Sildenafil Oral Suspension: Package Insert / Prescribing Info

503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider. 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices.

8.6 Patients with Hepatic Impairment

VIAGRA is indicated for the treatment of erectile dysfunction. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity. VIAGRA may be taken with or without food. VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see CONTRAINDICATIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on Sections or subsections omitted from the full prescribing information are not listed.

Dosage Forms and Strengths

alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use In Specific Populations and CLINICAL PHARMACOLOGY]. VIAGRA is supplied as blue, rounded diamond shaped film-coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Our team of experts has the answers you're looking for. A clinical pharmacist cannot recommend a specific doctor.

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Viagra Generic	25mg	60 + 4 Pills	71.99€ 68.56€	Buy
Kamagra Soft Tabs	100mg	32 Pills	120.11€ 114.39€	Buy
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Kamagra Oral Jelly	100mg	10 Sachets	54.55€ 51.95€	Buy
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Because we are licensed in all 50 states*, we can accept prescriptions from many licensed prescribers if the prescription is written within their scope of practice and with a valid patient-practitioner relationship. Each injectable IV product will have the osmolarity listed on the label located on the vial. Given the vastness and uniqueness of individualized compounded formulations, it is impossible to list every potential compound we offer. To inquire if we currently carry or can compound your prescription, please fill out the form located on our Contact page or call us at (877) 562-8577. We source all our medications and active pharmaceutical ingredients from FDA-registered suppliers and manufacturers.

Tip	Explanation	Goal
Follow dosage instructions	Take exactly as prescribed	Prevent side effects or interactions
Be aware of side effects	Recognize common side effects and when to seek help	Ensure safety
Avoid alcohol and heavy meals	May decrease effectiveness or increase side effects	Maximize efficacy
Report health issues	Communicate with doctor about any adverse reactions or concerns	Maintain safety and treatment efficacy

VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration. VIAGRA is indicated for the treatment of erectile dysfunction. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity. VIAGRA may be taken with or without food. VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see CONTRAINDICATIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on Sections or subsections omitted from the full prescribing information are not listed. alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Mechanism of action

Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking VIAGRA with and without antihypertensive medication. The following adverse reactions have been identified during post approval use of VIAGRA. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been blue sildenafil reported post-marketing in temporal association with the use of VIAGRA. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of VIAGRA without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA and sexual activity.

5.2 Worsening Pulmonary Vascular Occlusive Disease

It is not possible to determine whether these events are related directly to VIAGRA, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with VIAGRA for ED is not known. Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. VIAGRA is supplied as blue, rounded diamond shaped film-coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with “VIAGRA” on one side and “VGR 25”, “VGR 50” or “VGR 100” on the other to indicate the dosage strengths.

Report Problems to the Food and Drug Administration

503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider. 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices. Our team of experts has the answers you're looking for. A clinical pharmacist cannot recommend a specific doctor. Because we are licensed in all 50 states*, we can accept prescriptions from many licensed prescribers if the prescription is written within their scope of practice and with a valid patient-practitioner relationship.

Other Medical Problems

Each injectable IV product will have the osmolarity listed on the label located on the vial. Given the vastness and uniqueness of individualized compounded formulations, it is impossible to list every potential compound we offer. To inquire if we currently carry or can compound your prescription, please fill out the form located on our Contact page or call us at (877) 562-8577. We source all our medications and active pharmaceutical ingredients from FDA-registered suppliers and manufacturers. VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration. VIAGRA (sildenafil citrate) is supplied as blue, rounded diamond shaped film-coated tablets containing sildenafil oral solution sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature]. Distributed by: Viatris Specialty LLC, Morgantown, WV 26505 U.S.A. Revised: Nov 2023 The following are discussed in more detail in other sections of the labeling: Prolonged Erection and Priapism [see WARNINGS AND PRECAUTIONS] Effects on the Eye [see WARNINGS AND PRECAUTIONS] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see WARNINGS AND PRECAUTIONS] Adverse Reactions with the Concomitant Use of Ritonavir [see WARNINGS AND PRECAUTIONS] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see WARNINGS AND PRECAUTIONS] Effects on Bleeding [see WARNINGS AND PRECAUTIONS] Counseling Patients About Sexually Transmitted Diseases [see WARNINGS AND PRECAUTIONS] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. VIAGRA was administered to over 3700 patients (aged 19-87 years) during premarketing clinical trials worldwide. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%). Adverse Reactions Reported by ≥2% of Patients Treated with VIAGRA and More Frequent than Placebo in Fixed-Dose Phase II/III Studies * When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took VIAGRA at least once weekly, and the following adverse reactions were reported: Adverse Reactions Reported by ≥2% of Patients Treated with VIAGRA and More Frequent than Placebo in Flexible-Dose Phase II/III Studies * The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking VIAGRA with and without antihypertensive medication. The following adverse reactions have been identified during post approval use of VIAGRA. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been blue sildenafil reported post-marketing in temporal association with the use of VIAGRA. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of VIAGRA without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA and sexual activity. It is not possible to determine whether these events are related directly to VIAGRA, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo.

Warnings & Precautions

It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Urogenital: prolonged erection, priapism [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION], and hematuria.

Alcohol interaction warning

Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate the hypotensive effects of nitrates [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, CLINICAL PHARMACOLOGY]. Use caution when co-administering alpha-blockers with VIAGRA because of potential additive blood pressure-lowering effects. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. When VIAGRA 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. The clinical relevance of this finding to men treated with VIAGRA for ED is not known.

• Sildenafil tablets 125 mg are generally well-tolerated.
• Seek medical attention if you experience vision changes.
• They are typically used on an as-needed basis.
• Avoid heavy meals before taking sildenafil to improve absorption.
• Sildenafil is not a cure for erectile dysfunction.
• Pregnant women should avoid sildenafil use.
• It is important to stay hydrated while using the medication.
• Follow specific instructions provided by your healthcare provider.

Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

• Common side effects include headaches and facial flushing.
• Less common effects may include nasal congestion or upset stomach.
• Do not use sildenafil if allergic to it or similar drugs.
• Pregnant women should consult a healthcare provider before use.
• Be aware of the signs of allergic reactions.
• Sildenafil may also be indicated for certain heart conditions.
• Emergency services should be contacted if adverse reactions occur.
• Keep a record of any side effects experienced.

Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Urogenital: prolonged erection, priapism [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION], and hematuria. Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate the hypotensive effects of nitrates [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, CLINICAL PHARMACOLOGY]. Use caution when co-administering alpha-blockers with VIAGRA because of potential additive blood pressure-lowering effects. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. When VIAGRA 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

8.4 Pediatric Use

Tablets are debossed with “VIAGRA” on one side and “VGR 25”, “VGR 50” or “VGR 100” on the other to indicate the dosage strengths. VIAGRA (sildenafil citrate) is supplied as blue, rounded diamond shaped film-coated tablets containing sildenafil oral solution sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature]. Distributed by: Viatris Specialty LLC, Morgantown, WV 26505 U.S.A. Revised: Nov 2023 The following are discussed in more detail in other sections of the labeling: Prolonged Erection and Priapism [see WARNINGS AND PRECAUTIONS] Effects on the Eye [see WARNINGS AND PRECAUTIONS] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see WARNINGS AND PRECAUTIONS] Adverse Reactions with the Concomitant Use of Ritonavir [see WARNINGS AND PRECAUTIONS] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see WARNINGS AND PRECAUTIONS] Effects on Bleeding [see WARNINGS AND PRECAUTIONS] Counseling Patients About Sexually Transmitted Diseases [see WARNINGS AND PRECAUTIONS] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. VIAGRA was administered to over 3700 patients (aged 19-87 years) during premarketing clinical trials worldwide.

Warnings for people with certain health conditions

In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%). Adverse Reactions Reported by ≥2% of Patients Treated with VIAGRA and More Frequent than Placebo in Fixed-Dose Phase II/III Studies * When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took VIAGRA at least once weekly, and the following adverse reactions were reported: Adverse Reactions Reported by ≥2% of Patients Treated with VIAGRA and More Frequent than Placebo in Flexible-Dose Phase II/III Studies * The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.