Alvitra 20 Mg (Vardenafil)

Alvitra 20 is an oral tablet containing vardenafil 20 mg.

Vardenafil is a potent and selective inhibitor of PDE5. 

It is indicated for the treatment of erectile dysfunction in adult men. 

Alvitra 40 mg is the maximum recommended dose. 

Sexual stimulation is required for vardenafil to be effective. 

It is made by Alpha Pharmaceuticals in Faridabad, India.

The tablet is swallowed whole with water.

It is taken only when needed, not daily. 

It may be taken with or without food. 

It does not increase sexual desire or libido.

It does not cure the underlying cause of erectile dysfunction.

Alvitra 60 mg is not approved to delay ejaculation.

It offers no protection against sexually transmitted infections.

It is a prescription-only medicine, not available over the counter. 

Vardenafil is not indicated for use by women.

It is not indicated for anyone below 18 years of age. 

A medical history and physical examination should precede treatment. 

Penile erection is a haemodynamic process.

During sexual stimulation, nitric oxide is released.

Nitric oxide activates the enzyme guanylate cyclase.

This increases cyclic guanosine monophosphate (cGMP) in the corpus cavernosum.

Raised cGMP causes smooth muscle relaxation.

Relaxed muscle allows increased blood flow into the penis.

Phosphodiesterase type 5 (PDE5) breaks cGMP down.

Vardenafil potently and selectively inhibits PDE5.

cGMP levels therefore stay elevated.

Sexual stimulation is required for any therapeutic effect. 

Take one dose 25 to 60 minutes before sexual activity.

May be taken with or without food. Onset may be delayed by a high-fat meal.

Tolerability of the maximum 20 mg dose may be lower in patients aged 65 and over.

Drink a full glass of water with the tablet. This reduces fainting risk from dapoxetine.

Not applicable. This medicine is used only as needed.

Take the tablet exactly as your doctor prescribed.

Swallow the tablet whole with water.

Do not chew, crush, or break it.

Take it 25 to 60 minutes before sexual activity. 

It may be taken with or without food. 

Avoid a very high-fat meal, which delays onset. 

Sexual stimulation is required for the medicine to work. 

Take no more than one tablet per day. 

Do not combine it with any other ED treatment. 

Do not combine it with other forms of vardenafil. 

Do not take a second tablet if the first seems weak.

Avoid grapefruit and grapefruit juice. 

Be aware of how it affects you before driving. 

Stop and seek advice if you develop any rash. 

Do not share your tablets with anyone else.

Are hypersensitive to vardenafil or any excipient.

Take nitrates or nitric oxide donors, such as amyl nitrite, in any form.

Take ritonavir or indinavir, or another HIV protease inhibitor.

Take ritonavir or indinavir, or another HIV protease inhibitor.

Are older than 75 and take oral ketoconazole or itraconazole.

Have lost vision in one eye because of NAION.

Have severe cardiovascular disorders making sexual activity inadvisable.

Take nitrates or nitric oxide donors, such as amyl nitrite, in any form.

This includes unstable angina and severe cardiac failure (NYHA class III or IV).

Have severe hepatic impairment (Child-Pugh C).

Have end stage renal disease requiring dialysis.

Have hypotension below 90/50 mmHg.

Have had a stroke or myocardial infarction within the last 6 months.

Have a known hereditary retinal degenerative disorder such as retinitis pigmentosa.

Vardenafil is not indicated for use by women. 

Co-administration of vardenafil with nitrates or nitric oxide donors in any form is contraindicated. Vardenafil 20 mg potentiated the blood-pressure-lowering effect of sublingual nitroglycerin taken 1 and 4 hours after dosing. No effect was observed when nitroglycerin was taken 24 hours after a 20 mg dose. 

Nicorandil is a hybrid of potassium channel opener and nitrate. Because of its nitrate component, it has the potential for serious interaction with vardenafil.

Any irregular heartbeat or heart rhythm disorder. 

Congenital QT prolongation, or a family history of it. 

Low blood potassium. 

Any medicine for an irregular heartbeat. 

Any cardiovascular condition, since sexual activity carries cardiac risk. 

Left ventricular outflow obstruction, such as aortic stenosis.

Idiopathic hypertrophic subaortic stenosis. 

Any previous heart attack, stroke, or transient ischaemic attack.

Angina, or any prescription for nitrates in the past. 

High blood pressure, which may increase dizziness. 

Liver disease of any severity. 

Kidney disease or reduced kidney function. 

Any eye disease or sudden vision loss previously. 

Sickle cell anaemia, multiple myeloma, or leukaemia, which predispose to priapism. 

Any bleeding disorder or active peptic ulceration. 

Whether you take any alpha-blocker, and which one.

Recent or planned surgery, including dental procedures.

A doctor has prescribed this medicine and strength.

I have discussed whether 10 mg would suit me better.

I take no nitrate medicine of any kind. 

I take no nicorandil. 

I have not used poppers or amyl nitrite. 

I take no riociguat. 

I take no ritonavir or indinavir. 

I take no medicine for an irregular heartbeat. 

I have no known QT interval abnormality. 

My potassium level is normal, if it has been checked. 

If over 75, I take no ketoconazole or itraconazole. 

I take no erythromycin or clarithromycin, or my dose is 5 mg. 

I have taken no other ED medicine today. 

I have not taken a dose in the last 24 hours. 

My doctor knows all my current medicines.

My heart is fit enough for sexual activity. 

I have avoided grapefruit juice. 

I have not eaten a very high-fat meal. 

The strip is sealed and the expiry date valid.

I know the emergency warning signs listed below.

Sudden death, tachycardia, myocardial infarction, ventricular tachy-arrhythmia, angina pectoris and cerebrovascular disorders have been reported in temporal association with vardenafil. Most patients had pre-existing cardiovascular risk factors. 

In single-dose volunteer studies, doses up to 80 mg per day were tolerated without serious adverse reactions. When 40 mg was given twice daily, cases of severe back pain were reported, without muscle or neurological toxicity.

Nitrates and nitric oxide donors in any form, including amyl nitrite.

Riociguat and other guanylate cyclase stimulators.

HIV protease inhibitors: ritonavir and indinavir.

Oral ketoconazole and itraconazole, in men over 75.

Potent CYP3A4 inhibitors such as itraconazole and oral ketoconazole, at any age. Ketoconazole 200 mg with vardenafil 5 mg produced a 10-fold increase in exposure.

Grapefruit and grapefruit juice.

Nicorandil, because of its nitrate component.

Other pharmaceutical forms of vardenafil, or other ED treatments.

Class 1A antiarrhythmics: quinidine, procainamide.

Class III antiarrhythmics: amiodarone, sotalol.

Any other medicine known to prolong the QTc interval.

Erythromycin and clarithromycin: vardenafil should not exceed 5 mg. Erythromycin produced a 4-fold increase in exposure.

Alpha-blockers: begin at 5 mg. Vardenafil may be given at any time with tamsulosin or alfuzosin; with other alpha-blockers, separate the dosing times.

Ranitidine, digoxin, warfarin, glibenclamide, and antacids.

Acetylsalicylic acid, ACE inhibitors, beta-blockers, and diuretics.

Medicines for diabetes, including sulfonylureas and metformin.

Cimetidine had no effect on vardenafil levels.

Given with vardenafil 20 mg in hypertensive patients, there was an additional reduction of 6 mmHg systolic and 5 mmHg diastolic, with a 4 bpm heart rate increase. 

An erection that will not subside (priapism). 

A painful prolonged erection.

Chest pain, pressure, or tightness during or after sex. 

Pain spreading to the jaw, neck, or left arm.

A fast, irregular, or pounding heartbeat. 

Fainting or collapse. 

Any sudden visual defect or loss of vision. 

Sudden deafness or hearing loss. 

Epilepsy or any seizure disorder.

Liver disease or hepatitis of any type.

Kidney disease or reduced kidney function.

Any eye disease or sudden vision loss previously.

Sudden deafness or hearing loss. 

Severe shortness of breath. 

Swelling of the face, lips, tongue, or throat.

Any rash, blistering, or peeling of the skin. 

A seizure or convulsion. 

Sudden severe headache or confusion. 

Signs of stroke: sudden weakness, slurred speech, facial droop.

In the case of sudden visual defect, stop taking vardenafil and consult a physician immediately. 

If signs suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis appear, vardenafil should be withdrawn immediately and never restarted at any time. [Ref 1] Treat any developing rash as urgent.

Tell emergency staff you have taken vardenafil. State the dose as 20 mg. They must not give you nitrate medicines. Mention that vardenafil can affect the QT interval, particularly if you have palpitations.

20 mg is an authorised vardenafil strength. 

80% of men achieved successful penetration at this dose, versus 49% on placebo.

Erections sufficient for penetration occurred in some men as early as 15 minutes.

The overall response became significant 25 minutes after dosing. 

A meal containing 30% fat has no effect on absorption at all. 

Vardenafil has been given to over 17,000 men in clinical trials. 

Trials included men with diabetes, hypertension, and after prostatectomy. 

In diabetic men, 64% could obtain an erection at 20 mg versus 36% on placebo. 

Alcohol did not alter vardenafil’s blood pressure or heart rate effects. 

No significant interaction with warfarin, digoxin, or common diabetes medicines. 

20 mg is the maximum dose, not the recommended starting dose. 

The gain over 10 mg is modest: 80% versus 76% for successful penetration. 

Headache is very common, affecting 10% or more of patients. 

Tolerability at 20 mg may be lower in men aged 65 and over. 

Vardenafil prolongs the QTc interval, unlike tadalafil.

It carries contraindications the other PDE-5 inhibitors do not.

The duration is about 4 to 5 hours, far shorter than tadalafil’s 36. 

It is approved for erectile dysfunction only, despite some listings.

The brand range includes 40 mg and 60 mg, which exceed the approved maximum.

You are using vardenafil for the first time; 10 mg is recommended. 

You are aged 65 or over, where 20 mg tolerability may be lower. 

You take any heart rhythm medicine. 

You have liver impairment, where 10 mg is the ceiling. 

You take erythromycin or clarithromycin, where 5 mg is the ceiling.

You take an HIV protease inhibitor, where it is contraindicated. 

You want cover across a longer window than 4 to 5 hours.

Vardenafil is a well-studied alternative to sildenafil with a faster documented onset. 20 mg is the ceiling rather than the starting point, and the heart rhythm profile is the thing to settle with a doctor first.

The approved product information states no special storage conditions are required.

Store below 30°C in a cool, dry place as good practice.

Protect tablets from direct sunlight and heat.

Keep tablets sealed in the original strip until use.

Do not store in the bathroom or near a sink.

Do not transfer tablets into unlabelled containers.

Keep the original pack for the drug name and strength.

Never mix Alvitra strengths in one container.

The range includes strengths above the approved maximum.

Do not freeze or refrigerate this product.

Keep it out of the sight and reach of children.

Accidental ingestion by a child is a medical emergency.

Check the expiry date printed on the pack.

Never use tablets after the expiry date.

Discard damaged, cracked, or discoloured tablets.

Return unused tablets to a pharmacy where possible.

Do not flush tablets or throw them in household waste.