The recommended dose of sildenafil tablets is 20 mg three times a day.
Pediatric use information is approved for
Viatris Speciality LLC's, REVATIO (sildenafil) tablets.
CONTRAINDICATIONS Sildenafil tablets are
contraindicated in patients with:Concomitant use
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. However, due to Viatris Speciality LLC's marketing exclusivity rights, this drug product is not labeled with that information. of organic nitrates in any form, either regularly or intermittently,
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because of the greater risk of hypotension [see Warnings
Each batch of Sildenafil Citrate Tablets 120mg undergoes: This ensures every tablet meets global quality benchmarks before it reaches the end user. Taj Pharma provides cost-effective solutions without compromising on quality, making its products accessible across developing and developed markets. With a robust R&D team, Taj Pharma continuously innovates to improve bioavailability, patient compliance, and formulation efficiency. The company provides complete export support, including regulatory dossiers, logistics management, and international documentation, ensuring smooth global distribution. Taj Pharma’s strong international reputation, combined with ethical business practices, has made it a global leader in generic pharmaceutical exports.
Looking for a WHO-GMP-certified Sildenafil Citrate Tablets 120mg Manufacturer and Supplier in India? Partner with Taj Pharma Ltd., a trusted name in global healthcare with a reputation for quality, affordability, and reliability. Taj Pharma ensures complete export support, making it the #1 choice for international buyers seeking pharmaceutical excellence. 📞 Contact Taj Pharma Ltd.Email: info@tajpharma.comWebsite: Vapi, Gujarat, India What is Sildenafil Citrate Tablets 120mg used for?It treats erectile dysfunction by improving blood flow to the penis during sexual stimulation. 2.
Who manufactures Sildenafil Citrate Tablets 120mg in India?Taj Pharma Ltd. is a leading WHO-GMP-certified manufacturer and exporter from Vapi, Gujarat. Is a doctor’s prescription required?Yes, it should only be used under medical guidance. How should I take Sildenafil 120mg?Take one tablet 30–60 minutes before sexual activity, not exceeding one dose per day. What are the common side effects?Headache, flushing, dizziness, upset stomach, and nasal congestion. and Precautions (5.2)].Concomitant use of
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. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. riociguat, a guanylate cyclase stimulator.
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 oral sildenafil it safe for heart patients?Consult your doctor if you are on nitrate-based medications. 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. 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. How can I contact Taj Pharma for business inquiries?Visit or email info@tajpharma.com. PDE-5 inhibitors, including sildenafil, may
( 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. 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. 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 women sildenafil 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. NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14. potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or
| Condition | Risk Factors | Precautionary Notes |
|---|---|---|
| Nitrate use (e.g., nitroglycerin) | Risk of severe hypotension | Do not use sildenafil if on nitrates |
| Cardiovascular disease | Increased risk of adverse events | Consult cardiologist before use |
| Severe hepatic impairment | Slower drug metabolism | Adjust dosage accordingly |
| Retinitis pigmentosa | Possible worsening of condition | Use with caution, consult ophthalmologist |
| Recent stroke or MI | Elevated risk for complications | Avoid use unless cleared by a doctor |
any component of the tablet.
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, sildenafil citrate drug Taj Pharma remains the preferred partner for global pharmaceutical buyers. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. 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. 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 hearing occurs. ( 5.5, 5.6)Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 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.