Label: SILDENAFIL CITRATE- sildenafil tablet, film coated
See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL TABLETS, for oral useInitial U.S.
- "Blue 100 pills" can sometimes be illicit substances mistaken for pharmaceuticals, posing health risks.
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Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
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You may find alternative ways to save with this medication. Talk to your pharmacist about the potential option(s) noted below. View images of SILDENAFIL CITRATE (Generic for REVATIO) and identify pills by imprint, color or shape. If you need to save money on your SILDENAFIL CITRATE (Generic for REVATIO), compare our prices. Our prescription savings may even be lower than your insurance copay! However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours.
| Factor | Description | Typical Impact |
|---|---|---|
| Food consumption | Taking with a heavy meal delays absorption | Up to 1 hour delay |
| Physical activity | Exercise soon after intake accelerates effects | 15-20 min quicker |
| Pill formulation | Fast-release formulations expedite effect | Starts in ~15 min |
| Temperature of body | Higher body temperature may speed absorption | Slight acceleration |
Use sildenafil with caution in patients predisposed to priapism ( 5.2)Patients 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).
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Patients with a "crowded" optic disc may also be at an increased risk of NAION.
2.1 Dosage Information
The colour and shape of the pill have no impact on how effective the treatment is. The main difference between generic medication, such as sildenafil, and brand-name medication, such as Viagra, is the purchase price and the appearance of the pill. The pill with imprint S100 (Blue, Four-sided, 14 mm) has been identified as Sildenafil Citrate 100 mg and is used for Erectile Dysfunction, and Pulmonary Arterial Hypertension. It belongs to the drug classes agents for pulmonary hypertension, impotence medications and is not a controlled substance. NDC Code(s): 75834-240-00, 75834-240-01, 75834-240-05, 75834-240-30, view more75834-241-00, 75834-241-01, 75834-241-05, 75834-241-30, 75834-272-00, 75834-272-30, 75834-272-90 If you are a consumer or patient please visit this version. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.
- In medical research, "blue 100" might refer to dosages of experimental compounds.
- These are typically used in clinical trials with strict oversight and documentation.
- Unauthorized use of experimental pills poses serious ethical and health concerns.
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Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
| Country | Major Manufacturers | Quality Certification | Export Volume (annually) |
|---|---|---|---|
| China | Shanghai Pharma | GMP Certified | 50 million pills |
| India | Sun Pharma | ISO Certified | 30 million pills |
| Germany | Bayer AG | EU GMP Certified | 10 million pills |
| USA | Pfizer | FDA Approved | 5 million pills |
Decrease in sildenafil dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc.
2.5 Dosage Adjustments in Special Populations
Dr. Gussone discovered his passion for creating medical content and educating the public about health while working with CNN’s Dr. Sanjay Gupta. He realized that the media could deliver essential health information to millions, surpassing the reach of one-on-one care in a clinical setting. Scuba diving, traveling, cinema, and perfume making Scuba diving, traveling, cinema, and perfume making Erectile dysfunction is a condition in which you have trouble getting or keeping an erection firm enough for satisfying sex.
4 Contraindications
Erectile dysfunction affects as many as 30 million men in the United States. Premature ejaculation (PE) is a sexual dysfunction characterized by a short ejaculatory latency, a perceived lack of control about the timing of ejaculation, and distress and interpersonal difficulty related to ejaculating too quickly. Low testosterone or testosterone deficiency, also known as hypogonadism, is a condition in which patients develop symptoms such as low sex drive, erectile dysfunction (ED), and fatigue because the body doesn’t produce enough testosterone. Though many men don’t like to talk about it, ejaculation problems are very common. Some of the most common issues include premature, delayed, or retrograde ejaculation. at 1-877-977-0687 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) USE IN
- Certain "blue 100" pills are used in veterinary medicine but are intended only for animals.
- Using veterinary pills on humans can cause serious health complications.
- Always distinguish between human and animal medications to avoid accidental ingestion.
- Consult a healthcare provider if unsure about a medication labeled "blue 100."
SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 6/2023 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
| Condition | Details | Shelf Life | Precautions |
|---|---|---|---|
| Temperature | Store in a cool, dry place | 2-3 years | Avoid sunlight, maintain below 25°C |
| Humidity | Keep away from moisture | Use airtight container | |
| Packaging | Original blister or bottle | Keep out of reach of children |
However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1) Maximum recommended dosing frequency is once per day ( 2.1) Tablets: 25 mg, 50 mg and 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.
Drug Label Information
The main difference between sildenafil and Viagra is that Viagra is branded, and sildenafil is the generic, or unbranded, version of it. As both sildenafil and Viagra contain the same active lovegra tablet ingredient, sildenafil citrate, they are both effective treatments for men with ED. All generic medication has to contain the same active ingredient to ensure it works in the same way as its brand-name equivalent. Branded medication is often more expensive than generic medication. Any new brand-name medication will pitch the price relative to the amount of initial research needed to develop and prepare the treatment for marketing approval.
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Generic medication can typically be 20-90% cheaper than its brand-name equivalent because of this. The other important factor in pricing is competition: as sildenafil is widely available for manufacture, the price is more competitive (and therefore cheaper). A 2019 study was conducted into the effectiveness of generic medication, which found that there was no difference between how generic and brand-name medication works. Even though generic sildenafil is unbranded, it is still an effective treatment for ED and works in the same way as Viagra. Both Viagra and sildenafil are considered effective treatments for ED. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours.
5.2 Prolonged Erection and Priapism
Note: Multiple images may be displayed for medicines available in different strengths, sold under different brand names, or manufactured by different pharmaceutical companies. You’ve probably heard of Viagra being commonly referred to as “the little blue pill”, and its distinctive blue colour is synonymous with the treatment of erectile dysfunction (ED). Sildenafil, the active ingredient in Viagra, is manufactured in a variety of colours, but most commonly in either blue or white. But does the colour and shape of your pill make a difference in the effectiveness of the treatment? When Viagra was first approved as a treatment for ED in 1998, it was marketed as “the little blue pill”.
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The small, blue, diamond-shaped pill was patented by Viagra, meaning that both its appearance and active ingredient were exclusive to Viagra and couldn’t be copied by other manufacturers. After Pfizer’s patent for Viagra expired in 2013, sildenafil (the active ingredient in Viagra) was made more widely available for manufacturing by other companies. Nowadays, many manufacturers continue to make sildenafil as a blue-coloured pill, but it also comes in a variety of other shapes and colours, and is sometimes manufactured as a white pill. This is commonplace, and, as with many types of generic medication, you may find that the appearance of your pills sometimes changes each time you order them. However, don’t worry; the active ingredients and effectiveness of the treatment remain the same. Use sildenafil with caution in patients predisposed to priapism ( 5.2) Patients 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).
- The "blue 100 pill" often refers to medications with 100mg dosage, commonly used for treatment or recreation.
- These pills are frequently associated with certain prescription medications or illicit substances.
- The color blue is used to distinguish different drug dosages, brands, or types for easy identification.
- Always verify the pill's markings and consult a healthcare professional before use.