Prolong30 mg

Prolong is a short-acting selective serotonin reuptake inhibitor (SSRI) indicated for the on-demand treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.

Established Use

• Treatment of premature ejaculation in men who have an intravaginal ejaculatory latency time of less than about 2 minutes, together with marked personal or interpersonal distress and poor control over ejaculation.

Prolong is used only as needed before anticipated sexual activity and is not intended for continuous daily use, unlike SSRIs used for depression or anxiety.

Note: Prolong is not indicated for the treatment of depression, anxiety, or any psychiatric condition, and is not approved for use in women or children.

Each film-coated tablet contains Dapoxetine Hydrochloride equivalent to 30 mg or 60 mg of dapoxetine base. Tablets also contain standard pharmaceutical excipients such as microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate, along with a film coating.

Prolong is a fast-acting, short half-life selective serotonin reuptake inhibitor (SSRI) developed specifically for on-demand treatment of premature ejaculation rather than for chronic mood or anxiety disorders. It is rapidly absorbed and rapidly eliminated, which distinguishes it pharmacokinetically from other SSRIs used for psychiatric indications.

Unlike typical SSRIs that require weeks of continuous dosing to reach therapeutic effect, Prolong is taken only when needed, a few hours before sexual activity.

Prolong belongs to the therapeutic class of Selective Serotonin Reuptake Inhibitors (SSRIs), specifically formulated as an on-demand agent for premature ejaculation rather than a chronic antidepressant.

Dapoxetine Hydrochloride works by inhibiting the neuronal reuptake of serotonin (5-HT) in the presynaptic nerve terminal, thereby increasing serotonin activity at postsynaptic 5-HT receptors, including 5-HT1A, 5-HT1B, and 5-HT2C receptors believed to be involved in the ejaculatory reflex pathway. This action delays the ejaculatory reflex, which is mediated through spinal and supraspinal centers under sympathetic nervous control.

Pharmacokinetics

• Absorption: Rapidly absorbed with peak plasma concentration (Tmax) reached in about 1-2 hours; absolute bioavailability is approximately 42%.
• Distribution: Highly protein bound (greater than 99%); large volume of distribution (~162 L).
• Metabolism: Extensively metabolized in the liver via N-oxidation (primarily CYP3A4) and N-demethylation (primarily CYP2D6), followed by glucuronide/sulfate conjugation.
• Elimination: Terminal half-life of approximately 1.3 hours for the parent compound (with an active metabolite, desmethyldapoxetine, having a longer half-life of about 19 hours); eliminated mainly via urine as metabolites.

Take Prolong orally with a full glass of water, 1 to 3 hours before anticipated sexual activity. Do not take with alcohol. Sit or lie down for the first few hours after the first dose to reduce the risk of dizziness or fainting related to a drop in blood pressure on standing.

Because Prolong affects serotonergic pathways and blood pressure regulation, several clinically significant interactions must be avoided or managed with caution.

Contraindicated Combinations

• Monoamine oxidase inhibitors (MAOIs): Concomitant use, or use within 14 days of stopping an MAOI, can precipitate life-threatening serotonin syndrome.
• Other serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome; concurrent use is contraindicated.
• Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, itraconazole): Significantly increase dapoxetine plasma levels, raising the risk of syncope and other adverse effects; concurrent use is contraindicated.

Use with Caution

• Moderate CYP3A4 inhibitors (e.g. erythromycin, fluconazole) or CYP2D6 inhibitors: May increase dapoxetine exposure; use with caution and consider dose limitation.
• PDE5 inhibitors (e.g. sildenafil, tadalafil) used for erectile dysfunction: May increase the risk of orthostatic reactions (dizziness, fainting) when combined with Prolong.
• Alpha-blockers (e.g. tamsulosin) and other antihypertensives: Increased risk of orthostatic hypotension.
• Alcohol: Increases the risk of dizziness, drowsiness, impaired judgment, and syncope; avoid alcohol while using Prolong.
• Recreational/serotonergic drugs (e.g. MDMA, amphetamines): Increased risk of serotonin syndrome, arrhythmia, and hyperthermia; avoid concurrent use.
• Anticoagulants, antiplatelet agents (e.g. aspirin, warfarin, NSAIDs): SSRIs including Prolong may impair platelet function, increasing bleeding risk.

