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PMS-TADALAFIL 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 ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Treatment of ED Dosage Consideration:
The management of erectile dysfunction should be individualized. Dosage and regimen should be discussed between the physician and the patient based on effectiveness and tolerability. pms-TADALAFIL for treatment of ED works only in the presence of sexual stimulation.
pms-TADALAFIL On-Demand Dosing: The recommended dose of pms-TADALAFIL On-Demand for treatment of ED is 20 mg taken prior to anticipated sexual activity, without regard to food. The dose may be adjusted based on individual tolerability and effectiveness.
The maximum recommended dosing frequency is once per day. pms-TADALAFIL doses of 10 mg and 20 mg are intended for use prior to anticipated sexual activity and are not recommended for continuous daily use. Tadalafil has been shown to be effective within 30 minutes of taking the tablet, and up to 36 hours later.
Patients may initiate sexual activity at varying time points relative to dosing, in order to determine their own optimal window of responsiveness. For On-Demand dosing, pms-TADALAFIL may be administered with selective alpha-[1 or 1A] blockers such as alfuzosin or tamsulosin, and no dosage adjustment of pms-TADALAFIL is required.
However, when prescribing pms-TADALAFIL to patients who are taking non-selective alpha-blockers such as doxazosin, the recommended starting dose is 10 mg. , ketoconazole). A starting dose of 10 mg prior to anticipated sexual activity should be considered for these patients, but no more frequently than on alternate days, and not exceeding 3 times a week.
If the 10 mg dose is tolerated but insufficiently effective, the dose may be increased to 20 mg. If the 10 mg dose is not tolerated, pms-TADALAFIL On-Demand dosing should be discontinued (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics in Special Populations, WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS).
See also CONTRAINDICATIONS – Nitrates, and WARNINGS AND PRECAUTIONS – Alpha- blockers and Antihypertensives. There are no controlled clinical data on the safety or efficacy of tadalafil in the following groups; if prescribed, this should be done with caution: x patients with severe renal insufficiency (creatinine clearance <30 mL/min) x patients with severe hepatic insufficiency (Child-Pugh Class C) pms-TADALAFIL Once-a-Day Dosing: The recommended dose of pms-TADALAFIL Once–a-Day for treatment of ED is 5 mg per day, pms-TADALAFIL Product Monograph Page 17 of 57 taken at approximately the same time each day, without regard to food and without regard to timing of sexual activity.
Nitrates Tadalafil has been shown to potentiate the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/ cGMP pathway. , oral, sublingual, transdermal, by inhalation), either regularly and/or intermittently, is contraindicated, due to the risk of developing potentially life-threatening hypotension.
pms-TADALAFIL should not be prescribed to patients for whom nitrates are prescribed, even though the patient may not have actually used the nitrate therapy. In a patient prescribed pms-TADALAFIL, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of pms-TADALAFIL before nitrate administration is considered.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring. Hypersensitivity Reactions pms-TADALAFIL should not be used in patients with a known hypersensitivity to tadalafil or any component of the tablet (see DOSAGE FORMS, COMPOSITION AND PACKAGING).
Non-Arteritic Anterior Ischaemic Optic Neuropathy pms-TADALAFIL is contraindicated in patients with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS). Co-administration with Guanylate Cyclase Stimulators The co-administration of PDE5 inhibitors, including pms-TADALAFIL, with guanylate cyclase stimulators, such as riociguat, is contraindicated because it could lead to potentially life- threatening episodes of symptomatic hypotension or syncope.
WARNINGS AND PRECAUTIONS General The evaluation of erectile dysfunction and lower urinary tract symptoms should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg once a day, based on individual tolerability. No dose adjustment is required when pms-TADALAFIL Once-a-Day is used in combination with alpha-blockers. , ketoconazole). pms-TADALAFIL for Once-a-Day use is not recommended for patients with severe renal or hepatic impairment.
See also CONTRAINDICATIONS – Nitrates, and WARNINGS AND PRECAUTIONS – Alpha-blockers and Antihypertensives.
