Adegra 50 mg Tablet (Sildenafil Citrate) – ACI Limited

1. About Adegra 50 mg (Sildenafil Citrate)

Adegra 50 mg Tablet is the standard starting dose of Sildenafil Citrate manufactured by ACI Limited, Bangladesh. This is the most commonly prescribed strength for the treatment of erectile dysfunction (ED) in adult men, as recommended by international urology and andrology guidelines. The 50 mg dose strikes the optimal balance between efficacy and tolerability for most men with ED.

Sildenafil, classified as a phosphodiesterase type 5 (PDE5) inhibitor, was the world's first approved oral therapy for erectile dysfunction and remains the global gold standard. ACI Limited's Adegra brand makes this evidence-based treatment widely accessible to men in Bangladesh at an affordable price.

2. Mechanism of Action

Sildenafil 50 mg selectively inhibits cGMP-specific phosphodiesterase type 5 (PDE5) in penile smooth muscle. During sexual stimulation, nitric oxide (NO) is released from the endothelium and nerve endings, activating guanylate cyclase and elevating cyclic GMP (cGMP) levels. Elevated cGMP causes smooth muscle relaxation and vasodilation in the corpus cavernosum, increasing penile blood flow and enabling erection.

Sildenafil prevents PDE5-mediated degradation of cGMP, enhancing and prolonging the natural erectile response to sexual stimulation. The 50 mg dose provides robust PDE5 inhibition with an excellent safety profile in most adult male patients. The effect begins approximately 30–60 minutes after ingestion and persists for 4–6 hours.

3. Indications

Adegra 50 mg is indicated for:

• Erectile Dysfunction (ED): First-line pharmacological treatment for men unable to achieve or maintain penile erection sufficient for satisfactory sexual performance. Effective across organic, psychogenic, and mixed-etiology ED.
• Wide patient population: ED associated with diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, post-prostatectomy (nerve-sparing), spinal cord injury, benign prostatic hyperplasia, depression/anxiety, and other causes

Adegra 50 mg is the recommended first prescription for most men with ED unless there is a specific clinical reason to start at a lower dose (25 mg) or higher dose (100 mg).

4. Dosage and Administration

Standard dosing for ED:

• Starting dose: 50 mg taken orally approximately 1 hour before sexual activity
• Range: May be taken 30 minutes to 4 hours before sexual activity
• Frequency: As needed; maximum once in 24 hours
• Dose adjustment: If 50 mg is insufficiently effective → increase to 100 mg. If side effects are problematic → decrease to 25 mg.

Administration tips:

• Take on an empty stomach or with a light meal for fastest onset; a high-fat meal delays absorption by up to 60 minutes
• Swallow whole with water
• Avoid grapefruit juice — may increase sildenafil blood levels
• Avoid alcohol — impairs erectile function and increases hypotension risk
• Sexual stimulation is required — the tablet does not cause erections without arousal

Special dose recommendations:

• Elderly (≥65 years): Start with 25 mg — clearance reduced ~40%
• Hepatic impairment (Child-Pugh A/B): Start with 25 mg
• Severe renal impairment (CrCl <30 mL/min): Start with 25 mg
• With ritonavir: Maximum 25 mg per 48 hours

5. Contraindications

• All organic nitrates (nitroglycerine, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate) — risk of severe, potentially fatal hypotension
• Riociguat (sGC stimulator) — risk of severe hypotension
• Known hypersensitivity to sildenafil or any component
• Severe hepatic impairment (Child-Pugh C)
• Recent MI or stroke within last 6 months
• Severe cardiovascular disease making sexual activity inadvisable
• Severe hypotension (BP <90/50 mmHg) or uncontrolled hypertension (>170/100 mmHg)
• History of NAION (non-arteritic anterior ischemic optic neuropathy)

6. Warnings and Precautions

Cardiovascular Risk Assessment: Sexual activity imposes cardiovascular demands. Before prescribing Adegra, assess cardiovascular fitness for sexual activity. ED itself is a sentinel marker of cardiovascular disease — investigate underlying causes.

