Description
Daplong tabs 10’s is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.
Daplong should only be prescribed to patients who meet all the following criteria: An intravaginal ejaculatory latency time (IELT) of less than two minutes; persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; marked personal distress or interpersonal difficulty as a consequence of PE; poor control over ejaculation; a history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Daplong should be administered only as on-demand treatment before anticipated sexual activity. Daplong should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
DAPLONG DESCRIPTION
Each film-coated tablet contains Dapoxetine (as hydrochloride) 30 mg and 60 mg.
Excipients/Inactive Ingredients: Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg tablet contains 91.75 mg of lactose.
Tablet Core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate 17. Tablet Coating: Lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide black (E172), iron oxide yellow (E172)
DOSAGE
Adult Men (Aged 18-64 Years): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with Daplong should not be initiated with the 60 mg dose.
Daplong is not intended for continuous daily use. Daplong should be taken only when sexual activity is anticipated. Daplong 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, no dose escalation to 60 mg should be performed.
A careful appraisal of individual benefit risk of Daplong should be performed by the physician after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment with Daplong is appropriate.
Data regarding the efficacy and safety of Daplong beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Daplong should be re-evaluated at least every six months.
Elderly (Age 65 Years and Over): The efficacy and safety of Daplong have not been established in patients age 65 years and over.
Paediatric Population: There is no relevant use of Daplong in this population in the indication of premature ejaculation.
Patients with Renal Impairment: Caution is advised in patients with mild or moderate renal impairment. Daplong is not recommended for use in patients with severe renal impairment.
Patients with Hepatic Impairment: Daplong is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C).
Known CYP2D6 Poor Metabolizers or Patients Treated with Potent CYP2D6 Inhibitors Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors.
Patients Treated with Moderate or Potent Inhibitors of CYP3A4: Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose should be restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised.
Administration: For oral use. Tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Daplong may be taken with or without food.
Precautions to be Taken Before Handling or Administering the Medicinal Product: Before treatment is initiated, see Precautions regarding orthostatic hypotension.
