Vybrique 50 mg/1

sildenafil citrate · FILM · IBSA Pharma Inc.

No Recall History

Plain English

Vybrique is a film containing sildenafil citrate at 50 mg/1, taken oral. Manufactured by IBSA Pharma Inc..

Key Facts

Brand Name: Vybrique
Generic Name: sildenafil citrate
NDC Code (Product): 71858-0210
Manufacturer: IBSA Pharma Inc.
Strength: 50 mg/1
Dosage Form: FILM
Route: ORAL
Marketing Status
Application #: NDA210858
Marketing Start: 02/15/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea3,440 reports

headache2,964 reports

diarrhoea2,236 reports

nausea1,898 reports

fatigue1,810 reports

cough1,797 reports

dizziness1,612 reports

drug ineffective1,435 reports

death1,279 reports

hypotension1,075 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATION S AND USAGE VYBRIQUE TM is indicated for the treatment of erectile dysfunction. VYBRIQUE is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). ( 1 )

Dosage & Administration

2. DOSAGE AND ADMINISTRATION Dosage For most patients, the recommended dosage is 50 mg orally, taken as needed, approximately 1 hour before sexual activity. However, VYBRIQUE may be taken anywhere from 30 minutes to 4 hours before sexual activity. ( 2.1 ) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg. ( 2.1 ) Maximum recommended dosing frequency is once per day. ( 2.1 ) Dosage Modifications for Drug Interactions: Refer to the full prescribing information for recommended dosage. ( 2.2 ) Recommended Dosage in Specific Populations: Refer to the full prescribing information for recommended dosage. ( 2.3 ) Administration Administer with or without food. Place oral film directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Do not cut or chew VYBRIQUE. 2.1 Recommended Dosage For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. However, VYBRIQUE may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once pe…

Contraindications

4. CONTRAINDICATIONS Administration of VYBRIQUE to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VYBRIQUE was shown to potentiate the hypotensive effect of nitrates. ( 4.1 , 7.1 , 12.2 ) Known hypersensitivity to sildenafil or any component of oral film. ( 4.2 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat. ( 4.3 ) 4.1 Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology ( 12.1 , 12.2 ) ] , VYBRIQUE potentiates the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken VYBRIQUE it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 ) ]. 4.2 Hypersensitivity Reactions …

Drug Interactions

7. DRUG INTERACTIONS VYBRIQUE can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate VYBRIQUE at 25 mg dose. ( 2.2 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin) increase VYBRIQUE exposure. ( 2.2 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48- hour period. ( 2.2 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg. ( 2.2 , 7.4 ) 7.1 Nitrates Administration of sildenafil 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, sildenafil was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration ( 2.2 ), Contraindications ( 4.1 ), Clinical Pharmacology ( 12.2 ) ] . 7.2 Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressure lowering effects. When sildenafil is co-administered with an alpha-blocker, patients sho…

Adverse Reactions

6. ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions ( 5.1 )] Prolonged Erection and Priapism [see Warnings and Precautions ( 5.2 )] Effects on the Eye [see Warnings and Precautions ( 5.3 )] Hearing Loss [see Warnings and Precautions ( 5.4 )] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions ( 5.5 ) ] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions 5.6 )] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions ( 5.7 ) ] Effects on Bleeding [see Warnings and Precautions ( 5.8 ) ] The most common adverse reactions reported in clinical trials (≥ 2%) of sildenafil are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800-FDA-1088 or …

Frequently Asked Questions

What is Vybrique used for?

Vybrique contains sildenafil citrate. It is a film taken oral. Consult your doctor for specific uses.

Is Vybrique a controlled substance?

Vybrique is not classified as a controlled substance by the DEA.

What is the generic name for Vybrique?

The generic name for Vybrique is sildenafil citrate. There are 12 other brand versions of sildenafil citrate.

What is the NDC code for Vybrique 50 mg/1?

The NDC (National Drug Code) for Vybrique 50 mg/1 is 71858-0210, listed by IBSA Pharma Inc..

Product NDC

71858-0210

Package NDC

71858-0210-1

Other Sildenafil Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)