Brand Levitra online in Australia

Use

Therapeutic indications

Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual activity.

Sexual stimulation is necessary for Levitra to be effective.

Dosage and method of administration

Dose

Use in adult humans.

The recommended dose is 10 mg taken as needed, approximately 25 to 60 minutes before any sexual activity. Depending on the efficacy and tolerance, the dose can be increased to 20 mg or reduced to 5 mg. The maximum recommended dose is 20 mg. It is recommended to use the medication at most once a day. Levitra can be taken with or without food. The period of action may be delayed if taken during a meal high in fat (see section Pharmacokinetic properties).

Special populations

Elderly patients (≥ 65 years)

Dose adjustment is not necessary in elderly patients. However, an increase to the maximum dose of 20 mg should be considered with caution taking into account individual tolerance (see sections 4.4 and 4.8).

Liver failure

An initial dose of 5 mg should be considered in patients with mild to moderate hepatic impairment (Child-Pugh classes A and B). Depending on tolerance and effectiveness, the dose can be increased later. The maximum recommended dose in patients with moderate hepatic impairment (Child-Pugh class B) is 10 mg (see sections Contraindications and pharmacokinetic properties).

Renal insufficiency

No dosage adjustment is necessary in patients with mild to moderate renal impairment.

In patients with severe renal impairment (creatinine clearance minus 30 ml / min), use of a 5 mg dose should be considered. Depending on the efficacy and tolerance, the dose can be increased to 10 mg and 20 mg.

Pediatric population

Levitra is not indicated for people under the age of 18. There is no relevant use of Levitra in children and adolescents.

Use in patients taking other medications.

Concomitant administration of CYP3A4 inhibitors

When combined with CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg (see section Interactions with other medicinal products and other forms of interaction).

Administration form

Orally

Prescription and delivery conditions

List I.

Duration and special precautions for conservation

Shelf life: 3 years.

Special precautions for storage: There are no special precautions for storage.

Preclinical safety data

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive and developmental functions did not reveal any particular risk to humans.

Incompatibilities

Aimlessly

Employment precautions

Contraindications

Hypersensitivity to the active substance or to any of the excipients included in the Composition section.

Concomitant administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections Interactions with other medicinal products and other forms of pharmacodynamic properties).

Levitra is contraindicated in patients with vision loss in one eye due to anterior non-arteritic ischemic optic neuropathy (NOIAN), regardless of whether or not this event was associated with previous exposure to a phosphodiesterase inhibitor. type 5 (PDE5) (see section 4.4).

Medications used to treat erectile dysfunction should not be used in men for whom sexual activity is not recommended (eg, patients with severe cardiovascular disorders such as unstable angina or severe heart failure [NYHA III or IV]).

The safety of vardenafil has not been studied in the following patient subgroups and, therefore, its use in these patients is contraindicated until more information is available:

- severe liver failure (Child-Pugh class C),

- final stage of kidney failure requiring dialysis,

- hypotension (blood pressure minus 90/50 mmHg),

- recent history of stroke or myocardial infarction (in the last 6 months),

- unstable angina and inherited degenerative disorders of the retina, such as retinitis pigmentosa.

Co-administration of vardenafil with strong CYP3A4 inhibitors such as ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.

Concomitant use of vardenafil with HIV protease inhibitors, such as ritonavir and indinavir, is contraindicated as they are very potent CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction). )

Co-administration of PDE5 inhibitors, such as vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated due to the risk of symptomatic hypotension (see section Interactions with other medicinal products and other forms of interactions).

Pregnancy and lactation

Levitra is not indicated for women. No studies with vardenafil have been performed in pregnant women.

No fertility data is available.

Warnings and precautions for use

A history and clinical examination will be performed to diagnose erectile dysfunction and determine its possible underlying causes before considering medication.

Before starting treatment for erectile dysfunction, physicians should examine the cardiovascular function of their patients, since any sexual activity involves cardiac risk (see section 4.3). Vardenafil has vasodilatory properties that result in transient and slight decreases in blood pressure (see section Pharmacodynamic properties). Patients with obstruction to left ventricular ejection, such as aortic stenosis, idiopathic hypertrophic subaortic stenosis, may be sensitive to the action of vasodilators, including type 5 phosphodiesterase inhibitors.

Medicines used in the treatment of erectile dysfunction should be prescribed with caution in patients with an anatomical malformation of the penis (such as angulation, sclerosis of the corpora cavernosa or Peyronie's disease), or in patients with susceptible pathologies. to predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

The safety and efficacy of the combination of Levitra, film-coated tablet with Levitra, orodispersible tablet, or other treatments for erectile dysfunction have not been studied. Therefore, it is not recommended to use such associations. Tolerance to the maximum dose of 20 mg may be reduced in elderly patients (≥ 65 years of age) (see sections 4.2 and 4.8).

Concomitant administration of alpha blockers

Concomitant administration of alpha-blockers and vardenafil may cause symptomatic hypotension in some patients, since both are vasodilators. Concomitant treatment with vardenafil can only be started if the patient has been stabilized with his treatment with alpha blockers. In patients stabilized with alpha-blocking therapy, vardenafil treatment should be started with the lowest recommended starting dose, 5 mg film-coated tablets. Vardenafil can be administered at any time with tamsulosin or alfuzosin. For other alpha-blockers, a time interval between doses should be observed in case of concomitant use of vardenafil (see section Interactions with other medicinal products and other forms of interaction). In patients already treated with an optimal dose of vardenafil, treatment with alpha blockers should be started with the lowest dose. In patients taking vardenafil, increasing the dose of alpha-blockers in stages can cause a further decrease in blood pressure.

Concomitant administration of CYP3A4 inhibitors

Concomitant administration of vardenafil with strong CYP3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided (see section Interactions with other medicinal products and other forms of interactions), since elevated plasma concentrations of Vardenafil are obtained by combining these medications (see sections Contraindications and interactions with other medications and other forms of interaction).

The dose of vardenafil may need to be adjusted if given concomitantly with moderate CYP3A4 inhibitors such as erythromycin or clarithromycin (see sections 4.2 and 4.3). interactions).

Concomitant ingestion of grapefruit or grapefruit juice may increase the plasma concentrations of vardenafil. This association should be avoided (see section Interactions with other medicinal products and other forms of interaction).

Effect on QTc interval

The single 10 mg and 80 mg dose of vardenafil has been shown to prolong the QTc interval by 8 ms and 10 ms, respectively. Furthermore, the single intake of 10 mg of vardenafil administered in combination with 400 mg of gatifloxacin (an active substance with a comparable effect in the QT interval), results in a further prolongation of the QTc interval by 4 ms compared to the effect of each active substance taken separately. The clinical impact of these changes on QT is unknown (see section Pharmacodynamic properties).

The clinical relevance of these results is unknown and cannot be generalized to all patients in all circumstances, since it depends on individual risk factors, as well as the sensitivities that may exist at any given time for a given patient. Medications that can prolong the QTc interval, including vardenafil, are discouraged in patients with risk factors, for example, hypokalemia, congenital QT prolongation, co-administration of antiarrhythmic therapy. Class Ia (for example: quinidine, procainamide) or Class III (for example: amiodarone, sotalol).

Effect on vision

Visual abnormalities and cases of anterior non-arteritic ischemic optic neuropathy (NAION) have been reported with Levitra and other PDE5 inhibitors. The patient should be advised that, in the event of a sudden visual defect, he should stop taking Levitra and seek immediate medical attention (see section 4.3).

Effect on bleeding

In vitro studies on human blood platelets have shown that vardenafil does not have an antiplatelet aggregation effect on its own, but at high (therapeutic) doses, vardenafil enhances the antiplatelet effect of a donor of nitrogen monoxide, sodium nitroprusside. . In humans, vardenafil used alone or in combination with acetylsalicylic acid has no effect on bleeding time (see section Interactions with other medicinal products and other forms of interaction). There is no information available on the safety of vardenafil in patients with bleeding disorders or active peptic ulcer. Furthermore, in these patients, vardenafil should only be administered after careful evaluation of the benefit-risk balance.

