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IMIPRAMINE HYDROCHLORIDE is a brand name for Imipramine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of symptoms of depressive illness. Relief of nocturnal enuresis in children.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Depression:
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:
Patients over 60 years of age may respond to lower doses of Imipramine Hydrochloride 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.
Nocturnal Enuresis in Children:
Not for use in children under 6 years. 5mg/kg should not be exceeded in children. The dose should be taken just before bedtime. The maximum period of treatment should not exceed three months and withdrawal should be gradual. Should a relapse occur, a further course of treatment should not be started until a full physical examination has been made.
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If severe neurological or psychiatric reactions occur, Imipramine hydrochloride should be withdrawn.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 side effects, although not necessarily observed with imipramine, have occurred with tricyclic antidepressants. 001%).
Central Nervous System Psychiatric Effects:
Occasionally: 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.
Rarely: activation of psychotic symptoms. Isolated cases: 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).
Neurological Effects:
Frequently: tremor. Occasionally: paraesthesia, headache, dizziness. Rarely: epileptic seizures.
Isolated cases:
EEG changes, myoclonus, weakness, extrapyramidal symptoms, ataxia, speech disorder, drug fever.
Cardiovascular System:
Frequently: sinus tachycardia and clinically irrelevant ECG changes (T and ST changes) in patients of normal cardiac status, postural 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.
Warnings As improvement in depression may not occur for the first two to four weeks’ of treatment, 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). It appears that the occurrence of seizures is dose dependent. Concomitant treatment of Imipramine Hydrochloride and electroconvulsive therapy should only be resorted to under careful supervision. Caution is called for when giving tricyclic antidepressants to patients with severe renal disease.
5). If concomitant treatment with other serotonergic agents 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. phaeochromocytoma, neuroblastoma), in whom they may provoke hypertensive crises. Many patients with panic disorders experience intensified anxiety symptoms at the start of the 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 indicated in patients with hyperthyroidism or during concomitant treatment with thyroid preparations, since aggravation of unwanted cardiac effects may occur.
Before initiating treatment it is advisable to check the patient’s blood pressure, because individuals 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 or cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group. • Recent myocardial infarction. • Any degree of heart block or other cardiac arrhythmias. • Mania. • Severe liver disease. • Narrow angle glaucoma. • Infants and children under 6 years old.
• Retention of urine. • Concurrent use in patients receiving, or within 3 weeks of cessation of therapy with, monoamine oxidase inhibitors. • Concomitant treatment with selective, reversible MAO-A inhibitors such as moclobemide. • Porphyria.
Imipramine has been reported to be a porphyrinogenic agent and therefore should be avoided in patients with a known diagnosis or history of porphyria. Patients presenting with psychiatric symptoms in conjunction with gastrointestinal symptoms or dermatological conditions should be tested for porphyria prior to administration of imipramine.
Withdrawal of imipramine upon diagnosis of porphyria or acute porphyria attack should alleviate the symptoms.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Imipramine in United Kingdom.
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Occasionally: arrhythmias, conduction disorders (widening of QRS complex and PR interval, bundle-branch block), palpitations. Isolated cases: increased blood pressure, cardiac decompensation, peripheral vasospastic reactions.
Anticholinergic Effects:
Frequently: dry mouth, sweating, constipation, disorders of visual accommodation, blurred vision, hot flushes. Occasionally: disturbances of micturition. Isolated cases: mydriasis, glaucoma, paralytic ileus.
Gastro-Intestinal Tract:
Occasionally: nausea, vomiting, anorexia. Isolated cases: stomatitis, tongue lesions, abdominal disorders.
Hepatic Effect:
Occasionally: elevated transaminases. Rarely: impaired liver function. Isolated cases: hepatitis with or without jaundice.
Skin:
Occasionally: allergic skin reactions (skin rash, urticaria) Isolated cases: oedema (local or generalised), photosensitivity, hyperpigmentation, pruritus, petechiae, hair loss.
Endocrine System and Metabolism:
Frequently: weight gain. Occasionally: disturbances of libido, impotency or abnormal ejaculation. Isolated cases: enlarged mammary glands, galactorrhoea, SIADH (syndrome of inappropriate antidiuretic hormone secretion), increase or decrease in blood sugar, weight loss.
4).
Hypersensitivity:
Isolated cases: allergic alveolitis (pneumonitis) with or without eosinophilia, systemic anaphylactic/anaphylactoid reactions including hypotension.
Blood:
Isolated cases: agranulocytosis, bone marrow depression including eosinophilia, leucopenia, thrombocytopenia and purpura. 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).
Sense organs:
Tinnitus. 4). 5g of sorbitol per 5ml spoonful so may cause stomach upset and diarrhoea, particularly at high doses. 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.
8). Periodic monitoring of hepatic enzymes levels is recommended in patients with liver disease. In elderly patients monitoring of cardiac function is indicated. 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. Before general or local anaesthesia, the anaesthetist should be aware that the patient has been receiving Imipramine hydrochloride.
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 anticholinergic properties of tricyclic antidepressants may cause damage to the corneal epithelium in patients with contact lenses.
Suicide/suicidal thoughts or clinical worsening Risk of suicide is inherent to severe depression and may persist until significant remission occurs. 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 posing a high suicide risk require close supervision. 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 may cause anxiety, feelings of unrest, and hyperexcitation in agitated patients and patients with accompanying schizophrenic symptoms. 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 […]