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Drugs List
Therapeutic Indications
Dosage
Administration
Contraindications
Precautions and Warnings
Pregnancy and Lactation
Side Effects
Monograph

Dosage

Adults
Elderly
Children
Patients with Renal Impairment
Patients with Hepatic Impairment
Additional Dosage Information

Depression
The recommended starting dose is 50 or 100mg, given as a single dose in the evening. Within 3 to 4 weeks of starting treatment the dose should be reviewed and may be adjusted gradually to a maximum of 300mg daily if required. The usual effective dose is 100mg daily. Doses of up to 150mg may be given once daily in the evening, higher daily doses should be given in 2 to 3 divided doses. Higher doses may result in increased side effects and the lowest effective dose should be used.

Antidepressant medication should be continued for at least 6 months after recovery from a depressive episode. A dose of 100mg daily may be sufficient for this use.

Obsessive Compulsive Disorder
The recommended starting dose is 50mg given in the evening. The effective dose usually lies between 100 and 300mg per day. The dosage should be increased gradually until the effective dose is achieved, with a maximum of 300mg daily. Doses of up to 150mg can be given as a single daily dose, preferably in the evening. It is advisable that a total daily dose of more than 150mg is given in 2 or 3 divided doses.

If good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. If no improvement is observed within 10 weeks, treatment with fluvoxamine should be reconsidered. While there are no systematic studies to answer the question of how long to continue treatment, OCD is a chronic condition and it is reasonable to consider treatment beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically and efficacy beyond 24 weeks has not been demonstrated in OCD.

Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.

Precautions and Warnings

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 fluvoxamine 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.

Tapered withdrawal is recommended (see Withdrawal Symptoms and Signs )

Hepatic impairment (see Dosage - Hepatic impairment )

Renal impairment (see Dosage - Renal impairment )

Elderly (see Dosage - Elderly )

Children under 18 years with obsessive compulsive disorder should be monitored carefully for suicide related behaviours and hostility, predominantly, aggression, oppositional behaviour and anger.

Consider discontinuing treatment if the patient develops psychomotor restlessness / akathisia, characterised by a subjectively unpleasant or distressing need to move often accompanied by an inability to sit or stand still, which is more likely to occur in the first few weeks of treatment. In patients who develop these symptoms increasing the dose may be detrimental.

Discontinue if hepatic enzymes (AST or ALT) become persistently raised.

Monitor antidiabetic drug treatment, particularly during initiation or dose adjustments, in diabetic patients as fluvoxamine may disturb glycaemic control.

History of epilepsy or seizures - use cautiously, with close monitoring and discontinue if seizures occur or if there is an increase in seizures.

Caution is advised when electroconvulsive therapy (ECT) is considered as prolonged seizures have been reported with SSRIs.

Serotonin syndrome has been rarely reported, particularly in association with concomitant SSRIs or neuroleptics, therefore, only use on the advice of a specialist and discontinue if it occurs.

Neuroleptic Malignant Syndrome has been rarely reported, particularly in association with concomitant SSRIs or neuroleptics, therefore discontinue if it occurs. Symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability, possible repaid fluctuations in vital signs, mental status should prompt discontinuation and initiation of symptomatic treatment.

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.

Use with caution in patients predisposed to cutaneous bleeding, such as ecchymosis and purpura, the risk of skin and mucous membrane bleeding may be increased, particularly in those taking drugs which affect platelet function.

Use with caution in patients with a history of mania as activation of mania or hypomania has been reported in patients who have received antidepressants, including fluvoxamine. Discontinue if a patient enters a manic phase.

Use with caution following as a recent myocardial infarction due to a lack of clinical experience in this situation and the development of arrhythmias with other antidepressants (e.g. venlafaxine).

Drowsiness may impair ability to drive or operate machinery.

Patients should be advised to avoid alcohol.

Fluvoxamine should be used with caution in patients with glaucoma or a predisposition to angle closure glaucoma as SSRIs may exacerbate this condition.

Pregnancy (see Pregnancy)

Patients receiving SSRIs or TCAs, mainly those aged 50 years or older - a review of epidemiological studies shows an increased risk of bone fractures in these patients. The mechanism leading to this increased risk is unclear.

Family history of long QT syndrome

Electrolyte imbalance

History of torsade de pointes

Consider monitoring ECG in patients at risk of QT prolongation

Correct electrolyte disorders before treatment

Monitor serum electrolytes

CSM Warnings

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. Over all, 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.

The CSM, in the past (December 2003), indicated that there is insufficient information on the safety and efficacy of fluvoxamine in those under 18 years.

Drug interactions:
The CSM has advised that concomitant use of fluvoxamine and theophylline or aminophylline should usually be avoided.

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.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

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.

Reproduction studies in animals at high doses revealed no evidence of impaired fertility, reproductive performance or teratogenic effects in the offspring.

Isolated cases of withdrawal symptoms in the newborn child have been described after the use of fluvoxamine at the end of pregnancy.

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 14-17 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

Contraindicated in lactation. Fluvoxamine is excreted in human milk.

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

Presentation

Tablets containing 50mg fluvoxamine maleate
Tablets containing 100mg fluvoxamine maleate

Drugs List

FAVERIN 100mg tablets

FAVERIN 50mg tablets

fluvoxamine 100mg tablets

fluvoxamine 50mg tablets

Therapeutic Indications

Uses

Major depressive episode
Obsessive-compulsive disorder

Dosage

All patients should be evaluated for risk of suicide and monitored for clinical worsening.

There may be an increased risk of side effects at higher dosages.

(See CSM Warnings section)

Adults

Elderly

As per adult dose. However caution should be exercised when treating the elderly due to the possibility of renal impairment. The lowest effective dose should always be used, and patients carefully monitored when an increase in dose is required.

Children

Depression
Fluvoxamine should not be used in children and adolescents under the age of 18 for the treatment of major depressive episode. Safety and effectiveness have not been established. ( See CSM Warnings section )

Obsessive Compulsive Disorder
Children under 8 years:
Contraindicated

Children over 8 years:
The starting dose is 25mg per day. Increase in 25mg increments every 4-7 days as tolerated until an effective dose is achieved.

There is limited data on a dose of up to 100mg twice daily for 10 weeks; the maximum dose should not exceed 200mg per day.

It is advisable that a total dose of more than 50mg daily should be given in 2 divided doses. If the 2 doses are not equal, the larger dose should be given at bedtime.

If no improvement is observed within 10 weeks, treatment with fluvoxamine should be reconsidered.

Patients with Renal Impairment

Patients with renal impairment should be started on a low dose and carefully monitored.

Patients with Hepatic Impairment

Patients with hepatic impairment should be started on a low dose and carefully monitored.

Additional Dosage Information

Discontinuing fluvoxamine:
Abrupt discontinuation should be avoided.

When discontinuing fluvoxamine the dose should be gradually reduced over at least one or two weeks and the patient monitored in order to minimise the risk of withdrawal reactions. The period required for discontinuation may depend on the dose, duration of therapy and the individual patient.

If intolerable withdrawal symptoms occur following a dose decrease or cessation, resuming the previous dose may be considered with subsequent dose decrease at a more gradual rate.

Administration

For oral administration

Fluvoxamine tablets should be swallowed with water and without chewing

Contraindications

Children under 18 years with major depressive disorder

Children under 8 years with obsessive compulsive disorder

Within 2 weeks of discontinuing an irreversible MAOIs or within 24 hours of discontinuing a reversible MAOI (e.g. moclobemide)
Also allow at least 7 days after stopping fluvoxamine before starting any MAOI.

Unstable epilepsy

Mania or a manic phase

Breastfeeding (see Lactation)

Torsade de pointes
Long QT syndrome