Citalopram oral drops
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral drops containing citalopram
Drugs List
Therapeutic Indications
Uses
Depressive illness
Panic disorders with or without agoraphobia
Prevention of relapse or recurrence of depressive illness
Dosage
Dosage should be reviewed and adjusted as necessary within 3 to 4 weeks of therapy initiation, and thereafter as judged clinically appropriate. Depending on individual response, some patients may benefit from dosage increase if insufficient response is seen after some weeks on the recommended dose, despite the possible increased potential for undesirable effects at higher doses. Dosage adjustment should be made carefully on an individual patient basis, in order to maintain the lowest effective dose.
Citalopram oral drops can be taken as a single daily dose, at any time of day, without regard to food intake.
Adults
Depression
16mg (8 drops) once a day. I Improvement may become more evident within the second week of treatment.
Dose may be increased, if considered necessary, in 16mg (8 drops) steps at intervals of 3 to 4 weeks.
Maximum daily dose should not exceed 32mg (16 drops).
A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse.
Panic disorder
A low starting dose is recommended in order to reduce the likelihood of a paradoxical anxiogenic effect.
Initial dose: 8mg (4 drops) once a day.
Dose may be increased gradually in 8mg (4 drops) steps, if considered necessary, to the recommended optimum dose of 16mg to 24mg (8 to 12 drops) a day.
Maximum daily dose should not exceed 32mg (16 drops).
Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. Dependant on individual patient response it may be necessary to continue treatment for several months.
Elderly
Initial dose: 8mg (4 drops) once a day.
Dose may be gradually increased, if considered necessary, in steps of 8mg (4 drops).
Maximum daily dose should not exceed 16mg (8 drops).
Children
Major depression
Children 12 to 18 years (unlicensed)
Initial dose: 8mg (4 drops) once a day.
Dose may be increased to 16mg (8 drops) once a day over 2 to 4 weeks, if considered necessary.
Maximum daily dose should not exceed 32mg (16 drops).
Patients with Hepatic Impairment
Dose in patients with hepatic impairment should be restricted to the lower end of the dose range. Some manufacturers recommend in patients with mild to moderate hepatic impairment an initial dose of 8mg (4 drops) daily for the first two weeks of treatment. Depending on individual patient response, the dose may be increased to a maximum of 16mg (8 drops) daily.
Additional Dosage Information
Citalopram oral drops have approximately 25% increased bioavailability compared to tablets.
10mg dose of tablets is equivalent to 8mg (4 drops) of the oral drops
20mg dose of tablets is equivalent to 16mg (8 drops) of the oral drops
30mg dose of tablets is equivalent to 24mg (12 drops) of the oral drops
40mg dose of tablets is equivalent to 32mg (16 drops) of the oral drops
MAOIs
Citalopram may be started not less than 14 days after discontinuing treatment with an irreversible monoamine oxidase inhibitor (MAOI) and at least one day after discontinuing treatment with the reversible MAOI (RIMA) moclobemide.
An MAOI or RIMA should not be started until at least 7 days after discontinuing citalopram.
Poor metabolisers of CYP2C19
An initial dose of 8mg (4 drops) daily during the first two weeks is recommended. The dose may be increased to a maximum of 16mg (8 drops) daily depending on individual patient response.
Contraindications
Children under 12 years
Family history of long QT syndrome
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Long QT syndrome
Mania
Uncontrolled epileptic disorder
Precautions and Warnings
Children aged 12 to 18 years
Electroconvulsive therapy
Patients over 65 years
Predisposition to narrow angle glaucoma
Suicidal ideation
CYP2C19 poor metaboliser genotype
Diabetes mellitus
Epileptic disorder
Hepatic impairment
History of coagulopathy
History of hypomania
History of mania
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Narrow angle glaucoma
Pregnancy
Psychiatric disorder
Recent myocardial infarction
Renal impairment - creatinine clearance below 20ml/minute
Severe bradycardia
Uncontrolled cardiac failure
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains alcohol
Contains hydroxybenzoate
Discontinue treatment if patient develops seizures
Monitor ECG in patients at risk of QT prolongation
Monitor patients for adverse reactions including restlessness & agitation
Monitor patients with epilepsy while taking this treatment
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Do not increase dosage in patients who develop akathisia
Increased risk of fractures in patients over 50 years
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Discontinue at first sign of arrhythmia - perform ECG
Discontinue if patient enters a manic phase
Discontinue if serotonin syndrome develops
Reduce dose in elderly
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise patient concurrent illicit drug use may cause serious adverse effect
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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm
Other psychiatric conditions for which citalopram 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, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.
Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.
Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition. If serotonin syndrome occurs treatment with citalopram should be discontinued immediately and symptomatic treatment be initiated. If citalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan, caution is advisable.
Review ECG before treatment is started in patients with stable cardiac disease. Monitor ECG in case of overdose or in conditions of altered metabolism with increased peak levels e.g. liver impairment. If signs of cardiac arrhythmia occur during treatment, withdraw treatment and perform an ECG.
In patients receiving SSRIs or TCAs, mainly those aged 50 years or older, a review of epidemiological studies showed an increased risk of bone fractures in these patients. The mechanism leading to this increased risk is unclear.
Depressive illness in children and adolescents
The CSM has advised that the balance of risks and benefits for the treatment of depressive illness in individuals under 18 years is considered unfavourable for the SSRIs citalopram, escitalopram, paroxetine and sertraline, and for mirtazapine and venlafaxine. Clinical trials have failed to show efficacy and have shown an increase in harmful outcomes. However, it is recognised that specialists may sometimes decide to use these drugs in response to individual clinical need; children and adolescents should be monitored carefully for suicidal behaviour; self harm or hostility, particularly at the beginning of treatment.
Only fluoxetine has been shown in clinical trials to be effective for treating depressive illness in children and adolescents. However, it is possible that, in common with other SSRIs, it is associated with a small risk of self-harm and suicidal thoughts. Overall, the balance of risks and benefits for fluoxetine in the treatment of depressive illness in individuals under 18 years is considered favourable, but children and adolescents must be carefully monitored.
Hyponatraemia and antidepressant therapy
Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants; however, it has been reported more frequently with SSRIs than with other antidepressants. The CSM has advised that hyponatraemia should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant.
Suspected drug interaction with cocaine
The MHRA advises there is a suspected drug interaction between citalopram and cocaine after a death of a patient. There are plausible mechanisms for an interaction between cocaine and citalopram that could lead to subarachnoid haemorrhage, including hypertension related to cocaine and an additive increased risk of bleeding in combination with citalopram. An adequate history should be obtained from the patient which considers recent use of other medicines including non-prescription medicines, herbal medicines, legal drugs and medicines purchased online. Possible interactions with illicit drugs should be considered in patients who present with suspected adverse reactions.
Pregnancy and Lactation
Pregnancy
Use citalopram with caution in pregnancy.
The safety of citalopram in human pregnancy has not been established; use only if the potential benefit outweighs the risk.
SSRI antidepressants, including citalopram, have been associated with several developmental toxicities, including spontaneous abortions (SABs), low birth weight, prematurity, neonatal behavioural syndrome (withdrawal), possible sustained abnormal neurobehaviour beyond the neonatal period, respiratory distress and persistent pulmonary hypertension of the newborn (PPHN). However, although the data are still limited, citalopram does not appear to be a major human teratogen and the inadvertent use of any SSRI does not require termination of pregnancy.
Schaefer suggests that a pregnant patient who is stable with a second-choice antidepressant should not be changed to another drug, because this may worsen her health. A detailed ultrasonography may be offered. Regular psychiatric and obstetric care is recommended to diagnose in time a relapse or pregnancy complications (intrauterine growth retardation, premature contractions).
In the later stages of pregnancy, epidemiological data suggest that the use of SSRIs may increase the risk of persistent pulmonary hypertension in the newborn. After birth, close observation of neonates exposed to SSRIs or SNRIs for signs of PPHN is recommended. SSRIs may also increase the risk of postpartum haemorrhage within the month prior to birth.
The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later stages of pregnancy, respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms may be due to either the serotoninergic effects or discontinuation symptoms. In the majority of instances the complications occur immediately or soon after birth. After SSRI treatment near term, it is important to be aware of an increased haemorrhagic tendency in the newborn.
During pregnancy maternal drug concentrations of citalopram may be lower than in non-pregnant women, and could lead to therapeutic failure. The database of the world health organisation (WHO) was used in a 2005 report on neonatal SSRI withdrawal syndrome. Of 93 suspected cases with either neonatal convulsions or withdrawal syndrome, 7 were linked to citalopram. (For comparison: 64 suspected cases were linked to paroxetine, 14 to fluoxetine and 9 to sertraline.)
A large amount of data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foetal or neonatal toxicity.
Animal reproduction studies have shown reduced fertility, foetal growth retardation, reduced survival and teratogenicity at very high doses.
Neonates should be observed if the maternal use of citalopram continues into the later stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should be avoided in pregnancy due to the risk of neonatal withdrawal symptoms. Observation of the neonate for withdrawal symptoms or adaptation problems for at least 2 days is recommended when SSRIs have been used up to delivery. To prevent neonatal adaptation disorders, dose reduction or even treatment interruption in the days immediately preceding delivery can be discussed with the patient if the clinical course allows. However, to prevent a relapse at this vulnerable stage, pre-pregnancy dosage should be started immediately after delivery.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Citalopram is contraindicated in breastfeeding.
The safety of citalopram in breastfeeding has not been established. Manufacturers recommend that breastfeeding should be discontinued if treatment is considered necessary.
