Efficacy/Effectiveness

the treatment of premature ejaculation

- If the time from intravaginal insertion to ejaculation is less than 2 minutes, and if the premature ejaculation continues or recurs, personal pain or difficulty in interpersonal relationships, and poor control of ejaculation

Usage/Capacity

- One dose of this drug is administered once about 2 to 6 hours before sexual activity. The maximum number of doses does not exceed one dose within 24 hours,

Physicians who prescribe the medication for the treatment of premature ejaculation should assess the balance between the risk of the medication and the benefits reported by the patient after the first four or six weeks of administration and determine whether it is appropriate to continue the medication.

Precautions for Use

1. Treatment for premature ejaculation

Chloromipramine hydrochloride, the main component of this drug, has previously been used as an antidepressant. However, this drug is for male patients with premature ejaculation and should not be used in patients with depression or other psychiatric disorders. This drug should not be used in children and women.

Symptoms and signs of depression should be evaluated prior to administration of this drug to exclude undiagnosed depression. The combination of this drug with antidepressants including SSRI and SNRI is contraindicated. It is not recommended to stop treating depression or anxiety for the administration of this drug. Since this drug is not used for mental illness and worsening symptoms due to depression cannot be excluded, this drug should not be administered to patients with mental illness such as schizophrenia or coexisting with depression. This is because symptom worsening may occur as a result of underlying mental illness or drug treatment. In addition, if the patient has a feeling or depression, it should be recommended to notify the doctor immediately. If depression occurs during the administration of this drug, this drug should be stopped.

2. Do not administer to the following patients

1)Patients who have hypersensitivity to the main or other ingredients of this drug

2)Patients with major psychiatric conditions such as organic disorders of the brain, depression, anxiety disorders, suicidal tendencies, schizophrenia, bipolar disorder, etc. or a medical history

3)Patients taking other treatments for premature ejaculation (do not administer it in combination with other treatments as no studies have been conducted)

4)Patients with cross-sensitivity to tricyclic antidepressants (dibenzazepine series)

5)Patients receiving MAO inhibitors (including selective and reversible MAO-A inhibitors such as moclobemide), selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and selective serotonin inhibitors (tryptans) within 14 days before and after administration of this drug

6)a recent patient with myocardial infarction

7)Patients with glaucoma (symptoms may be exacerbated by anticholinergic action)

8)a patient with or suspected history of severe hypotension or orthostatic reactions

9)a woman under the age of 19

10)Aged persons 65 years of age or older

Storage and handling

1. Keep out of reach of children

2. Be careful not to put it in another container as it may cause an accident or maintain the quality