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TRAZODONE HYDROCHLORIDE is a brand name for Trazodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Trazodone hydrochloride tablet is indicated for major depressive episodes.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology a) Adults:
Initially 150mg/day in divided doses after food or as a single dose on retiring. The dose will be increased every 3 to 4 days by 50 mg a day (preferably upon retiring) until an optimal therapeutic effect is achieved. This may be increased up to a dose of 300 mg a day, administered in divided doses after food, or as a single dose upon retiring.
In administering divided doses the major part of the divided dose should be taken upon retiring. In hospitalised patients, the maximum daily dose may be incrementally increased to a maximum of 600 mg per day, administered as divided doses.
After reaching an effective dose, clinical response is usually evident within two to four weeks. In the case of non – responders the dosage may be increased to the maximum recommended. If, following this, there is no response after two to four weeks, therapy should be discontinued.
Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment. In general, it is preferable to continue therapy with an antidepressant until the patient has been symptomless for four to six months.
In order to avoid withdrawal symptoms abrupt discontinuation of treatment should be avoided. At the end of treatment, the dose should be gradually decreased. 4). This may be incrementally increased, under supervision, according to efficacy and tolerance.
In general, single doses above 100 mg should be avoided in these patients. It is unlikely that 300mg/day will be exceeded.
Paediatric population:
The safety and efficacy of Trazodone hydrochloride tablet in children below the age of 18 years has not yet been established therefore Trazodone hydrochloride tablet is not recommended for use in this age group. 8). Therefore caution should be exercised when prescribing for patients with hepatic impairment, particularly in cases of severe hepatic impairment.
Periodic monitoring of liver function may be considered. 2). Method of administration For oral use. A decrease of the side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Trazodone hydrochloride tablets after a meal.
4). The following symptoms, some of which arecommonly reported in cases of untreated depression,. MedDRA System Organ Class Frequency Blood and the lymphatic system disorders Blood dyscrasias including agranulocytosis, thrombocytopenia, eosinophilia, leucopenia and anaemia Immune system disorders Allergic reactions Endocrine disorders Syndrome of Inappropriate Antidiuretic Hormone Secretion Metabolism and nutrition disorders Hyponatraemia1, weight loss anorexia and increased Uncommon: Weight loss Not known: Hyponatraemia1 Psychiatric disorders , Suicidal ideation or suicidal confusional state, disorientation, mania, agitation (very occasionally exacerbating to delirium), aggressive reaction, hallucinations.
Not known:
Worsening delusions, inhibition, anxiety, suicidal ideation and suicidal behaviours2, insomnia, nightmares, withdrawal syndrome.
Nervous system disorders Very common:
Dizziness, drowsiness3 Common: Tinnitus, headache, tremor Uncommon: Serotonin syndrome4, convulsions Rare: Myoclonus Very rare: Neuroleptic malignant syndrome Not known: Vertigo, restlessness, decreased alertness, memory disturbance, paraesthesia, dystonia.
Eye disorders Common:
Accommodation and vision disorders, sometimes glaucoma, ocular pruritus, blurred vision Cardiac disorders Common: Palpitation5, bradycardia, tachycardia Not known: Cardiac arrhythmias5 (including Torsades de Pointes, premature ventricular couplets, ventricular tachycardia), ECG abnormalities (QT prolongation) Vascular disorders Common: Orthostatic hypotension, hypertension, syncope Respiratory, thoracic and mediastinal disorders Common: Nasal/sinus congestion Uncommon: Dyspnoea Gastrointestinal disorders Very common: Dry mouth Common: Taste changes, flatulence, nausea, vomiting, constipation and diarrhoea, dyspepsia, stomach pain, gastroenteritis.
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.
To minimise the potential risk of suicide attempts, particularly at therapy initiation, only restricted quantities of Trazodone hydrochloride tablets should be prescribed at each occasion. It is recommended that careful dosing and regular monitoring is adopted in patients with the following conditions: • Epilepsy, specifically abrupt increases or decreases of dosage should be avoided • Patients with hepatic or renal impairment, particularly if severe • Patients with cardiac and vascular disease, such as cardiovascular insufficiency, angina pectoris, conduction disorders or AV blocks of different degree, arrhythmias, recent myocardial infarction, congenital long QT syndrome or bradycardia.
