WARNINGS AND PRECAUTIONS

5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
2.4 Dosage Adjustments Due to Drug Interactions
Side effects of Sildenafil (Viagra)
Brand names
What side effects can this medication cause?
5.2 Prolonged Erection and Priapism

5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease

Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe sildenafil with caution in these patients.5.6 Hearing LossCases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported 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, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA®. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn 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 than by those randomized to placebo.

What does Teva sildenafil do?

The effectiveness and safety of sildenafil in the treatment of PAH secondary to sickle cell anemia has not been established. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed. Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. (5.7) (7)See 17 for PATIENT COUNSELING INFORMATION.Revised: 8/2023 Warnings and Precautions, Visual Loss (5.5) 07/2017 Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Tablet: 20 mg three times a day, 4-6 hours apart (2.1) • Increased mortality with increasing doses in pediatric patients.

Sildenafil tablets are sometimes prescribed for conditions other than ED.
The active ingredient aids in relaxing blood vessels in the body.
White sildenafil tablets are often associated with certain pharmaceutical brands.
Some countries have strict regulations on sildenafil distribution and sale.
Sildenafil is typically not recommended for men with severe eyesight diseases.
Adherence to prescribed guidelines optimizes treatment outcomes.
The tablets are manufactured with quality control practices to ensure safety.
Patients should avoid sudden changes in medication or dosage.
Reactions to sildenafil can be immediate or delayed; monitor closely.
Lifestyle factors like smoking can influence sildenafil’s effectiveness.
Educate yourself on proper storage to maintain medication integrity.

Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis.

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• Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS & USAGE2 DOSAGE & ADMINISTRATION2.1 Sildenafil Tablets3 DOSAGE FORMS & STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Mortality with Pediatric Use5.2 Hypotension5.3 Worsening Pulmonary Vascular Occlusive Disease5.4 Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7 Combination with other PDE-5 inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

2.4 Dosage Adjustments Due to Drug Interactions

Sildenafil tablets are contraindicated in patients with: 5 WARNINGS AND PRECAUTIONS 5.1 Mortality with Pediatric UseIn a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].5.2 sildenafil tablets lp 100 mg HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, 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 [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

Overall Rating

Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. 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).The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration.5.5 Visual LossWhen 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 phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. 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. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. 2 DOSAGE & ADMINISTRATION 2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day. Administer sildenafil tablets doses 4-6 hours apart.In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended. The recommended dose of sildenafil tablets is 20 mg three times a day. In the clinical trial no greater efficacy was achieved with the use of higher doses. 4 CONTRAINDICATIONS Sildenafil tablets are 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 (5.2)].• Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.• Known hypersensitivity to sildenafil or any component of the tablet. Sildenafil tablets are contraindicated in patients with: 5 WARNINGS AND PRECAUTIONS 5.1 Mortality with Pediatric UseIn a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].5.2 sildenafil tablets lp 100 mg HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure.

Sildenafil tablets are available in various generic versions.
White sildenafil tablets are often easier to swallow due to their shape.
The cost of sildenafil varies depending on the brand and dosage.
Using sildenafil responsibly can improve quality of life for users.
Not all erectile issues require medication; consult a doctor for underlying causes.
Sildenafil is not suitable for women or children.
The drug works by blocking PDE5, enhancing natural erections.
Physical activity after taking sildenafil can enhance its effectiveness.
Sildenafil is sometimes used off-label for pulmonary hypertension.
Proper hydration may help reduce side effects like headaches.
Patients should report any persistent or severe side effects to a healthcare professional.

Before prescribing sildenafil, 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 [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

Side effects of Sildenafil (Viagra)

The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. 2 DOSAGE & ADMINISTRATION 2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day. Administer sildenafil tablets doses 4-6 hours apart.In the clinical trial no greater efficacy was achieved with the use of higher doses.

Pulmonary hypertension

Treatment with doses higher than 20 mg three times a day is not recommended. The recommended dose of sildenafil tablets is 20 mg three times a day. In the clinical trial no greater efficacy was achieved with the use of higher doses. 4 CONTRAINDICATIONS Sildenafil tablets are 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 (5.2)].• Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.• Known hypersensitivity to sildenafil or any component of the tablet. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. 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).The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration.5.5 Visual LossWhen 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 phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil.

Brand names

Professional resources

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. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil.

Sildenafil tablets are specifically formulated to mitigate potential side effects.
The tablet's white color is typical for certain dosages or brands.
Patients with cardiovascular issues should consult a doctor before use.
Sildenafil is sometimes used to treat certain cases of erectile dysfunction caused by depression medication.
The effects of sildenafil can be enhanced by reducing alcohol intake.
Contraceptive methods do not impact sildenafil's effectiveness.
Sildenafil does not cause spontaneous erections without sexual stimulation.
It is important to remain seated or relaxed after taking sildenafil.
The pill’s manufacturing process includes strict quality control protocols.
Beware of unregulated markets selling unverified sildenafil tablets.
Follow dosing instructions carefully to prevent overdose or underdose.

Precaution/Contraindication	Description	Notes
Nitrate use	Do not take with nitrates for chest pain	Risk of severe hypotension
Heart conditions	Consult a doctor if you have cardiovascular issues	Risk of adverse cardiovascular events
Liver or kidney impairment	Reduced dosing may be necessary	Altered drug metabolism
Drug interactions	Combine with caution; may interact with other meds	Always consult a healthcare provider

Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).

Brand Name	Manufacturer	Dosage	Market Region	Price Range (USD)	Packaging Options
Viagra	Pfizer	50 mg	Global	10-20 per pill	Blister pack of 4-12 pills
Revatio	Pfizer	20 mg	Global	15-25 per pill	Blister pack of 30 pills
Kamagra	Ajanta Pharma	50 mg	India, SE Asia	2-5 per pill	Varies (blister)
Sildenafil Original	Local Pharmacies	50 mg	Local Markets	12-18 per pill	Bottle/Blister

If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn 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 than by those randomized to placebo. The effectiveness and safety of sildenafil in the treatment of PAH secondary to sickle cell anemia has not been established. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed.

What side effects can this medication cause?

Who should not take sildenafil?

Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].

5.2 Prolonged Erection and Priapism

(5.9)ADVERSE REACTIONSMost common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. (6.1, 6.2)To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or FDA at 1-800-FDA-1088 or INTERACTIONS• Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. (7)• Use with ritonavir and other potent CYP3A inhibitors: Not recommended. (7, 12.3)• Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5 inhibitors. (5.7) (7)See 17 for PATIENT COUNSELING INFORMATION.Revised: 8/2023 Warnings and Precautions, Visual Loss (5.5) 07/2017 Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

Sildenafil: the science

Tablet: 20 mg three times a day, 4-6 hours apart (2.1) • Increased mortality with increasing doses in pediatric patients. Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. • Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS & USAGE2 DOSAGE & ADMINISTRATION2.1 Sildenafil Tablets3 DOSAGE FORMS & STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Mortality with Pediatric Use5.2 Hypotension5.3 Worsening Pulmonary Vascular Occlusive Disease5.4 Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7 Combination with other PDE-5 inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.