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CITALOPRAM is a brand name for Citalopram. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Citalopram Film-Coated Tablets is also indicated in the treatment of panic disorder with or without agoraphobia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Major depressive episodes Adults:
Citalopram Film-coated Tablets should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 40 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. 1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Panic Disorder Adults:
A single oral dose of 10 mg daily is recommended for the first week before increasing the dose to 20 mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 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 symptoms, which is generally recognised to occur early in the treatment of this disorder. 1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer. g. 10-20 mg daily. The recommended maximum dose for the elderly is 20 mg daily.
4).
Reduced hepatic function:
An initial dose of 10 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
2).
Reduced renal function:
). 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.
Method of administration Citalopram Film-coated Tablets are administered as a single daily dose. Citalopram Film-coated Tablets can be taken at any time of the day without regard to food intake. 1.
Monoamine Oxidase Inhibitors (MAOIs):
Some cases presented with features resembling serotonin syndrome. Citalopram should not be used in combination with a MAOI, including selegiline, in daily doses exceeding 10 mg/day. Citalopram may be started 14 days after discontinuing treatment with an irreversible MAOI and or for the time specified after discontinuing of a reversible MAOI (RIMA), as stated in the prescribing text of the RIMA.
5). 5). Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. 5). 4 Special warnings and precautions for use Use in children and adolescents under 18 years of age Citalopram Film-coated Tablets 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.
8 Undesirable Effects). 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.
Method of administration Citalopram Film-coated Tablets are administered as a single daily dose. Citalopram Film-coated Tablets can be taken at any time of the day without regard to food intake. 1.
Monoamine Oxidase Inhibitors (MAOIs):
Some cases presented with features resembling serotonin syndrome. Citalopram should not be used in combination with a MAOI, including selegiline, in daily doses exceeding 10 mg/day. Citalopram may be started 14 days after discontinuing treatment with an irreversible MAOI and or for the time specified after discontinuing of a reversible MAOI (RIMA), as stated in the prescribing text of the RIMA.
5). 5). Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. 5). 4 Special warnings and precautions for use Use in children and adolescents under 18 years of age Citalopram Film-coated Tablets 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.
1.
Monoamine Oxidase Inhibitors (MAOIs):
Some cases presented with features resembling serotonin syndrome. Citalopram should not be used in combination with a MAOI, including selegiline, in daily doses exceeding 10 mg/day. Citalopram may be started 14 days after discontinuing treatment with an irreversible MAOI and or for the time specified after discontinuing of a reversible MAOI (RIMA), as stated in the prescribing text of the RIMA.
5). 5). Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosage adjustment is not necessary in cases of mild or moderate renal impairment. No information is available in cases of severe renal impairment (creatinine clearance < 20 mL/min). Poor metabolisers of CYP2C19 An initial dose of 10 mg daily during the first two weeks of treatment is recommended for patients who are known to be poor metabolisers with respect to CYP2C19.
2).
Withdrawal symptoms seen on discontinuation of citalopram:
Abrupt discontinuation should be avoided. When stopping treatment with citalopram it is recommended that the dose is gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section
2). 2). Serotonin syndrome Rarely, the occurrence of “serotonin syndrome” has been reported in patients receiving SSRIs. 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. 5). If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Serotonergic medicines Citalopram should not be used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs and generally reverses on discontinuation of therapy.
Especially elderly female patients seem to be at particularlyrisk group. Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Seizures Seizures are a potential risk with antidepressant drugs.
The drug should be discontinued in any patient who develops seizures. Citalopram should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Citalopram should be discontinued if there is an increase in seizure frequency.
ECT (electroconvulsive therapy) There is limited clinical experience of concurrent administration of citalopram and ECT, therefore caution is advisable. 5. St. John's wort Undesirable effects may be more common during concomitant use of citalopram and herbal preparations containing St John's wort (Hypericum perforatum).
Therefore citalopram and St. 5). Mania In patients with manic-depressive illness a change towards the manic phase may occur. Citalopram should be discontinued in any patient entering a manic phase. 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 Citalopram Film-coated Tablets 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 […]
2). 2). Serotonin syndrome Rarely, the occurrence of “serotonin syndrome” has been reported in patients receiving SSRIs. 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. 5). If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Serotonergic medicines Citalopram should not be used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs and generally reverses on discontinuation of therapy.
Especially elderly female patients seem to be at particularlyrisk group. Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Seizures Seizures are a potential risk with antidepressant drugs.
The drug should be discontinued in any patient who develops seizures. Citalopram should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Citalopram should be discontinued if there is an increase in seizure frequency.
ECT (electroconvulsive therapy) There is limited clinical experience of concurrent administration of citalopram and ECT, therefore caution is advisable. Reversible, selective MAO-A inhibitors For information on concomitant treatment with non-selective, irreversible MAO-inhibitors see section