FILDENA PROFESSIONAL 100MG SILDENAFIL CITRATE SUBLINGUAL TABLETS

This survey is being conducted by the WebMD marketing sciences department.

Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. Sildenafil does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis).

Liver Dose Adjustments

CAUTION & SCHEDULE:

What are the serious side effects of sildenafil?

Practice "safe sex" such as using latex condoms.

Consult your doctor or pharmacist for more details. Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension). Do not take sildenafil with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil).

• The sublingual route offers an alternative for patients with GI issues.
• They are suitable for those who need rapid erectile function support.
• Use only as directed; overdose can cause serious health risks.
• Avoid taking with high-fat meals to improve absorption.
• Be aware of potential side effects like headache or indigestion.
• Do not use if you are taking other medications for pulmonary hypertension without consulting.
• Take care when operating machinery until effects are known.
• This medication does not protect against sexually transmitted infections.
• Regularly review treatment efficacy with your healthcare provider.
• Be aware of contraindications with nitrate drugs.
• Proper hydration may assist in medication effectiveness.

Sildenafil is available under the following different brand names: Revatio, and Viagra. Dosage Considerations – Should be Given as Follows: 50 mg orally 1 hour before sexual activity may be increased to 100 mg or reduced to 25 mg, depending on effectiveness and tolerance Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Hepatic impairment or severe renal impairment: Use initial dose of 25 mg Older than 65 years: 25 mg orally initially 1 hour before sexual activity Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (65 years and older) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively Not to be prescribed to children (1-17 years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective in improving exercise ability Side effects associated with use of Sildenafil, include the following: Postmarketing side effects of sildenafil reported include: Vaso-occlusive crisis (PAH secondary to sickle-cell anemia) This document does not contain all possible side effects and others may occur.

• Sildenafil citrate sublingual tablets facilitate quicker onset compared to oral forms.
• They are prescribed for erectile dysfunction and pulmonary hypertension treatment.
• Proper placement under the tongue ensures rapid absorption.
• Do not use if pregnant or breastfeeding.
• Patients with cardiac issues should get clearance from a doctor before use.
• Side effects can include muscle aches, flushing, or nasal congestion.
• Avoid use with other erectile dysfunction treatments.
• Inform your healthcare provider about all medical conditions.
• The medication may interact with certain antifungals and antibiotics.
• Never take medication that is expired or stored improperly.
• Always follow the instructions provided with the medication.

Check with your physician for additional information about side effects. If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. Sildenafil has serious interactions with at least 48 different drugs. Sildenafil has moderate interactions with at least 72 different drugs.

Who Should Consider This Product

This information does not contain all possible interactions or adverse effects.

Side Effects

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or sildenafil 45 mg chewable tablets for more information about this medicine. Do not take Revatio or Viagra if you are allergic to sildenafil or any ingredients contained in this drug.

Patient resources

In case of overdose, get medical help or contact a Poison Control Center immediately Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Co-administration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure. See "What Are Side Effects Associated with Using Sildenafil?" Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi See "What Are Side Effects Associated with Using Sildenafil?” Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure Use with caution in patients with anatomic deformation of penis (e.g., angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease Patients taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initiated at lowest dose to avoid hypotension Not to be taken with other PDE-5 inhibitors Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION; patients with a ”crowded” optic disc may also be at an increased risk of NAION Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (e.g., scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%) Sildenafil may be acceptable for use during pregnancy Either animal studies show no risk but human studies are not available, or animal studies showed minor risks and human studies were done and showed no risk It is unknown whether sildenafil is distributed into breast milk. Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability. Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity. TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability.

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Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally. Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite a lack of observed dose-response improvement in exercise ability in short-term clinical studies. In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy. Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.

Dose Adjustments

This survey is being conducted by the WebMD marketing sciences department. Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. Sildenafil does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Consult your doctor or pharmacist for more details. Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension). Do not take sildenafil with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). Sildenafil is available under the following different brand names: Revatio, and Viagra. Dosage Considerations – Should be Given as Follows: 50 mg orally 1 hour before sexual activity may be increased to 100 mg or reduced to 25 mg, depending on effectiveness and tolerance Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Hepatic impairment or severe renal impairment: Use initial dose of 25 mg Older than 65 years: 25 mg orally initially 1 hour before sexual activity Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (65 years and older) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively Not to be prescribed to children (1-17 years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective in improving exercise ability Side effects associated with use of Sildenafil, include the following: Postmarketing side effects of sildenafil reported include: Vaso-occlusive crisis (PAH secondary to sickle-cell anemia) This document does not contain all possible side effects and others may occur.

How is sildenafil supplied (dosage forms)?

Check with your physician for additional information about side effects. If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. Sildenafil has serious interactions with at least 48 different drugs. Sildenafil has moderate interactions with at least 72 different drugs. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or sildenafil 45 mg chewable tablets for more information about this medicine. Do not take Revatio or Viagra if you are allergic to sildenafil or any ingredients contained in this drug. In case of overdose, get medical help or contact a Poison Control Center immediately Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Co-administration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure.

• Sildenafil citrate sublingual tablets are part of ED treatment options.
• They should be stored securely to prevent unauthorized use.
• The typical onset of action is within 15-30 minutes.
• They are not intended for use by women or children.
• Patients should inform their physician of all health conditions.
• Do not take more than one dose in 24 hours.
• If adverse reactions occur, seek medical help immediately.
• Avoid excessive physical activity after taking the medication.
• Use in conjunction with healthy lifestyle changes may improve outcomes.
• The tablet should dissolve completely under the tongue.
• Ensure the medication is obtained from reputable sources.

See "What Are Side Effects Associated with Using Sildenafil?" Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi See "What Are Side Effects Associated with Using Sildenafil?” Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure Use with caution in patients with anatomic deformation of penis (e.g., angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease Patients taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initiated at lowest dose to avoid hypotension Not to be taken with other PDE-5 inhibitors Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION; patients with a ”crowded” optic disc may also be at an increased risk of NAION Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (e.g., scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%) Sildenafil may be acceptable for use during pregnancy Either animal studies show no risk but human studies are not available, or animal studies showed minor risks and human studies were done and showed no risk It is unknown whether sildenafil is distributed into breast milk. Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability. Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity.

• Sildenafil citrate sublingual tablets are an alternative to oral pills.
• They may work faster due to bypassing stomach and liver metabolism.
• Avoid concurrent use with medications containing nitrates.
• Do not take if you have been advised to avoid sexual activity.
• Always adhere to medical advice regarding dosage.
• The tablets should be kept dry and stored at room temperature.
• Be aware of potential allergic reactions like rash or swelling.
• Report any chest pain or severe dizziness immediately.
• They are designed specifically for adult male patients.
• Use only the prescribed amount to prevent overdosage.
• Consult your healthcare provider if you experience no effect.

TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability. Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally. Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite a lack of observed dose-response improvement in exercise ability in short-term clinical studies. In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy. Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration.

Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity.

What to Expect After Taking It

Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity. A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults.

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A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults.