DRUG INTERACTIONS

The recommended dosage of sildenafil tablets are 20 mg three times a day.

• Sildenafil tablets 125 mg should not be used by women.
• Always read the medication guide thoroughly.
• Overdose can cause serious health issues.
• Sildenafil can cause a sudden decrease in blood pressure.
• Inform your doctor of all medications you take.
• Sildenafil may improve erectile function in men with ED.
• Do not use sildenafil more than once per day.
• Effects can vary based on individual health.

Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)].

2.2 Recommended Dosage in Pediatric Patients The recommended dosage in patients ≤20 kg is 10 mg three times a day.

8.2 Lactation

It’s not known whether those changes are clinically significant. Using sildenafil with epoprostenol can reduce sildenafil levels in the blood. Using sildenafil with beta blockers (a heart or blood pressure medicine) can increase sildenafil levels. SILDENAFIL CITRATE- sildenafil citrate tablet Advanced Rx Pharmacy of Tennessee, LLC Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)]. For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day.

For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day.

About the Company

Revatio is a round, white 20 mg pill, which distinguishes it from Viagra, a blue diamond-shaped pill. The recommended, FDA-approved dose for Revatio is 20 mg three times a day. Patients have received up to 80 mg three times a day in trials and clinical practice. Take each dose four to six hours apart, with or without food. The injected form of Revatio generally is available only in hospitals.

Regional issues

It’s administered three times a day, through single-use 10 mg (125 mL) doses. Doctors must prescribe sildenafil, and you likely will need approval from your insurance company before starting therapy. Depending on your insurance plan, you might fill your prescription at a retail pharmacy or through specialty pharmacies such as Accredo, Aetna, Alliance Rx Walgreens Prime, Axium, BriovaRx, Cigna, CVS specialty, Humana and Kaiser Permanente. Other side effects include fluid retention, nausea and diarrhea, arm or leg pain, temporary muscle aches, fever and numbness. Low blood pressure: Blood pressure throughout the body can decrease because sildenafil relaxes arteries throughout the body. A maximum dose in pediatric patients has not been identified.

8.5 Geriatric Use

However, birth effects haven’t been studied in pregnant or nursing women. There are no adequate and well-controlled human studies. In clinical practice, sildenafil is commonly used for pregnant and lactating women with severe PAH, as the risk of untreated or undertreated PAH is higher than the risk of adverse effects from sildenafil. Children and teens: Clinical trials of sildenafil for pediatric PAH patients have been small and part of studies with a wide range of ages and diseases. Generally, sildenafil seems safe and effective for pediatric patients.

How sildenafil is used

The treatment algorithm from the sildenafil 100mg lowest price sixth World Symposium on Pulmonary Hypertension recommended PDE5 inhibitors for pediatric patients. People with liver disease: People with mild to moderate liver disease don’t need to adjust their sildenafil doses. Severe liver disease hasn’t been studied. People with kidney disease: People with kidney disease don’t have to adjust their dosage. People with sickle cell disease: People with PH related to sickle cell disease can develop a serious condition known as vaso-occlusive crisis. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients >45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14)].

Sildenafil tablets, USP are supplied as white to off-white, round, biconvex, film-coated tablets debossed with '85' on one side and plain on other side containing sildenafil citrate equivalent to 20 mg of sildenafil.

5.8 Effects on Bleeding

Don’t take sildenafil with nitrates or nitric oxide donors because your systemic blood pressure could drop to unsafe levels. Use caution when drinking alcoholic beverages or taking anti-hypertension or blood pressure-lowering medications. Sildenafil is broken down predominantly by an enzyme called CYP3A in the liver. Significant interactions can occur with medications that affect this enzyme pathway. Simultaneous use of bosentan and sildenafil can increase bosentan in blood and decrease sildenafil levels. Sildenafil citrate is contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions ( 5.1)] . Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

Side Effects

People with low blood pressure (less than 90/50 mmHg) should use sildenafil with caution. Prolonged erection: Prolonged erection (greater than four hours) is rare but serious. If you experience prolonged erection, go to an emergency room or contact your doctor immediately. Vision loss: Sudden loss of vision in one or both eyes has occurred in people taking phosphodiesterase 5 inhibitors, including sildenafil. Sudden vision loss can indicate serious dysfunction of the optic nerve and needs immediate medical attention.

Indications and Usage for Sildenafil Oral Suspension

This type of blindness, called non-arteritic anterior ischemic optic neuropathy, can be permanent. It isn’t clear whether the blindness is related to the drug or underlying cardiovascular diseases that increase the risk for this type of blindness, even without sildenafil use. No research exists to determine whether sildenafil is beneficial or safe for people with retinitis pigmentosa. Sildenafil isn’t recommended for people with that condition. Seek immediate medical attention if you suddenly lose your vision. Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

6.1 Clinical Trials Experience

Hearing loss: If you have sudden hearing loss accompanied by dizziness and/or ear ringing occurs, seek prompt medical attention. Allergic reaction: Although allergies to sildenafil are possible, they aren’t likely. Any medication can cause side effects or sensitivities. Check with your doctor if you develop a rash or throat tightening. No regular bloodwork for side effects is required.

8.5 Geriatric Use

Your doctor might ask you to monitor your blood pressure regularly, particularly during your first few days taking the drug or when your dose increases. Blood pressure monitoring isn’t necessary for most patients. Note: If you experience any symptoms/side effects mentioned above, promptly notify your physician. Certain patient populations must take precautions while taking sildenafil, while others should avoid it. Learn about who can and who shouldn’t take this medication: Pregnant and breastfeeding patients: Sildenafil hasn’t caused harm to fetuses in animal studies. 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients.

HOW SUPPLIED

Sildenafil’s effectiveness for PH related to sickle cell anemia hasn’t been established. People with HIV/AIDS: If you have human immunodeficiency virus (HIV/AIDS), consult you pharmacist. Phosphodiesterase inhibitors such as sildenafil can significantly impede the efficacy of some antiretroviral medications. Other conditions: People with dehydration, left-heart diseases and certain abnormalities of the body’s nervous system function should use sildenafil with caution. Sildenafil isn’t recommended for people with pulmonary veno-occlusive disease and pulmonary capillary hemangiomatosis. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

• Sildenafil tablets 125 mg can be part of a broader ED treatment plan.
• Psychological counseling may enhance effectiveness.
• Combining therapies can improve outcomes.
• Lifestyle modifications include weight management and exercise.
• Quitting smoking can improve erectile health.
• Vasodilator drugs should be avoided when using sildenafil.
• Maintain a balanced diet alongside medication.
• Support groups can offer additional assistance.

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil tablets. 5.6 Combination with Other PDE-5 inhibitors The safety and efficacy of combinations of sildenafil tablets with VIAGRA or other PDE-5 inhibitors have not been studied.

Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. 5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. The following serious adverse events are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Vision Loss [see Warnings and Precautions (5.4)] Hearing Loss [see Warnings and Precautions (5.5)] Priapism [see Warnings and Precautions (5.7)] Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• For best results, take sildenafil on an empty stomach.
• Eating fatty foods may delay its onset.
• The medication should be taken approximately 30 minutes before activity.
• Do not double dose to compensate for missed doses.
• Keep regular medical appointments during treatment.
• Report any worsening of symptoms to your doctor.
• Never use sildenafil if experiencing chest pain without medical guidance.
• Always follow the prescribed health regimen.