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MINT-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: MINT-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.
2 Recommended Dose and Dosage Adjustment 07/2024 7 WARNINGS AND PRECAUTIONS, Ear/Nose/Throat 07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES....................................................................................................
2 TABLE OF CONTENTS ...................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 4 Administration ........................................................................................................... 5 5 OVERDOSAGE .....................................................................................................................
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5 POST-MARKET ADVERSE REACTIONS and PATIENT MEDICATION INFORMATION). Health professionals should advise patients to stop taking MINT-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 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).
MINT-SILDENAFIL (sildenafil) Page 9 of 49 There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Therefore, MINT-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 MINT-SILDENAFIL, and consult their health professional immediately if they experience a decrease in, or sudden loss of, vision in one or both eyes.
, Ear/Nose/Throat 07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES....................................................................................................
2 TABLE OF CONTENTS ...................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 4 Administration ........................................................................................................... 5 5 OVERDOSAGE .....................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 6 7 WARNINGS AND PRECAUTIONS .......................................................................................... 1 Special Populations ..................................................................................................
• 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.
Other brands of Sildenafil in Canada.
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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.
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 MINT-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 REACTIONS). 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 MINT-SILDENAFIL (sildenafil) Page 10 of 49 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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3 Pediatrics................................................................................................................. 4 Geriatrics .................................................................................................................
10 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Reaction Overview......................................................................................
2 Clinical Trial Adverse Reactions................................................................................. 3 Less Common Clinical Trial Adverse Reactions........................................................... 5 Post-Market Adverse Reactions ................................................................................
14 9 DRUG INTERACTIONS........................................................................................................ 1 Serious Drug Interactions .........................................................................................
2 Drug Interactions Overview...................................................................................... 4 Drug Drug Interactions .............................................................................................
5 Drug-Food Interactions............................................................................................. 6 Drug-Herb Interactions.............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 22 10 CLINICAL PHARMACOLOGY ...............................................................................................
1 Mechanism of Action ............................................................................................... 2 Pharmacodynamics ..................................................................................................
3 Pharmacokinetics .................................................................................................... 24 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
26 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................... 26 PART II: SCIENTIFIC INFORMATION...............................................................................................
27 13 PHARMACEUTICAL INFORMATION.................................................................................... 27 14 CLINICAL TRIALS ...............................................................................................................
1 Trial Design and Study Demographics ....................................................................... 2 Study Results ...........................................................................................................
3 Comparative Bioavailability Studies .......................................................................... 31 15 MICROBIOLOGY ................................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ............................................................................................. 32 17 SUPPORTING PRODUCT MONOGRAPHS ............................................................................
42 PATIENT MEDICATION INFORMATION ......................................................................................... 43 MINT-SILDENAFIL (sildenafil) Page 4 of 49 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MINT-SILDENAFIL (sildenafil) is indicated for: • the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection […]