Chemical name: (1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenylpropan-1-amine
Formula: C21H23NO
Anabolic activity index: not a steroid
Androgenic activity index: not a steroid

VRILIGY-60

Introduction

VRILIGY-60 is a pharmaceutical product containing the active ingredient Dapoxetine at a concentration of 60 mg per tablet. Manufactured by Centurion Laboratories, VRILIGY-60 is designed to treat premature ejaculation (PE) in men aged 18 to 64. This medication belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), which are commonly used to manage conditions related to neurotransmitter imbalances in the brain. By specifically targeting the serotonin levels in the brain, VRILIGY-60 helps to enhance control over ejaculation and increase the time to ejaculation during sexual activity.

Composition

Each tablet of VRILIGY-60 contains:

Active Ingredient: Dapoxetine Hydrochloride (equivalent to Dapoxetine 60 mg)
Inactive Ingredients: These may include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and other excipients. The exact composition of inactive ingredients may vary depending on the manufacturing process and formulation practices of Centurion Laboratories.

Indications

VRILIGY-60 is indicated for the treatment of premature ejaculation in adult men aged 18 to 64. Premature ejaculation is a common sexual dysfunction characterized by ejaculation that occurs with minimal sexual stimulation and before the individual wishes it, leading to distress or interpersonal difficulty. VRILIGY-60 is effective in increasing the time it takes to ejaculate and improving control over ejaculation, thereby enhancing sexual satisfaction for both the patient and their partner.

Mechanism of Action

Dapoxetine, the active ingredient in VRILIGY-60, functions as a selective serotonin reuptake inhibitor (SSRI). By inhibiting the reuptake of serotonin in the synaptic cleft, Dapoxetine increases the levels of serotonin in the central nervous system. Serotonin is a neurotransmitter that plays a significant role in modulating mood, emotion, and sexual function. In the context of ejaculation, increased serotonin levels are associated with delayed ejaculation. Thus, VRILIGY-60 helps extend the time to ejaculation and improves ejaculatory control by enhancing serotonergic activity in the brain.

Dosage and Administration

Recommended Dosage: The usual recommended dose of VRILIGY-60 is 60 mg taken as needed, approximately 1 to 3 hours before sexual activity.
Administration: The tablet should be swallowed whole with at least one full glass of water to prevent any potential throat irritation or discomfort. VRILIGY-60 can be taken with or without food.
Dosage Adjustment: Depending on individual response and tolerance, the dose may be adjusted. However, the maximum recommended dosing frequency is once every 24 hours.
Important Note: It is crucial to consult with a healthcare provider before starting VRILIGY-60 to determine the appropriate dosage and ensure safe use, particularly in patients with underlying health conditions or those taking other medications.

Contraindications

VRILIGY-60 is contraindicated in patients who have:

Hypersensitivity to Dapoxetine or any of the excipients in the formulation.
A history of heart failure, significant cardiac arrhythmias, or significant coronary artery disease.
Severe liver impairment, as Dapoxetine is extensively metabolized in the liver.
Concurrent use of monoamine oxidase inhibitors (MAOIs), thioridazine, or other SSRIs.
A history of syncope (fainting) or conditions that predispose to fainting.

Precautions and Warnings

Orthostatic Hypotension: VRILIGY-60 can cause orthostatic hypotension (a sudden drop in blood pressure when standing up), leading to dizziness or fainting. Patients are advised to rise slowly from a sitting or lying position to minimize this risk.
Serotonin Syndrome: Although rare, combining VRILIGY-60 with other serotonergic agents may increase the risk of serotonin syndrome, a potentially life-threatening condition. Symptoms include agitation, hallucinations, fever, sweating, shivering, tachycardia, and muscle rigidity.
Avoid Alcohol: Alcohol consumption should be avoided while taking VRILIGY-60 as it may increase the risk of side effects such as dizziness, drowsiness, and impaired judgment.
Renal Impairment: Caution is advised in patients with mild to moderate renal impairment. The use of VRILIGY-60 in patients with severe renal impairment is not recommended.
Mental Health: Patients with a history of depression or bipolar disorder should be monitored closely while on VRILIGY-60, as it may exacerbate these conditions.

Side Effects

Like all medications, VRILIGY-60 may cause side effects. The most commonly reported side effects include:

Very Common (≥10%): Nausea, dizziness, headache.
Common (1% to 10%): Diarrhea, insomnia, fatigue, dry mouth, upper respiratory tract infection.
Uncommon (<1%): Anxiety, restlessness, blurred vision, tremor, excessive sweating, increased blood pressure, tachycardia, palpitations.
Rare: Syncope, particularly when rising quickly from a sitting or lying position.

Most side effects are mild to moderate in intensity and tend to decrease with continued use of the medication. However, if any severe side effects or signs of an allergic reaction occur, such as rash, itching, swelling, severe dizziness, or trouble breathing, patients should seek immediate medical attention.

Drug Interactions

VRILIGY-60 can interact with several other medications, which may alter its effects or increase the risk of adverse reactions:

SSRIs, SNRIs, MAOIs, and other serotonergic drugs: Concurrent use can increase the risk of serotonin syndrome.
CYP3A4 inhibitors: Strong inhibitors of CYP3A4 (such as ketoconazole, itraconazole, and ritonavir) can increase the plasma concentration of Dapoxetine, raising the risk of side effects.
Thioridazine: Co-administration can increase thioridazine levels and the risk of serious ventricular arrhythmias.
NSAIDs and anticoagulants: Use with caution as VRILIGY-60 can increase bleeding risks when taken with medications that affect bleeding time.

Storage

Temperature: Store VRILIGY-60 at room temperature, between 20°C to 25°C (68°F to 77°F).
Conditions: Keep the tablets in their original packaging, away from direct light, moisture, and heat.
Keep Out of Reach of Children: Ensure that this medication is stored in a secure location out of the reach of children and pets.

Packaging

VRILIGY-60 is available in blister packs containing 10 tablets each. The packaging is designed to maintain the integrity and stability of the medication, ensuring that each dose delivers the intended therapeutic effect.

Manufacturer Information

Centurion Laboratories is a renowned pharmaceutical company that specializes in manufacturing a wide range of high-quality medications. With a commitment to innovation and adherence to stringent quality standards, Centurion Laboratories ensures that all its products, including VRILIGY-60, are safe, effective, and reliable.

Conclusion

VRILIGY-60 (Dapoxetine Tablets 60 mg) is a well-established treatment option for men experiencing premature ejaculation. By increasing serotonin levels in the brain, it helps delay ejaculation and improve control, thereby enhancing sexual satisfaction. As with any medication, it is essential to use VRILIGY-60 under the guidance of a healthcare provider to ensure safe and effective treatment. For those affected by premature ejaculation, VRILIGY-60 offers a promising solution to improve quality of life and intimate relationships.