Label: VARDENAFIL HYDROCHLORIDE tablet

Vardenafil is an erectile dysfunction drug that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction (impotence). Vardenafil is available under the following different brand names: Levitra and Staxyn ODT. Adult and Pediatric Dosage Forms and Strengths Dosage Considerations – Should be Given as Follows: Film-coated tablet: 10 mg orally approximately 1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day Orally disintegrating tablet (ODT): 10 mg orally placed on tongue approximately 1 hour before sexual activity; not to exceed 1 dose/day 10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed 5 mg orally approximately 1 hour before sexual activity AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men under 45 years) Hepatic impairment: Use contraindicated in chronic or active liver disease Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day Ritonavir (600 mg every 12 hours): Vardenafil dosage not to exceed 2.5 mg/72 hours Erythromycin 500 mg every 8 hours: Vardenafil dosage not to exceed 5 mg/day Stabilized on alpha-blocker therapy (e.g., alfuzosin, terazosin, tamsulosin): 5 mg/day orally initially Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day orally initially Mild, moderate, severe impairment: Dosage adjustment not necessary Child-Pugh class A: Dosage adjustment not necessary Child-Pugh class B: Film-coated tablet, 5 mg orally approximately 1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended Flushing (warmth or redness in your face, neck, or chest) Less common side effects of vardenafil include: This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first. Severe interactions of vardenafil include: isosorbide dinitrateisosorbide mononitratenitroglycerin IVnitroglycerin POnitroglycerin rectalnitroglycerin sublingualnitroglycerin topicalnitroglycerin transdermalnitroglycerin translingualriociguat Vardenafil has serious interactions with at least 36 different drugs.

Storage Parameter	Recommended Condition	Notes
Temperature	Below 25°C (77°F)	Store in a cool, dry place
Humidity	Avoid excessive moisture	Keep away from water
Light exposure	Keep in original container, protect from light	Prevent degradation
Shelf life	2-3 years from manufacturing date	Check expiration date

Vardenafil has moderate interactions with at 105 different drugs. This document does not contain all possible interactions.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.

Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns. Do not take Levitra or Staxyn ODT if you are women libido pills allergic to vardenafil or any ingredients contained in this drug. In case of overdose, get medical help or contact a Poison Control Center immediately. Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined See "What Are Side Effects Associated with Using Vardenafil?" See "What Are Side Effects Associated with Using Vardenafil?" Anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors.

Vardenafil Adverse Reactions

Avoid in patients with congenital QT prolongation or those taking class IA or III antiarrhythmics.

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Use in combination with other treatment for erectile dysfunction has not been studied and is not recommended.

5.13 Risks in Patients with Phenylketonuria

Concomitant use of alpha-blockers increases risk of low blood pressure (hypotension). May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician. Vardenafil may be acceptable for use during pregnancy.

• Vardenafil 10mg is available by prescription only, ensure your doctor’s approval.
• It is intended for use in adult men diagnosed with erectile dysfunction.
• Be cautious with dosing if you have kidney or liver problems.
• Remember that sexual activity carries health risks for some men.
• Report any adverse effects, especially chest pain or prolonged erections.
• It’s important to discuss your complete medical history before use.
• The medication does not protect against sexually transmitted infections.
• Do not share your medication with others to prevent misuse.
• Use vardenafil only as directed to avoid potential health hazards.
• Pharmacist or doctor can clarify any questions about proper use.

Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk. It is unknown whether vardenafil is distributed into breast milk. Vardenafil indicated for males and is unlikely to be used in females. Bayer healthcare pharmaceuticals inc • Vardenafil is indicated for the treatment of erectile dysfunction. Vardenafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction. Vardenafil inhibits cyclic guanosine monophosphate (GMP) specific phosphodiesterase type 5 (PDE5), which is responsible for the degradation of cyclic GMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. Therefore, the inhibition of PDE5 by vardenafil enhances erectile function by increasing the amount of cyclic GMP. Vardenafil is indicated for the treatment of erectile dysfunction. 10 mg as needed, 60 minutes prior to sexual activity Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability For patients taking potent or moderate inhibitors of CYP3A4, dose adjustment is as follows: Ritonavir: no more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: no more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: no more than 5 mg in a 24-hour period. Cardiovascular effects vardenafil tablets - patients should not use Vardenafil if sex is inadvisable due to cardiovascular status. Risk of priapism - in the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance Effects on the eye - patients should stop treatment and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be sign of nonarteritic anterior ischemic optic neuropathy (NAION).

