At a glance......
- 1 Do NOT use vardenafil if
- 2 Before using vardenafil
- 3 How to use vardenafil
- 4 Important safety information
- 5 Dosage
- 6 Indications
- 7 Dosage
- 8 Dosage Details
- 9 Special Patient Group
- 10 Renal Impairment
- 11 Hepatic Impairment
- 12 Administration
- 13 Contraindications
- 14 Special Precautions
- 15 Adverse Drug Reactions
- 16 Pregnancy Category (US FDA)
- 17 Drug Interactions
- 18 Food Interaction
- 19 Mechanism of Action
- 20 Storage
- 21 MIMS Class
User Review( votes)
Are you worried about your panis black colour & small size? Lets go for solution. Treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.
Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection.
Do NOT use vardenafil if
- you are allergic to any ingredient in vardenafil
- you have been advised by your doctor to avoid sexual activity because of heart problems
- you have certain heart problems (eg, severe heart failure, angina), low or high blood pressure, severe liver problems or severe kidney problems that require dialysis
- you have certain hereditary degenerative eye problems (eg, retinitis pigmentosa)
- you have had a heart attack, stroke, or life-threatening irregular heartbeat within the past 6 months
- you have a history of a certain type of irregular heartbeat (eg, congenital QT prolongation) or you take certain antiarrhythmic medicines (eg, quinidine, procainamide, amiodarone, sotalol)
- you are taking a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, capsule, ointment, patch, tablet), or nitroprusside
- you use certain recreational drugs called “poppers” (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
- you take another PDE5 inhibitor (eg, sildenafil, tadalafil) or another medicine that contains vardenafil
Contact your doctor or health care provider right away if any of these apply to you.
Before using vardenafil
Some medical conditions may interact with vardenafil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged erection (priapism)
- if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
- if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
- if you have a history of liver or kidney problems, dialysis, high or low blood pressure, ulcers, seizures, lung problems (eg, pulmonary veno-occlusive disease), bleeding problems, blood vessel problems, or heart problems (eg, angina, aortic stenosis, heart failure)
- if you have a history of heart attack, stroke, a certain type of irregular heartbeat (long QT syndrome), or a family history of long QT syndrome
Some MEDICINES MAY INTERACT with vardenafil. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
- Certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol) because the risk of irregular heartbeat may be increased
- Azole antifungals (eg, itraconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of vardenafil’s side effects
- Rifampin because it may decrease vardenafil’s effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if vardenafil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use vardenafil
Use vardenafil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with vardenafil. Talk to your pharmacist if you have questions about this information.
- Take vardenafil by mouth with or without food.
- Take vardenafil about 1 hour before sexual activity.
- Do not take vardenafil more often than once daily, or as directed by your doctor.
- Check with your doctor before you eat grapefruit or drink grapefruit juice while you use vardenafil.
- If you miss a dose of vardenafil and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.
Ask your health care provider any questions you may have about how to use vardenafil.
Important safety information
- Vardenafil may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use vardenafil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Vardenafil may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Patients with heart problems who take vardenafil may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
- Vardenafil may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Vardenafil does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
- Vardenafil will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
- Vardenafil may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
- Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took vardenafil. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
- Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken vardenafil. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
- Do not use other medicines or treatments for ED while you are taking vardenafil without first checking with your doctor.
- Use vardenafil with caution in the ELDERLY; they may be more sensitive to its effects.
- Vardenafil is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Vardenafil is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using vardenafil while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use vardenafil, check with your doctor. Discuss any possible risks to your baby.
|Adult : PO Initial: 10 mg 60 mins before sexual activity. Adjust dose according to response. Max: 20 mg as a single dose. Max frequency: Once daily.|
Adult: Initially, 10 mg taken 60 minutes before sexual activity. Adjust subsequent doses according to response. Max: 20 mg as a single dose. Max frequency: Once daily. Sexual stimulation needed for response to therapy.
Elderly: ≥65 yr: Initially 5 mg 60 minutes before sexual activity, increased to 10 mg then 20 mg if needed.
