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 .
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.
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.
Vriligy should be swallowed whole with a full glass of water one to three hours before sexual activity . 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.
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 .
Vriligy lasts for one to three hours. The drug can retain its effectiveness for as long as twelve hours.
Dapoxetine’s discontinuation rate is significant, mainly due to its high cost . 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.
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].
Vriligy is recommended for use in adult men aged 18 to 64 years who have PE . 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 :
- 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.
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.
The following are the side effects of Vriligy:
- A rise in blood pressure
- Blurred vision
- Decreased libido
- Diarrhea or constipation
- Difficulty in achieving or maintaining an erection
- Difficulty in concentrating
- Dry mouth
- Feeling Sick
- Irritability, agitation
- Nasal congestion
- Pins and needle sensation
- Shaking or trembling
- Strange dreams
- Abnormal taste
- Blurred Vision
- Change in mood (excitement, depression, confusion, nervousness, disorientation, etc.)
- Feeling dizzy upon standing
- Feeling hot or jittery
- Low or high blood pressure
- Spinning sensation
- Teeth grinding
- Weakness, sedation, and lethargy
- 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
- Suicidal thoughts
Co-administrating certain medications may increase the adverse effects.
Medications that should not be mixed with dapoxetine include:
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.
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.
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 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.
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.
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.
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.
- 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
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 .
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 .
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 .
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.
Alternative prescription medications that have the same mechanism of action as Vriligy are:
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)
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.
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