Vardenafil Note

Vardenafil is indicated for the treatment of erectile dysfunction. 10 mg as needed, 60 minutes prior to sexual activity Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability For patients taking potent or moderate inhibitors of CYP3A4, dose adjustment is as follows: Ritonavir: no more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: no more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: no more than 5 mg in a 24-hour period. Cardiovascular effects vardenafil tablets - patients should not use Vardenafil if sex is inadvisable due to cardiovascular status. Risk of priapism - in the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance Effects on the eye - patients should stop treatment and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be sign of nonarteritic anterior ischemic optic neuropathy (NAION). Use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

How should I store vardenafil?

Patients with a "crowed" optic disc may also be at an increased risk of NAION. Sudden hearing loss - patients should stop treatment and seek medical attention in the event of sudden decrease or loss in hearing Alpha-blockers - caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting) QT prolongation - patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using Vardenafil Other erectile dysfunction therapies - the safety and efficacy of vardenafil used in combination with other treatments for ED have not been studied. Signs and symptoms may include reversible back pain/myalgia and/or "abnormal vision." Standard supportive measures should be taken as required. Pregnancy: Pregnancy Category B; not indicated for use in women.

storage temp.

Nursing Mothers: Not indicated for use in women. Renal Impairment: Do not use in patients on renal dialysis; no dosage adjustment necessary in patients with ClCr 30-80 mL/min. Hepatic Impairment: Do not use in patients with severe impairment (Child-Pugh C); dosage adjustment is necessary in patients with moderate impairment. Pediatric Patients: Not indicated for use in pediatric patients; safety and efficacy have not been established in this population. Geriatric Patients: No differences in safety and effectiveness noted between elderly (≥65 years of age) and younger patients. Use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowed" optic disc may also be at an increased risk of NAION. Sudden hearing loss - patients should stop treatment and seek medical attention in the event of sudden decrease or loss in hearing Alpha-blockers - caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting) QT prolongation - patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using Vardenafil Other erectile dysfunction therapies - the safety and efficacy of vardenafil used in combination with other treatments for ED have not been studied. Signs and symptoms may include reversible back pain/myalgia and/or "abnormal vision." Standard supportive measures should be taken as required.

Vardenafil Contraindications

Vardenafil is an erectile dysfunction drug that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction (impotence). Vardenafil is available under the following different brand names: Levitra and Staxyn ODT. Adult and Pediatric Dosage Forms and Strengths Dosage Considerations – Should be Given as Follows: Film-coated tablet: 10 mg orally approximately 1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day Orally disintegrating tablet (ODT): 10 mg orally placed on tongue approximately 1 hour before sexual activity; not to exceed 1 dose/day 10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed 5 mg orally approximately 1 hour before sexual activity AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men under 45 years) Hepatic impairment: Use contraindicated in chronic or active liver disease Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day Ritonavir (600 mg every 12 hours): Vardenafil dosage not to exceed 2.5 mg/72 hours Erythromycin 500 mg every 8 hours: Vardenafil dosage not to exceed 5 mg/day Stabilized on alpha-blocker therapy (e.g., alfuzosin, terazosin, tamsulosin): 5 mg/day orally initially Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day orally initially Mild, moderate, severe impairment: Dosage adjustment not necessary Child-Pugh class A: Dosage adjustment not necessary Child-Pugh class B: Film-coated tablet, 5 mg orally approximately 1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended Flushing (warmth or redness in your face, neck, or chest) Less common side effects of vardenafil include: This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them.

Patient resources

Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first. Severe interactions of vardenafil include: isosorbide dinitrateisosorbide mononitratenitroglycerin IVnitroglycerin POnitroglycerin rectalnitroglycerin sublingualnitroglycerin topicalnitroglycerin transdermalnitroglycerin translingualriociguat Vardenafil has serious interactions with at least 36 different drugs. Vardenafil has moderate interactions with at 105 different drugs. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.

Approval Year

Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns. Do not take Levitra or Staxyn ODT if you are women libido pills allergic to vardenafil or any ingredients contained in this drug. In case of overdose, get medical help or contact a Poison Control Center immediately. Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined See "What Are Side Effects Associated with Using Vardenafil?" See "What Are Side Effects Associated with Using Vardenafil?" Anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors. Pregnancy: Pregnancy Category B; not indicated for use in women. Nursing Mothers: Not indicated for use in women. Renal Impairment: Do not use in patients on renal dialysis; no dosage adjustment necessary in patients with ClCr 30-80 mL/min. Hepatic Impairment: Do not use in patients with severe impairment (Child-Pugh C); dosage adjustment is necessary in patients with moderate impairment. Pediatric Patients: Not indicated for use in pediatric patients; safety and efficacy have not been established in this population. Geriatric Patients: No differences in safety and effectiveness noted between elderly (≥65 years of age) and younger patients.

What are the Patent Expirations and Regulatory Status?

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg should be considered in the elderly. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents. Effects on Blood Pressure and Heart Rate when Combined with Nitrates: A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with vardenafil 20 mg at various times before NTG administration. Vardenafil 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration. The blood pressure effects were observed when vardenafil 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG.

Before taking vardenafil,

Additional blood pressure and heart rate changes were not detected when vardenafil 20 mg was dosed 24 hours before NTG. Because the disease state of patients requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated.

Usual Adult Dose for:

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg should be considered in the elderly.

• Vardenafil interacts with certain blood pressure medicines, affecting efficacy.
• The medication can be used by men of most adult age groups.
• Women who are pregnant or breastfeeding should not use vardenafil.
• It’s advisable to avoid grapefruit or grapefruit juice when on vardenafil.
• Always complete your prescribed course even if symptoms improve.
• Seek medical attention if you notice symptoms of allergic reaction.
• Vardenafil is not intended for use by individuals with recent stroke or heart attack.
• Sexual activity may be dangerous for some men with cardiovascular issues.
• The medication is not approved for use in women or children.
• Use caution when combining vardenafil with other erectile dysfunction drugs.

Vardenafil may add to the blood pressure lowering effects of antihypertensive agents. Effects on Blood Pressure and Heart Rate when Combined with Nitrates: A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with vardenafil 20 mg at various times before NTG administration. Vardenafil 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration.

Drug Label Information

Avoid in patients with congenital QT prolongation or those taking class IA or III antiarrhythmics. Use in combination with other treatment for erectile dysfunction has not been studied and is not recommended. Concomitant use of alpha-blockers increases risk of low blood pressure (hypotension). May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician. Vardenafil may be acceptable for use during pregnancy.

Less common

Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk. It is unknown whether vardenafil is distributed into breast milk. Vardenafil indicated for males and is unlikely to be used in females. Bayer healthcare pharmaceuticals inc • Vardenafil is indicated for the treatment of erectile dysfunction. Vardenafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction.

Hazard Classifications

Vardenafil inhibits cyclic guanosine monophosphate (GMP) specific phosphodiesterase type 5 (PDE5), which is responsible for the degradation of cyclic GMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. Therefore, the inhibition of PDE5 by vardenafil enhances erectile function by increasing the amount of cyclic GMP. The blood pressure effects were observed when vardenafil 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG.

Parameter	Value	Notes
Absorption Time	30-60 minutes	After oral intake
Peak Plasma	60 minutes	Approximate peak
Half-life	4-5 hours	Duration of effect
Bioavailability	~15%	Oral bioavailability

Additional blood pressure and heart rate changes were not detected when vardenafil 20 mg was dosed 24 hours before NTG. Because the disease state of patients requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated.