Loading…
MYLAN-VARDENAFIL is a brand name for Vardenafil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates, and therefore co-administration of MYLAN-VARDENAFIL (vardenafil tablets) with nitrates and nitric oxide donors is contraindicated.
In a patient prescribed MYLAN-VARDENAFIL (vardenafil tablets), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 24 hours should have elapsed after the last dose of MYLAN-VARDENAFIL (vardenafil tablets) before nitrate administration is considered.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring. Concomitant use of MYLAN-VARDENAFIL (vardenafil tablets) with medicinal products containing cobicistat, HIV protease inhibitors such as indinavir, ritonavir, saquinavir, or atazanavir, and combinations of these, ketoconazole, or itraconazole is contraindicated, as they are potent inhibitors of CYP3A4 (see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION).
MYLAN-VARDENAFIL (vardenafil tablets) is contraindicated in patients with erectile dysfunction with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS). The co-administration of PDE5 inhibitors, including MYLAN-VARDENAFIL, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life-threatening episodes of symptomatic hypotension or syncope (see DRUG INTERACTIONS).
WARNINGS AND PRECAUTIONS General The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment and the identification of appropriate treatment. Before prescribing MYLAN-VARDENAFIL (vardenafil tablets), it is important to note the following: Vardenafil tablets has not been administered to patients with bleeding disorders or significant active peptic ulceration.
Therefore MYLAN-VARDENAFIL should be Page 5 of 58 administered to these patients after careful benefit-risk assessment. In humans, vardenafil tablets has no effect on bleeding time alone or with acetylsalicyclic acid. In vitro studies with human platelets indicate that vardenafil tablets does not inhibit platelet aggregation induced by a variety of platelet agonists.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Vardenafil in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
A small, concentration-dependent, enhancement of the anti-aggregation effects of a nitric oxide donor, nitroprusside, was observed with supra- therapeutic concentrations of vardenafil tablets in the presence of platelet agonists. The bleeding time in rats with a combination of heparin and vardenafil was not different from that observed with heparin alone.
However, this interaction has not been studied in humans. Treatment for erectile dysfunction should generally 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 that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Vardenafil tablets has not been studied in patients with CNS disease (other than spinal cord injury), hypoactive sexual desire, or in patients who have undergone pelvic surgery (except nerve sparing prostatectomy), pelvic trauma, or radiotherapy.
Post-marketing reports of sudden loss of vision have occurred rarely, in temporal association with the use of PDE5 inhibitors. It is not clear whether these are related directly to the use of PDE5 inhibitors or to other factors. There may be an increased risk to patients who have already experienced Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).
Cardiovascular Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, including uncontrolled hypertension (with BP > 140/90 mmHg), any treatment for erectile dysfunction, including MYLAN-VARDENAFIL generally should not be used.
Physicians are advised to consult the recommendations of the Princeton Consensus Panel (DeBusk et al. Am J Cardiol 2000;86:175-81). The following groups of patients with cardiovascular disease were not included in clinical trials: patients with a myocardial infarction or stroke within the last 6 months, patients with unstable angina pectoris or acute myocardial ischemia, patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg), uncontrolled hypertension (>170/110 mmHg), patients with symptomatic postural hypotension in the last six months.
MYLAN-VARDENAFIL has vasodilator properties which may result in mild and transient decreases in blood pressure. Patients with left ventricular outflow obstruction, eg, aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including Type 5 phosphodiesterase inhibitors.
Patients should be stable on alpha-blocker therapy before prescribing MYLAN-VARDENAFIL. Page 6 of 58 Patients receiving alpha-blocker therapy should be initiated at the lowest dose of 5 mg MYLAN- VARDENAFIL. Congenital and Acquired QT Prolongation In a study of the effect of vardenafil tablets on the QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil tablets produced minimal increases in QTc interval.
) In a post-marketing study evaluating the effect of combining vardenafil tablets with another drug of comparable QT effect (400 mg gatifloxacin), it was shown that the drug combination produced an additive QT effect […]