Special Patient Group
|Patients stabilised on α-blocker therapy: max daily dose 5 mg and not to be taken within 6 hr of the α-blocker (except tamsulosin). Patients on erythromycin: Max: 5 mg daily.|
|Child Pugh A-B (mild to moderate) impairment: Initiate with 5 mg. Max dose in moderate impairment: 10 mg. Child-Pugh C (severe impairment): No studies done.|
|May be taken with or without food.|
|Known prolongation of QT interval (congenital or acquired); men for whom sexual intercourse is inadvisable due to CV risk factors; hypotension (systolic <90 mm Hg); hypertension (systolic >170 mm Hg or diastolic >110 mm Hg); recent stroke or MI (within last 6 mth); unstable angina; severe heart failure; end-stage renal disease requiring dialysis; severe hepatic impairment; known degenerative retinal disorders e.g. retinitis pigmentosa. Women, child.|
|Anatomical deformation of the penis; predisposition to priapism e.g. sickle cell anaemia, multiple myeloma, or leukaemia; bleeding disorders or active peptic ulceration; left ventricular outflow obstruction; elderly (≥ 65 yr). Discontinue and seek medical advice if there is sudden vision loss or decreased vision in one or both eyes or tinnitus, dizziness or sudden loss or decrease in hearing, while taking vardenafil. May cause dizziness or abnormal vision so avoid driving or operating machinery until effects of vardenafil is known. Seek immediate medical advice if erection last > 4 hr.|
Adverse Drug Reactions
|Dyspepsia, vomiting, headache, flushing, dizziness, visual disturbances, colour vision changes, raised intra-ocular pressure, nasal congestion, hypersensitivity reactions, nausea, photosensitivity reactions, hypotension, hypertension, priapism, palpitations, myalgia, increased creatinine kinase, sudden decrease or loss of hearing, tinnitus.
Pregnancy Category (US FDA)
|Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).|
|Increased risk of hypotension with α-blockers. Increased risk of priapism with alprostadil. Increased serum levels of vardenafil when used with erythromycin.
Potentially Fatal: Increased risk of hypotension with nitrates, nitrites, and nitric oxide donors, either regularly or intermittently (avoid combination). Increased risk of ventricular arrhythmias with drugs that prolong QT interval e.g. Class IA or Class III antiarrhythmics (avoid combination). Increased vardenafil concentrations with potent CYP 3A4 inhibitors e.g. ketoconazole, itraconazole, HIV-protease inhibitors such as indinavir and ritonavir (avoid combination).
|Increased vardenafil concentration levels with grapefruit juice.|
Mechanism of Action
|Description: Vardenafil is a phosphodiesterase type-5 inhibitor. It manages erectile dysfunction by increasing the amounts of cyclic guanosine monophosphate (cGMP).
Absorption: Rapidly absorbed from GI tract with 15% bioavailability. Peak plasma concentration: 30-120 minutes. Rate of absorption decreased with high fat meal.
Distribution: Widely distributed. Protein binding: 95%.
Metabolism: Metabolised in the liver primarily by cytochrome P450 isoenzymes CYP3A4 (the major route), CYP3A5 and CYP2C. Major metabolite has some activity.
Excretion: Excreted as metabolites mainly in faeces (91-95%), and some in urine (2-6%). Terminal half life: 4-5 hr.
|Store between 59-86°F (15-30°C).|
|Drugs for Erectile Dysfunction & Ejaculatory Disorders|
Major Side Effects
If any of the following side effects occur while taking vardenafil, check with your doctor immediately:
- Arm, back, or jaw pain
- blurred vision
- chest pain or discomfort
- chest tightness or heaviness
- cold sweats
- decreased vision
- difficult or labored breathing
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- hives, itching, or skin rash
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow or fast heartbeat
- tightness in the chest
- unusual tiredness or weakness
Incidence not known:
- Hearing loss
Minor Side Effects
Some vardenafil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
- Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
- stuffy nose
- Abnormal ejaculation
- abdominal or stomach pain
- abnormal vision
- acid or sour stomach
- back pain
- bloody nose
- body aches or pain
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- changes in color vision
- changes in vision
- difficulty seeing at night
- difficulty with moving
- difficulty with swallowing
- dim vision
- dry mouth
- dryness or soreness of the throat
- excessive muscle tone
- eye pain
- face swelling
- fast heartbeat
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- increased redness of the eye
- increased sensitivity of the eyes to sunlight
- joint pain
- lack or loss of strength
- loss of appetite
- muscle aches and pains
- muscle cramping
- muscle stiffness
- muscle tension or tightness
- neck pain
- pain or burning in the throat
- runny nose
- sensation of spinning
- sleepiness or unusual drowsiness
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stomach discomfort, upset, or pain
- swollen joints
- tender, swollen glands in the neck
- tenderness in the stomach area
- trouble with sleeping
- trouble with swallowing
- voice changes
- watery eyes
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