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SEROXAT is a brand name for Paroxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of - Major Depressive Episode - Obsessive Compulsive Disorder - Panic Disorder with and without agoraphobia - Social Anxiety Disorders/Social phobia - Generalised Anxiety Disorder - Post-Traumatic Stress Disorder
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Major depressive episode The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.
In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Obsessive compulsive disorder (OCD) The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.
Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. 1). Panic disorder The recommended dose is 40 mg daily. Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose.
A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.
Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. 1). Social anxiety disorder/social phobia The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day.
1). Generalised anxiety disorder The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day.
Some of the adverse drug reactions listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy. Adverse drug reactions are listed below by system organ class and frequency.
Frequencies are defined as: 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); very rare (<1/10,000); not known (cannot be estimated from the available data). Blood and lymphatic system disorders Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (including ecchymoisis and gynaecological bleeding), leukopenia.
Very rare: thrombocytopenia. Immune system disorders Very rare: severe and potentially fatal allergic reactions (including anaphylactoid reactions urticaria and angioedema). Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Metabolism and nutrition disorders Common: increases in cholesterol levels, decreased appetite. 4). Rare: hyponatraemia. Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Psychiatric disorders Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares). Uncommon: confusion, hallucinations. 4). Not known: suicidal ideation, suicidal behaviour, aggression, bruxism. 4). Cases of aggression were observed in post marketing experience.
These symptoms may also be due to the underlying disease Nervous system disorders Common: dizziness, tremor, headache, concentration impaired. Uncommon: extrapyramidal disorders. Rare: convulsions, restless legs syndrome (RLS). Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).
Treatment with paroxetine should be initiated cautiously two weeks after terminating treatment with an irreversible MAOI or 24 hours after terminating treatment with a reversible MAO inhibitor. 5). Paediatric population Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years.
Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
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. Other psychiatric conditions for which paroxetine is prescribed can also be associated with an increased risk of suicide-related events.
In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
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.
1. Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). 5). g. moclobemide, linezolid, methylthioninium chloride (methylene blue)). At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Post-traumatic stress disorder The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day.
1). 8). The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Children and adolescents (7-17 years) Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility.
8). Children aged below 7 years The use of paroxetine has not been studied in children less than 7 years. Paroxetine should not be used, as long as safety and efficacy in this age group have not been established. Elderly Population Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Dosing should commence at the adult starting dose. Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily. Renal/hepatic impairment Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or in those with hepatic impairment.
Therefore, dosage should be restricted to the lower end of the dosage range. Method of administration It is recommended that paroxetine is administered once daily in the morning with food. The tablet should be swallowed rather than chewed.
Reports of extrapyramidal disorder including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication. Eye disorders Common: blurred vision. 4). Very rare: acute glaucoma.
Ear and labyrinth disorders Not known: tinnitus. Cardiac disorders Uncommon: sinus tachycardia. Rare: bradycardia. Vascular disorders Uncommon: transient increases or decreases in blood pressure, postural hypotension. Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.
Respiratory, thoracic and mediastinal disorders Common: yawning. Gastrointestinal disorders Very common: nausea. Common: constipation, diarrhoea, vomiting, dry mouth. Very rare: gastrointestinal bleeding. Not known: colitis microscopic.
Hepato-biliary disorders Rare: elevation of hepatic enzymes. Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure). Elevation of hepatic enzymes have been reported. Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure) have also been received very rarely.
Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results. Skin and subcutaneous tissue disorders Common: sweating. Uncommon: skin rashes, pruritus Very rare: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions.
Musculoskeletal and connective tissue disorders Rare: arthralgia, myalgia 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. Renal and urinary disorders Uncommon: urinary retention, urinary incontinence. Reproductive system and breast disorders Very common: sexual dysfunction. Rare: hyperprolactinaemia/galactorrhoea menstrual disorders (including menorrhagia, metrorrhagia, amenorrhoea, menstruation delayed and menstruation irregular).
Very rare: priapism. 6). General disorder and administration site conditions Common: asthenia, body weight gain Very rare: peripheral oedema. Withdrawal symptoms seen on discontinuation of paroxetine treatment Common: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.
Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability. Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported.
Generally, these events are mild to moderate and are self-limiting; however, in some patients they may be severe and/or prolonged. 4). Adverse events from paediatric clinical trials The following adverse events were observed: Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.
Suicidal thoughts and suicide […]
1). Close supervision of patients and in particular those at high risk should accompany medicinal product 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.
Akathisia/psychomotor restlessness The use of paroxetine has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Serotonin Syndrome/Neuroleptic Malignant Syndrome On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events may occur in association with treatment of paroxetine, particularly when given in combination with other serotonergic and/or neuroleptic medicinal products.
As these syndromes may result in potentially life-threatening conditions, treatment with paroxetine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Paroxetine should not be used in combination with serotonin-precursors (such as L- tryptophan, oxitriptan) due to the risk of serotonergic syndrome. 5). Mania As with all antidepressants, paroxetine should be used with caution in patients with a history of mania.
Paroxetine should be discontinued in any patient entering a manic phase. 2). Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. 5). Epilepsy As with other antidepressants, paroxetine should be used with caution in patients with epilepsy.
1% in patients treated with paroxetine. The medicinal product should be discontinued in any patient who develops seizures. Electroconvulsive therapy (ECT) There is little clinical experience of the concurrent administration of paroxetine with ECT.
Glaucoma As with other SSRIs, paroxetine can cause mydriasis and should be used with caution in patients with narrow angle glaucoma or history of glaucoma. Cardiac Conditions The usual precautions should be observed in patients with cardiac conditions.
QT Prolongation Cases of QT interval prolongation have been reported during the post-marketing period. 1). Paroxetine should be used with caution in patients with a (family) history of QT interval prolongation, concomitant use of anti-arrhythmic medications or other medications that may potentially prolong QT interval, […]