Vigora 100Mg

Introduction to Vigora

Vigora 100 mg is a branded drug with sildenafil citrate as its active pharmaceutical ingredient.

German Remedies, a subsidiary of Zydus Cadila Healthcare, produces Vigora. Vigora is a well-established drug for erectile dysfunction (ED) in the majority of markets across the globe.

The 100 mg dosage is the maximum strength standard dosage most commonly used for the treatment of erectile dysfunction, for those patients who need a higher dose based on efficacy and tolerability evaluations by physicians.

Composition and Pharmaceutical Status

Each Vigora tablet has exactly 100 mg of sildenafil citrate as the active therapeutic component. The composition is supplemented with a number of excipients such as microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, and magnesium stearate.

The blue, diamond-shaped, film-coated tablets have suitable markings to differentiate them from other drugs. This particular form of the drug allows identification while giving the active ingredient the desired stability.

Pharmacological Mechanism of Action

Sildenafil citrate is a cGMP-specific phosphodiesterase type 5 (PDE5) inhibitor. Sexual stimulation leads to the liberation of nitric oxide (NO) within the corpus cavernosum, which stimulates the guanylate cyclase enzyme to increase the levels of cGMP. Elevations in cGMP levels cause relaxation of the smooth muscles, promoting an increase in blood flow into penile tissues.

Prevention of the enzyme that breaks down cGMP by PDE5 allows Vigora to have elevated levels of cGMP, leading to vasodilation and facilitating sexual intercourse.

This action is selectively evoked by sexual stimulation, i.e., Vigora does not induce erections spontaneously in the absence of sexual stimulation. The profile of selective activity separates the PDE5 inhibitors from the other erectile dysfunction drugs and is the basis for their physiological action.

Clinical Pharmacokinetics

Following oral administration, Vigora is well absorbed with plasma levels being measurable in 30-60 minutes. Vigora has:

1. Complete oral bioavailability of about 40%
2. Peak plasma concentration (Cmax) usually between 30-120 minutes (median 60 minutes) when administered under fasting conditions
3. Delayed absorption when co-administered with high-fat meals, with possible extension of time to onset of action
4. Distribution volume of 105 liters, suggesting widespread tissue distribution
5. Plasma protein binding of about 96%
6. Metabolism primarily by hepatic enzymes, ie, cytochrome P450 isoenzymes 3A4 (major pathway) and 2C9 (minor pathway)
7. Terminal half-life of 3-5 hours
8. Excretion mainly in the form of metabolites, about 80% via the feces and 13% via the urine

Therapeutic Use and Dosage Details

Vigora 100 mg is utilized for the specific purpose of erectile dysfunction, a repeated inability to attain or maintain penile erection adequate for successful sexual performance.

The administration route generally adheres to the following practices:

• Initial starting dose generally usually 50 mg in most patients, titrated to 100 mg in accordance with the individual‘s response
• Administration 30-60 minutes prior to planned sexual intercourse
• Not to be used twice in a 24-hour period
• Possible dose reduction to 25-50 mg in patients >65 years old, patients with hepatic or severe renal impairment (creatinine clearance <30 mL/min), or patients on concomitant CYP3A4 inhibitors

The 100 mg dose is usually reserved in a patient who has already received 50 mg but found it inadequate for their requirements, after proper medical assessment to ascertain the suitability of the escalation of the dose.

Effectiveness in Clinical Trials

Large-scale clinical trials established the efficacy of sildenafil citrate in the therapy of erectile dysfunction in diverse etiologies. Some of the most significant outcomes of landmark studies are:

• 60-80% improvement in erectile function scores compared to placebo
• Effective intercourse rates of about 70-80% in the overall ED population
• Efficacy sustained during prolonged treatment durations (>1 yr)
• Moderate improvement in quality-of-life outcomes and relationship satisfaction
• Positive outcomes between various ED etiologies, including diabetes, post-prostatectomy, spinal cord injury, and psychogenic etiologies
• Dose-response with 100 mg having progressively greater efficacy than 50 mg in the selected patient groups

Safety Profile and Side Effects

As with any drug, Vigora can cause side effects, which are usually mild to moderate and reversible. The safety profile derived from clinical trials and post-marketing experience demonstrates:

Common Adverse Effects

• Headache 
• Facial flushing
• Dyspepsia/indigestion
• Nasal congestion
• Dizziness
• Visual symptoms such as blue vision and heightened light sensitivity

Less Common Side Effects

• Myalgia or back pain
• Rash or cutaneous reactions
• Gastroesophageal reflux
• Palpitations or tachycardia
• Epistaxis (nosebleeds)
• Insomnia or somnolence

Infrequent but Serious Side Effects

• Priapism (throbbing erection lasting >4 hours) needing emergency treatment
• Non-arteritic anterior ischemic optic neuropathy (NAION)
• Sudden sensorineural hearing loss
• Ventricular arrhythmias
• Hypersensitivity reactions such as Stevens-Johnson syndrome
• Seizures

Contraindications and Special Cases

Patients should not take Vigora if:

