Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt

Pulmonary arterial hypertension (high blood pressure in the lungs) or Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution.

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American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. The American Society of Health-System Pharmacists, Inc. represents that the database provided hereunder as formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty or merchantability and/or fitness for a particular purpose, with respect to such database and specifically disclaims all such warranties and representations.

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Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the database if provided for informational purposes only. The entire monograph for a drug should be reviewed for a throrough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug in the database. The information contained in the database is not a substitute for medical care or treatment by a licensed health care provider. Use sildenafil exactly as directed by your doctor.

• Store sildenafil citrate 100 mg at room temperature, away from moisture and heat.
• Keep out of reach of children and pets for safety reasons.
• Check the expiration date before use to ensure medication efficacy.

Do not use more of it and do not use it more often than your doctor ordered.

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If too much is used, the chance of side effects is increased.

How should this medicine be used?

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Abnormal penis, including a curved penis or birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients. Arrhythmia (irregular heartbeat, within the last 6 months) or Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or Heart attack (within the last 6 months) or Retinitis pigmentosa (an inherited eye disorder) or Stroke (within the last 6 months)—Should not be used in patients with these conditions.

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Crowded disc or low cup to disc ratio in the eye (an eye disorder) or Hyperlipidemia (high fats in the blood) or Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or Retinitis pigmentosa (an inherited eye disorder) or Smoking—May increase the chance for a serious side effect in the eye called NAION. Stomach ulcer, or history of or—Chance of problems sildenafil 100mg blue pill occurring may be increased. It is not known if the medicine is safe for use in these patients. The effects may be increased because of slower removal of the medicine from the body. Sickle-cell anemia (blood disorder)—Sildenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur. This medicine comes with a patient information leaflet.

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Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children younger than 1 year of age. Safety and efficacy have not been established. Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be used for pulmonary arterial hypertension in children, especially for chronic use. Use of sildenafil oral film is not indicated for use in the pediatric population.

Other Interactions

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly. However, elderly patients are more likely to have white sildenafil tablets age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving sildenafil. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Read and follow these instructions carefully before you start using

Dose Adjustments

Introduction: Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. Aim: Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. Methods: Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). Main outcome measures: Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. Results: Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo.

Other Medical Problems

At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. Conclusions: Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. sildenafil and each time you get a refill of your medicine.

Contraindication	Reason	Alternatives
Concurrent Nitrate Use	Risk of severe hypotension	Use other ED treatments
Cardiovascular Instability	May exacerbate underlying conditions	Consult cardiologist
Hypersensitivity Reactions	Allergic response	Discontinue use
Severe Liver Impairment	Altered drug metabolism	Lower dose or avoid

Ask your doctor if you have any questions.

Side Effects

This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart. This medicine is available only with your doctor's prescription.

Usual Geriatric Dose for:

This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. You may take this medicine with or without food.

• Sildenafil 100 mg is not a cure for erectile dysfunction but helps temporarily.
• Lifestyle changes like exercise and diet can enhance treatment effectiveness.
• Open communication with a partner can improve the sexual experience and treatment satisfaction.

Place the film on top of your tongue.

What other drugs will affect sildenafil?

Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose. Sildenafil is used to treat erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

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Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sildenafil premature ejaculation sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection. Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. It will dissolve in your mouth and can be

Condition	Purpose of Use	Additional Notes
Erectile Dysfunction	Improve ability to achieve/maintain an erection	Usually prescribed as 100 mg dose
Pulmonary Hypertension	Off-label use for PAH	Under specific medical supervision
Altitude Sickness	To improve oxygenation in high altitudes	Experimental use

swallowed with saliva without using water or other liquids.

Why is this medication prescribed?

In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

IV Administration

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur.