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ADCIRCA is a brand name for Tadalafil, 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 ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Cardiovascular Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of ADCIRCA. In such a patient, who has taken ADCIRCA, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of ADCIRCA before nitrate administration is considered.
In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention.
As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. While this effect should not be of consequence in most patients, prior to prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.
Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors. , aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Pulmonary Veno-Occlusive Disease:
Administration to patients with pulmonary veno-occlusive disease is not recommended. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of ADCIRCA to patients with veno-occlusive disease, administration of ADCIRCA to such patients is not recommended.
Should signs of pulmonary edema occur when ADCIRCA is administered, the possibility of associated PVOD should be considered. The following groups of patients with cardiovascular disease were excluded in the PAH clinical trials: Patients with clinically significant aortic and mitral valve disease Patients with pericardial constriction Patients with restrictive or congestive cardiomyopathy Patients with significant left ventricular dysfunction Patients with life-threatening arrhythmias Patients with symptomatic coronary artery disease Patients with hypotension (< 90/50 mm Hg), or uncontrolled hypertension.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
ADCIRCA® (tadalafil) Product Monograph Page 5 Ophthalmologic Physicians should advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.
An increased risk of acute NAION has been suggested from analyses of observational data in men with erectile dysfunction (ED) within 1 to 4 days of episodic PDE5 inhibitor use. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors (see ADVERSE REACTIONS).
g. crowded disc) prior to development of the condition. If physicians are concerned about the overall risk of NAION, they should consider discussing these concerns with an ophthalmologist. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.
Otologic Physicians should advise patients to seek immediate medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including ADCIRCA.
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). Reproduction/ Urogenital ADCIRCA 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 anemia, multiple myeloma, or leukemia).
Long-term human studies with subjects 45 years or older have shown that tadalafil therapy may decrease sperm concentration in some patients, but the clinical relevance of this to human fertility is unknown.
Special Populations Pregnant Women:
There are no adequate and well controlled studies of ADCIRCA use in pregnant women. Animal reproduction studies in rats and mice revealed no evidence of fetal harm. ADCIRCA® (tadalafil) Product Monograph Page 6 Non-teratogenic effects — Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 9 times the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis (see TOXICOLOGY).
Nursing Women:
It is not known whether tadalafil or its metabolites are excreted into human breast milk. Since many drugs are excreted in human milk, caution should be used when ADCIRCA is administered to nursing women.
Pediatric Use:
The pharmacokinetics, safety or effectiveness of ADCIRCA in pediatric patients has not been established.
Use in the Elderly (> 65 years of age):
Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. No overall differences in safety were observed between […]