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It is also important information to carry with you in case of emergencies. Levitra В® Staxyn В® AHFS В® Patient Medication Informationв„ў.

The American Society of Health-System Pharmacists В® , 4500 East-West Highway, Suite 900, Bethesda, Maryland.

Duplication for commercial use must be authorized by ASHP. Uses Side Effects Precautions Interactions Overdose Images Uses Side Effects Precautions Interactions Overdose Images. Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED).

In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis).

Consult your doctor or pharmacist for more details.

Read the Patient Information Leaflet provided by your pharmacist before you start taking vardenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication as directed by your doctor, usually as needed.

Take vardenafil, with or without food, about 1 hour before sexual activity. Remove the dose from the blister package right before use. Place the tablet on your tongue and allow it to dissolve completely.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely.

Grapefruit can increase the chance of side effects with this medicine.

Vardenafil disintegrating tablets are absorbed differently in the body than vardenafil film-coated tablets. Do not switch from one to the other without consulting your doctor.

Tell your doctor if your condition does not improve.

Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sexual activity may put extra strain on your heart, especially if you have heart problems.

If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea. Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur.

If this serious problem occurs, stop taking vardenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur.

Stop viagra pills pharmacy taking vardenafil and get medical help right away if these effects occur. In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, seizures, temporary memory loss.

A very viagra pills pharmacy serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects.

You may report side effects to Health Canada at 1-866-234-2345. Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (

such

sickle

QT prolongation can rarely cause serious (rarely viagra pills pharmacy fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using vardenafil, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. This drug may make you dizzy or cause vision changes.

Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely.

Talk to your doctor if you are using marijuana (cannabis). If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

Drug interactions may change how your medications work or

increase

This document does not contain all possible drug interactions.

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: riociguat.

Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.

If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. To manage this drug interaction, you should not start vardenafil treatment with the disintegrating tablet. Your doctor will start treatment with a lower dose of the regular vardenafil tablets first to minimize your risk of low blood pressure, and then may direct you to switch to vardenafil disintegrating tablets later.

Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works.

Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.

Many drugs besides vardenafil may affect the heart rhythm (QT prolongation), including amiodarone, procainamide, quinidine, sotalol, among others. Do not take this medication with any other product that contains vardenafil or other similar

medications

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away.

US residents can call their local poison control center at 1-800-222-1222.

Canada residents can call a provincial poison control center.

Symptoms of overdose may include: back/muscle pain, abnormal vision. Store this medication in the original packaging at room temperature away from light and moisture.

Report Side Effect Related Medicines Same active ingredients Same company Bookmark Email.

Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.6 Fertility, pregnancy and lactation 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 4.9 Overdose 5.

Pharmacological properties 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties 5.3 Preclinical safety data 6.

Pharmaceutical particulars 6.1 List of excipients 6.2 Incompatibilities 6.3 Shelf life 6.4 Special precautions for storage 6.5 Nature and contents of

container

Date of first authorisation/renewal of the authorisation 10.

This information is intended for use by health professionals.

Each tablet contains 20 mg of vardenafil (as hydrochloride).

Vardenafil 20 mg is presented as 9 mm orange, round, biconvex tablets marked “20” on one side.

Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vardenafil to be effective, sexual stimulation is required. The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity.

Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dosing frequency is once per day. The onset of activity may be delayed if taken with a high fat meal (see section 5.2).

Elderly (? 65 years old) Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8). A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased.

The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).

No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance 15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).

In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing. The overall response of these subjects to vardenafil became statistically significant, compared to placebo, 25 minutes after dosing. Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 20 mg and 40 mg vardenafil were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of vardenafil, when compared to placebo.

These effects are consistent with the viagra pills pharmacy vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.

Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers. A single dose, double blind, crossover, randomised trial in 59 healthy males compared the effects on the QT interval of vardenafil (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo.

Moxifloxacin (400 mg) was included as an active internal control.

Effects on the QT interval were measured one hour post-dose (average t max for vardenafil). The primary objective of this study was to rule out a greater than 10 msec effect (i.e., to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point. The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose. At t max , only the mean change in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11). When using the individual correction formulae, none of the values were out of the limit. In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.

Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone.

The actual clinical impact of these QT changes is unknown. In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.

Over 2,500 patients have been treated with vardenafil for six months or longer.

Of these, 900 patients have been treated for one year or longer. The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidemia (22%), depression (5%), radical prostatectomy (9%).

The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).

No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed. Across the pivotal trials, treatment with

vardenafil

In fixed dose studies ( tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period.

The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo. In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).

In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.

The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.

In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.

In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, viagra pills pharmacy the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo.

The number of patients who returned to a normal IIEF domain score ( >26) were 53% on vardenafil compared to 9% on placebo.

The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p th Floor, 40 Bank Street, Canary Wharf. 1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day.

Orally disintegrating tablet (ODT): 10 mg PO placed on tongue.

1 hour before sexual activity; not to exceed 1 dose/day. 10-mg

ODT

Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day Ketoconazole 400 mg/day or itraconazole 400 mg/day:

Vardenafil

Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day. Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO initially. Mild, moderate, severe impairment: Dosage adjustment not necessary Hemodialysis: Not recommended. Child-Pugh class A: Dosage adjustment not necessary Child-Pugh class B: Film-coated tablet, 5 mg PO.

1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended Child-Pugh class C: Not recommended. Pulmonary Arterial Hypertension (Orphan) Orphan designation for treatment of pulmonary arterial hypertension.

Respira Therapeutics, Inc; 5901 Indian School Road NE, suite 107; Albuquerque, New Mexico 87110.

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