Dapotin 30 mg (Tablet)

Indications

• Treatment of premature ejaculation
• Men 18 to 64 years of age
• Persistent or recurrent ejaculation with minimal sexual stimulation
• Marked personal distress or interpersonal difficulty
• Poor control over ejaculation

Pharmacology

• Mechanism of action linked to serotonin reuptake inhibition
• Neuronal reuptake of serotonin
• Potentiation of neurotransmitter's action
• Rapid absorption with maximum plasma concentrations occurring approximately 1-2 hours after tablet intake
• Absolute bioavailability is 42%
• More than 99% of Dapoxetine is bound in vitro to human serum proteins
• Rapid distribution with a mean steady state volume of distribution of 162 L
• Metabolized to multiple metabolites primarily through N-oxidation, N-demethylation, Naphthyl hydroxylation, Glucuronidation, and Sulfation
• Evidence of presystemic first-pass metabolism after oral administration
• Metabolites of Dapoxetine primarily eliminated in urine as conjugates
• Rapid elimination with a terminal half-life of approximately 19 hours

Dosage & Administration

• Recommended starting dose for all patients is 30 mg
• Maximum recommended dose of 60 mg
• Recommended to be taken 1 to 3 hours prior to sexual activity
• Maximum recommended dosing frequency is once every 24 hours
• Dapoxetine may be taken with or without food
• Not recommended for use in individuals below 18 years of age
• Caution advised in patients with renal impairment
• Contraindicated in patients with moderate and severe hepatic impairment

Interaction

• Concomitant administration of CNS active medicinal products
• Concomitant administration with PDE5 inhibitors
• Concomitant administration with Tamsulosin
• No data evaluating the effect of chronic use of Warfarin with Dapoxetine
• Concomitant use of alcohol and Dapoxetine

Contraindications

• Known hypersensitivity to Dapoxetine Hydrochloride
• Significant pathological cardiac conditions
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine
• Concomitant treatment with serotonin reuptake inhibitors
• Concomitant treatment with other medicinal/herbal products with serotonergic effects

Side Effects

• Nausea
• Dizziness
• Dry mouth
• Headache
• Diarrhea
• Insomnia
• Low rates of sexual dysfunction
• Adverse effects are dose related

Pregnancy & Lactation

• Not indicated for use by women
• Unknown excretion through human breast milk

Precautions & Warnings

• Use with recreational drugs
• Ethanol
• Syncope
• Orthostatic hypotension
• Haemorrhage
• Use with PDE5 inhibitors
• Use with Tamsulosin

Overdose Effects

• No case of overdose reported
• No unexpected adverse events in a clinical pharmacology study of Dapotin with daily doses up to 240 mg
• Symptoms of overdose with SSRIs include serotonin-mediated adverse reactions
• No evidence of withdrawal syndrome

Therapeutic Class

• Drugs for Erectile Dysfunction

Storage Conditions

• Store below 30°C
• Protect from light and moisture
• Keep out of reach of children

Related Brands

• Daporex 30 mg (Tablet) - euro-pharma-ltd
• Daporex 60 mg (Tablet) - euro-pharma-ltd