Nitrate Prohibition: The combination of sildenafil with any nitrate is absolutely contraindicated due to severe synergistic hypotension. Patients using sublingual or spray nitrates for angina must not use sildenafil. If a patient has taken sildenafil and subsequently requires nitrate therapy for chest pain, at least 24–48 hours must elapse.

Priapism: Seek emergency medical attention for any erection persisting beyond 4 hours. Delayed treatment risks permanent penile damage and future erectile dysfunction.

Sudden Sensory Loss: Discontinue sildenafil and seek immediate medical care for any sudden decrease or loss of vision or hearing.

Diabetes Mellitus: A very significant proportion of men attending Bangladeshi clinics for ED have diabetes. Sildenafil is safe and effective in this group but blood pressure should be optimally controlled, and concurrent antihypertensive therapy carefully reviewed.

Alpha-Blocker Caution: Combination with alpha-blockers for BPH or hypertension can cause symptomatic hypotension — start with 25 mg and maintain separate dosing times if alpha-blocker is already stabilized.

7. Side Effects

Very common (≥10%):

• Headache — typically mild, frontal, resolving within 2–3 hours
• Flushing — warmth and redness, especially face and neck; vasodilatory effect

Common (1–10%):

• Nasal congestion (rhinitis)
• Dizziness
• Dyspepsia (stomach discomfort)
• Visual effects: altered colour perception (blue-green tinge), increased sensitivity to light — transient, dose-dependent PDE6 inhibition in retina
• Back pain, myalgia (at 50 mg, less common than at 100 mg)

Rare but serious:

• Priapism (prolonged erection >4 hours) — emergency
• Sudden visual loss (NAION) — discontinue and seek emergency care
• Severe hypotension — particularly if nitrate interaction or contraindications violated
• Sudden hearing loss or tinnitus

8. Drug Interactions

Contraindicated: All organic nitrates; riociguat; amyl nitrite

Use with caution (dose adjustment may be needed):

• Strong CYP3A4 inhibitors: ritonavir (max 25 mg/48h), ketoconazole, itraconazole, erythromycin, clarithromycin — increase sildenafil exposure
• CYP3A4 inducers: rifampicin, carbamazepine, phenytoin — reduce sildenafil levels and efficacy
• Alpha-1 blockers (doxazosin, prazosin): additive hypotension — use lowest dose (25 mg), separate timing by ≥4 hours
• Antihypertensives: amlodipine, ACE inhibitors, ARBs — additive vasodilation and BP lowering
• Alcohol: additive vasodilation, increased dizziness/hypotension, and independently impairs erection
• Grapefruit juice: modestly increases sildenafil plasma levels

9. Pharmacokinetics

Absorption: Rapidly absorbed; absolute bioavailability ~41%. Median Tmax ~60 minutes (fasted). High-fat meal delays Tmax by ~60 minutes. Mean Cmax at 50 mg ~0.74 mcg/mL.

Distribution: Vd ~105 L. Protein binding ~96% (sildenafil and active metabolite N-desmethylsildenafil). Negligible distribution into erythrocytes.

Metabolism: Hepatic via CYP3A4 (major) and CYP2C9 (minor). Active metabolite N-desmethylsildenafil (~50% potency of parent) represents ~20% of total pharmacological activity at 50 mg.

Elimination: Terminal t½ ~3–5 hours. Primarily excreted as metabolites in feces (~80%) and urine (~13%). Plasma clearance ~41 L/h. Clearance reduced in elderly, hepatic impairment, and severe renal impairment.

