X-Ride 30 mg (Tablet)

Indications

• Treatment of premature ejaculation (PE) in men 18 to 64 years of age
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration
• Marked personal distress or interpersonal difficulty as a consequence of PE
• Poor control over ejaculation

Pharmacology

• Inhibition of neuronal reuptake of serotonin
• Potentiation of neurotransmitter's action
• Rapid absorption
• Maximum plasma concentrations occurring approximately 1-2 hours after tablet intake
• Absolute bioavailability is 42%
• Extensive metabolism to multiple metabolites
• Rapid distribution with a mean steady state volume of distribution of 162 L
• Presystemic first-pass metabolism after oral administration
• Rapid elimination with a terminal half-life of approximately 19 hours

Dosage & Administration

• Recommended starting dose for all patients is 30 mg
• Taken as needed approximately 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
• Dapoxetine should not be used in individuals below 18 years of age
• Caution is advised in patients with mild or moderate renal impairment
• Dapoxetine is contraindicated in patients with moderate and severe hepatic impairment

Interaction

• Caution advised with concomitant administration of CNS active medicinal products
• Prescribed with caution in patients who use PDE5 inhibitors
• Prescribed with caution in patients who use alpha adrenergic receptor antagonists
• Caution advised when used in patients taking Warfarin chronically
• Patients advised to avoid alcohol while taking X-Ride

Contraindications

• Known hypersensitivity to Dapoxetine Hydrochloride
• Significant pathological cardiac conditions
• Concomitant treatment with monoamine oxidase inhibitors, thioridazine, or within 14 days of discontinuing treatment with MAOIs, thioridazine
• Concomitant treatment with serotonin reuptake inhibitors or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these products

Side Effects

• Nausea
• Dizziness
• Dry mouth
• Headache
• Diarrhea
• Insomnia
• Low rates of sexual dysfunction
• Mild adverse effects on loss of libido and ED

Pregnancy & Lactation

• Not indicated for use by women
• Not known if dapoxetine or its metabolites are excreted through human breast milk

Precautions & Warnings

• Patients advised not to use X-Ride in combination with recreational drugs
• Patients advised to avoid alcohol while taking X-Ride
• Patients need to be made aware that they could experience syncope at any time during their treatment with X-Ride
• An orthostatic test should be performed before initiating therapy
• Caution advised in patients taking X-Ride with medicinal products known to affect platelet function or anticoagulants
• Prescribed with caution in patients who use alpha adrenergic receptor antagonists

Overdose Effects

• No case of overdose reported
• Symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances, tachycardia, tremor, agitation and dizziness
• No evidence of withdrawal syndrome in clinical trial subjects

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

• X-Ride 60 mg (Tablet) - somatec-pharmaceuticals-ltd