• Simultaneously administering nitric oxide donors or nitrates of any type
• With hypersensitivity to sildenafil or to any ingredient in the formulation
• With cases where sexual activity is not recommended owing to cardiovascular status
• In advanced hepatic insufficiency (Child-Pugh class C)
• With recent history of myocardial infarction or stroke within the last 90 days
• With severe hypotension (resting BP <90/50 mmHg) or uncontrolled hypertension (>170/110 mmHg)
• With inherited degenerative retinal diseases
• Under the age of 18 years

Special Cases requiring careful consideration include:

• Elderly patients (changed clearance can require reduced dosing)
• Renal impairment patients (dose adjustment is advised in severe cases)
• Individuals with anatomical deformation of the penis
• Patients with conditions that predispose to priapism
• Individuals with cardiovascular risk factors

Drug Interactions and Polypharmacy Issues

• The hepatic metabolism of sildenafil by cytochrome P450 enzymes results in many possible drug interactions:
• Major Interactions (Contraindicated Combinations)
• Organic nitrates and nitric oxide donors (severe, potentially fatal hypotension)
• Guanylate cyclase stimulators such as riociguat (additive hypotensive effect)
• Multiple PDE5 inhibitors simultaneously (increased adverse effect risk)

Important Interactions (Necessitating Dosage Adjustment or Closely Monitoring)

• CYP3A4 inhibitors: HIV protease inhibitors (particularly ritonavir), azole antifungals, macrolide antibiotics, and some antidepressants can increase sildenafil plasma levels substantially

• Alpha-adrenergic blocking agents: Other alpha-blockers may enhance hypotensive effects with doxazosin

• Antihypertensive drugs: Possible additive effect on blood pressure

• CYP3A4 inducers: Rifampin, carbamazepine, phenytoin, and St. John’s wort may reduce sildenafil plasma concentrations

• Grapefruit juice: Can inhibit sildenafil metabolism, raising plasma levels

Patient Education and Counseling Highlights

Prescribers must emphasize the following to the patients while prescribing Vigora:

Administration Rules

• Take 30-60 minutes before anticipated sexual activity
• May be administered with or without food, although fatty meals can cause delay in onset
• Avoid excessive alcohol consumption, which can lower efficacy and raise side effects
• Do not administer more than the dose of one dose every 24 hours
• Warning Signs That Need Medical Attention
• Sustained erection for more than 4 hours (priapism)
• Abrupt loss or loss of sight
• Abrupt loss or reduction of hearing 

Conclusion 

Vigora 100 mg is a potent therapeutic option in the management of erectile dysfunction, with successful control of the disorder affecting millions of men worldwide. The safety and efficacy profile of sildenafil citrate has been established hand in hand with extensive clinical experience and post-marketing surveillance.

As with all prescription medications, the optimal outcome occurs when Vigora is taken under appropriate medical supervision, with appropriate consideration of the patient’s overall health profile, concomitant therapy, and response. 

Medical professionals should perform adequate evaluations prior to prescribing Vigora, taking into account underlying conditions of erectile dysfunction and possible contraindications.

Patients need to be adequately educated on proper use, possible side effects, and when to seek medical attention. Proper use of Vigora can possibly improve erectile function, sexual satisfaction, and overall quality of life among men with erectile dysfunction.

Frequently Asked Questions

1. What is the difference between Vigora 100 mg and Viagra?

Both contain 100 mg of sildenafil citrate and work identically. The differences are in manufacturer (Vigora by German Remedies/Zydus Cadila; Viagra by Pfizer), appearance, inactive ingredients, and regional availability. Efficacy should be comparable, though some patients may notice slight variations in response time or side effects due to different formulations.

2. How quickly does Vigora work and how long does it last?

Vigora typically begins working in 30-60 minutes and remains effective for 4-6 hours. Individual response varies based on metabolism, food consumption (high-fat meals delay onset), and other factors. For optimal results, take on an empty stomach approximately one hour before sexual activity.

3. What are the common side effects?

Most common side effects include headache (16-28%), facial flushing (10-18%), indigestion (7-10%), nasal congestion (4-9%), and visual disturbances like blue-tinged vision (3-11%). These are usually mild and temporary. If side effects persist or become severe, consult your healthcare provider about reducing the dosage.

4. Can I take Vigora with alcohol or food?

Light, low-fat meals have minimal impact, but high-fat meals may delay absorption by up to an hour. Moderate alcohol (1-2 drinks) typically doesn’t significantly affect Vigora’s efficacy, but excessive consumption can impair erectile function regardless of medication and may increase side effects like dizziness and blood pressure changes.

5. When is Vigora unsafe to use?

Vigora is contraindicated with nitrate medications (potentially fatal blood pressure drop), recent heart attack or stroke, severe liver disease, certain eye conditions, and previous allergic reactions to sildenafil. Use cautiously with cardiovascular disease, penile anatomical abnormalities, bleeding disorders, kidney disease, and certain medications that affect sildenafil metabolism. Always consult a healthcare provider before starting treatment.