Susten 30

Indications

Recommended for addressing premature ejaculation (PE) in males aged 18 to 64 years who meet the following criteria:

• Experience persistent or recurring ejaculation with minimal sexual stimulation before, during, or shortly after penetration, against their desire.
• Encounter significant personal distress or interpersonal challenges due to PE and lack adequate control over ejaculation.

Pharmacological Overview

The mechanism of action is believed to involve inhibiting the neuronal reuptake of serotonin, thereby enhancing serotonin activity. The central neural circuit responsible for ejaculation involves spinal and cerebral regions forming an intricate network. Sensory genital and cerebral stimuli, processed at the spinal cord level, integrate with sympathetic, parasympathetic, and somatic spinal centers to coordinate physiological events during ejaculation. Experimental findings suggest serotonin (5-HT) plays an inhibitory role in ejaculation via brain descending pathways. Three 5-HT receptor subtypes (5-HT(1A), 5-HT(1B), and 5-HT(2C)) are implicated in mediating 5-HT’s modulatory effect on ejaculation.

Dosage & Administration

For adults aged 18 to 64 years:

• Initiate treatment with a 30 mg dose, taken as needed approximately 1 to 3 hours before sexual activity.
• If the response to 30 mg is inadequate and side effects are tolerable, consider increasing the dose to a maximum of 60 mg.
• Limit dosing to one per 24 hours.

Interactions

• Concurrent use with CNS active medicinal products: The combined use of Susten and CNS active drugs has not been systematically studied in PE patients. Therefore, exercise caution if coadministration is necessary.
• Interaction with PDE5 inhibitors: Tadalafil does not impact Susten pharmacokinetics significantly, while sildenafil may cause minor changes unlikely to be clinically relevant. Nonetheless, use Susten cautiously in patients using PDE5 inhibitors due to potential reduced orthostatic tolerance.
• Interaction with tamsulosin: Co-administration of Susten with tamsulosin did not alter tamsulosin pharmacokinetics. However, exercise caution due to potential decreased orthostatic tolerance.
• Interaction with warfarin: Limited data exist regarding chronic use of warfarin with Susten; therefore, caution is warranted.
• Interaction with ethanol: Combining alcohol with Susten may heighten adverse effects such as dizziness, drowsiness, and altered judgment. Patients should be advised against consuming alcohol while taking Susten.

Contraindications

• Hypersensitivity to Dapoxetine Hydrochloride.
• Significant cardiac conditions like heart failure, conduction abnormalities, or ischemic heart disease.
• Concurrent use with monoamine oxidase inhibitors (MAOIs), thioridazine, SSRIs, SNRIs, TCAs, or other products with serotonergic effects.

Side Effects

Possible side effects include dizziness, headache, somnolence, tremor, blurred vision, tinnitus, sinus congestion, nausea, diarrhea, abdominal pain, dry mouth, fatigue, insomnia, and hypertension.

Pregnancy & Lactation

Dapoxetine is not intended for use by women, and it’s unknown whether dapoxetine or its metabolites are excreted in human breast milk.

Precautions & Warnings

Exercise caution in patients with bleeding disorders, epilepsy, angle-closure glaucoma susceptibility, or raised intraocular pressure. Not suitable for female use. Consideration for known CYP2D6 poor metabolizers.

Overdose Effects

No unexpected adverse events were observed in a clinical study with daily Susten doses up to 240 mg. Overdose symptoms may include serotonin-mediated reactions like somnolence, gastrointestinal disturbances, tachycardia, tremor, agitation, and dizziness. Manage overdose with standard supportive measures as needed.

Therapeutic Class

Belongs to the category of drugs for Erectile Dysfunction.

Storage Conditions

Store below 30°C, protected from light and moisture, and keep out of children’s reach.