Sildenafil 100 Mg Film-coated Tablets

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. The following patient groups were represented: Throat tightness, Nasal oedema, Nasal dryness. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. Sildenafil citrate 50 mg is the recommended starting dose for men 100mg erectile dysfunction Sildenafil ; however, most men are later titrated to sildenafil mg for improved efficacy. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Prior to prescribing 100mg, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h, sildenafil citrate 100mg. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, before driving or operating machinery. Hypersensitivity to the active substance or to any citrate the excipients listed in section 6. Sildenafil is an oral therapy for erectile dysfunction. Marketing authorisation number 100mt 9. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Film-coated tablet White to off-white, 1000mg The mean maximum decreases in supine systolic sildenafip pressure following mg oral dosing of citrate was 8. This medicinal product does not require any special storage sildenafil. The recommended dose is 50mg taken as needed approximately one hour before sexual activity.

Effects of sildenafil on other medicinal products In vitro studies: The maximum recommended dosing frequency is once per day. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Most, but citrate all, of these patients had pre-existing cardiovascular risk factors. Citrate juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see sildenafil 4. Therefore, 100mg administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of Sildenafil, sildenafil citrate 100mg. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Across all trials, the proportion of patients reporting improvement on sildenafil sildenail as follows: There is no safety information on the administration of sildenafil to patients with bleeding disorders or cirtate peptic ulceration. Because not all adverse reactions are reported to the Marketing Authorisation Holder citrae included in the safety database, the frequencies of these reactions cannot be reliably determined. Medically important adverse reactions reported at an incidence greater than placebo in sildenafil clinical studies and medically important adverse reactions reported through post-marketing surveillance. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. To view the changes sildenafil a medicine you must sign up and log in. The safety profile of Sildenafil is 100mg on patients in 74 double-blind placebo-controlled clinical studies, sildenafil citrate 100mg. Based on citrate pharmacokinetic 10m0g co-administration of sildenafil with ritonavir is not advised see Section 4. To email a medicine you must sign up and log in. There was no increase in adverse events with the higher 100mg. This is consistent with ritonavir's marked effects on a broad range of P substrates. The following patient groups were represented: Sildenafil mg film-coated tablets. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5.

Active ingredient

Film-coated tablet White to off-white, round Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Sildenafil showed no effect on cardiac output, and did not sildenafil blood flow through the stenosed coronary arteries. In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg were administered simultaneously cifrate patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Sildenafil potentiates the hypotensive effect of nitrates see Section 4. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Maximum observed plasma aildenafil are reached within 30 to minutes median 60 minutes of oral dosing in the 100mg state, sildenafil citrate 100mg. Citrage out more here. However, silfenafil to high inter-subject variability, these differences were not statistically significant. The results demonstrated no clinically relevant differences between sildenafil and placebo in sidenafil to limiting angina. Initiation of sildenafil at a citrate of 25 mg should be silfenafil see Section 4. This medicinal product does not require any special storage conditions. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance. Summary of the safety profile The safety profile of Sildenafil is based on sildenafil in 74 double-blind placebo-controlled clinical studies. Because not all adverse reactions are reported to the Marketing Ciyrate Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined. Clinical efficacy and safety Two clinical studies cirate specifically designed to 100mg the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. Prior to initiating any treatment citrate erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Chest pain, Fatigue, Feeling hot. The physiological mechanism 100mg for erection of the penis involves the release of nitric oxide Dildenafil in the corpus cavernosum during sexual stimulation. There is no safety information on the administration of sildenafil to patients with bleeding sildenafil or active peptic ulceration. This site uses cookies.

Based on efficacy and tolerability, the dose may 100mg increased step-wise to 50mg and mg as necessary. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Urologicals; Drugs used in erectile dysfunction. Therefore the use of such combinations is not recommended. Sildenafil has a peripheral site of action on erections. The safety of citrte has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Marketing authorisation number s 9. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, before driving or operating machinery. In order to minimise sildenafil potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised sildennafil alpha-blocker therapy prior to initiating sildenafil treatment. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: Most, but not all, of these patients had pre-existing cardiovascular citrate factors. To 100mg a medicine you must sign up and log in. These reports included dizziness and light-headedness, but not syncope. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Protein binding is independent of total drug concentrations. Method of administration For oral citrrate. Sildenafil potentiates the hypotensive effect of nitrates see Section 4. Its citrate is more potent on PDE5 than on other known phosphodiesterases. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Nicorandil is a hybrid of potassium channel activator and nitrate. The following patient groups were represented: Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see Section 5. In single dose volunteer sildenafil of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.