1. • Alcohol intoxication and intoxication with hypnotics. • Acute myocardial infarction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Trazodone in United Kingdom.
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Trazodone hydrochloride tablets should be taken together with a glass of water.
Not known:
Intestinal perforation, paralytic ileus, gastrointestinal spasm, and hiatus hernia, increased salivation Hepato-biliary disorders Rare: Hepatic function abnormalities (including jaundice and hepatocellular damage)6, severe hepatic disorders such as hepatitis/fulminant hepatitis, hepatic failure with potential fatal outcome.
Not known:
Intrahepatic cholestasis Skin and subcutaneous tissue disorders Common: Skin rash, pruritus Not known: Hyperhidrosis Musculoskeletal and connective tissue disorders Common: Asthenia, chest pain, limb pain, back pain Not known: Myalgia, arthralgia Renal and urinary disorders Not known: Urinary hesitancy, micturition disorders Reproductive system and breast disorders Uncommon: Decreased libido Very rare: Priapism2 General disorders and administration site conditions Common: Perspiration, hot flushes, oedema, influenza-like symptoms Not known: Weakness, fatigue, fever Investigations Not known: Elevated liver enzymes 1 Fluid and electrolyte status should be monitored in symptomatic patients.
4. 3 Trazodone is a sedative antidepressant and drowsiness, sometimes experienced during the first days of treatment, usually disappears with continued therapy. 4 Studies in animals have shown that Trazodone hydrochloride is less cardiotoxic than the tricyclic antidepressants, and clinical studies suggest that the drug may be less likely to cause cardiac arrhythmias in manClinical studies in patients with pre- existing cardiac disease indicate that trazodone may be arrhythmogenic in some patients in that population.
6 Adverse effects on hepatic function, sometimes severe, have been rarely reported. Should such effects occur trazodone should be immediately discontinued. 4 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.
• Hyperthyroidism • Micturition disorders, such as prostate hypertrophy, although problems would not be anticipated as the anticholinergic effect of Trazodone hydrochloride tablet is only minor • Acute narrow angle glaucoma, raised intra-ocular pressure, although major changes would not be anticipated due to the minor anticholinergic effect of Trazodone hydrochloride tablet.
Patients with hypokalaemia or hypomagnesemia. 8). Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician. Investigations including clinical examination and biological assessment of liver function should be undertaken immediately, and withdrawal of Trazodone hydrochloride tablet therapy be considered.
Should jaundice occur in a patient, Trazodone hydrochloride tablet therapy must be withdrawn. Administration of antidepressants in patients with schizophrenia or other psychotic disorders may result in a possible worsening of psychotic symptoms.
Paranoid thoughts may be intensified. During therapy with Trazodone hydrochloride tablet a depressive phase can change from a manic – depressive psychosis into a manic phase. In that case Trazodone hydrochloride tablet must be stopped.
Should jaundice occur in a patient, Trazodone hydrochloride tablets therapy must be withdrawn. g. tricyclic antidepressants, SSRI’s, SNRI’s, tryptophan and MAO-inhibitors), triptans and neuroleptics. 8). Treatment with trazodone must be stopped immediately and supportive symptomatic treatment should be initiated.
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. Agranulocytosis Since agranulocytosis may clinically reveal itself with influenza-like symptoms, sore throat, and fever, in these cases it is recommended to check haematology.
Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving Trazodone hydrochloride tablets. Concomitant administration of antihypertensive therapy with Trazodone hydrochloride tablets may require a reduction in the dose of the antihypertensive drug Elderly Elderly patients may more often experience orthostatic hypotension, somnolence, and other anticholinergic effects of trazodone.
Careful consideration should be given to the potential for additive effects with concomitant medication use such as with other psychotropics or antihypertensives or in the presence of risk factors such as comorbid disease, which may exacerbate these reactions.
It is recommended that the patient/carer is informed of the potential for these reactions and monitored closely […]