Interaction with other medicinal products and other forms of interaction

Effects of other drugs on vardenafil

In vitro studies

Vardenafil is primarily metabolized by liver enzymes through the 3A4 isoform of cytochrome P450 (CYP), with the contribution of the CYP3A5 and CYP2C isoforms. Therefore, inhibitors of these isoenzymes can decrease vardenafil clearance.

In vivo studies

Co-administration of indinavir antiprotease (800 mg three times daily), a potent CYP3A4 inhibitor, and vardenafil (10 mg film-coated tablets) resulted in a 16-fold increase in AUC and 7-fold Cmax of vardenafil. At 24 hours, plasma vardenafil concentrations dropped to approximately 4% of the maximum plasma vardenafil concentration (Cmax).

Co-administration of ritonavir (600 mg twice daily) and vardenafil 5 mg resulted in a 13-fold increase in Cmax for vardenafil and a 49-fold increase in AUC0-24 for vardenafil. This interaction results from an inhibition of hepatic metabolism of vardenafil by ritonavir, a very strong CYP3A4 inhibitor and also an inhibitor of CYP2C9. Ritonavir significantly prolongs the half-life of vardenafil to 25.7 hours (see section 4.3).

Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, and vardenafil (5 mg) resulted in a 10-fold increase in AUC and a 4-fold increase in Cmax for vardenafil (see Warnings and precautions for use. ).

Although no specific interaction studies have been performed, co-administration of other potent CYP3A4 inhibitors (such as itraconazole) can be expected to induce a plasma concentration of vardenafil comparable to that induced by ketoconazole. Co-administration of vardenafil with strong CYP3A4 inhibitors such as itraconazole and ketoconazole (orally) should be avoided (see sections 4.3 and 4.4). In men over 75 years of age, concomitant administration of vardenafil and itraconazole or ketoconazole is contraindicated (see section 4.3).

Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, and vardenafil (5 mg) resulted in a 4-fold increase in AUC and a 3-fold increase in Cmax for vardenafil. Although no specific interaction studies have been performed, co-administration of clarithromycin may have a similar effect on the AUC and Cmax of vardenafil. In case of concomitant use with a moderate CYP3A4 inhibitor such as erythromycin or clarithromycin, a dose adjustment of vardenafil may be necessary (see sections Dosage and method of administration and Warnings and precautions for use). Cimetidine (400 mg twice daily), a non-specific inhibitor of cytochrome P450, combined with vardenafil (20 mg) in healthy volunteers, had no effect on AUC and Cmax of vardenafil.

Since grapefruit juice is a mild inhibitor of CYP3A4 metabolism in the intestinal wall, it may slightly increase plasma concentrations of vardenafil (see section 4.4).

The pharmacokinetics of vardenafil (20 mg) were not changed with the concomitant administration of an H2 antagonist, ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (average maximum blood alcohol level of 73 mg / dl ) or single doses of gastric antacid (magnesium or aluminum hydroxide).

Although no studies focusing specifically on interactions have been performed for all drugs, analysis of population pharmacokinetic data has shown no effect on the pharmacokinetics of vardenafil used in combination with the following drugs: acetylsalicylic acid, ACE inhibitors , beta-blockers, weak CYP3A4 inhibitors, diuretics and antidiabetics (sulfonamides and metformin).

Effects of vardenafil on other medicines.

There are no data from the interaction of vardenafil and nonspecific phosphodiesterase inhibitors, such as theophylline or dipyridamole.

In vivo studies

No potentiation of the hypotensive effect of sublingual nitroglycerin (0.4 mg) in combination with vardenafil (10 mg) administered at variable time intervals (1 hour to 24 hours) prior to nitroglycerin dose has been observed in a study in 18 male volunteers. healthy. Vardenafil 20 mg (film-coated tablet) enhances the hypotensive effect of nitroglycerin sublingually (0.4 mg) administered 1 hour and 4 hours after taking vardenafil in healthy middle-aged subjects. No effect on blood pressure was observed when taking nitroglycerin 24 hours after a single 20 mg dose of vardenafil (film-coated tablet). However, there is no information available on the potential potentiation by vardenafil of the hypotensive effect of nitrates. Consequently, its concomitant use is contraindicated (see section Contraindications).

Nicorandil is a hybrid molecule, activator of potassium channels and nitro derivative. Due to the nitro derived component, it can cause serious interaction with vardenafil.

Since administration of alpha blockers as monotherapy can lead to marked hypotension, in particular orthostatic hypotension and syncope, drug interaction studies have been conducted with vardenafil. Hypotension (sometimes symptomatic) has been observed in two interaction studies in a significant number of healthy normotensive volunteers, after forced titration with high-dose alpha blockers (tamsulosin or terazosin), in combination with vardenafil. In subjects treated with terazosin, this hypotension was observed more frequently when vardenafil and terazosin were administered simultaneously than when the administrations were separated by a time interval of 6 hours.

According to the results of the interaction studies with vardenafil in patients with benign prostatic hyperplasia (BPH) in stable treatment with tamsulosin, terazosin or alfuzosin:

● No symptomatic decrease in blood pressure was observed in patients

receiving stable tamsulosin treatment, when vardenafil (film-coated tablet) was

administered in doses of 5, 10 or 20 mg, although 3 of the 21 patients treated with tamsulosin

had transient systolic blood pressures below 85 mmHg.

● A case of symptomatic orthostatic hypotension was observed in one of 21 patients treated with 5 mg vardenafil (film-coated tablet) in combination with 5 or 10 mg terazosin. This hypotension was not observed when the administrations of 5 mg of vardenafil and terazosin were spaced 6 hours apart.

● When vardenafil (film-coated tablet) was administered in doses of 5 or 10 mg in patients receiving stable alfuzosin treatment, no symptomatic decrease in blood pressure was observed in these patients compared to placebo.

Therefore, concomitant treatment with vardenafil should only be started if the patient is stable on alpha-blocker therapy. In these patients, vardenafil should be started with the lowest recommended starting dose, 5 mg. Levitra can be administered at any time with tamsulosin or alfuzosin. As with other alpha-blockers, a time interval between doses should be observed in case of concomitant use of vardenafil (see section Warnings and precautions for use).

No specific interaction with co-administration of vardenafil (20 mg film-coated tablet) with warfarin (25 mg), a substance metabolized by CYP2C9, or with digoxin (0.375 mg) has been observed. The relative bioavailability of glibenclamide (3.5 mg) is not affected by co-administration of vardenafil (20 mg). In a specific study in which vardenafil (20 mg) was administered with prolonged-release nifedipine (30 or 60 mg) in hypertensive patients, a further decrease in lying systolic blood pressure of 6 mmHg was observed, and a further decrease of 5 mmHg in diastolic pressure at bedtime, accompanied by an increase in heart rate of 4 bpm.

When taken simultaneously, vardenafil (20 mg film-coated tablet) does not potentiate the effects of alcohol (average maximum concentration of alcohol 73 mg / dl in blood) on blood pressure or heart rate and vardenafil pharmacokinetics are not it changes.

Vardenafil (10 mg) does not potentiate the lengthening of bleeding time induced by acetylsalicylic acid (2 x 81 mg).

Preclinical studies have shown an increase in the systemic hypotensive effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to increase the hypotensive effects of PDE5 inhibitors. There was no evidence of benefit of the association in the study population. Concomitant use of riociguat with PDE5 inhibitors, such as vardenafil, is contraindicated (see section 4.3).

Caution

Undesirable effects

Side effects reported in clinical trials with Levitra, film-coated tablet, or Levitra 10 mg, orodispersible tablet, were generally transient and mild to moderate in intensity. The most commonly reported side effect, which occurs in at least 10% of patients, is headache.

Unwanted effects are presented according to the MedDRA convention in terms of frequency: very common (≥ 1/10), common (≥ 1/100 to minus 1/10), uncommon (≥ 1/1000 to minus 1/100) , rare (≥ 1/10000 to at least 1/1000) and frequency unknown (cannot be estimated from the available data).

Within each frequency group, undesirable effects are presented in order of decreasing severity.

The following side effects have been reported:

Classes of

systems

organs

Very common

(≥ 1/10)

Frequent

(≥ 1/100 and less 1/10)

Rare

(≥ 1/1000 and less 1/100)

Rare

(≥ 1/10000 and less 1/1000)

Frequency not known

(cannot be estimated from the available data)

Infections and infestations.

Conjunctivitis

Affects of

system

immune

Allergic edema and angioedema

Allergic reaction

Psychiatric disorders

Sleep disorders

Anxiety

Nervous system disorders

Headache

Dizzying sensations

Drowsiness Paresthesia and dysesthesia

Syncope

Seizures

Amnesia

Eye conditions

Disorders

view

Hyperemia

ocular

Alteration of

the vision of

colors

Pain

eyepiece and

discomfort

ocular

Photophobia

Increased intraocular pressure Increased tear secretions

Neuropathy

optics

ischemic

previous no

arterial

Anomalies

visual

Ear and labyrinth disorders.

Vertigo tinnitus

Sudden deafness

Heart conditions

Palpitations Tachycardia

Heart attack

myocardium

Tachyarrhythmia

ventricular

Angina

the chest

Vascular disorders

Redness

Hypotension Hypertension

Thoracic and mediastinal respiratory disorders.

Nasal congestion

Dyspnoea sinus congestion

Epistaxis

Gastrointestinal disorders.

Dyspepsia

Gastroesophageal reflux Gastritis

Abdominal and gastrointestinal pain Diarrhea Vomiting Nausea Dry mouth

Hepatobiliary disorders.

Elevated transaminases

Gamma-glutamyl transferase elevation

(γGT)

Skin and subcutaneous tissue disorders.

Erythema rash

Photosensitivity reaction

Musculoskeletal and connective tissue disorders.

Pains

spine

Elevation of

CPK (creatine

phosphokinase

blood)

Myalgia

Increase

tone

muscle and

cramps

Kidney and urinary tract disorders.

Hematuria

Reproductive system and breast disorders.

Prolonged erections

Priapism

Hemorrhage

penis

Hemospermia

General disorders and administration site conditions.

Feel bad

Chest pain

When all PDE5 inhibitors are used, including vardenafil, penile hemorrhage, hemospermia, and hematuria, they have been reported in clinical trials and spontaneously reported as part of post-marketing surveillance.

At the 20 mg dose of Levitra, film-coated tablet, elderly patients (≥65 years) had higher frequencies of headaches (16.2%) compared to younger patients (younger than 65 years). versus 11.8%) and dizziness (3.7% versus 0.7%). The incidence of side effects (especially "dizziness") has been shown to be generally slightly higher in patients with a history of hypertension.

Post-marketing reports of other products in the same class.

Vascular disorders

As part of post-market monitoring of other medicinal products in the PDE5 inhibitor class, serious cardiovascular reactions such as cerebrovascular hemorrhage, sudden cardiac death, transient ischemic attack, unstable angina pectoris, and ventricular arrhythmia, a temporary causal link has been reported. with taking these medications.

Notification of suspected adverse reactions.

Notification of suspected adverse reactions after authorization of the medicinal product is important. Allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals should report any suspected adverse reactions through the national reporting system; see Annex V.

Overdose

In studies in healthy volunteers, single doses of vardenafil (film-coated tablet) of up to 80 mg per day were well tolerated without causing serious adverse effects.

Vardenafil administered in large repeated doses and above the recommended dose (40 mg film-coated tablet twice daily) has caused severe back pain. This was not associated with any form of muscular or neurological toxicity.

In the event of an overdose, the usual symptomatic treatment measures should be implemented as necessary. Renal dialysis should not accelerate the elimination of the product, since it is strongly bound to plasma proteins and is not significantly eliminated in the urine.

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