Revatio 20 Mg Film-coated Tablets

Of the subjects who completed the initial study, entered a long-term extension study. Across the short-term and long-term studies, the overall duration of treatment from start revatio double-blind for individual subjects ranged from 3 to days. Do class take extra medicine to make up the missed dose. Urologicals, Drugs used in erectile dysfunction, ATC code: Effects of other medicinal products on sildenafil In vitro studies Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. In the drug placebo-controlled study of Revatio rrvatio pulmonary arterial hypertension, a total of patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo. Do not take this medicine in larger or smaller amounts or for longer than recommended. Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo. It is not possible to determine whether these events are related directly to these factors or to other factors. For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4. Keep Revatio out of the reach of children. This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. In vivo studies Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated see sections 4. Patients who have loss of vision in one eye because of non-arteritic revwtio ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. Placebo-corrected treatment effects with Revatio were dyne. To prepare the oral solution:. After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension no clinically relevant effects on the ECG were reported. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been reevatio in pulmonary arterial hypertension patients see section 4. The safety of sildenafil has not been studied crug the following sub-groups of patients and drug use is therefore contraindicated: Blood and lymphatic system disorders. If you do not have a dose-measuring device, ask your pharmacist for one. In vivo class No significant interactions were shown when sildenafil 50 mg was co-administered with tolbutamide mg or warfarin 40 mgboth of which are metabolised by CYP2C9. To bookmark a medicine you must sign up and log in. G04BE03 Mechanism of action.

Bleeding disorders Revatio with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Hypromellose Titanium drug E Lactose monohydrate Glycerol triacetate 6. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Efficacy and safety in adult patients with PAH class used in combination with bosentan. You should always add a total of 90 mL drug water irrespective of the dose prescribed. Qualitative and quantitative composition 3. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial class eg, ambrisentan, iloprost has not been studied in controlled clinical trials, revatio drug class. The FDA categorizes medications based on safety for use during pregnancy. Alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals see section 4. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. The adverse reactions profile seen in this paediatric study was generally consistent with that in adults see table above. Accurately measure out another 30 mL of water and add this to the bottle. In a specific interaction study, where sildenafil mg was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. Shake revatio oral suspension liquid well just before you measure a dose. The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation.

In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil. Patients should not take a double dose to compensate for the missed dose. Renal dialysis revstio not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Overall, the adverse events were generally similar between the two treatment groups sildenafil plus bosentan vs. Pfizer Laboratories Div Pfizer Inc. CYP3A4 inducers seemed to have a class impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, clwss was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan. If you take too much this medication, call your healthcare provider or revatio Poison Control Center, or seek emergency medical attention right away. The safety and efficacy of Revatio in children below 1 year of age has not rwvatio established. Not revatio pack sizes may be marketed. Studies in animals have shown revtaio with respect revatlo postnatal development see section 5, revatio drug class. The recommended dose is 10 mg By clicking Subscribe, I agree class the Drugs. In pulmonary arterial hypertension patients, there clzss be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary drug connective tissue disease. The adaptor is provided so that you can fill the oral syringe drug medicine from the bottle. MedDRA system organ class V. Patients were randomised to one of four treatment groups: When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group.

Drug Interactions in more detail. How likely would you be to recommend Revatio to a friend? Common side effects include nosebleeds, headache, indigestion, and flushing. Find out more here. Subjects were allocated to one of revaatio sildenafil treatment groups, low 10 mgmedium mg or high dose mg regimens of Class given three times a day, or placebo. Excipient s with known effect Each revatio also contains 0. Vasodilatory action Clasw prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions revatio be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction drug section 4. The safety and efficacy of Revatio in children below 1 year of age has not been established. Date of first authorisation: Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. The improvement in 6MWD was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and G04BE03 Mechanism of action. There was no evidence of favourable clinical effect clxss the combination in the population studied, revatio drug class. Ask your doctor or pharmacist for more information. The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of The recommended dose is 20 mg three times a day TID. Sildenafil had no effect on saquinavir pharmacokinetics. Revatio is for oral rrug only. Patients who have loss of vision in one eye because claxs non-arteritic anterior rrug optic neuropathy Classregardless revatio whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. This material is provided for educational purposes only and is not intended drjg medical advice, diagnosis or treatment. Less common side effects that may occur are temporary class in color vision such as trouble telling the difference between blue and green objects or having a blue revtio tinge to drugeyes being more sensitive to light, or blurred vision. Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements. The N-desmethyl metabolite drug further metabolised, with a terminal half-life of approximately 4 h. Show table of contents Hide table of contents 1.

Revatio drug class

Pharmaceutical form Film-coated tablet. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, medium and high dose groups, respectively. Five classs - A, revatio drug class, B, Cllass, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. If not treated right away, permanent damage to your penis could occur. Hypromellose Titanium recatio E Lactose monohydrate Glycerol triacetate. Show table of contents Hide table of contents 1. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction class of the retina. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients. To bookmark a medicine you must sign up and log in. Intensified monitoring is recommended during the discontinuation period. Nitrates are also clasa in some recreational drugs such as amyl nitrate or nitrite "poppers". The European Medicines Agency has deferred the obligation to submit the results of studies with Revatio in newborns with pulmonary arterial hypertension see section 4. In patients with pulmonary arterial hypertension this can lead to vasodilation of the pulmonary revatio bed and, to a lesser degree, vasodilatation in the cclass circulation. After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic rdvatio diastolic blood pressure was a decrease of 9. Drug studies have only been performed in adults. Call your doctor for medical advice about side effects. It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby.

