This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Citalopram oral drops

Presentation

Oral drops containing citalopram

Drugs List

  • CIPRAMIL 2mg/drop (40mg/ml) oral drops
  • citalopram 2mg/drop (40mg/ml) oral drops sugar-free
  • 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

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Medications and Mother's Milk, 14th edition (2010) Hale, T.W. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Cipramil Drops 40 mg/ml. Lundbeck Ltd. Revised April 2020.

    Summary of Product Characteristics: Citalopram 40mg/ml Oral Drops Solution. Rosemont Pharmaceuticals Ltd. Revised September 2010.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    MHRA Drug Safety Update July 2016
    Available at: https://www.mhra.gov.uk
    Last accessed: 16 August 2016

    MHRA 19th September 2005
    https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/Citalopram/
    Last accessed: 03 September, 2014.

    MHRA Drug Safety Update May 2010 - Antidepressants: Risk of fractures
    https://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON085136
    Last accessed: 03 September, 2014.

    MHRA Drug Safety Update January 2021 Available at: https://www.mhra.gov.uk Last accessed: 12 February 2021

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Citalopram Last revised: September 07, 2013.
    Last accessed: 02 September, 2014.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.