Citalopram is known to be excreted in breast milk and estimates of the dose a nursing infant may ingest range from 0.7% to 5.9% of the weight-adjusted maternal dose. The effects on the nursing infant are unknown but may be of concern because of the potential for toxicity.
Various case reports describe the effects on infants exposed to citalopram through breastfeeding. Adverse affects on infants from citalopram exposure are low varying from no untoward effects to disruption of sleep patterns, restlessness, irritability, colic, somnolence, decreased feeding and weight loss.
The UK Drugs in Lactation Advisory Service indicate that citalopram may not be suitable for use during breastfeeding due to its long half life and potential risk of infant drug accumulation adverse drug reactions.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Counselling
Patients and caregivers should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour and the need to seek medical advice immediately if they present.
Advise patients to avoid alcohol during treatment.
Advise patients not to take St John's Wort concurrently.
Advise patient not to take NSAIDs such as aspirin unless under the guidance of a physician.
Advise patient concurrent illicit drug use may cause serious adverse effects.
Advise patients to be cautious about their ability to drive or operate machinery.
Citalopram does not impair intellectual function or psychomotor performance. However, patients receiving citalopram may be expected to have some impairment of general attention and concentration either due to the illness itself, the medication, or both and should be cautioned about their ability to drive or operate machinery.
Side Effects
Abdominal pain
Aggression
Agitation
Akathisia
Alopecia
Altered liver function tests
Amnesia
Anaphylactoid reaction
Angioedema
Anorexia
Anxiety
Apathy
Arthralgia
Asthenia
Bradycardia
Bruxism
Confusion
Constipation
Cough
Depersonalisation
Diarrhoea
Disturbances in accommodation
Disturbances of appetite
Dizziness
Dream abnormalities
Drowsiness
Dry mouth
Dyspepsia
Ecchymosis
Epistaxis
Euphoria
Extrapyramidal effects
Fatigue
Flatulence
Galactorrhoea
Gastrointestinal bleeding
Haemorrhage
Hallucinations
Headache
Hepatitis
Hostility
Hypersalivation
Hypersensitivity reactions including anaphylaxis
Hypokalaemia
Hypomania
Hyponatraemia
Impaired concentration
Impaired vision
Inappropriate secretion of antidiuretic hormone
Increased risk of fractures
Increased sweating
Insomnia
Malaise
Mania
Menorrhagia
Metrorrhagia
Micturition disorders
Migraine
Movement disturbances
Myalgia
Mydriasis
Narrow angle glaucoma
Nausea
Nervousness
Oedema
Palpitations
Panic attack
Paraesthesia
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pruritus
Psychomotor restlessness
Purpura
Pyrexia
Rash
Rhinitis
Seizures
Serotonin syndrome
Sexual dysfunction
Sleep disturbances
Somnolence
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urticaria
Vasculitis
Ventricular arrhythmias
Visual disturbances
Vomiting
Weight changes
Withdrawal symptoms
Yawning
Withdrawal Symptoms and Signs
Withdrawal symptoms (dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability and visual disturbances) have been reported in association with selective serotonin reuptake inhibitors (SSRIs). Most symptoms were mild to moderate and self-limiting. Symptoms usually resolve within 2 weeks, though in some individuals they may be prolonged (2 to 3 months or more).
Abrupt discontinuation of citalopram should be avoided. When stopping treatment, gradually reduce the dose over several weeks to months to reduce the risk of withdrawal reactions.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below:
Fatal dose not known. Patients have survived the ingestion of up to 2 g citalopram The effects will be potentiated by alcohol taken at the same time. Potential interaction with tricyclic antidepressants and MAOIs.
Signs and Symptoms
Nausea, vomiting, sweating, tachycardia, drowsiness, coma, dystonia, convulsions, hyperventilation and hyperpyrexia have been reported. Cardiac features that have been observed include nodal rhythm, prolonged QT intervals and wide QRS complexes. Prolonged bradycardia with severe hypotension and syncope has also been reported.
Rarely, features of the "serotonin syndrome" may occur in severe poisoning. This includes alteration of mental status, neuromuscular hyperactivity and autonomic instability. There may be hyperpyrexia and elevation of serum creatine kinase. Rhabdomyolysis is rare.
Treatment
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral activated charcoal in adults and children who have ingested more than 5 mg/kg body weight within 1 hour. Observe for a minimum of 4 hours due to long half life of citalopram.
Control convulsions with intravenous diazepam if they are frequent or prolonged. An ECG should be taken.
Further Information
Last full review date: September 2014
Reference Sources
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Medications and Mother's Milk, 14th edition (2010) Hale, T.W. Hale Publishing, Amarillo, Texas.
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Last accessed: 03 September, 2014.
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Citalopram Last revised: September 07, 2013.
Last accessed: 02 September, 2014.
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