Filitra 20 Mg (Vardenafil) Medically reviewed by Sanjay Gangani, B.Pharm, CMO & Pharmacist
Active Ingredient Vardenafil Indication Erectile Dysfucntion Manufacturer Fortune Healthcare Pvt. Ltd. Strength:- 20mg Packaging 10 tablets in 1 strip
INQUIRE ABOUT Filitra 20 Mg (Vardenafil)
What is Filitra 20 Mg? Filitra 20 is a prescription tablet for erectile dysfunction.
Each tablet contains 20 mg of vardenafil hydrochloride.
Vardenafil belongs to the PDE-5 inhibitor drug class.
It is made by Fortune Healthcare Product Pvt. Ltd. in Gujarat, India.
It carries the same active molecule as Levitra tablets by Bayer.
It is a generic alternative, sold at a lower price point.
It helps men get and keep an erection firm enough for sex.
Sexual stimulation is still required for the tablet to work.
Filitra 10 mg strength is the maximum approved vardenafil dose.
Most men are advised to begin on 10 mg, not 20 mg.
It does not cure erectile dysfunction permanently.
It does not increase sexual desire or libido.
It does not protect against HIV or other sexually transmitted infections.
It is not a contraceptive and does not prevent pregnancy.
It is for adult men only, under medical supervision.
How It Works (Mechanism of Action) An erection is a blood-flow event. Vardenafil supports it in seven steps.
Sexual arousal releases nitric oxide inside penile nerve and vessel tissue.
Nitric oxide switches on an enzyme called guanylate cyclase.
This enzyme increases cyclic guanosine monophosphate, known as cGMP.
cGMP relaxes the smooth muscle of the corpus cavernosum.
Relaxed muscle lets the arteries widen, so blood flows in.
The enzyme PDE-5 normally breaks cGMP down and ends the erection.
Vardenafil blocks PDE-5, so cGMP lasts longer and the erection holds.
Vardenafil is highly selective for PDE-5 over other enzyme types.
Selectivity is over 15-fold versus PDE6 in the retina.
Selectivity is over 130-fold versus PDE1 and over 300-fold versus PDE11.
PDE-5 is the most abundant such enzyme in penile tissue.
Without arousal, blocking PDE-5 produces no erection at all.
Absolute bioavailability of vardenafil is about 15 percent.
Peak blood levels occur between 30 minutes and 2 hours after a tablet.
The median time to peak level is about 60 minutes.
The elimination half-life is roughly 4 to 5 hours.
The liver enzyme CYP3A4 does most of the drug breakdown.
About 91 to 95 percent is cleared in the faeces as metabolites.
Dosage Guide Doses below follow the approved vardenafil prescribing information. Your doctor decides your dose.
Patient situation Vardenafil dose Timing before sex Maximum frequency Usual adult starting dose, 18 to 64 years 10 mg 25 to 60 minutes Once in 24 hours Filitra 20 tablet, one whole tablet 20 mg 25 to 60 minutes Once in 24 hours Maximum approved single dose 20 mg 25 to 60 minutes Once in 24 hours Age 65 years and above Start at 5 mg 25 to 60 minutes Once in 24 hours Moderate liver impairment (Child-Pugh B) Start 5 mg, never above 10 mg 25 to 60 minutes Once in 24 hours Severe liver impairment (Child-Pugh C) Do not use Not applicable Not applicable Patients on renal dialysis Do not use Not applicable Not applicable Stable alpha-blocker therapy Start at 5 mg 25 to 60 minutes Once in 24 hours With erythromycin, ketoconazole 200 mg or itraconazole 200 mg Maximum 5 mg 25 to 60 minutes Once in 24 hours With indinavir, saquinavir, atazanavir, clarithromycin, ketoconazole 400 mg or itraconazole 400 mg Maximum 2.5 mg 25 to 60 minutes Once in 24 hours With ritonavir or cobicistat Maximum 2.5 mg 25 to 60 minutes Once in 72 hours Mild to severe kidney impairment, not on dialysis No dose change needed 25 to 60 minutes Once in 24 hours
Important dosing cautions Filitra 40 mg is the maximum dose, not the usual starting dose.
