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Paroxetine oral formulations

Presentation

Oral formulations containing paroxetine

Drugs List

  • paroxetine 10mg tablets
  • paroxetine 20mg tablets
  • paroxetine 30mg tablets
  • paroxetine 40mg tablets
  • SEROXAT 10mg tablets
  • SEROXAT 20mg tablets
  • SEROXAT 30mg tablets
  • Therapeutic Indications

    Uses

    Depression - severe
    Obsessive-compulsive disorders
    Panic disorders with or without agoraphobia
    Treatment of generalised anxiety disorder (GAD)
    Treatment of post-traumatic stress disorder
    Treatment of social phobia

    Unlicensed Uses

    Menopausal symptoms in women with breast cancer

    Dosage

    The dosage should be reviewed and adjusted as necessary 3 to 4 weeks after initiating therapy and thereafter as judged clinically appropriate.

    The dose should be given once daily in the morning with food.

    Adults

    Major depressive episodes:
    The recommended dose is 20 mg daily increasing if necessary by 10 mg increments up to a maximum of 50 mg daily according to patient response. Treat for at least 6 months following recovery.

    Obsessive-compulsive disorder (OCD):
    Initially 20 mg daily increasing weekly by 10 mg increments to the recommended dose of 40 mg daily. However up to 60mg daily may be necessary. Treatment should continue for a sufficient period to ensure freedom from symptoms. This may be longer than the treatment period for depression.

    Panic disorder:
    Initial dose 10 mg daily increasing weekly by 10 mg increments to the recommended dose of 40 mg daily, according to the patient's response. The dose may be increased gradually up to a maximum of 60 mg in some patients. A low initial starting dose is recommended as there is the potential for worsening of panic symptoms during the early treatment of panic disorder. Treatment should continue for a sufficient period to ensure freedom from symptoms. This may be longer than the treatment period for depression.

    Social anxiety disorder/social phobia:
    The recommended dose is 20 mg daily. If no improvement, increase gradually by 10 mg increments at weekly intervals up to a maximum of 50 mg daily, according to the patient's response. Long term use should be regularly evaluated.

    Post-traumatic stress disorder:
    The recommended dose is 20 mg daily. If no improvement, increase gradually by 10 mg increments at weekly intervals up to a maximum of 50 mg daily, according to the patient's response. Long term use should be regularly evaluated.

    Generalised anxiety disorder:
    The recommended dose is 20 mg daily. If no improvement, increase gradually by 10 mg increments at weekly intervals up to a maximum of 50 mg daily, according to the patient's response. Long term use should be regularly evaluated.

    Menopausal symptoms in women with breast cancer (except those taking tamoxifen) (unlicensed)
    10mg once daily

    Elderly

    (See Dosage; Adult) Dosing should commence at the adult starting dose and may be increased weekly in 10 mg increments to a maximum of 40 mg per day according to the patient's response.

    Additional Dosage Information

    As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Patients should be treated for a sufficient period to ensure that they are free from symptoms. This period should be at least 4 to 6 months after recovery for depression and may be longer for OCD and panic disorder.
    As with many psychoactive medications, abrupt discontinuation should be avoided.

    Discontinuation of treatment
    Avoid abrupt discontinuation. 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 dose decrease of discontinuation of treatment, consider resuming the previously prescribed dose. Subsequently, consider reducing the dose at a more gradual rate.

    CSM advice
    The recommended dose for the treatment of depression, social anxiety disorder, generalised anxiety disorder, and post-traumatic stress disorder is 20mg daily and for obsessive-compulsive disorder and panic disorder it is 40 mg daily. There is no evidence that higher doses are more effective.

    Administration

    For oral administration.

    The dose should be given once daily in the morning with food.

    Tablets should be swallowed not chewed.

    For paroxetine liquid, shake the bottle before use.

    Contraindications

    Children under 18 years
    Within 2 weeks of discontinuing MAOIs
    Mania
    Uncontrolled epileptic disorder

    Precautions and Warnings

    Elderly
    Electroconvulsive therapy
    Predisposition to narrow angle glaucoma
    Suicidal ideation
    Young adults
    Breastfeeding
    Cardiac disorder
    Coagulopathy
    Diabetes mellitus
    Epileptic disorder
    Hepatic impairment
    Hereditary fructose intolerance
    History of coagulopathy
    History of glaucoma
    History of hypomania
    History of mania
    History of seizures
    Hyponatraemia
    Narrow angle glaucoma
    Pregnancy
    Renal impairment - creatinine clearance below 30 ml/minute

    Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
    Patients at risk of suicide should be closely supervised
    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
    Some formulations contain hydroxybenzoate
    Diabetic control may need adjustment
    Discontinue treatment if patient develops seizures
    Monitor elderly for hyponatraemia if drowsy, confused, fitting
    Monitor patients for adverse reactions including restlessness & agitation
    Monitor patients for signs and symptoms of Serotonin Syndrome
    Refer women considering pregnancy for specialist advice and monitoring
    Advise patient to report any new or worsening depression/suicidal ideation
    Advise patients/carers to seek medical advice if suicidal intent develops
    Do not increase dosage in patients who develop akathisia
    Increased risk of fractures in patients over 50 years
    Potential for withdrawal symptoms
    Avoid abrupt withdrawal
    To discontinue, reduce dose gradually
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if patient enters a manic phase
    Discontinue if serotonin syndrome develops
    Discontinue if significant/persistent hepatic function abnormalities occur
    Reduce dose in elderly
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    May reduce sperm count, function, motility or seminal fluid volume

    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 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, 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.

    Paroxetine has been associated with the development of akathisia (inner sense of restlessness and psychomotor agitation, such as an inability to stand or sit still, usually associated with subjective distress), and is most likely to occur within the first few weeks of treatment. An increase in dose may be detrimental.

    There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs. Other haemorrhagic manifestations e.g. gastrointestinal and gynaecological haemorrhage have been reported. Elderly patients may be at an increased risk for non-menses related events of bleeding.

    Increased risk of bleeding disorders due to predisposing conditions and/or family history of bleeding disorders or due to concurrent drug treatment (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin and non-steroidal anti-inflammatory drugs).

    It has been shown in clinical studies that SSRI's (including paroxetine) may affect sperm quality. The affect on sperm quality appears to be reversible on cessation of treatment. These studies have not examined the impact on fertility, but changes in sperm quality may affect fertility in some men.

    Use with caution in patients with a high gastric pH or achlorhydria due to certain drugs (antacids, proton pump inhibitors), disease states (e.g. atrophic gastritis, pernicious anaemia) or after surgery (vagotomy, gastrectomy) as changing formulation from tablet to oral suspension may result in a change in paroxetine plasma concentration.

    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.

    CSM Warnings

    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 (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant.

    Extrapyramidal reactions (including orofacial dystonias) and withdrawal syndrome are reported to the CSM more commonly with paroxetine than with other SSRIs.

    Pregnancy and Lactation

    Pregnancy

    Use with caution in pregnancy.

    Some epidemiological studies of maternal exposure to paroxetine in the first trimester have suggested a small increase in the risk of cardiovascular malformations (e.g. ventricular and atrial septum defects). The mechanism is unknown. The data suggests that the risk of having an infant with a cardiovascular defect following paroxetine exposure is 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population. Available data do not suggest an increase of the overall rate of congenital malformations.

    Possible neonatal withdrawal symptoms may be seen in babies born to patients who have taken paroxetine during the last three months of pregnancy. These symptoms usually begin during the first 24 hours after the baby is born and include not sleeping, not feeding properly, breathing difficulties, blue-ish skin, being too hot or too cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits.

    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.

    Women should be advised to consult their doctor if they are planning a pregnancy or become pregnant. Abrupt withdrawal should be avoided during pregnancy.

    Animal studies showed reproductive toxicity, but did not provide any evidence of teratogenicity.

    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

    Use with in caution breastfeeding.

    Serum concentrations in breast fed infants were undetectable, less than 2 nanograms per ml, or very low, less than 4 nanogram per ml, and no sign of drug effects were observed in these infants. The age range of these infants ranged from 6 to 13 weeks. There are, however, some reports of adverse effects in the breastfed infant so that the breast fed infant should be monitored for symptoms associated with maternal treatment.

