Dapoxetine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing dapoxetine
Drugs List
Therapeutic Indications
Uses
Premature ejaculation
Dosage
Adults
Men (aged 18 to 64 years)
The starting dose for all patients is 30 mg.
Take as needed approximately 1 to 3 hours prior to sexual activity. Treatment with dapoxetine should not be initiated with the 60 mg dose.
Dapoxetine is not intended for continuous daily use. It should be taken only when sexual activity is anticipated and must not be taken more frequently than once every 24 hours.
If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity. The incidence and severity of adverse events is higher with the 60 mg dose.
If the patient experienced orthostatic reactions on the starting dose, there should be no dose escalation to 60 mg.
Contraindications
Children under 18 years
Patients over 65 years
Predisposition to syncope
Sinus node dysfunction
Within 2 weeks of discontinuing MAOIs
Bipolar disorder
Galactosaemia
Hypomania
Ischaemic heart disease
Mania
Moderate hepatic impairment
New York Heart Association class II failure
Postural hypotension
Second degree atrioventricular block
Severe renal impairment
Third degree atrioventricular block
Uncontrolled epileptic disorder
Valvular heart disease
Precautions and Warnings
Predisposition to hypotension
Cardiac impairment
CYP2D6 poor metaboliser genotype
Epileptic disorder
Glucose-galactose malabsorption syndrome
Lactose intolerance
Moderate renal impairment
Narrow angle glaucoma
Raised intra-ocular pressure
Advise hypotension/syncope may affect ability to drive/operate machinery
Co-morbid symptoms of depression: screen for risk of bipolar disorder
Contains lactose
Evaluate need for continued treatment after 6 months
Monitor patients with a history of treatment of mental depression
Review treatment after 6 weeks
Advise patient to sit or lie down at first signs of orthostatic hypotension
May activate mania or hypomania
Discontinue drug if bleeding abnormalities occur
Discontinue if depression worsens or recurs
Advise patient not to take St John's wort concurrently
Advise patient that the effects of alcohol may be potentiated
Advise patient grapefruit products may increase plasma level
Grapefruit juice should be avoided within 24 hours prior to taking dapoxetine.
Pregnancy and Lactation
Pregnancy
Dapoxetine is not indicated for use by women.
Lactation
Dapoxetine is not indicated for use by women.
Side Effects
Abdominal distension
Abdominal pain
Abnormal thinking
Agitation
Akathisia
Anorgasmia
Anxiety
Apathy
Asthenia
Blurred vision
Bruxism
Changes in libido
Cold sweat
Confusion
Constipation
Depressed mood
Depression
Desire to defaecate
Diaphoresis
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Dry mouth
Dysgeusia
Dyspepsia
Erectile dysfunction
Euphoria
Failure of ejaculation
Fatigue
Feeling abnormal
Feeling drunk
Feeling hot
Flatulence
Flushing
Headache
Hot flushes
Hyperhidrosis
Hypotension
Increased blood pressure
Increased heart rate
Insomnia
Irritability
Light-headedness
Mood changes
Mydriasis
Naso-sinus congestion
Nausea
Nervousness
Nightmares
Orthostatic hypotension
Paraesthesia
Pruritus
Restlessness
Sedation
Sinus arrest
Sinus bradycardia
Sinus tachycardia
Sleep disturbances
Somnolence
Syncope
Tinnitus
Tremor
Vertigo
Visual disturbances
Vomiting
Yawning
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 ).
Further Information
Last Full Review Date: December 2013
Reference Sources
Summary of product characteristics: Priligy 30mg and 60mg film-coated tablets. A.Menarini Farmaceutica Internzionale SRL. Revised March 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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