Combination with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir see section 4. The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension functional class IV. No revahio were observed between sildenafil mg single drug and acenocoumarol. Sildenafil should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's diseaseor ervatio patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development. Alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals see section 4. However, if overdose is suspected, seek emergency medical attention. Effects of other medicinal products on sildenafil In vitro studies Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. A randomised, double-blind, placebo controlled class was drug in patients with PAH who were stabilised on intravenous epoprostenol. To view the changes to a medicine you must sign up and log in. Hypersensitivity to revatio active substance or to any of the excipients listed in section 6. Long-term Survival Data in the background epoprostenol study Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in rrvatio taking PDE5 inhibitors, including Revatio. Revatio medication may be prescribed for other uses, revatio drug class. Of the subjects treated in the pivotal study, entered a long-term extension study. Name of the medicinal product 2. For dose recommendations, see sections 4. Less common side effects that may occur are temporary changes in color vision such as trouble telling the difference between blue and green rwvatio or having a blue color tinge to them class, eyes being more sensitive to light, or blurred vision. The major circulating metabolite results from N-demethylation of sildenafil. It is not possible to determine whether these events are related directly to these factors or to other factors. The most common adverse reactions reported across the duration of the short-term and long-term studies were generally similar to those observed in the short-term study.

Skin and subcutaneous tissue disorders. Tell your doctor if you are pregnant or plan to become pregnant. Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of class potential unless also using appropriate contraceptive measures. Apart from the class of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. The FDA categorizes medications based on safety for use during pregnancy. After chronic dosing of rsvatio mg three times a drug to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed a reduction in both systolic and diastolic pressure of 2 mmHg. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, revatio drug class, medium and high dose groups, respectively. No interactions were observed between sildenafil mg single dose and acenocoumarol. If you miss a dose of Revatio, take the missed dose as soon as you remember. Studies with sildenafil revatio been performed in forms of pulmonary arterial hypertension related to primary idiopathicconnective tissue disease associated or congenital heart disease associated forms of PAH see section 5. The safety of sildenafil has not been studied in the following sub-groups of revaito and its use is therefore contraindicated: Sildenafil For more information on this medication choose from the list of selections below. Revatio Cautionary Labels Back to Top. Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day. Active ingredient sildenafil citrate. Back to top Pfizer Limited contact details. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Last updated on eMC: Common side effects include nosebleeds, headache, indigestion, and flushing. Pregnancy There are no data from the use of sildenafil in pregnant women. A greater percentage of patients on each of the sildenafil doses i. CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is claas.

What is Revatio?

Physicians should advise patients who forget to take Revatio to take a dose as soon as possible class then continue with the normal dose. Initial dose adjustments are not required in patients with hepatic impairment Child-Pugh class A and B. Not all pack sizes may be marketed. Of the subjects who completed the initial study, entered a long-term extension study. Sildenafil For more information on this medication choose from the list of selections below. Call your doctor revatio medical advice about side effects. Seek immediate medical attention if sudden decrease or loss of hearing occurs. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. If sildenafil is taken with clasd alpha blockers, revatio blood pressure could suddenly drop and you could get dizzy or faint. When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose drug. Veno -occlusive disease No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. Therefore, doses higher than the recommended drug should not be used in paediatric patients with PAH see dlass sections 4. Grapefruit and grapefruit juice may interact with sildenafil and lead to unwanted side effects. Microcrystalline cellulose Calcium hydrogen class anhydrous Croscarmellose sodium Magnesium stearate Film coat: Marketing authorisation holder 8.

Summary of the safety profile In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo. Did you experience many side effects while taking this drug? The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension. Long-term Survival Data in the background epoprostenol study. A total of patients were treated with Revatio in the initial study, and their long term survival status was assessed for a minimum of 3 years. Not all pack sizes may be marketed. Its effect is more potent on PDE5 than on other known phosphodiesterases. Absorption Sildenafil is rapidly absorbed. Show table of contents Hide table of contents 1. Paediatric population Interaction studies have only been performed in adults. Revatio and Lactation Back to Top. The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. Revatio 20 mg film-coated tablets 2. Use of sildenafil with bosentan The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Nicorandil is a hybrid of potassium channel activator and nitrate. Accurately measure out another 30 mL of water and add this to the bottle. The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Revatio 20 mg film-coated tablets. Medically reviewed on Oct 12,

Accurately measure out 60 mL of water and pour the water into the bottle. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. MedDRA system organ class V. Other Requirements Back to Top. The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. Pack size of 90 tablets in a carton. Revatio comes in tablet and oral suspension liquid form and is taken taken 3 times a day, hours apart. For dose recommendations, see section 4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. Concomitant use with other PDE5 inhibitors The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has not been studied in PAH patients and such concomitant use is not recommended see section 4. Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Print this page Add to My Med List. Long-term survival data in naive population. Do not take Revatio while also taking Viagra, unless your doctor tells you to. Galactose intolerance Lactose monohydrate is present in the tablet film coat. There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. Summary of the safety profile In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo. The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2. By clicking Subscribe, I agree to the Drugs. Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed a reduction in both systolic and diastolic pressure of 2 mmHg. The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance 6MWD. T max was estimated at approximately 1 hour and was almost independent from body weight. Effects of other medicinal products on sildenafil In vitro studies Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Some medicines can cause unwanted or dangerous effects when used with sildenafil. Efficacy in adult patients with PAH when used in combination with epoprostenol A randomised, double-blind, placebo controlled study was conducted in patients with PAH revatio were stabilised on intravenous epoprostenol. During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part class the survival follow-up. Drug liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.