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M-SILDENAFIL is a brand name for Sildenafil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-SILDENAFIL (sildenafil) is indicated for: • the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. 1.1. Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not…
Verbatim from this product's HC label. Tap a section to expand.
). • After patients have taken sildenafil, it is unknown when nitrates, if necessary, can be safely administered. Plasma levels of sildenafil at 24 hours post-dose are much lower (2 ng/mL) than at peak concentration (440 ng/mL). g. g. CLcr < 30 mL/min), and concomitant use of potent cytochrome P-450 3A4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hours post-dose have been found to be 3 to 8 times higher than those seen in healthy volunteers.
Although plasma levels of sildenafil at 24 hours post-dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point. • Treatments for erectile dysfunction should not be generally used in men for whom sexual activity is inadvisable (see also 7 WARNINGS AND PRECAUTIONS).
• M-SILDENAFIL is contraindicated in patients with a known hypersensitivity to any component of the tablet (see 13 PHARMACEUTICAL INFORMATION). • M-SILDENAFIL is contraindicated in patients with erectile dysfunction with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see 7 WARNINGS M-SILDENAFIL (Sildenafil Citrate) Page 5 of 47 AND PRECAUTIONS).
• The co-administration of PDE5 inhibitors, including M-SILDENAFIL, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life- threatening episodes of symptomatic hypotension or syncope.
g. g. g. erythromycin: 182%; saquinavir: 210%; ritonavir: 1000%). It can also be expected that more potent cytochrome P-450 3A4 inhibitors such as ketoconazole and itraconazole would result in increased levels of sildenafil. 2 Recommended Dose and Dose Adjustment, 10 CLINICAL PHARMACOLOGY, 7 WARNINGS AND PRECAUTIONS).
Sildenafil has been shown to potentiate the hypotensive effects of nitrates in healthy volunteers and in patients, and is therefore contraindicated in patients who are taking any type of nitrate drug therapy, or who utilize short-acting nitrate-containing medications, due to the risk of developing potentially life-threatening hypotension.
g. oral, sublingual, transdermal, by inhalation) is absolutely contraindicated (see 10 CLINICAL PHARMACOLOGY, 2 CONTRAINDICATIONS). 2 Recommended Dose and Dosage Adjustment For most patients, the recommended dose of M-SILDENAFIL is 50 mg taken as needed.
5 POST-MARKET ADVERSE REACTIONS and PATIENT MEDICATION INFORMATION). Health professionals should advise patients to stop taking sildenafil and seek prompt medical attention in case of sudden decrease or loss of hearing. Hematologic In clinical trials, sildenafil has been shown to have systemic vasodilatory properties that result in transient decreases in blood pressure.
This is of little or no consequence in most patients. However, prior to prescribing sildenafil, health professionals should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity.
, aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. In humans, sildenafil has no effect on bleeding time when taken alone or with acetylsalicylic acid.
In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). The combination of M-SILDENAFIL (Sildenafil Citrate) Page 9 of 47 heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans (see 10 CLINICAL PHARMACOLOGY).
There is no safety information on the administration of M-SILDENAFIL to patients with bleeding disorders or active peptic ulceration. Therefore, M-SILDENAFIL should be administered with caution to these patients. Hepatic/Biliary/Pancreatic In volunteers with hepatic cirrhosis (Child-Pugh A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
A starting dose of 25 mg should be considered in patients with hepatic impairment (see 10 CLINICAL PHARMACOLOGY, 4 DOSAGE AND ADMINISTRATION) Ophthalmologic Patients should stop taking PDE5 inhibitors, including sildenafil, and consult their health professional immediately if they experience a decrease in, or sudden loss of, vision in one or both eyes.
). • M-SILDENAFIL is contraindicated in patients with a known hypersensitivity to any component of the tablet (see 13 PHARMACEUTICAL INFORMATION). • M-SILDENAFIL is contraindicated in patients with erectile dysfunction with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see 7 WARNINGS M-SILDENAFIL (Sildenafil Citrate) Page 5 of 47 AND PRECAUTIONS).
• The co-administration of PDE5 inhibitors, including M-SILDENAFIL, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life- threatening episodes of symptomatic hypotension or syncope.
g. g. g. erythromycin: 182%; saquinavir: 210%; ritonavir: 1000%). It can also be expected that more potent cytochrome P-450 3A4 inhibitors such as ketoconazole and itraconazole would result in increased levels of sildenafil. 2 Recommended Dose and Dose Adjustment, 10 CLINICAL PHARMACOLOGY, 7 WARNINGS AND PRECAUTIONS).
Sildenafil has been shown to potentiate the hypotensive effects of nitrates in healthy volunteers and in patients, and is therefore contraindicated in patients who are taking any type of nitrate drug therapy, or who utilize short-acting nitrate-containing medications, due to the risk of developing potentially life-threatening hypotension.
g. oral, sublingual, transdermal, by inhalation) is absolutely contraindicated (see 10 CLINICAL PHARMACOLOGY, 2 CONTRAINDICATIONS). 2 Recommended Dose and Dosage Adjustment For most patients, the recommended dose of M-SILDENAFIL is 50 mg taken as needed.
The maximum recommended dose is 100 mg. Dosage may be decreased to 25 mg if necessary. 1 Dosing Considerations above, 10 CLINICAL PHARMACOLOGY, 7 WARNINGS AND PRECAUTIONS). The concomitant use of the potent cytochrome P-450 3A4 inhibitor, ritonavir is associated with a 1000% (11-fold) increase in plasma levels (AUC) of sildenafil.
• Sildenafil has been shown to potentiate the hypotensive effects of nitrates in healthy volunteers and in patients, and is therefore contraindicated in patients who are taking any type of nitrate drug therapy, or who utilize short-acting nitrate-containing medications, due to the risk of developing potentially life-threatening hypotension.
g. oral, sublingual, transdermal, by inhalation) is absolutely contraindicated (see 10 CLINICAL PHARMACOLOGY,
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The maximum recommended dose is 100 mg. Dosage may be decreased to 25 mg if necessary. 1 Dosing Considerations above, 10 CLINICAL PHARMACOLOGY, 7 WARNINGS AND PRECAUTIONS). The concomitant use of the potent cytochrome P-450 3A4 inhibitor, ritonavir is associated with a 1000% (11-fold) increase in plasma levels (AUC) of sildenafil.
Given the extent of the interaction with patients receiving concomitant therapy with ritonavir, it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48-hour period (see 7 WARNINGS M-SILDENAFIL (Sildenafil Citrate) Page 6 of 47 AND PRECAUTIONS).
4 Administration To be taken as needed approximately 30 – 60 minutes before sexual activity. 5 hour to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. M-SILDENAFIL tablets should be swallowed whole with water.
Postmarketing reports of sudden loss of vision have occurred rarely, in temporal association with the use of PDE5 inhibitors. An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION.
The results suggest an approximate 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. Individuals who have already experienced NAION are at increased risk of NAION recurrence. PDE 5 inhibitors, including sildenafil, are not recommended in patients with male erectile dysfunction with a previous episode of NAION (see 2 CONTRAINDICATIONS).
There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). If prescribed, this should be done with caution.
(see 10 CLINICAL PHARMACOLOGY). g. impairment of colour discrimination, increased perception to light, blurred vision, eye pain, ocular redness) after taking sildenafil. If this happens, then the patient should not operate a motor vehicle or any heavy machinery until the adverse effects disappear (see 10 CLINICAL PHARMACOLOGY).
Rare cases of central serous chorioretinopathy have been reported during the post-marketing period in temporal association with the use of sildenafil citrate. It is not known if medical and other facts were reported that may have also played a role in the development of the condition.
It is not possible to determine whether the development of the condition was related directly to the use of sildenafil, to the patient’s possible underlying risk factors, a combination of these factors, or to other factors. These cases of central serous chorioretinopathy in patients receiving sildenafil did not provide evidence of serious or permanent alteration in visual function.
5 POST-MARKET ADVERSE DRUG REACTIONS). M-SILDENAFIL (Sildenafil Citrate) Page 10 of 47 Renal In volunteers with mild (CLcr = 50-80 mL/min) and moderate (CLcr = 30-49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil (50 mg) was not altered.
In volunteers with severe (CLcr <30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in increases in AUC (100%) and Cmax (88%) compared to age-matched volunteers with no renal impairment. A starting dose of 25 mg should be considered in patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY, 4 DOSAGE AND ADMINISTRATION).
Reproductive Health:
Female and Male Potential Function Although priapism had not been reported during clinical trials, prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently during the post-marketing surveillance of sildenafil.
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see 8 ADVERSE REACTIONS).
Agents 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 anemia, multiple myeloma or leukemia).
The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other agents for the treatment of erectile dysfunction have not been studied.
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Given the extent of the interaction with patients receiving concomitant therapy with ritonavir, it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48-hour period (see 7 WARNINGS M-SILDENAFIL (Sildenafil Citrate) Page 6 of 47 AND PRECAUTIONS).
4 Administration To be taken as needed approximately 30 – 60 minutes before sexual activity. 5 hour to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. M-SILDENAFIL tablets should be swallowed whole with water.
5 OVERDOSAGE In studies with healthy volunteers of single doses of up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required.
Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Treatment of Priapism Patients should be instructed to report any erections persisting for more than 4 hours to a health professional.
The treatment of priapism/prolonged erection should be according to established medical practice. Health professionals may refer to two suggested protocols for detumescence presented below. Detumescence Protocols 1) Aspirate 40 to 60 mL blood from either left or right corpora using vacutainer and holder for drawing blood.
Patient will often detumesce while aspirating. Apply ice for 20 minutes post aspiration if erection remains. If procedure 1) is unsuccessful, then try procedure 2). 2) Put patient in supine position. 05%). 2 mL (50-100 μg) into the corpora every 2 to 5 minutes, until the detumescence occurs.
The occasional patient may experience transient bradycardia and hypertension when given phenylephrine injections, therefore monitor patient’s blood pressure and pulse every 10 minutes. Patients at risk include those with cardiac arrhythmias and diabetes.
Refer to the prescribing information for phenylephrine before use. Do not give phenylephrine to patients on MAO inhibitors. When phenylephrine is used within the first 12 hours of erection, the majority of patients will respond. If procedure 2) is unsuccessful, then try procedure 3).
3) If the above measures fail to detumesce the patient, a urologist should be consulted as soon as possible, especially if the erection has been present for many hours. If priapism is not treated immediately, penile tissue damage and/or permanent loss of potency may result.
M-SILDENAFIL (Sildenafil Citrate) Page 7 of 47 For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1– Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets 25 mg, 50 mg and 100 mg microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose and opadry blue.
Description M-SILDENAFIL 25 mg tablets: each tablet contains sildenafil citrate equivalent to 25 mg sildenafil. Blue colored, biconvex, diamond-shaped film coated tablets with ‘SIL’ debossed on one side and ‘25’ on the other side. […]