    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

    Side Effects

    Abdominal pain
    Abnormal bleeding
    Acute glaucoma
    Aggression
    Agitation
    Akathisia
    Allergic reaction
    Anaphylactoid reaction
    Anaphylaxis
    Angioedema
    Anorexia
    Anxiety
    Arthralgia
    Asthenia
    Blood pressure changes
    Blurred vision
    Bradycardia
    Confusion
    Constipation
    Convulsions
    Decreased appetite
    Decreased glycaemic control in diabetes
    Depersonalisation
    Diaphoresis
    Diarrhoea
    Dizziness
    Dream abnormalities
    Drowsiness
    Dry mouth
    Dyskinesia
    Dyspepsia
    Ecchymosis
    Emotional lability
    Erythema multiforme
    Extrapyramidal effects
    Galactorrhoea
    Gastrointestinal bleeding
    Hallucinations
    Headache
    Hepatic failure
    Hepatitis
    Hostility
    Hyperkinesia (children)
    Hyperprolactinaemia
    Hyperreflexia
    Hypomania
    Hyponatraemia
    Impaired concentration
    Inappropriate secretion of antidiuretic hormone
    Increase in total cholesterol
    Increased appetite
    Increased risk of fractures
    Increases in hepatic enzymes
    Insomnia
    Irritability
    Jaundice
    Mania
    Menstrual disturbances
    Myalgia
    Mydriasis
    Myoclonus
    Nausea
    Nervousness
    Neuroleptic malignant syndrome-like effect
    Palpitations
    Panic attack
    Paraesthesia
    Peripheral oedema
    Photosensitivity
    Postural hypotension
    Priapism
    Pruritus
    Purpura
    Rash
    Restless legs
    Sensory disturbances
    Serotonin syndrome
    Sexual dysfunction
    Shivering
    Sinus tachycardia
    Skin and mucosal bleeding
    Sleep disturbances
    Somnolence
    Stevens-Johnson syndrome
    Suicidal tendencies
    Tachycardia
    Thrombocytopenia
    Tinnitus
    Toxic epidermal necrolysis
    Tremor
    Urinary incontinence
    Urinary retention
    Urticaria
    Visual disturbances
    Vomiting
    Weight gain
    Weight loss
    Withdrawal symptoms
    Yawning

    Withdrawal Symptoms and Signs

    Dizziness, sensory disturbances (e.g. paraesthesia, tinnitus and electric shock sensations), anxiety, sleep disturbances (including intense dreams), agitation, tremor, nausea, sweating, confusion, headache, diarrhoea, palpitations, emotional instability, irritability and visual disturbances have been reported following abrupt withdrawal of paroxetine.

    The symptoms are usually mild to moderate and self-limiting however, in some patients they may be severe in intensity and prolonged.
    It is advised that paroxetine should be gradually tapered when discontinuing treatment.

    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 has 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 is not known. Adults have survived ingestion of 2000 mg without serious sequelae. There is also a potential interaction with tricyclic antidepressants and monoamine-oxidase inhibitors.

    Signs and Symptoms

    These include nausea, vomiting, agitation, tremor, nystagmus, dilated pupils, dry mouth, irritability, sweating and drowsiness leading to coma. Convulsions may occur. Sinus tachycardia is common. Less frequently, bradycardia, hypertension and junctional rhythm may occur.

    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

    This should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 600 mg or a child more than 5 mg/kg.

    Patients should be observed for at least six hours after ingestion of potentially toxic quantities.

    Further Information

    Last Full Review Date: October 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Seroxat 10mg, 20mg, 30mg tablets, 20mg/10ml oral susp ension. GlaxoSmithKline UK. Revised September 2019.
    Summary of Product Characteristics: Paroxetine 20mg Tablets. Aurobindo Pharma Lt d. Revised June 2011.
    Summary of Product Characteristics: Paroxetine 20mg Tablets. Sandoz Ltd. Revised October 2011.
    Summary of Product Characteristics: Paroxetine 30mg Tablets. Sandoz Ltd. Revised October 2011.
    Summary of Product Characteristics: Paroxetine 20mg Tablets. Actavis UK Ltd. Revised October 2012.
    Summary of Product Characteristics: Paroxetine 30mg Tablets. Actavis UK Ltd. Revised October 2012.
    Summary of Product Characteristics: Paroxetine 30mg Tablets. Winthrop Pharmaceuticals UK Ltd. Revised August 2010.
    Summary of Product Characteristics: Paroxetine 40mg Tablets. Teva UK Ltd. Revised May 2015.

    MHRA 19th September 2005
    https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/Paroxetine/index.htm
    Last accessed: 20 October 2016

    MHRA 4th February 2008
    https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
    Last accessed: 20 October 2016

    MHRA Drug Safety Update May 2010
    https://www.mhra.gov.uk/home/groups/pl-p/documents/publication/con081866.pdf
    Last accessed: 20 October 2016

    MHRA Drug Safety Update January 2021 Available at: https://www.mhra.gov.uk
    Last accessed: 11 February 2021

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 March 2018

    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
    Paroxetine Last revised: 01 September 2016
    Last accessed: 20 October 2016

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