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REVATIO 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: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
g. g. g. ). 5 mL) three times a day administered as an intravenous bolus injection. A 10 mg dose of REVATIO solution is predicted to provide exposure of sildenafil and its N- desmethyl metabolite and pharmacological effects comparable to those of a 20 mg oral dose.
Use in patients with renal and hepatic impairment:
No dose adjustments are required for renal impaired patients (including severe renal impairment, creatinine clearance <30 mL/min), and hepatic impaired patients (Child Pugh class A and B). g. potent inducers such as barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin, rifabutin) may alter plasma levels of either or both medications.
Dosage adjustments may be necessary (see PRECAUTIONS). g. ketoconazole, itraconazole, ritonavir) with REVATIO substantially increases serum concentrations of sildenafil and is therefore not recommended (see WARNINGS, DRUG INTERACTIONS).
A downward dose adjustment to 20 mg (10 mg if by intravenous injection) twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20 mg (10 mg if by intravenous injection) once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
Sildenafil was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors, or nitrates in any form, is therefore contraindicated. REVATIO may be used concomitantly in patients stabilized on epoprostenol (see ADVERSE REACTIONS and Drug-Drug Interactions).
REVATIO (sildenafil citrate) – Product Monograph Page 25 of 55 Geriatric Use (≥ 65 years): No dose adjustment is required. However, in general, dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see ACTION AND CLINICAL PHARMACOLOGY).
Use in children:
REVATIO is not indicated for use in children less than 18 years of age. Administration Oral Dose Administration REVATIO should be taken approximately 6-8 hours apart, with or without food. Intravenous Dose Administration REVATIO solution is for intravenous use as a bolus injection.
Serious Warnings and Precautions Before taking REVATIO, talk to your doctor or pharmacist if you: • have high blood pressure in your lung arteries (pulmonary veno-occlusive disease) • have had temporary, decrease, or permanent loss of vision in one or both eyes including a condition called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
BEFORE you use REVATIO talk to your doctor or pharmacist if you: • have heart problems (irregular heartbeats, angina, chest pain, or had a heart attack or stroke) • have high or low blood pressure • have kidney problems • have liver problems • have blood problems, including sickle cell anemia or leukemia • have a deformed penis (Peyronie’s disease, abnormal curvature of the penis), or ever had an erection lasting more than 4 hours • have stomach ulcers or any types of bleeding problems • have an eye disease called retinitis pigmentosa • are taking an alpha blocker (a drug used to treat high blood pressure or prostate problems) • are pregnant or breastfeeding • are taking bosentan therapy for pulmonary arterial hypertension.
• are taking products such as Viagra (sildenafil), Cialis, Levitra, Adcirca and Staxyn. • are taking any other medicines Driving and using machines: A small percentage of patients experience dizziness or altered vision. You should be aware of how you might be affected by REVATIO before driving or operating machinery.
INTERACTIONS WITH THIS MEDICATION Serious Drug Interactions • Use of organic nitrates in any form is absolutely contraindicated (see Do not use REVATIO if:) • Use of products such as Viagra (sildenafil), Cialis, Levitra, Adcirca and Staxyn, and • Use of other vasodilators, a class of drugs that open (dilate) the blood vessels (see WARNINGS AND PRECAUTIONS) Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
g. doxazosin), drugs used to treat high blood pressure or prostate problems • Beta-Blockers and amlodipine, drugs used to treat high blood pressure • Bosentan therapy for pulmonary arterial hypertension. g. amlodipine, verapamil) drugs used to treat high blood pressure, angina and abnormal heart rhythms • Ketoconazole or itraconazole to treat fungal infections.
• Sildenafil citrate 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 ACTION AND CLINICAL PHARMACOLOGY, DOSAGE AND ADMINISTRATION). • REVATIO is contraindicated in patients who are hypersensitive to this drug or 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. • REVATIO is contraindicated in patients with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS).
, ketoconazole, itraconazole, ritonavir). • Vaso-occlusive crises in patients with sickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving REVATIO than those receiving placebo leading to the premature termination of this study.
• The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: o Severe hepatic impairment, o Recent history of stroke or myocardial infarction, or life-threatening arrhythmia o Patients with coronary artery disease causing unstable angina; o Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
• The co-administration of PDE5 inhibitors, including REVATIO, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life- threatening episodes of symptomatic hypotension or syncope.
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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This medicinal product does not require dilution or reconstitution before use. 5 mL and dispose of all the remainder of the solution after use. Each dose requires a new vial. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or intravenous diluents.
OVERDOSAGE In studies with healthy volunteers of single oral doses 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 it is not eliminated in the urine (see DETAILED PHARMACOLOGY). For management of a suspected drug overdose, contact your regional Poison Control Centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type-5 (PDE5) in the smooth muscle of the pulmonary vasculature, where PDE5 is responsible for degradation of cGMP.
Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with pulmonary hypertension, this can lead to selective vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.
REVATIO (sildenafil citrate) – Product Monograph Page 26 of 55 Studies in vitro have shown that sildenafil has between 10 and 10,000-fold greater selectivity for PDE5 than for other phosphodiesterase isoforms namely PDEs 1, 2, 3, 4, and 6 and greater than 700-fold effect on PDE7-PDE11.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. Sildenafil is about 10-fold as potent for PDE5 compared to PDE6, an isoenzyme found in the retina; this lower selectivity is thought to be the basis for colour vision abnormalities observed with higher doses or plasma levels of sildenafil (see PRECAUTIONS, DETAILED PHARMACOLOGY).
In addition to pulmonary vascular smooth muscle and the corpus cavernosum, PDE5 is also found in other tissues including vascular and visceral smooth muscle and in platelets. The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet anti- aggregatory activity observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.
3 mmHg). The decrease in blood pressure was most notable […]
• Nitrates in any form (oral, sublingual [under the tongue], skin patch or by inhalation). Nitrates are found in many prescriptions that are used to treat angina (chest pain due to heart disease) (also see Section “When it should not be used”).
• Ritonavir and saquinavir or other drugs used for the treatment of HIV. • Cimetidine (a drug generally used to treat duodenal or gastric problems) • Erythromycin, clarithromycin and telithromycin (drugs used to treat bacterial infections) • Nefazodone (a drug used to treat depression) Grapefruit juice may affect REVATIO blood levels.
You should avoid taking REVATIO with grapefruit juice. Alcohol can react with REVATIO. It may increase the heart rate, decrease standing blood pressure, or cause dizziness, and headache. You should avoid consuming alcohol while taking REVATIO.
St-Johns’s Wort may affect REVATIO blood levels. You should advise your doctor if you are taking St-Johns’s wort. If you are unsure about the medications you are taking, ask your doctor or pharmacist.
PROPER USE OF THIS MEDICATION Usual dose:
Always take REVATIO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended oral dose is 20 mg three times a day (taken 6 to 8 hours apart) swallowed with or without food.
5 mL) three times a day administered as an intravenous bolus injection administered by your doctor who will tell you when to resume to the tablets. Each dose requires a new vial. If you have the impression that the effect of REVATIO is too strong or too weak, talk to your doctor or pharmacist.
REVATIO is not indicated for use in children less than 18 years of age.
IMPORTANT:
PLEASE READ REVATIO (sildenafil citrate) – Product Monograph Page 54 of 55 Overdose: You should not take more tablets than your doctor tells you. If you take more tablets than you have been told to take contact your doctor. If you think you have taken too much REVATIO, contact your health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you missed a dose of REVATIO, take it as soon as you remember, then continue with your next scheduled dose. Do not take two doses at the same time. SIDE EFFECTS AND WHAT TO DO ABOUT THEM These are not all the possible side effects you may feel when taking REVATIO.
If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. As with most drugs, REVATIO can cause some side effects. The most common side effects are headache, facial flushing, indigestion, back pain, diarrhoea, nausea and pain in extremity.
Other side effects you might notice: flu-like symptoms, difficulty sleeping, muscle aches. If any of these side effects is severe, talk with your doctor or pharmacist. If you notice any side effects not mentioned in this leaflet, or any of the above-mentioned effects persist or become bothersome, please inform your doctor or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Frequency Symptom / effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacistOnly if severe In all cases Less Common Effect on hearing (sudden decrease or loss of hearing) ✓ Blurred vision ✓ […]
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions • Administration to patients with pulmonary veno-occlusive disease is not recommended. 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 REVATIO (sildenafil citrate) – Product Monograph Page 5 of 55 General REVATIO (sildenafil citrate) is not recommended in the following cases: • Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease.
Since there are no clinical data on administration of REVATIO to patients with venous occlusive disease, administration of REVATIO to such patients is not recommended. • The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated (6-minute walk distance (6MWD)).
No benefit of sildenafil coadministered with bosentan was demonstrated over bosentan alone. The results of the 6MWD were different between primary PAH (PPH) and PAH associated with CTD. 32m vs. 50m). The concomitant administration of sildenafil and bosentan is not an optimal choice in PPH patients stable on bosentan therapy and the use of sildenafil with bosentan is not recommended in patients with PAH associated with CTD (see DRUG INTERACTIONS, Drug-Drug Interactions and DETAILED PHARMACOCOLGY, Human, Pharmacodynamic Studies).
Before prescribing REVATIO, it is important to note the following: • In clinical trials, sildenafil has been shown to have systemic vasodilatory properties that result in transient decreases in blood pressure (see ACTION AND CLINICAL PHARMACOLOGY).
Prior to prescribing REVATIO, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, for example patients with resting hypotension (BP <90/50), or with fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction.
• Sildenafil citrate is also marketed as VIAGRA for male erectile dysfunction. When used to treat male erectile dysfunction, non-arteritic anterior ischaemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of all phosphodiesterase type-5 inhibitors.
NAION, a rare condition, can result in varying degrees of permanent loss of vision, for which there is no treatment. Most, but not all of these patients had underlying risk factors for the development of NAION, including but not necessarily limited to: low cup to optic disc ratio (the “crowded disc at risk”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidaemia and smoking.
An observational study evaluated whether recent, episodic use of PDE5 inhibitors (as a class), typical of erectile dysfunction treatment, was associated with acute onset of NAION. The results suggest an approximately 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use.
8 cases per 100,000 males aged ≥ 50 per year in the general population. In case of sudden visual loss, patients should be advised to stop taking sildenafil and consult a physician immediately. Individuals who have already experienced NAION are at increased risk of NAION recurrence.
Therefore physicians should discuss this risk with these patients and whether they could be adversely affected by use of PDE5 inhibitors. PDE5 inhibitors, including REVATIO (sildenafil citrate) – Product Monograph Page 6 of 55 sildenafil should be used with caution […]