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Vivanza is a brand name for Vardenafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vivanza to be effective, sexual stimulation is required.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Use in adult men 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 dose is 20 mg.
The maximum recommended dosing frequency is once per day. Vivanza can be taken with or without food. 2). Special populations Elderly (>65 years old) Dose adjustments are not required in elderly patients. 8). Hepatic impairment 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. 2). Renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance <30 ml/min), a starting dose of 5 mg should be considered.
Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg. Paediatric population Vivanza is not indicated for individuals below 18 years of age. There is no relevant indication for use of Vivanza in children. 5).
Method of administration For oral use.
Summary of the safety profile The adverse reactions reported with Vivanza film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Tabulated list of adverse reactions Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Medicinal product no longer authorised 8 The following adverse reactions have been reported: System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data) Infection and infestations Conjunctivitis Immune system disorders Allergic oedema and angioedema Allergic reaction Psychiatric disorders Sleep disorder Anxiety Nervous system disorders Headache Dizziness Somnolence Paraesthesia and dysaesthesia Syncope Seizure Amnesia Transient ischaemic attack Cerebral haemorrhage Eye disorders Visual disturbance Ocular hyperaemia Visual colour distortions Eye pain and eye discomfort Photophobia Increase in intraocular pressure Lacrimation increased Non-arteritic anterior ischemic optic neuropathy Visual defects Ear and labyrinth disorders Tinnitus Vertigo Sudden deafness Cardiac disorders Palpitation Tachycardia Myocardial infarction Ventricular tachy-arrhyth- mias Angina pectoris Sudden death Vascular disorders Flushing Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasal congestion Dyspnoea Sinus congestion EpistaxisMedicinal product no longer authorised 9 System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data) Gastrointestinal disorders Dyspepsia Gastro-oesopha- geal reflux disease Gastritis Gastrointestinal and abdominal pain Diarrhoea Vomiting Nausea Dry mouth Hepatobiliary disorders Increase in transaminases Increase in gamma-glutamyl transferase Skin and subcutaneous tissue disorders Erythema Rash Photosensitivity reaction Musculoskeletal and connective tissue disorders Back pain Increase in creatine phosphokinase Myalgia Increased muscle tone and cramping Renal and urinary disorders Haematuria Reproductive system and breast disorders Increase in erection Priapism Penile Haemorrhage Haemato- spermia General disorders and administration site conditions Feeling unwell Chest pain Description of selected adverse reactions Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
3). 1). g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors. Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack and cerebral haemorrhage), have been reported in temporal association with vardenafil.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Medicinal products for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
The safety and efficacy of combinations of Vivanza film-coated tablets with Vivanza orodispersible tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
8). Concomitant use of alpha-blockers The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets. Vardenafil may be administered at any time with tamsulosin or with alfuzosin.
1. 1). 4). g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]). The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: - severe hepatic impairment (Child-Pugh C), - end stage renal disease requiring dialysis, - hypotension (blood pressure <90/50 mmHg), - recent history of stroke or myocardial infarction (within the last 6 months), - unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years. 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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7%) than younger patients (<65 years old). Medicinal product no longer authorised 10 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
5). In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
3). 2). Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. 5). Effect on QTc interval Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone. 1). The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present atMedicinal product no longer authorised 5 any time in any given patient.
g. g. amiodarone, sotalol). Effect on vision Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Vivanza and other PDE5 inhibitors. 8). 3). Effect on bleeding In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations, vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
5). There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration. Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.