Treatment of BPH and ED/BPH:
The recommended dose of pms-TADALAFIL Once–a-Day for treatment of BPH and ED/BPH is 5 mg per day, taken at approximately the same time each day, without regard to food and in men with ED, without regard to timing of sexual activity.
No dose adjustment is required when pms-TADALAFIL Once–a-Day is used in combination with alpha-blockers. pms-TADALAFIL is not recommended for use in combination with alpha blockers for the treatment of BPH (see WARNINGS AND PRECAUTIONS – Alpha-blockers and Antihypertensives).
, ketoconazole). 5 mg/day in these patients, based on individual tolerability. pms-TADALAFIL for Once-a-Day use is not recommended for patients with severe renal or hepatic impairment. See also CONTRAINDICATIONS – Nitrates, and WARNINGS AND PRECAUTIONS – Alpha-blockers and Antihypertensives.
OVERDOSAGE Symptoms and Treatment of Overdosage Single doses of up to 500 mg tadalafil have been given to healthy subjects, and multiple doses of 100 mg/day for 21 days have been given to patients. , headache, dyspepsia) were similar to those seen at lower doses.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance, as tadalafil is highly bound to plasma proteins. pms-TADALAFIL Product Monograph Page 18 of 57 Treatment of Priapism All patients should be counselled to contact a physician if they experience any erection persisting for more than 4 hours.
Priapism should be treated according to established medical practice. One algorithm aimed primarily at treating priapism secondary to pharmacological agents is presented below: Procedure 1 – External Perineal Compression: Although frequently unsuccessful, the use of prolonged external perineal compression, including ice, may be applied as a temporizing measure.
If procedure 1 is unsuccessful, proceed to procedure 2.
Procedure 2 – Penile Aspiration:
Place the patient in the supine position and assure local anesthesia of the penis. The penile shaft should be punctured at either the 2 o’clock or the 10 o’clock position, and 20-30 mL of blood aspirated from the corpus cavernosum. If detumescence has occurred, the penis should be dressed with an elasticized bandage to ensure continued emptying of the corpora and to compress the puncture site(s).
If procedure 2 is unsuccessful, proceed to procedure 3. […]
Counselling Patients About Sexually Transmitted Diseases The use of pms-TADALAFIL offers no protection against sexually transmitted diseases. Counselling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.
pms-TADALAFIL Product Monograph Page 5 of 57 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH Prior to initiating treatment with pms-TADALAFIL for BPH, consideration should be given to other urological conditions that may cause similar symptoms.
In addition, prostate cancer and BPH may coexist. Cardiovascular Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including pms-TADALAFIL, should not be used in men with cardiac disease for whom sexual activity is inadvisable.
, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. , nitrates, alpha-blockers, antihypertensives and potent inhibitors of CYP3A4). Sexual Function/Prolonged Erection Priapism was not reported in clinical trials with tadalafil.
However, priapism has been reported rarely in post-marketing surveillance with PDE5 inhibitors, including tadalafil. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile injections containing vasoactive agents.
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Tadalafil should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease).
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. pms-TADALAFIL Product Monograph Page 6 of 57 Ophthalmology/Eye Post-marketing reports of sudden loss of vision have occurred rarely, in temporal association with the use of PDE5 inhibitors, including tadalafil (see ADVERSE REACTIONS, Post-Market Experience).
An approximate 2 to 4-fold increased risk of acute Non-Arteritic Ischemic Optic Neuropathy (NAION) has been suggested from analyses of observational data in men with ED within 1 to 4 days (5 half-lives) of episodic PDE5 inhibitor use, including tadalafil.
There is an increased risk of NAION in patients who have already experienced NAION. The use of PDE5 inhibitors, including tadalafil, is contraindicated in patients with a previous episode of NAION (see CONTRAINDICATIONS). Physicians should instruct patients to stop taking pms- TADALAFIL and immediately seek medical attention if they experience changes in, sudden decrease or loss of vision in one or both eyes.
Ear/Sudden Hearing Loss Sudden decrease or […]