Most men should trial 10 mg properly before moving to 20 mg.
Many rows in the table above need a dose below 20 mg.
Do not split or halve the tablet unless a pharmacist confirms it is scored.
Ask your doctor for a lower strength if you need 2.5, 5 or 10 mg.
Never take two tablets in the same 24-hour period.
Never raise your own dose because the first dose felt weak.
Doses above 20 mg have caused severe back pain and vision problems.
How to Take It Take Filitra 20 only when a doctor has prescribed it.
Check the expiry date printed on the blister strip.
Check the blister pocket is sealed and the tablet is intact.
Push the tablet out through the foil. Do not cut the blister open.
Swallow the tablet whole with a glass of water.
Do not crush, chew, split or dissolve the tablet.
Take the dose about 25 to 60 minutes before sex.
Allow sexual stimulation, since the drug needs arousal to work.
Wait at least 24 hours before taking another tablet.
Return any tablet you drop or damage to the pharmacy.
Practical tips The tablet can be taken with or without food.
A light or low-fat meal is better than a heavy one.
A high-fat meal can cut peak drug levels by 18 to 50 percent.
Do not use it with any other erectile dysfunction treatment.
There is no daily schedule. It is taken only when needed.
If a planned dose is skipped, take it before the next occasion.
Never double a dose to make up for a missed one.
Keep the blister in its carton so the batch number stays readable.
Carry a written list of all your medicines for your doctor.
Precautions Absolute contraindications (never use) Any nitrate medicine, in any form or schedule.
Nitrate examples: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate.
Nitrate sprays, patches, ointments and pastes are also included.
Nitric oxide donors such as nicorandil.
Recreational “poppers” containing amyl nitrite or butyl nitrite.
Riociguat or any other guanylate cyclase stimulator.
Known allergy to vardenafil or to any tablet ingredient.
Men advised by a doctor that sexual activity is unsafe.
Severe liver impairment, meaning Child-Pugh class C.
Patients receiving renal dialysis.
Congenital or known long QT syndrome.
Class IA antiarrhythmics such as quinidine or procainamide.
Class III antiarrhythmics such as amiodarone or sotalol.
Women, children and anyone under 18 years of age.
Conditions to disclose to your doctor Angina, heart failure, or an irregular heartbeat.
Heart attack or stroke within the last six months.
Uncontrolled high blood pressure above 170/110 mmHg.
Low blood pressure, with resting systolic below 90 mmHg.
Aortic stenosis or other left ventricular outflow obstruction.
Any liver disease, even if it is mild.
Any kidney disease, and whether you need dialysis.
Retinitis pigmentosa or another inherited retinal disorder.
Past sudden vision loss or diagnosed NAION.
Hearing loss, tinnitus or recurring vertigo.
Sickle cell anaemia, multiple myeloma or leukaemia.
Peyronie disease, penile curvature or cavernosal fibrosis.
Any past erection that lasted longer than four hours.
Active stomach ulcers or any bleeding disorder.
A history of seizures.
Family history of long QT syndrome or sudden cardiac death.
Every prescription, over-the-counter and herbal product you use.
Food and drink precautions Avoid grapefruit and grapefruit juice on dosing days.
Grapefruit blocks CYP3A4 and raises vardenafil blood levels.
Avoid Seville oranges and bitter orange marmalade for the same reason.
Avoid heavy, high-fat meals shortly before your dose.
High-fat food can reduce peak drug levels by 18 to 50 percent.
A light, low-fat meal is the better choice.
Limit alcohol, since it worsens erectile function on its own.
Alcohol can also add to dizziness and low blood pressure.
Avoid herbal male enhancement supplements entirely.
Such products have been found to contain hidden PDE-5 drugs.
Never combine the tablet with sildenafil, tadalafil or avanafil.
Before-use safety checklist Confirm every point below before each dose.
I have a valid prescription from a registered doctor.
My doctor has agreed that 20 mg is the right strength for me.
I take no nitrate medicine of any kind.
I do not use poppers or any nitric oxide donor.
I do not take riociguat or a similar medicine.
My doctor has confirmed sexual activity is safe for my heart.
I have given my doctor a full list of my medicines.
I have declared my liver, kidney, eye and hearing history.
I have taken no vardenafil in the last 24 hours.
I have taken no other ED medicine in the last 24 hours.
The blister is sealed, undamaged and within its expiry date.
I have avoided grapefruit and a heavy fatty meal today.
I know the emergency warning signs listed in Section 8.
Side Effects Common side effects Rates below come from placebo-controlled trials of vardenafil 5 mg, 10 mg and 20 mg.
Side effect What it feels like Reported rate What to do Headache Dull ache, often frontal 15 percent Rest and hydrate. Usually settles in hours. Flushing Warmth and redness of face or neck 11 percent Stay cool. Avoid alcohol and hot rooms. Rhinitis Blocked or runny nose 9 percent Usually short-lived. Saline spray may help. Dyspepsia Indigestion or burning in the stomach 4 percent Avoid rich food before your dose. Sinusitis Facial pressure and congestion 3 percent Tell your doctor if it keeps returning. Flu-like symptoms Aches and feeling generally unwell 3 percent Usually mild and self-limiting. Dizziness Light-headed, especially on standing 2 percent Sit or lie down. Do not drive. Nausea Queasy stomach 2 percent Sip water. Eat something light. Raised creatine kinase A blood test change, usually silent 2 percent No action unless your doctor advises. Back pain Ache in the lower back About 2 percent Ask a pharmacist about a simple painkiller.
Less common side effects Each of these was reported by fewer than 2 in 100 users.
Body system Reported effects Action needed Heart and circulation Palpitations, fast heartbeat, low blood pressure, chest pain, angina Stop and seek urgent medical advice Eyes Blurred vision, blue tinge to objects, light sensitivity, eye pain, red eyes Report to your doctor promptly Ears Ringing in the ears, vertigo Stop the medicine and call your doctor Nervous system Drowsiness, sleep problems, tingling, fainting, memory loss, seizure Seek medical advice without delay Digestive system Dry mouth, diarrhoea, vomiting, acid reflux, abdominal pain Usually self-limiting. Report if severe. Muscles Muscle ache, cramps, increased muscle tone Usually mild. Report if persistent. Breathing Shortness of breath, sinus congestion Seek review if breathless at rest Skin Rash, redness, swelling of face or throat Stop at once if the face or throat swells Urogenital Increased erection frequency, prolonged erection, priapism Erection over 4 hours is an emergency Rare post-marketing Sudden hearing loss, NAION with sudden vision loss Stop the medicine. Get urgent care.
Drug Interactions – Avoid With Never combine with these Nitrates: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate.
Nitrate patches, sprays, ointments and pastes.
Nicorandil and other nitric oxide donors.
Poppers containing amyl nitrite or butyl nitrite.
Riociguat and other guanylate cyclase stimulators .
Class IA antiarrhythmics: quinidine, procainamide.
Class III antiarrhythmics: amiodarone, sotalol.
Other ED drugs: sildenafil, tadalafil, avanafil, alprostadil.
Herbal ED supplements that may hide undeclared PDE-5 inhibitors.
Use only with a doctor-adjusted dose Ritonavir and cobicistat: maximum 2.5 mg in 72 hours.
Indinavir, saquinavir, atazanavir: maximum 2.5 mg in 24 hours.
Ketoconazole 400 mg or itraconazole 400 mg: maximum 2.5 mg in 24 hours.
Riociguat and other soluble guanylate cyclase stimulators.
Ketoconazole 200 mg or itraconazole 200 mg: maximum 5 mg in 24 hours.
SSRIs: fluoxetine, sertraline, paroxetine, citalopram, escitalopram.
Alpha-blockers: tamsulosin, terazosin, doxazosin, alfuzosin, silodosin, prazosin.
All blood pressure medicines, because effects on pressure add together.
Grapefruit juice, which acts as a dietary CYP3A4 inhibitor.
Any medicine known to prolong the QT interval.
No significant interaction found in studies Glyburide (glibenclamide), with no change in glucose control.
Warfarin, with no change in prothrombin time.
Digoxin, ranitidine, cimetidine and magnesium-aluminium antacids.
Aspirin, with no added increase in bleeding time.
Nifedipine, though blood pressure fell slightly further.
Still tell your doctor about every medicine you take.
Emergency Warning Signs Stop the medicine and seek immediate medical help for any of these.
An erection lasting longer than four hours.
A painful erection lasting longer than six hours.
Sudden loss or blurring of vision in one or both eyes.
Sudden drop or loss of hearing, with or without ringing.
Chest pain, tightness, or pain spreading to the jaw or arm.
Fainting, near-fainting, or collapse.
A very fast, very slow, or irregular heartbeat.
Breathlessness while at rest.
Swelling of the face, lips, tongue or throat.
A spreading rash, hives, or difficulty breathing.
A seizure or sudden episode of memory loss.
Stroke signs: facial droop, arm weakness, or slurred speech.
Critical: If you get chest pain, do not take a nitrate. Tell emergency staff exactly when you last took vardenafil.
Why Choose This Medicine The tablet delivers a precise, factory-controlled 20 mg dose.
Blister packing protects each tablet from air and moisture.
Blister strips are discreet, flat and easy to carry.
Vardenafil is one of the most selective PDE-5 inhibitors available.
High selectivity may mean fewer visual side effects than less selective drugs.
Trials showed clear benefit across ages 18 to 80 and above.
Trials also showed benefit in men with diabetes-related ED.
Benefit was shown in men with ED after radical prostatectomy.
In trials, 20 mg vardenafil improved penetration success to 80 percent.
Placebo achieved 52 percent in the same North American trial.
It can be taken with or without food, within the limits above.
Onset is typically faster than sildenafil for many users.
Fortune Healthcare lists GMP certification for its manufacturing.
It offers a lower-cost alternative to the originator brand.
Storage Instructions Store at room temperature, between 15 and 30 degrees Celsius.
Keep each tablet sealed in its blister until the moment of use.
Keep the blister inside its original carton.
Protect the pack from direct sunlight and heat.
Do not freeze or refrigerate the tablets.
Avoid storing in a bathroom, where humidity is high.
Keep the product out of the sight and reach of children.
Do not use the tablets after the printed expiry date.
Do not use a blister that is punctured, torn or wet.
Do not use a tablet that is chipped, discoloured or crumbling.
Return unused or expired tablets to a pharmacy for disposal.
Do not flush tablets down the toilet or bin them loose.
Medical & Compliance Disclaimer This content is for information only. It is not medical advice.
Filitra 20 is a prescription-only medicine in most countries.
It must be sold and used under a registered doctor prescription.
Do not self-diagnose or self-prescribe erectile dysfunction treatment.
Erectile dysfunction can be an early sign of heart disease or diabetes.
A proper medical assessment should come before any treatment.
Always read the patient leaflet supplied with your pack.
Report any suspected side effect to your national drug safety authority.
Sanjay Gangani
B.Pharm, CMO & Pharmacist
Licensed pharmacist (B.Pharm) with 12+ years in clinical pharmacy and patient care. Reviews every article for evidence-based accuracy before it is published on ACTIZA Store.
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