Labedra 20 Mg (Vardenafil)

Medically reviewed by Sanjay Gangani, B.Pharm, CMO & Pharmacist

Active Ingredient	Vardenafil
Indication	Erectile Dysfucntion
Manufacturer	Sozin Flora Pharma LLP
Strength:-	20mg
Packaging	10 tablets in 1 strip

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Labedra 20 Mg (Vardenafil)
Pack Size	Price	Price/unit	Quantity	Add To Cart
60 Tablet/s	$90	$1.50/Pill
90 Tablet/s	$128	$1.42/Pill
120 Tablet/s	$165	$1.38/Pill

What is Labedra 20 mg

Labedra 20 mg is a tablet containing vardenafil 20 mg.
Vardenafil is a phosphodiesterase type 5 inhibitor, or PDE-5 inhibitor.
It treats erectile dysfunction in adult men.
It is taken only when needed, not every day.
It works only with sexual stimulation.
It does not increase sexual desire.
It offers no protection against sexually transmitted infection.
It is not for women, children or anyone under 18.

Product identity

Field	Detail
Brand name	Labedra 20 mg
Generic name	Vardenafil (as vardenafil hydrochloride)
Strength	20 mg per tablet
Drug class	PDE-5 inhibitor
Primary use	Erectile dysfunction in adult men
Dosage form	Film-coated oral tablet
Pack stated on listings	10 tablets per strip
Brand owner claimed	RSM Enterprises, Chandigarh (unverified licence)
Published licence number	None found in public records
Regulated pharmacy listing	None found in India
Legal status in India	Prescription only, Schedule H
ATC code	G04BE09 (vardenafil)

Reference labels used for all clinical content

Label	Regulator	Role in this page
Vardenafil hydrochloride tablets, Macleods	US FDA	Dose caps, QT warning, strengths
Vardenafil 20 mg film-coated tablets	MHRA, via the eMC	Contraindications, adverse reactions, pharmacokinetics

How it works (mechanism of action)

The chain of events

Sexual stimulation releases nitric oxide in the penis.
Nitric oxide activates the enzyme guanylate cyclase.
That enzyme produces cyclic GMP, a signalling molecule.
Cyclic GMP relaxes the smooth muscle of the penile arteries.
Relaxed arteries let more blood flow into the erectile tissue.
The expanding tissue compresses the draining veins.
Blood is held in place and an erection results.
An enzyme called PDE-5 normally breaks cyclic GMP down.
Vardenafil blocks PDE-5, so cyclic GMP lasts longer.
The erection therefore becomes firmer and better sustained.
Vardenafil does not create nitric oxide.
It only preserves the signal that nitric oxide starts.
Without stimulation there is no signal to preserve.
So the tablet alone produces no erection.

Key pharmacokinetics

Parameter	Value from the reference label
Median time to peak level	About 60 minutes when fasted
Peak range	30 to 120 minutes in 90% of men
Earliest reported peak	As early as 15 minutes in some men
Terminal half-life	About 4 to 5 hours
Absolute oral bioavailability	About 15%
Effect of a 57% fat meal	Peak delayed about 1 hour
Peak concentration after that meal	Reduced by about 20%
Total exposure after that meal	Unchanged

Dosage guide

Figures below are from the reference labels. Only a prescriber may set your dose.

Patient group or situation	Starting dose	Maximum dose	Maximum frequency
Adult man, no complicating factor	10 mg	20 mg	Once in 24 hours
Adult man, dose felt too strong	5 mg	20 mg	Once in 24 hours
Age 65 years or over	5 mg considered	20 mg with care	Once in 24 hours
Mild liver impairment, Child-Pugh A	5 mg considered	20 mg	Once in 24 hours
Moderate liver impairment, Child-Pugh B	5 mg	10 mg	Once in 24 hours
Severe liver impairment, Child-Pugh C	Do not use	Contraindicated	Not applicable
Mild or moderate kidney impairment	No adjustment	20 mg	Once in 24 hours
Severe kidney impairment, CrCl under 30	5 mg considered	20 mg	Once in 24 hours
Dialysis-dependent kidney failure	Do not use	Contraindicated	Not applicable
Stable on an alpha-blocker	5 mg	Per prescriber	Once in 24 hours
On ritonavir or cobicistat	2.5 mg	2.5 mg	Once in 72 hours
On clarithromycin or atazanavir	2.5 mg	2.5 mg	Once in 24 hours
On erythromycin	5 mg	5 mg	Once in 24 hours
Women of any age	Not indicated	Not applicable	Not applicable
Anyone under 18 years	Not indicated	Not applicable	Not applicable

The two label positions differ on protease inhibitors

Drug	US label position	EU label position
Ritonavir	Cap at 2.5 mg per 72 hours	Contraindicated
Indinavir	Cap at 2.5 mg per 24 hours	Contraindicated
Oral ketoconazole	Cap at 2.5 mg or 5 mg by dose	Contraindicated over age 75
Oral itraconazole	Cap at 2.5 mg or 5 mg by dose	Contraindicated over age 75

How to take it

Confirm your prescriber has agreed the 20 mg strength.
Take one tablet by mouth with a glass of water.
Swallow the tablet whole; do not chew it.
Take it about 25 to 60 minutes before sexual activity.
Take it with or without food, as you prefer.
Expect a slower onset after a heavy, fatty meal.
Engage in sexual stimulation; the tablet needs it.
Take no more than one tablet in 24 hours.
Do not combine it with any other erectile dysfunction drug.
Do not drink heavily before or after the dose.
Do not take a second tablet the same day.
Do not assume a higher dose is the answer.
Filitra 20 mg is already the labelled maximum.
Report failure to your prescriber instead.
Technique, timing and underlying causes are reviewed first.

Missed dose

There is no missed dose, because it is used on demand.
Simply take it before the next planned activity.
Never take two tablets to compensate.
Alcohol does not neutralise the tablet but worsens erections.
Alcohol also adds to dizziness and low blood pressure.
Amyl nitrite, called poppers, is an absolute contraindication.
Mixing poppers with vardenafil can cause fatal hypotension.
Never take vardenafil if you may use poppers that night.

Precautions

Absolute contraindications

Allergy to vardenafil or any tablet excipient.
Nitrates or nitric oxide donors in any form.
Amyl nitrite, including recreational poppers.
Riociguat or any other guanylate cyclase stimulator.
HIV protease inhibitors such as ritonavir and indinavir.
Oral ketoconazole or itraconazole in men over 75.
Severe liver impairment, Child-Pugh C.
Dialysis-dependent end-stage kidney disease.
Blood pressure below 90/50 mm Hg.
Stroke within the last six months.
Heart attack within the last six months.
Unstable angina.
Heart failure of NYHA class III or IV.
Any condition making sexual activity inadvisable.
Retinitis pigmentosa.
Previous loss of vision in one eye from NAION.

Conditions to disclose to your doctor

Condition	Why it matters
Congenital QT prolongation	The US label says to avoid vardenafil
Taking amiodarone or sotalol	Class III antiarrhythmic; avoid
Taking quinidine or procainamide	Class 1A antiarrhythmic; avoid
Any heart or blood vessel disease	Sexual activity carries cardiac risk
Low or unstable blood pressure	Risk of fainting
Taking any blood pressure medicine	Added blood pressure fall
Taking an alpha-blocker for prostate	Start vardenafil at 5 mg only
Liver disease of any severity	Dose is reduced or the drug avoided
Kidney disease or dialysis	Dose is reduced or the drug avoided
Sickle cell anaemia	Predisposes to priapism
Multiple myeloma or leukaemia	Predisposes to priapism
Penile deformity or Peyronie disease	Needs assessment first
Any bleeding disorder	No safety data exist
Active peptic ulcer	No safety data exist
Any eye or retinal disorder	Rare visual effects are reported
Sudden hearing loss in the past	Reported with PDE-5 inhibitors
Any CYP3A4 inhibitor medicine	Dose caps may apply
Any recreational drug use	Poppers are an absolute contraindication

Food and drink precautions

Food does not stop the tablet working.
A high-fat meal delays the peak by about one hour.
That meal also lowers the peak level by about 20%.
Total exposure over the day is unchanged.
So eat lightly if you want a faster onset.
Grapefruit and grapefruit juice inhibit CYP3A4.
Grapefruit can therefore raise vardenafil levels.
Avoid grapefruit products around a dose.
Limit alcohol, which worsens erectile function itself.
Alcohol also adds to dizziness and low blood pressure.

Before-use safety checklist

Confirm a registered doctor has prescribed vardenafil for you.
Confirm the prescriber chose 20 mg, not 5 mg or 10 mg.
Confirm you take no nitrate medicine of any kind.
Confirm you will not use poppers that night.
Confirm you are not taking riociguat.
Confirm you take no HIV protease inhibitor.
Confirm you take no oral ketoconazole or itraconazole.
Confirm you take no clarithromycin or erythromycin.
Confirm you have no congenital QT prolongation.
Confirm you take no Class 1A or Class III antiarrhythmic.
Confirm your blood pressure is above 90/50 mm Hg.
Confirm you have had no stroke or heart attack in six months.
Confirm your liver and kidney function have been reviewed.
Confirm your doctor agrees sexual activity is safe for you.
Confirm the pack, batch number and expiry date are legible.
Confirm the pharmacy verified a valid prescription.

Common and less common side effects

Frequency	Side effect	What to do
Very common	Headache	Usually mild; report if severe
Common	Dizziness	Sit down; avoid driving
Common	Flushing of the face	Settles without treatment
Common	Blocked or stuffy nose	Settles within hours
Common	Indigestion or dyspepsia	Take with a light meal
Uncommon	Visual disturbance	Stop and seek advice
Uncommon	Sleep disturbance	Report to your prescriber
Uncommon	Drowsiness	Do not drive
Uncommon	Pins and needles	Report if persistent
Uncommon	Ringing in the ears	Report promptly
Uncommon	Vertigo	Report promptly
Uncommon	Palpitations	Report to your prescriber
Uncommon	Fast heart rate	Report to your prescriber
Uncommon	Breathlessness	Seek medical advice
Uncommon	Nausea or vomiting	Usually short-lived
Uncommon	Diarrhoea	Keep hydrated
Uncommon	Dry mouth	Sip water
Uncommon	Rash or skin redness	Report before the next dose
Uncommon	Back pain or muscle ache	Usually settles in a day
Uncommon	Prolonged or increased erection	Seek advice if over four hours
Uncommon	Feeling generally unwell	Report to your prescriber
Rare	Fainting	Stop the drug; seek advice
Rare	Seizure	Emergency care
Rare	Memory loss	Seek medical assessment
Rare	Transient ischaemic attack	Emergency care
Rare	Heart attack	Emergency care
Rare	Ventricular tachyarrhythmia	Emergency care
Rare	Angina	Emergency care
Rare	Low or high blood pressure	Seek medical assessment
Rare	Priapism	Emergency care within four hours
Rare	Nosebleed	Apply pressure; report if heavy
Rare	Anxiety	Report to your prescriber
Rare	Light sensitivity of the skin	Avoid strong sun
Rare	Chest pain	Emergency care
Not known	NAION, a sudden optic nerve event	Stop and seek care immediately
Not known	Central serous chorioretinopathy	Stop and seek eye care
Not known	Sudden deafness	Stop and seek care immediately
Not known	Sudden death	Reported in surveillance data
Not known	Bleeding into the brain	Emergency care
Not known	Stevens-Johnson syndrome	Emergency care
Not known	Blood in urine or semen	Seek medical assessment
Not known	Bleeding from the penis	Seek medical assessment

Drug interactions – avoid with

Never combine

Drug or group	Effect	Status
Glyceryl trinitrate, any form	Severe blood pressure fall	Contraindicated
Isosorbide mononitrate or dinitrate	Severe blood pressure fall	Contraindicated
Nicorandil	Nitric oxide donor effect	Contraindicated
Sodium nitroprusside	Nitric oxide donor effect	Contraindicated
Amyl nitrite, poppers	Severe blood pressure fall	Contraindicated
Riociguat	Symptomatic hypotension	Contraindicated
Ritonavir	Large rise in vardenafil level	Contraindicated in the EU label
Indinavir	Large rise in vardenafil level	Contraindicated in the EU label
Another PDE-5 inhibitor	Duplicated effect, added risk	Do not combine

Use only with a reduced dose or specialist advice

Drug or group	Effect	Action
Cobicistat	Potent CYP3A4 inhibition	Cap at 2.5 mg per 72 hours
Saquinavir or atazanavir	Potent CYP3A4 inhibition	Cap at 2.5 mg per 24 hours
Clarithromycin	Potent CYP3A4 inhibition	Cap at 2.5 mg per 24 hours
Ketoconazole 400 mg daily	Potent CYP3A4 inhibition	Cap at 2.5 mg per 24 hours
Itraconazole 400 mg daily	Potent CYP3A4 inhibition	Cap at 2.5 mg per 24 hours
Ketoconazole 200 mg daily	CYP3A4 inhibition	Cap at 5 mg per 24 hours
Itraconazole 200 mg daily	CYP3A4 inhibition	Cap at 5 mg per 24 hours
Erythromycin	CYP3A4 inhibition	Cap at 5 mg per 24 hours
Tamsulosin or alfuzosin	Additive blood pressure fall	May be given at any time
Terazosin and other alpha-blockers	Additive blood pressure fall	Separate doses by about 6 hours
Any antihypertensive medicine	Additive blood pressure fall	Monitor and report
Class 1A antiarrhythmics	Added QT risk	Avoid the combination
Class III antiarrhythmics	Added QT risk	Avoid the combination
Grapefruit juice	CYP3A4 inhibition	Avoid around a dose

Always disclose

Every prescription medicine you take, including eye drops.
Every over-the-counter medicine and supplement.
Any herbal or ayurvedic sexual tonic.
Any other erectile dysfunction product, including unlabelled ones.

Emergency warning signs

Call emergency services or go to hospital

Warning sign	Possible cause
Erection lasting more than four hours	Priapism; tissue damage risk
Painful erection that will not subside	Priapism
Chest pain during or after sex	Angina or heart attack
Sudden severe breathlessness	Cardiac or pulmonary event
Fainting or near-fainting	Severe hypotension
Irregular or racing heartbeat	Arrhythmia
Sudden loss of vision in one or both eyes	NAION
Sudden blurred or distorted vision	Retinal event
Sudden hearing loss or severe tinnitus	Sudden sensorineural deafness
Sudden one-sided weakness or slurred speech	Stroke or TIA
Seizure	Rare neurological reaction
Swollen lips, tongue, face or throat	Angioedema
Widespread blistering rash with fever	Stevens-Johnson syndrome
Bleeding from the penis	Urological emergency

About the four-hour rule

Trapped blood loses oxygen inside the erectile tissue.
Oxygen-starved tissue begins to scar.
Scarred tissue causes permanent erectile dysfunction.
Treatment is simple and effective if given early.
So four hours is a hospital deadline, not a guideline.
Both NAION and sudden deafness can be permanent.
Neither gives much warning before it happens.
Do not take another dose to see if it recurs.
Stop the drug and seek care the same day.

Why choose this medicine

This section is written about vardenafil 20 mg, the molecule and strength.

Clinical reasons a prescriber may select vardenafil 20 mg

It is the labelled maximum dose, for men who needed more than 10 mg.
Onset is reasonably quick, with a median peak near 60 minutes.
Some men reach peak levels as early as 15 minutes.
A heavy meal shifts onset but does not reduce total exposure.
Dosing is on demand, so there is no daily tablet burden.
The adverse reaction profile is well characterised in two labels.

How vardenafil differs from the alternatives

Point of difference	What it means in practice
Half-life about 4 to 5 hours	A shorter window than long-acting options
Explicit congenital QT warning	Needs a cardiac history before use
Strict CYP3A4 dose-cap table	Many common drugs force a lower strength
Four marketed strengths	Allows 2.5 mg and 5 mg where required
Food only delays onset	Total effect is not lost after a meal

A verifiable alternative if you want a regulated Indian brand

Zhewitra 20 mg is vardenafil 20 mg from Sunrise Remedies Pvt Ltd.
It is listed on PharmEasy, a regulated Indian pharmacy.
The listed MRP is about Rs. 800 for a strip of 10 tablets.
That listing is subject to prescription verification.
This is stated as a factual comparison, not a recommendation.

Honest limitations

20 mg is the ceiling, so there is no higher dose to try.
It is unsuitable for anyone needing a 2.5 mg or 5 mg cap.
It is unsuitable in Child-Pugh B, where 10 mg is the maximum.
It is contraindicated in several common cardiac situations.
It treats the erection, not the cause of the problem.
No regulator label exists for the Labedra brand itself.
No published licence ties the brand to a named plant.

Storage instructions

Instruction	Detail
Temperature	Store below 30 degrees Celsius
Humidity	Keep in a cool, dry place
Light	Protect from direct sunlight
Container	Keep tablets in the original blister strip
Bathroom storage	Avoid; humidity degrades tablets
Refrigeration	Not required; do not freeze
Children	Store well out of sight and reach
Expiry	Do not use after the printed expiry date
Damaged tablets	Discard chipped, soft or discoloured tablets
Unlabelled tablets	Never take a loose tablet with no strip
Disposal	Return unused tablets to a pharmacy
Sharing	Never share with another person

A storage caution specific to this product

No approved pack insert was found for Labedra 20 mg.
So no manufacturer storage statement could be quoted.
The conditions above are standard for film-coated tablets.
Follow the printed pack text if it differs from this.
Ask your pharmacist if the pack carries no storage text.

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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Labedra 20 Mg (Vardenafil)