Sildenafil (Sildenafil)

Trade Name : Sildenafil

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 20 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 Teva Pharmaceuticals USA, Inc.. It is available in strength of 20 mg/1 per ml. Read more

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No data

Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Arrayn- see Clinical Studies ()
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ()
Limitation of Use

The recommended dose of sildenafil tablets is 20 mg three times a day. Administer sildenafil tablet doses 4 to 6 hours apart.
In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.

Tablet: 20 mg three times a day, 4 to 6 hours apart ()

Sildenafil Tablets USP
Sildenafil Tablets USP are supplied as white, film-coated, unscored, round biconvex tablets, debossed with u201cTEVAu201d on one side and u201c5517u201d on the other side containing sildenafil citrate, USP equivalent to 20 mg of sildenafil.

Tablets:
3

Sildenafil tablets are contraindicated in patients with:

Use with organic nitrates or riociguat ()
History of hypersensitivity reaction to sildenafil or any component of the tablet ()

No data

Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. ()
Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ()
Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ()
Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (, )
Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ()

The following serious adverse events are discussed elsewhere in the labeling:
Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. (, )
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Nitrates
Concomitant use of sildenafil with nitrates in any form is contraindicated [].
Ritonavir and other Potent CYP3A Inhibitors
Concomitant use of sildenafil with ritonavir and other potent CYP3A inhibitors is not recommended [].
Other drugs that reduce blood pressure
Alpha blockers.
Amlodipine.
Monitor blood pressure when coadministering blood pressure lowering drugs with sildenafil [].

Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. ()
Use with ritonavir and other potent CYP3A inhibitors: Not recommended. (, )
Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5 inhibitors. ()

No data

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but 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.

Sildenafil Tablets USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA (sildenafil citrate tablets) for erectile dysfunction.
Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1-pyrazolo [4,3-] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
CHNOSu2022CHOM.W. 666.7
Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water.
Sildenafil citrate, USP is formulated as white, film-coated, unscored, round biconvex tablets equivalent to 20 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, talc, and titanium dioxide.

No data

Sildenafil was not carcinogenic when administered to rats for up to 24 months at 60 mg/kg/day, a dose resulting in total systemic exposure (AUC) to unbound sildenafil and its major metabolite 33- and 37- times, for male and female rats respectively, the human exposure at the RHD of 20 mg three times a day. Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/mbasis.
Sildenafil was negative in bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and human lymphocytes and mouse micronucleus assays to detect clastogenicity.
There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19 and 38 times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day.

Studies of Adults With Pulmonary Arterial Hypertension
Study 1 (Sildenafil monotherapy (20 mg, 40 mg, and 80 mg three times a day))
A randomized, double-blind, placebo-controlled study of sildenafil (Study 1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure of greater than or equal to 25 mmHg at rest with a pulmonary capillary wedge pressure less than 15 mmHg). Patients were predominantly World Health Organization (WHO) functional classes II-III. Allowed background therapy included a combination of anticoagulants, digoxin, calcium channel blockers, diuretics, and oxygen. The use of prostacyclin analogues, endothelin receptor antagonists, and arginine supplementation were not permitted. Subjects who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.
Patients were randomized to receive placebo (n = 70) or sildenafil, 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%). The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6 minute walk distance between 100 and 450 meters (mean 343).
The primary efficacy endpoint was the change from baseline at week 12 (at least 4 hours after the last dose) in the 6 minute walk distance. Placebo-corrected mean increases in walk distance of 45 to 50 meters were observed with all doses of sildenafil. These increases were significantly different from placebo, but the sildenafil dose groups were not different from each other (see ), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.
Figure 10
Key:
Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. At the end of 1 year, 94% of these patients were still alive. Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil. Without a control group, these data must be interpreted cautiously.
Study 2 (Sildenafil coadministered with epoprostenol)
A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6 minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters). Patients were randomized to placebo or sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.
At baseline patients had PPH (80%) or PAH secondary to CTD (20%); WHO functional class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.
There was a statistically significant greater increase from baseline in 6 minute walk distance at Week 16 (primary endpoint) for the sildenafil group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009).
Patients on sildenafil achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).
Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). displays the number of patients with clinical worsening events in Study 2. Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil-treated patients and that sildenafil-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). Kaplan-Meier plot of time to clinical worsening is presented in .
Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.
Study 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))
A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled. Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6 minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters). Patients were randomized to 1 of 3 doses of sildenafil: 1 mg, 5 mg, and 20 mg, three times a day.
At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian.
The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6 minute walk distance. Similar increases in walk distance (mean increase of 38 to 41 meters) were observed in the 5 and 20 mg dose groups. These increases were significantly better than those observed in the 1 mg dose group ().
Arrayn- Study 4 (Sildenafil added to bosentan therapy u2013 lack of effect on exercise capacity)
A randomized, double-blind, placebo controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone.

Sildenafil Tablets USP, 20 mg are supplied as white, film-coated, unscored, round biconvex tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c5517u201d on the other side, in bottles of 90 (NDC 0093-5517-98).
Recommended Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

See FDA-approved patient labeling (Patient Information).
This productu2019s label may have been updated. For current full prescribing information, please call 1-888-838-2872.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. N 10/2018

Sildenafil () Tablets
Read this Patient Information before you start taking sildenafil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.
What is the most important information I should know about sildenafil tablets?
Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.
Nitrate medicines include:
Guanylate cyclase stimulators include:
Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.
What are sildenafil tablets?
Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.
Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.
Sildenafil tablets contain the same medicine as VIAGRA (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets with VIAGRA or other PDE-5 inhibitors.
Who should not take sildenafil tablets?
Do not take sildenafil tablets if you:
What should I tell my doctor before taking sildenafil tablets?
Tell your doctor about all of your medical conditions, including if you
Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products.
Especially tell your doctor if you take
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take sildenafil tablets?
Sildenafil may be prescribed to you as
What are the possible side effects of sildenafil tablets?
The most common side effects with sildenafil tablets include:
Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.
Arrayn- Tell your doctor if you have any side effect that bothers you or doesnu2019t go away.
Arrayn- These are not all the possible side effects of sildenafil tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store sildenafil tablets?
General information about sildenafil tablets
Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use sildenafil tablets for a condition for which they were not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms you have. They could harm them.
This patient leaflet summarizes the most important information about sildenafil tablets. If you would like more information about sildenafil tablets, talk with your doctor. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals. For more information, call Teva Pharmaceuticals at 1-888-838-2872.
What are the ingredients in sildenafil tablets?
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
This productu2019s label may have been updated. For current full prescribing information, please call 1-888-838-2872.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. J 10/2018

No data

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Sildenafil (Sildenafil)

Trade Name : Sildenafil

TABLET, FILM COATED

Delivery Process

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Disclaimer

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)

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