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PRAMINIL, IMIPRAMINE HCL 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 the symptoms of depressive illness and for the relief in children of nocturnal enuresis.
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 10 mg daily, gradually increasing to 30-50 mg daily. The optimum dose should be reached after about 10 days and then continued until the end of treatment.
Children (for nocturnal enuresis only):
The tablets should be administered just before bedtime. Over 11 years (weight 35-54kg or 77-119lbs): 50-75mg daily. 8-11 years (weight 25-35kg or 55-77lbs): 25-50mg daily. 6-7 years (weight 20-25kg or 44-55lbs): 25mg daily.
Under 6 years:
Not to be given to children under 6 years of age. The dose should not exceed 75mg 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.
001%. If severe neurological or psychiatric reactions occur, imipramine should be withdrawn.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.
Effects on the central nervous system: fatigue, drowsiness, restlessness, delirium, confusion, disorientation, hallucinations (particularly in geriatric patients and those suffering from Parkinson’s disease), increased anxiety, agitation, sleep disturbances, swings from depression to hypomania or mania have been reported occasionally.
Activation of psychotic symptoms has been reported rarely. In isolated cases aggressiveness has been reported. Paranoid delusion may be exacerbated during treatment with tricyclic antidepressants. These are more frequently seen in elderly patients or those on high doses.
4). Neurological effects: tremor has been reported frequently. Paraesthesia, headache and dizziness have been reported occasionally. Epileptic seizures have been reported rarely. In isolated cases EEG changes, myoclonus, weakness, extrapyramidal symptoms, ataxia, speech disorders, drug fever has been reported.
Effects on the cardiovascular system:
Sinus tachycardia and clinically irrelevant ECG changes (T and ST changes) in patients of normal cardiac status, and postural hypotension have been reported frequently. Cardiac arrhythmias and severe hypertension are likely to occur with high dosage or in deliberate overdosage.
, Arrhythmias, conduction disorders (widening of QRS complex and PR interval, bundle-branch block), palpitations have been reported occasionally. Isolated cases of increased blood pressure, cardiac decompensation, peripheral vasospastic reactions have been reported.
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.
g. g. benzodiazepines). Occurrence of seizures appears to be dose-dependent. Concomitant treatment with imipramine and electroconvulsive 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 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.
Caution is required in patients with hyperthyroidism or during concomitant treatment with thyroid preparations as aggravation of unwanted cardiac effects may occur. Before starting treatment it is advisable to check the patient’s blood pressure because those 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.
8). Periodic monitoring of hepatic enzyme levels is recommended in patients 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, particularly in elderly and bedridden patients. Before general or local anaesthesia, the anaesthetist should be aware that the patient has been receiving imipramine. 5). An increase in dental caries has been reported during long-term treatment with tricyclic antidepressants.
• Hypersensitivity to imipramine, any of the excipients in the tablets or cross- sensitivity to other tricyclic antidepressants of the dibenzazepine group. g. moclobemide. • Children under six years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Anticholinergic effects: dry mouth, constipation, sweating, disturbances of visual accommodation, blurred vision, hot flushes have been frequently reported. Disturbances of micturition have been occasionally reported. Isolated cases of mydriasis and paralytic ileus have been reported.
Effects on the gastro-intestinal tract:
Nausea, vomiting, anorexia has been reported occasionally. Isolated cases of stomatitis, tongue lesions, abdominal disorders have been reported.
Hepatic effects:
Elevated transaminases have been reported occasionally. Impaired liver function has been reported rarely. Isolated cases of hepatitis with or without jaundice have been reported.
Effects on the skin:
Allergic reactions (such as urticaria, skin rash) have been reported occasionally. Isolated cases of oedema (local or generalised), photosensitivity, pruritus, petechiae, hair loss have been reported. Effects on the endocrine system and metabolism: weight gain has been reported frequently.
Disturbances in libido and potency have been reported occasionally. Isolated cases of enlarged mammary glands, galactorrhoea, SIADH (syndrome of inappropriate antidiuretic hormone secretion), increase or decrease in blood sugar, weight loss have been reported.
4).
Hypersensitivity:
Isolated cases of allergic alveolitis (pneumonitis) with or without eosinophilia, systemic anaphylactic/anaphylactoid reactions including hypotension have been reported. Effects on the blood: isolated cases of agranulocytosis, bone marrow depression including leucopenia, eosinophilia and thrombocytopenia have been reported.
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) Effects on the sense organs: tinnitus has been reported.
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 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. uk/yellowcard or search for MHRA Yellow Card Google play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 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 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.
Imipramine contains lactose This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine.