Label: SILDENAFIL CITRATE tablet

Sildenafil and other PDE5 inhibitors are used off-label to alleviate

• Sildenafil 100mg is generally intended for adult males with diagnosed ED.
• It is not suitable for individuals with severe liver or kidney impairment.
• Use under medical supervision ensures proper dosing and reduces risks.

vasospasm and treat severe ischemia and ulcers in fingers and

toes for people with secondary

8.7 Hepatic Impairment

[8] It also results in dilation of the blood vessels in the lungs. Pfizer originally discovered the medication in 1989 while looking for a treatment for angina. [11] It was approved for medical use in the United States and in the European Union in 1998. [5][8][11][12] In 2023, it was the 151st most commonly prescribed medication in the United States, with more than 3 million prescriptions. [13][14] It is available as a generic medication.

What should I know about sildenafil before taking it?

[15][16] In the United Kingdom, it is available as a pharmacy medicine. The primary indication of sildenafil is treatment of erectile dysfunction (inability to sustain a satisfactory erection to complete sexual intercourse). Its use is now one of the standard treatments for erectile dysfunction, including for males with diabetes mellitus. Tentative evidence suggests that sildenafil may help males who experience antidepressant-induced erectile dysfunction. While sildenafil improves some markers of disease in people with pulmonary arterial hypertension, it does not appear to affect the risk of death or serious side effects. Raynaud's phenomenon;[9][21] these drugs have

moderate efficacy for reducing the

• Proper storage of the blue sildenafil pill is in a cool, dry place away from moisture.
• Keep out of reach of children to prevent accidental ingestion.
• Expiry dates should be checked regularly to ensure potency and safety.

frequency and duration of vasospastic episodes.

Further information

[4][8] It is also sometimes used off-label for the treatment of certain symptoms in secondary Raynaud's phenomenon. [9] It is unclear if it is effective for treating sexual dysfunction in females. [8] It can be taken orally (swallowed by mouth), intravenously (injection into a vein), or through the sublingual route sildenafil premature ejaculation (dissolved under the tongue). [8][10] Onset when taken orally is typically within twenty minutes and lasts for about two hours. Common side effects include headaches, heartburn, and flushed skin.

Missed Dose

[8] Caution is advised in those with cardiovascular disease. [8] Rare but serious side effects include vision problems, hearing loss, and prolonged erection (priapism) that can lead to damage to the penis. [8] Sildenafil should not be taken by people on nitric oxide donors such as nitroglycerin, as this may result in a serious drop in blood pressure. Sildenafil acts by blocking phosphodiesterase 5 (PDE5), an enzyme that promotes breakdown of cGMP, which regulates blood flow in the penis. [8] It requires sexual arousal to work, and does not by itself cause or increase sexual arousal. [9] As of 2016,[update] their role

• Sildenafil is available in many countries but must be obtained through proper medical channels.
• Using counterfeit or unregulated versions can pose serious health risks.
• Always check for proper branding and packaging when purchasing.

more generally in Raynaud's was not clear.

Route of administration

The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Advise the patient to read the FDA-approved patient labeling (Patient Information) take medicines called nitrates (such as nitroglycerin) use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate take any medicines called guanylate cyclase stimulators such as riociguat (Adempas) are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets? have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure have had heart surgery within the last 6 months have low blood pressure, or high blood pressure that is not controlled have had an erection that lasted for more than 4 hours have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil: the science

medicines called nitrates (see “What is the most importantinformation I should know about sildenafil tablets?”) medicines called guanylate cyclase stimulators, such as riociguat (Adempas) medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin other medicines that treat high blood pressure Sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Sildenafil has shown some potential for

5.6 Adverse Reactions with the Concomitant Use of Ritonavir

sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. It is not known if sildenafil tablets caused these problems.

Sildenafil: what you need to know

Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep sildenafil tablets and all medicines out of the reach of children. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsMAGNESIUM STEARATE (UNII: 70097M6I30)HYPROMELLOSES (UNII: 3NXW29V3WO)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeROUNDSize7mmFlavorImprint Code25;SLContainsPackagingNDC:75834-272-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-001000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021Marketing InformationANDAANDA20930206/16/2021Labeler - NIVAGEN PHARMACEUTICALS, INC. (052032418)EstablishmentUMEDICA LABORATORIES PRIVATE LIMITED920635096manufacture(75834-272, 75834-240, 75834-241) Sildenafil, sold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. improving exercise performance at high altitudes.

Medical uses

Take sildenafil tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. Your healthcare provider may change your dose if needed. Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.

Your expert team

Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working Do nottake sildenafil tablets more than 1 time a day. If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away. an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis. However, its overall efficacy is not clear.

Sildenafil has been studied for high-altitude pulmonary edema (HAPE), but its use is currently not recommended for that indication.

• The blue sildenafil pill is not intended for use by women or children.
• It does not cure erectile dysfunction but helps manage symptoms temporarily.
• Lifestyle factors, such as exercise and diet, can also influence erectile health.