11 years (weight 25-35kg or 55-77lbs): 25 – 50 mg daily Over 11 years (weight 35-54kg or 77-119lbs): 50 – 75 mg daily.
Children under 6 years:
Not to be given to children under 6 years of age. The dose should not exceed 75 mg daily. The maximum period of treatment should not exceed three months, and withdrawal should be gradual. If relapse should occur, treatment should not be re-instituted until a full physical examination has been carried out.
Method of administration:
For oral administration.
If severe neurological or psychiatric reactions occur, Imipramine hydrochloride should be withdrawn. Elderly patients are particularly sensitive to anticholinergic, neurological, psychiatric, or 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 frequency estimates are used: very common (≥1/10), common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000).
Blood and lymphatic system disorders:
Rare: agranulocytosis, bone marrow depression including leucopenia, eosinophilia, purpura, thrombocytopenia. It is advisable to perform blood counts during treatment with tritetracyclic antidepressants, especially if the patient develops fever, sore throat or other signs of infection.
4).
Immune system disorders:
Rare: allergic alveolitis (pneumonitis) with or without eosinophilia, systemic anaphylactic/anaphylactoid reactions including hypotension. 4).
Psychiatric Disorders:
Behavioural changes in children may occur. Common: fatigue, drowsiness, restlessness, delirium, confusion, disorientation and hallucination (particularly in geriatric patients and those suffering from Parkinson's disease), increased anxiety, agitation, sleep disturbances, swings from depression to hypomania or mania.
Uncommon: activation of psychotic symptoms Rare: aggressiveness 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:
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. 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.
Blood sugar concentrations may be altered in diabetic patients. Caution is required in patients with hyperthyroidism or during treatment with thyroid preparations as aggravation of unwanted cardiac effects may occur. Before starting treatment it is advisable to check the patients’ blood pressure because patients with hypotension or a labile circulation may react to the drug with a fall in blood pressure.
1 • Cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group. • Any degree of heart block or other cardiac arrhythmias; recent myocardial infarction. • Mania • Porphyria • Severe liver disease • Narrow angle glaucoma • Children under 6 years of age • Retention of urine • Concomitant therapy with selective, reversible MAO-A inhibitors such as moclobemide, or within 3 weeks of cessation of therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Very common: tremor Common: paraesthesiae, headache, dizziness. Uncommon: epileptic seizures/convulsions.
Rare:
EEG changes, myoclonus, weakness, extrapyramidal symptoms, ataxia, speech disorder, drug fever. Syncope has also been reported.
Eye disorders:
Very common: blurred vision, disorders of visual accommodation Rare: glaucoma, mydriasis Ear and labyrinth disorders: Rare: Tinnitus Cardiac disorders: Very common: sinus tachycardia and clinically irrelevant ECG changes (T and ST changes) in patients of normal cardiac status, postural hypotension.
Common: arrhythmias and heart block follow the use of imipramine and may be the cause of sudden death in patients with cardiac disease, conduction disorders (widening of QRS complex and PR interval, bundle-branch block), palpitations.
Rare: increased blood pressure, cardiac decompensation, peripheral vasospastic reactions. 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.
Vascular disorders:
Very common: hot flushes Gastro-Intestinal disorders: Very common: constipation, dry mouth. Common: nausea, vomiting, anorexia. Rare: stomatitis, tongue lesions, abdominal disorders, and paralytic ileus have been reported.
Hepatobiliary disorders:
Common: elevated transaminases Uncommon: impaired liver function Rare: hepatitis with or without jaundice.
Skin and subcutaneous tissue disorders:
Very common: sweating Common: allergic skin reactions (skin rash, urticaria) Rare: oedema (local or generalised), photosensitivity, pruritus, petechiae, hair loss.
Renal and urinary disorders:
Common: disturbances of micturition, urinary retention. 4). Respiratory depression, agitation and withdrawal symptoms have been reported in neonates whose mothers received imipramine during the last trimester of pregnancy.
Investigations:
Very common: weight gain Rare: increase or decrease in blood sugar and weight loss.
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.
g. phaeochromocytoma, neuroblastoma), as hypertensive crises may be provoked. 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 two weeks.
Concomitant treatment of imipramine and electroconvulsive therapy should only be resorted to under careful supervision. g. prostatic hypertrophy. Lengthy treatment with tricyclic antidepressants can lead to an increased incidence of dental caries.
Regular dental check-ups are therefore advisable during long-term treatment. Activation of psychosis has occasionally been observed 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 hydrochloride or to withdraw it and administer an antipsychotic agent. After such episodes have subsided, low dose therapy with Imipramine hydrochloride 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.
8). 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. A swing from depression to hypomania or mania is possible in patients with bipolar affective disorders.
In such cases it may be necessary to withdraw imipramine and administer drugs to control the mania. After such episodes have subsided, low-dose therapy with imipramine may be resumed if required. Behavioural changes may occur in children receiving imipramine for treatment of nocturnal enuresis.
g. g. benzodiazepines). It appears that the occurrence of seizures is dose dependent. Caution is required when giving tricyclic antidepressants to patients with severe renal disease. 8). g. diseases of the prostate). Caution is called for in patients with chronic constipation.
Tricyclic antidepressants may cause paralytic ileus, particularly in the elderly and bedridden patients. Decreased lacrimation and accumulation of mucoid secretions due to 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. Before general or local anaesthesia, the anaesthetist should be aware that the patient has been receiving imipramine.
Anaesthetics given during tri/tetracyclic […]