Sildenafil (Sildenafil)

Trade Name : Sildenafil

REMEDYREPACK INC.

TABLET, FILM COATED

Strength 100 mg/1

SILDENAFIL CITRATE Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sildenafil (Sildenafil) which is also known as Sildenafil and Manufactured by REMEDYREPACK INC.. It is available in strength of 100 mg/1 per ml. Read more

Sildenafil (Sildenafil) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Warnings and Precautions, Effects on the Eyeu00a0n n n u00a0u00a0u00a0u00a008/2017n nn

Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) n n n n

u2022For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity n n n n u2022Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg n n n n u2022Maximum recommended dosing frequency is once per day n n n n

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side. n n n Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '36' on the other side.n n n Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '58' on the other side.n nn
Tablets: 25 mg, 50 mg, 100 mg n n n n

u2022Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates (n n n , n n n , n n n )n n n u2022Known hypersensitivity to sildenafil or any component of tablet n n n n u2022Administration with guanylate cyclase (GC) stimulators, such as riociguat n n n n

u2022Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status n n n n u2022Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism n n n n u2022Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with au201dcrowdedu201d optic disc may also be at an increased risk of NAION.n n n n u2022Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing n n n n u2022Caution is advised when sildenafil tablets are co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension n n n n u2022Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommendedu00a0n n n n n

The following are discussed in more detail in other sections of the labeling: n n n u2022Cardiovascular n n n n n u2022Prolonged Erection and Priapism n n n n u2022Effects on the Eye n n n n n u2022Hearing Loss [n n n n u2022Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives n n n n n u2022Adverse Reactions with the Concomitant Use of Ritonavir n n n n n u2022Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies n n n n u2022Effects on Bleeding n n n n n u2022Counseling Patients About Sexually Transmitted Diseasesn n n n The most common adverse reactions reported in clinical trials (u2265 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.n nn
Most common adverse reactions (u2265 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash n n n n n n

u2022Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (n n n ,u00a0n n n ,n n n ,n n n ,n n n , n n n )n n n u2022With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dosen n n n u2022CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure n n n ,u00a0n n n n )n n n u2022Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period (n n n , n n n n u2022Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mgu00a0n n n n n

u2022Geriatric use: Consider a starting dose of 25 mg n n n , n n n n u2022Severe renal impairment: Consider a starting dose of 25 mg (n n n n n u2022Hepatic impairment: Consider a starting dose of 25 mg(2.5,n n n n

In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.n n n 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.n nn

Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).n n n Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:n nn
Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility ofu00a03.5 mg/mL in water and a molecular weight of 666.7.n n n Sildenafil tablet, USP is formulated as white, film-coated rounde-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous,u00a0 hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.n nn

No data

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In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Sildenafil tablets were evaluated primarily at doses of 25 mg,u00a0 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). Sildenafil tablets were administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. Sildenafil tablets demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. n n n n n The effectiveness of sildenafil tablets were evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function -IIEF) administeredn n n during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction. Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.n n n n n The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil tablets were better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients who were less impaired at baseline. n n n Effect of Sildenafil Tablets on Maintenance of Erection byn n n Baseline Scoren nn
Effect of Placebo on Maintenance of Erection byn n n Baseline Scoren nn
Figure 6. Effect of Sildenafil Tablets and Placebo onn n n Maintenance of Erection by Baseline Score.n n n
Overall treatment p<0.0001 n n n n n .n n n The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.n n n In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets vs about 20% on placebo.n n n During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections.n n n Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.n n n One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil tablets; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.n n n One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. n n n Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.n n n Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. n n n n n A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics.n nn

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'u00a0I ' on one side and '35'on the other side. They are available as follows:n n n Bottles of 30 tabletsu00a0u00a0 NDC 31722-709-30n n n Bottles of 500 tablets NDC 31722-709-05n n n Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'u00a0I ' on one side and '36'on the other side. They are available as follows:n n n Bottles of 30 tabletsu00a0u00a0 NDC 31722-710-30n n n Bottles of 100 tablets NDC 31722-710-01n n n Bottles of 500 tablets NDC 31722-710-05n n n Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'u00a0I ' on one side andu00a0 '58' on the other side. They are available as follows:n n n Bottles of 30 tabletsu00a0u00a0 NDC 31722-711-30n n n Bottles of 100 tablets NDC 31722-711-01n n n Bottles of 500 tablets NDC 31722-711-05n n n n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].n nn

Advise the patient to read the FDA-approved patient labeling (Patient Information)n n n n n Physicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form n n n n n n n
Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat n n n n
Concomitant Use with Drugs Which Lower Blood Pressuren- [see Warnings and Precautionsu00a0n n n n n- Cardiovascular Considerationsn- [see Warnings and Precautions n n n n n- Sudden Loss of Visionn- [see Warnings and Precautionsu00a0n n n and Adverse Reactions n n n n- Arrayn- Sudden Hearing Lossn- [see Warnings and Precautionsu00a0n n n and Adverse Reactionsn n n n- Arrayn- Priapismn- [see Warnings and Precautions n n n n n- Avoid Use with other PDE5 Inhibitorsn- [see Warnings and Precautions n- Arrayn- Sexually Transmitted Diseasen- [see Warnings and Precautions n n n n n- HETROn n n n n
*All brands listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse Hetero Labs Limited or its products.

Patient Informationn n n Sildenafil Tablets, USPn n n (sil den' a fil)n n n What is the most important information I should know about sildenafil tablets? n n n Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. n n n n n- Tell all your healthcare providers that you take sildenafil tablets.n- What are sildenafil tablets?n- Who should not take sildenafil tablets? n n n Do not take sildenafil tablets if you:n n n n- What should I tell my healthcare provider before taking sildenafil tablets?n- Tell your healthcare provider about all the medicines you take*,n- (see 'What is the most important information I should know about sildenafil tablets?')n- How should I take sildenafil tablets?n- What are the possible side effects of sildenafil tablets? n n n Sildenafil tablets can cause serious side effectsn n n n- an erection that will not go away (priapism)n- u00a0sudden vision loss in one or both eyesn- u00a0sudden hearing decrease or hearing lossn- The most common side effects of sildenafil tablets are:n- How should I store sildenafil tablets?n- Keep sildenafil tablets and all medicines out of the reach of children. n n n General information about the safe and effective use of sildenafil tablets.n n n n- What are the ingredients in sildenafil tablets?n- Active ingredient:n- Inactive ingredients:
Manufactured for:n n n Camber Pharmaceuticals, Inc.n n n Piscataway, NJ 08854.n n n Manufactured by:n nn
HETEROn n n n n

DRUG: Sildenafil
GENERIC: Sildenafil
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-2128-0.
NDC: 70518-2128-1
NDC: 70518-2128-2
NDC: 70518-2128-3
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 14 mm
IMPRINT: I;58
PACKAGING: 20 in 1 BOTTLE, PLASTIC
PACKAGING: 10 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 6 in 1 BOTTLE PLASTIC
ACTIVE INGREDIENT(S):
INACTIVE INGREDIENT(S):

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Sildenafil (Sildenafil)

Trade Name : Sildenafil

TABLET, FILM COATED

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Sildenafil (Sildenafil)

Trade Name : Sildenafil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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