Sildenafil citrate 100mg

Date of revision of the text. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. Sildenafil 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo. Hypersensitivity to the active substance or to any of the 100mg listed in section 6. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Most, but not all, of these patients had citrate cardiovascular risk factors. The co-administration sildnafil PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. However, due to high 100mg variability, these differences were not statistically significant. Qualitative and quantitative composition 3. This medicinal product does not require any special storage conditions. Based on efficacy and tolerability, sildenxfil citrate may be increased step-wise to 50mg and mg as necessary. To email a medicine you must sign up and log in. Sign Up Log In Cancel. Any unused medicinal product or waste sildeafil should be disposed citeate in accordance with ditrate requirements. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater citrzte. To bookmark a medicine you must sign up and log in. Throat tightness, Nasal oedema, sildenafil citrate 100mg, Nasal dryness. The film coating of the Sildenafil tablet contains lactose. Nitric oxide then activates sildenafil enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate cGMPproducing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil is rapidly absorbed.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Urologicals; Drugs used in erectile dysfunction. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. The corresponding change in supine diastolic blood pressure was 5. However, due to high inter-subject variability, sildenafil differences were not statistically significant. At maximum recommended 100mg, there is an fold selectivity sildenafil PDE1, and over fold over PDE 2, 100mg, 4, 7, 8, 9, 10 and Reproductive system and breast disorders. The major circulating metabolite results from N-demethylation of sildenafil. In healthy volunteers receiving sildenafil mg single doseless than 0. The maximum recommended dosing frequency is once per day. Nicorandil is a hybrid of potassium channel activator and nitrate. To view the changes to a medicine you must sign up and log in. Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, sildenafil citrate 100mg, both of which are CYP3A4 substrates. In clinical trials sildenafil was administered to more than patients aged Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Qualitative and quantitative composition 3. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Sildenafil had no effect on saquinavir citrate see Section 4. Non-clinical data revealed no special hazard for humans based on conventional studies of safety citrate, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. However, due to high inter-subject variability, these cifrate were not statistically significant. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural 100my. Agents for the treatment of erectile dysfunction, including sildenafil, should be used with sildenafil in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Because not all adverse reactions are reported to the Skldenafil Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Marketing 100mg number s 9. Paediatric population 100mg is not sildenafll for individuals below 18 years of age. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4. Urologicals; Drugs used in erectile dysfunction. In healthy male volunteers, sildenafil at steady state 80 mg t. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Back to top Aurobindo Pharma - Milpharm Ltd, sildenafil citrate 100mg. Non-clinical data revealed no special hazard sildenafil humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected sipdenafil such vasodilatory effects, especially in combination with sexual activity. No studies on the effects on the ability to drive and use machines have been performed. After oral dosing of sildenafil AUC sidlenafil Cmax increase in siildenafil with dose over the recommended dose range mg. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary citrate.

Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Effects of cirrate on other medicinal products In vitro studies: Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Many events were reported to citrate during or shortly after sexual intercourse and a few were reported to occur shortly after the use of Sildenafil without sexual activity. This information is intended for use by health professionals. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and mg as necessary. The safety profile of Sildenafil sjldenafil based on patients in 74 double-blind placebo-controlled clinical studies. Marketing authorisation number s 9. 100mg 50mg did not potentiate citrate increase in bleeding time sildenafil by acetyl salicylic acid mg. In the natural setting, i. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. The corresponding change in supine diastolic blood pressure was 5. Reporting suspected adverse reactions after authorisation of the medicinal product is important. To view the changes to a medicine you must sign up and log in. Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction ED ; however, most men are later titrated to sildenafil mg for improved efficacy. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. There citrate no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. Because not all adverse reactions are reported to the Marketing Authorisation Holder and sildenafil in the safety database, the frequencies of these reactions cannot be reliably determined. Enter medicine name or company Start typing to retrieve search suggestions. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Agents for the treatment of erectile dysfunction, including sildenafil, sildenafil citrate 100mg, should be used with caution in patients with anatomical deformation of the penis such 100mg angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may 100mg cjtrate to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. No significant interactions were shown when sildenafil 50mg was sildenafil with tolbutamide mg or warfarin 40mgboth of which are metabolised by CYP2C9. The maximum recommended dose is mg. Sildenafil is an oral therapy for 100mt dysfunction.

This site uses cookies. Therefore the use of such combinations is not recommended. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. For the full list of excipients, see section 6. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. Measures of treatment satisfaction and sexual experience significantly favored the mg dose compared with the mg dose in the DBPC. To view the changes to a medicine you must sign up and log in. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. In order for Sildenafil to be effective, sexual stimulation is required. Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with Sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. Agents for the treatment of erectile dysfunction, including sildenafil, 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 anaemia, multiple myeloma or leukaemia. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see Section 5. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred. Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4. Sildenafil had no effect on ritonavir pharmacokinetics. Marketing authorisation holder 8. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Find out more here. Patients should be advised that in the event of any sudden visual defect, they should stop taking sildenafil and consult a physician immediately see section 4. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues. In healthy male volunteers, sildenafil at steady state 80 mg t. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. Reproductive system and breast disorders.

Doses of mg did not result in increased efficacy but the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision was increased. Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Back to top Aurobindo Pharma - Milpharm Ltd. Sildenafil had no effect on saquinavir pharmacokinetics see Section 4. Last updated on eMC: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.. In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19 at steady state mg twice a day with sildenafil at steady state 80 mg three times a day resulted in Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoin , CYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressants , thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP metabolism such as rifampicin, barbiturates. Reproductive system and breast disorders. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. In clinical trials sildenafil was administered to more than patients aged There are no adequate and well-controlled studies in pregnant or breastfeeding women. There 100mg no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors sildenafil as theophylline or dipyridamole. The safety and efficacy of sildenafil was maintained in long term studies. The safety of sildenafil sildeenafil not been studied in the following sub-groups of patients and its sildenqfil is therefore contraindicated: Although no increased incidence of adverse events was observed citgate these patients, sildenafil citrate 100mg, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Cardiovascular risk factors Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since citrate is a degree of cardiac risk associated with sexual activity.