Wonder

Wonder Dosage/Direction for Use

dapoxetine

Manufacturer:

Kusum

Distributor:

JDS
Full Prescribing Info
Dosage/Direction for Use
Dosage: Adult men (aged 18 to 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 Wonder should not be initiated with the 60 mg dose.
Wonder tablet 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, no dose escalation to 60 mg should be performed.
A careful appraisal of individual benefit risk of Wonder 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 Wonder is appropriate.
Data regarding the efficacy and safety of Wonder beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Wonder should be re-evaluated at least every six months.
Elderly (age 65 years and over): The efficacy and safety of Wonder tablets have not been established in patient's age 65 years and over.
Paediatric population: There is no relevant use of Wonder tablets in this population in the indication of premature ejaculation.
Patients with renal impairment: Caution is advised in patients with mild or moderate renal impairment. Wonder tablet is not recommended for use in patients with severe renal impairment.
Patients with hepatic impairment: Wonder tablet 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.
Method of administration: For oral use.
Wonder tablet should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water and 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.
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