Side effects of Prolong are generally dose-related and more frequent with the 60 mg dose than the 30 mg dose.

Very Common / Common

• Dizziness, headache
• Nausea, diarrhea, dry mouth
• Insomnia, somnolence
• Fatigue

Less Common

• Blurred vision
• Anxiety, irritability, restlessness
• Palpitations
• Orthostatic hypotension, presyncope, and syncope (fainting), particularly after the first dose (see Precautions and Warnings)

Rare but Serious

• Serotonin syndrome (when combined with contraindicated serotonergic drugs)
• Significant mood changes, including rare reports of suicidal ideation

Patients should seek prompt medical attention for fainting, severe dizziness on standing, unusual bleeding, agitation, high fever, muscle rigidity, or rapid heartbeat while taking Prolong.

Prolong is not indicated for use in women. It has not been studied in pregnant or breastfeeding women, and its safety in these populations has not been established. It should never be used by women, including during pregnancy or lactation.

Syncope and Orthostatic Reactions

Prolong is associated with a risk of syncope (fainting), most often related to orthostatic hypotension, and this risk is highest with the first few doses. Warning symptoms such as dizziness, lightheadedness, nausea, sweating, or palpitations may precede fainting, typically within 1 to 3 hours of dosing. Patients should be advised to sit or lie down at the onset of any such symptoms and to avoid situations where injury could result from a fall (e.g. driving, operating machinery, standing for long periods) after taking the first dose, until they know how they respond to the medicine.

Cardiac Disease

Not for use in patients with significant structural heart disease (see Contraindications).

Psychiatric Effects

As with other SSRIs, mood changes, anxiety, or agitation may occur; patients or caregivers should report any unusual changes in mood or behavior.

Serotonin Syndrome

Concurrent use with other serotonergic drugs increases the risk of serotonin syndrome (agitation, hallucinations, tachycardia, hyperthermia, muscle rigidity); such combinations are contraindicated (see Interactions).

Bleeding Risk

Use with caution in patients taking anticoagulants, antiplatelet agents, or NSAIDs due to an increased risk of bleeding.

Alcohol

Avoid alcohol while taking Prolong, as it increases the risk of dizziness, drowsiness, and syncope.

Driving and Operating Machinery

Patients should not drive or operate hazardous machinery until they are aware of how Prolong affects them, particularly regarding dizziness or fainting.

There is limited clinical experience with overdose of Prolong. Expected symptoms based on its SSRI pharmacology may include somnolence, nausea, vomiting, tremor, tachycardia, dizziness, and agitation; in significant overdose, syncope and serotonin syndrome may occur, particularly if taken with other serotonergic drugs.

There is no specific antidote. In case of suspected overdose, seek immediate medical attention or contact emergency services / a poison control center. Management is supportive and symptomatic, typically provided in a hospital setting with monitoring of vital signs and cardiac status.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Women

Prolong is not indicated for use in women.

Pediatric Patients

Safety and efficacy of Prolong have not been established in individuals under 18 years of age; use in this population is contraindicated.

Elderly Patients (65 years and older)

Safety and efficacy have not been established in men over 64 years of age; Prolong is not recommended in this age group.

Renal Impairment

Use with caution in mild-to-moderate renal impairment; not recommended in severe renal impairment (see Dosage and Administration).

Hepatic Impairment

Contraindicated in moderate-to-severe hepatic impairment.

Prolong is used on an as-needed basis only, not as a continuous course of treatment. It should not be taken more than once in any 24-hour period. If premature ejaculation persists despite appropriate on-demand use, patients should consult their physician to reassess the treatment plan; long-term daily use has not been evaluated and is not recommended.

Selective Serotonin Reuptake Inhibitor (SSRI); on-demand agent for premature ejaculation.

Dapoxetine Hydrochloride selectively inhibits the presynaptic reuptake of serotonin, increasing serotonin concentration in the synaptic cleft and enhancing stimulation of postsynaptic serotonin receptors involved in the spinal ejaculatory reflex, thereby delaying ejaculation. Its rapid absorption and rapid elimination make it suitable for on-demand rather than chronic dosing.

Prolong is not indicated for use in children or adolescents under 18 years of age. Safety and efficacy in this population have not been established, and use is contraindicated.