10. OVERDOSAGE

However, due to Viatris Speciality LLC's marketing exclusivity rights, this drug product is not labeled with that information.

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( 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 Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 9/2024 Sildenafil tablets are 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. Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Tablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1) Increased mortality with increasing doses in pediatric patients. Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

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Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. 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. To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. The recommended dose of sildenafil tablets is 20 mg three times a day.

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Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets.

Liver Dose Adjustments

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)]. DOSAGE AND ADMINISTRATION 2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day. [See Clinical Studies (14)]Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets. 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 sildenafil chewable tablets hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

• Sildenafil 120 mg can cause flushing and nasal congestion as common side effects.
• It is important to follow medical advice to minimize health risks.
• The drug's effectiveness can be influenced by other health conditions like diabetes.
• Consuming grapefruit or grapefruit juice may affect sildenafil’s metabolism.
• Patients should seek emergency care if experiencing an erection lasting longer than 4 hours.
• Sildenafil’s effects typically last about 4-6 hours, depending on individual factors.

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)].

How should this medicine be used?

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1. 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. USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10. CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

Dosage And Administration

NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14. PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. INDICATIONS AND 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. 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. Known hypersensitivity to sildenafil or any component of the tablet. 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 tablets dose was observed.

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

What are the export markets?Taj Pharma exports to over 80 countries across Asia, Africa, and Latin America. Does Taj Pharma offer PCD franchise?Yes, nationwide franchise opportunities are available. What certifications does Taj Pharma hold?WHO-GMP, ISO 9001:2015, EU-GMP, and GLP compliance. Can importers request dossiers and regulatory data?Yes, complete CTD/ACTD dossiers are available for submission. Is it available for hospital tenders?Yes, Taj Pharma supplies to hospitals and government procurement agencies globally.

Dosage for pulmonary arterial hypertension (PAH)

How can sildenafil gel I contact Taj Pharma for business inquiries?Visit or email info@tajpharma.com. When searching for the most trusted Sildenafil Citrate Tablets 120mg Manufacturer Supplier in India, Taj Pharma Ltd. stands out as the global leader. With WHO-GMP-certified facilities, rigorous quality control, regulatory expertise, and competitive pricing, Taj Pharma remains the preferred partner for global pharmaceutical buyers. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH.

Use Case	Description	Dosage Recommendations	Special Considerations
Erectile Dysfunction (ED)	To improve blood flow to the penis during arousal	120 mg as prescribed	Not for use with nitrates
Pulmonary Arterial Hypertension	Off-label for vasodilation in lungs	Under doctor guidance	Monitor blood pressure
Off-label Use in Sexual Dysfunction	Sometimes used in other sexual dysfunctions	As prescribed	Limited evidence for other uses
Enhancement of Exercise Capacity	Occasionally used in sports medicine	Not approved	Risk of adverse effects

Use of sildenafil tablets, particularly chronic use, is not recommended in children.

• Side effects from high doses may include dizziness, flushing, or stomach upset.
• The onset of action is typically within 30 to 60 minutes after intake.
• Patients should avoid heavy meals before taking sildenafil for quicker results.
• Overdose symptoms include chest pain, loss of vision, and fainting.
• Sildenafil is not a cure for erectile dysfunction but enhances blood flow temporarily.
• Medical review is crucial for safety when considering high-dose sildenafil.

[see Use in Specific Populations (8.4)].5.2 HypotensionSildenafil tablets has vasodilatory properties, resulting in mild and transient decreases in blood pressure.

Why Taj Pharma is the Most Trusted Sildenafil Citrate Tablets 120mg Manufacturer, Supplier, and Exporter

What are the common side effects?Headache, flushing, dizziness, upset stomach, and nasal congestion. Can women take Sildenafil Citrate Tablets 120mg?No, it is not approved for use in women. How long does the effect last?Typically up to 4 hours. Can I take it after food?Avoid heavy meals; light food is acceptable for better absorption. Is it safe for heart patients?Consult your doctor if you are on nitrate-based medications.

Dosage Forms & Strengths

What should I do if I overdose?Seek immediate medical attention. Can alcohol reduce its effectiveness?Yes, excessive alcohol can interfere with Sildenafil’s action. Is Taj Pharma WHO-GMP certified?Yes, Taj Pharma operates WHO-GMP and EU-GMP certified plants in India. What is the shelf life?24 to 36 months from the manufacturing date. Can I get customized packaging?Yes, Taj Pharma provides export-specific labeling and multilingual packaging. 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 [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

Frequently asked questions

Approval: 1998INDICATIONS AND USAGESildenafil tablets are 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. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ( 1)Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1, 14)DOSAGE AND ADMINISTRATIONTablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSIncreased mortality with increasing doses in pediatric patients.

Clinical monitoring

Not recommended for use in pediatric patients. ( 5.1)Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.2)Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ( 5.3)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or sildenafil 100mg lowest price hearing occurs. ( 5.5, 5.6)Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).