10. Efficacy Data

Sildenafil 50 mg has demonstrated robust efficacy across all major clinical trial programs:

• General ED population: ~74% of patients reported improved erections vs ~22% placebo in pivotal trials
• Diabetic ED: 57% of patients on sildenafil achieved successful intercourse vs 10% placebo (NEJM 1998)
• Post-radical prostatectomy (nerve-sparing): 43% improved erections vs 15% placebo
• Psychogenic ED: ~84% response rate
• Hypertensive patients: Effective and safe when used appropriately with antihypertensives (except nitrates)

IIEF (International Index of Erectile Function) scores improved significantly across all ED severity levels — mild, moderate, and severe.

11. Erectile Dysfunction and Diabetes in Bangladesh

Erectile dysfunction is one of the most common yet underreported complications of diabetes in Bangladesh. Studies suggest:

• ED prevalence in diabetic men: 50–75% (significantly higher than 15–25% in age-matched non-diabetic men)
• ED often appears 10–15 years earlier in diabetic men than in the general population
• Causes: diabetic vasculopathy reduces penile blood supply; autonomic neuropathy impairs nerve-mediated vasodilation; hypogonadism (low testosterone) is more prevalent in T2DM
• Sildenafil 50 mg remains the evidence-based first-line oral pharmacological treatment for diabetic ED in both Bangladesh and international guidelines
• Consistent glycemic control (HbA1c <7%) improves endothelial function and may enhance sildenafil response

12. Adegra Product Range — ACI Limited

• Adegra 25 mg: For elderly patients, renal/hepatic impairment, or patients with drug interactions. Lower starting dose for sensitive populations.
• Adegra 50 mg: Standard recommended starting dose for most adult men with erectile dysfunction.
• Adegra 100 mg: Maximum dose; for patients with inadequate response to 50 mg.

13. Storage

• Store below 30°C in a cool, dry place
• Protect from direct sunlight, heat, and humidity
• Keep out of reach of children
• Do not use after the expiry date on the blister pack
• Keep in original packaging until use

Frequently Asked Questions (FAQ)

Q1: How quickly does Adegra 50 mg work?

Adegra 50 mg typically starts working within 30 to 60 minutes when taken on an empty stomach. For most men, the optimal time to take it is about 1 hour before sexual activity. The effect lasts for approximately 4 to 6 hours, during which time sexual stimulation will produce a response. Eating a heavy or high-fat meal before taking the tablet can delay the onset by up to 1 hour. Alcohol and anxiety can also reduce effectiveness.

Q2: Is Adegra 50 mg safe for diabetic men?

Yes — sildenafil 50 mg is considered safe and effective for diabetic men with erectile dysfunction and is the first-line recommended oral treatment in this population. It can be used alongside common diabetes medications (metformin, sulphonylureas, DPP-4 inhibitors, insulin) without pharmacokinetic interactions. The key precaution: sildenafil must not be taken with nitrate medications. Blood pressure should be well-controlled, and your cardiologist or diabetologist should assess cardiovascular fitness before starting therapy. Response rates in diabetic men (~57%) are somewhat lower than in men without diabetes due to vascular and nerve damage.

Q3: What should I do if Adegra 50 mg is not working?

If 50 mg is not producing satisfactory results, consider: (1) ensuring you take it on an empty stomach — a heavy meal delays absorption significantly; (2) allowing sufficient time (at least 60 minutes) after taking the tablet before sexual activity; (3) ensuring adequate sexual stimulation — sildenafil amplifies the natural response but does not work without arousal; (4) avoiding alcohol. If consistently unsuccessful after these adjustments, your doctor may increase the dose to 100 mg or investigate underlying causes of ED (low testosterone, severe vascular disease, psychological factors). Do not exceed 100 mg or take more than once per day.

Q4: Can I take Adegra 50 mg with my blood pressure medication?

Sildenafil can generally be used safely alongside most blood pressure medications including ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers — though it may cause additional blood pressure lowering. However, sildenafil is absolutely contraindicated with nitrate medications (such as nitroglycerin used for angina) — this combination can cause a dangerous, potentially fatal drop in blood pressure. Always tell your doctor about all medications you take, including heart and blood pressure medicines, before starting Adegra.