Vriligy

Vriligy is a medication containing dapoxetine. It is used in the treatment and prevention of persistent or recurrent premature ejaculation (PE). It improves control over ejaculation and reduces the distress associated with faster ejaculation.

This comprehensive article on Vriligy will discuss the mechanism of action along with the dosage, use, safety profile, and drug interaction.

What is Vriligy?

Vriligy is manufactured by the Indian pharmaceutical company Centurion Laboratories. Each film-coated round tablet of Vriligy contains 30mg of dapoxetine hydrochloride. It is also available in 60mg tablets.

Dapoxetine is a fast-acting selective serotonin reuptake inhibitor (SSRI). This reuptake inhibition increases serotonin levels at the nerve endings and leads to ejaculatory delay. Unlike other SSRIs, dapoxetine was explicitly developed to treat PE [1].

Vriligy is structurally similar to Priligy and contains the same active ingredient. Keep in mind that the drug is not a sexual stimulant or a cure for PE. This medication is available only with a licensed doctor’s prescription and must be taken as directed by your healthcare provider.

What is the Dose of Vriligy?

Dapoxetine is approved in dosages of 30 mg and 60 mg. The recommended starting dose is 30 mg. If this is insufficient and moderate or severe adverse effects are absent, the dose can be increased to 60 mg. Two doses should be twenty-four hours apart.

Vriligy is an on-demand drug used when sexual activity is anticipated. It is not for continuous daily use.

How Should I Take Vriligy?

Vriligy should be swallowed whole with a full glass of water one to three hours before sexual activity [1]. The tablet has a bitter taste hence crushing or chewing should be avoided. The tablet can be taken with or without food. Avoid drinking grapefruit juice and alcohol while using this medication.

Follow all directions given to you by your doctor or pharmacist carefully. Do not stop the drug without consulting your healthcare provider.

How Long Does it Take for Vriligy to Kick In?

Vriligy has a short onset of action and is rapidly absorbed following oral administration. The time duration required for the drug to show its effects varies in different individuals. Generally, the peak plasma level of the drug is achieved within sixty minutes after a single oral dose [1].

How Long Does Vriligy Last?

Vriligy lasts for one to three hours. The drug can retain its effectiveness for as long as twelve hours.

How Much Does Vriligy Cost?

Dapoxetine’s discontinuation rate is significant, mainly due to its high cost [2]. Vriligy is a very reasonably priced drug, unlike other brands. Each tablet costs $0.032 and comes in a strip of 10 tablets. Prices depend upon the type of insurance coverage and the availability of the drug.

The History of Vriligy

Dapoxetine was created by the pharmaceutical company Eli Lilly. It was initially manufactured as an antidepressant but was ineffective. The drug was shelved for some time before it was revived and subsequently developed to treat PE. Dapoxetine was sold to Johnson & Johnson’s subsidiary Alza in 2003.

Dapoxetine has been in phase III development and is not yet approved by the US Food and Drug Administration (FDA). It has received marketing authorization in 33 countries worldwide, including Germany, Finland, Sweden, Portugal, Austria, Italy, Mexico, Spain, South Korea, and New Zealand. Dapoxetine is currently manufactured under different brand names, such as Priligy and Vriligy [1, 3, 4].

Who Should Take Vriligy?

Vriligy is recommended for use in adult men aged 18 to 64 years who have PE [1]. It should not be used to delay ejaculation in men who have not been diagnosed with PE. Dapoxetine should only be used by men who meet all of the following criteria [5]:

An intravaginal ejaculatory latency time (IELT) of less than two minutes
Recurrent or persistent ejaculation with minimal sexual stimulation
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

Before using the drug, consult your doctor about whether or not the drug is appropriate for you.

What Are the Side Effects of Vriligy?

Vriligy is rapidly eliminated from the body. The plasma levels fall below 5% by twenty-four hours post-administration. This reduces the probability of unwanted side effects. Nevertheless, there are some adverse effects associated with the use of Vriligy. The incidence and severity of adverse events are higher with the 60 mg dose.

Common Side Effects

The following are the side effects of Vriligy:

A rise in blood pressure
Anxiety
Blurred vision
Decreased libido
Diarrhea or constipation
Difficulty in achieving or maintaining an erection
Difficulty in concentrating
Dizziness
Dry mouth
Feeling Sick
Flushing
Headache
Indigestion
Insomnia
Irritability, agitation
Nasal congestion
Pins and needle sensation
Restlessness
Shaking or trembling
Strange dreams
Sweating
Tinnitus
Tiredness

Uncommon Side Effects

Abnormal taste
Arrhythmia
Blurred Vision
Bradycardia
Change in mood (excitement, depression, confusion, nervousness, disorientation, etc.)
Fainting
Feeling dizzy upon standing
Feeling hot or jittery
Low or high blood pressure
Pruritus
Spinning sensation
Sweating
Tachycardia
Teeth grinding
Weakness, sedation, and lethargy

Rare Side Effects

Feeling dizzy following exertion
Sudden onset of sleepiness

Vriligy should be discontinued immediately if the following adverse effect occurs:

Feeling light-headed while standing up
Mood changes
Seizures
Suicidal thoughts

Potential Drug Interactions With Vriligy

Co-administrating certain medications may increase the adverse effects.

Medications that should not be mixed with dapoxetine include:

Nitrates

Dapoxetine and nitrates should not be mixed as there is a possibility of reduced orthostatic tolerance. Lightheadedness, fainting, and a rapid increase in heart rate can occur when standing in an upright posture.

Antidepressants

Dapoxetine has serious interactions with monoamine oxidase inhibitors such as Isocarboxazid, Phenelzine, and Selegiline. Combination therapy should be avoided as there are reports of serious and lethal reactions. Worsening of symptoms associated with depression is also reported.

Antipsychotics

Thioridazine with Vriligy can lead to serious ventricular arrhythmias. Dapoxetine inhibits the CYP2D6 isoenzyme, inhibiting the metabolism of thioridazine. Elevated levels of thioridazine cause ventricular arrhythmias.

Drugs Used for Migraines

Drugs like sumatriptan should be avoided when taking Vriligy. Both drugs increase serotonin levels in the body leading to confusion, agitation, increased blood pressure, and heart rate.

Alcohol

The neurocognitive effects of alcohol may increase when taken with Vriligy. It also enhances the neuro-cardiac genetic effect and can put you at risk for accidental injury from fainting.

Recreational Drugs

Vriligy should not be combined with recreational drugs. Drugs like MDMA, ketamine, and lysergic acid (LSD) further increase serotonin levels. Other drugs like narcotics and benzodiazepines enhance the sedative effects of dapoxetine.

Drugs That Affect Platelet Function

Concomitant use with drugs like nonsteroidal anti-inflammatory drugs (NSAIDs), anti-platelet agents, or anticoagulants like warfarin should be avoided. Bleeding abnormalities have been reported with SSRIs, and co-administration may cause hemorrhage.

Medicinal & Herbal Products With Serotonergic Effects

Vriligy should not be used with other SSRIs and herbal products that increase serotonin, like St. John’s wort. This can cause serotonin syndrome, which can be deadly [3].

Who Should Avoid Using Vriligy?

Vriligy should not be used in pregnant women (Pregnancy Category C)
Nursing mothers
Patients with known hypersensitivity to dapoxetine or any of the excipients
Men under the age of 18 years
Elderly patients of more than 65 years
Individuals with severe renal impairments
Individuals with moderate to severe hepatic impairment
Patients with raised intraocular pressure or those at risk of angle-closure glaucoma
Patients treated with moderate or potent CYP3A4 and CYP2D6 inhibitors (e.g., Itraconazole, ketoconazole, ritonavir, saquinavir, telithromycin, nelfinavir, nefazodone, atazanavir, etc.)
Patients with underlying heart disease (heart failure, significant ischemic or valvular heart disease, and conduction abnormalities)
Patient with a history of fainting
Psychiatric patients (mania or depression)
Patients on drugs that can potentially interact with dapoxetine (e.g., monoamine oxidase inhibitors, lithium, tramadol, tryptophan, thioridazine, and other SSRIs)
Patients using other herbal products with serotonergic effects

What is the Mechanism of Action of Vriligy?

The process of ejaculation is affected by numerous factors. The most important one is the central serotonin levels. A serotonin-induced decrease in dopamine leads to an inhibitory effect on libido, ejaculation, and orgasms.

Dapoxetine is a fast-acting inhibitor of serotonin reuptake. This potentiates the action of serotonin at the pre and post-synaptic receptors and aids in prolonging ejaculation [5].

Medical Research Involving Vriligy

One study tested the safety and efficacy of dapoxetine in 212 adult men. This study population received 30 mg of dapoxetine and was evaluated for 12 weeks. There was a 2.9-fold increase in IELT in men using dapoxetine [5].

Dapoxetine (30 and 60 mg) has also been evaluated in five randomized, double-blind, placebo-controlled studies. These studies included 6081 men above 18 years of age. The mean IELT improved significantly with both doses of dapoxetine versus placebo [6].

Can Vriligy be Used in Women?

Vriligy is not recommended for use in pregnant women. The excretion of dapoxetine in human milk is unknown. Hence, it should be avoided in lactating mothers.

Pharmaceutical Alternatives to Vriligy

Alternative prescription medications that have the same mechanism of action as Vriligy are:

Dapigra
Extensil
Kutub
Priligy
Sustinex
Xydap

Other Natural Alternatives to Vriligy

Natural and herbal formulations can be used as an alternative to Vriligy. The following natural alternatives should be used with caution and must not be simultaneously used with the drug.

Ayurvedic herbal medicine (Kaunch beej, Kamini vidrawan ras, and Yauvanamrit vati)
Foods that increase serotonin (eggs, cheese, pineapples, tofu, salmon, nuts, and seeds)
Food rich in zinc and magnesium (soybeans, oysters, yogurt, spinach)

Where to Buy Vriligy?

Vriligy needs a registered physician’s prescription for use. The drug can be purchased online or in your local pharmacies. Purchasing the drug online is time and cost-saving and also maintains privacy.

References Cited

McCarty, E. J., & Dinsmore, W. W. (2012). Dapoxetine: an evidence-based review of its effectiveness in the treatment of premature ejaculation. Core evidence, 7, 1
Park, H. J., Park, N. C., Kim, T. N., Baek, S. R., Lee, K. M., & Choe, S. (2017). Discontinuation of dapoxetine treatment in patients with premature ejaculation: a 2-year prospective observational study. Sexual medicine, 5(2), e99-e105.
Dapoxetine: LY 210448. (2005). Drugs in R&D, 6(5), 307–311.
McMahon, C. G. (2012). Dapoxetine: a new option in the medical management of premature ejaculation. Therapeutic advances in urology, 4(5), 233-251
Safarinejad, M. R. (2008). Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Neuropsychopharmacology, 33(6), 1259-1265.
McMahon, C. G., Althof, S. E., Kaufman, J. M., Buvat, J., Levine, S. B., Aquilina, J. W., … & Porst, H. (2011). Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. The journal of sexual medicine, 8(2), 524-539.