4 CONTRAINDICATIONS
Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets.
- Sildenafil citrate is commonly used to treat erectile dysfunction.
- It works by relaxing blood vessels in the penis.
- The medication typically starts working within 30-60 minutes.
- It should be taken as directed by a healthcare provider.
It is not known if sildenafil tablets caused these problems. Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep sildenafil tablets and all medicines out of the reach of children. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsMAGNESIUM STEARATE (UNII: 70097M6I30)HYPROMELLOSES (UNII: 3NXW29V3WO)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeROUNDSize7mmFlavorImprint Code25;SLContainsPackagingNDC:75834-272-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-001000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021Marketing InformationANDAANDA20930206/16/2021Labeler - NIVAGEN PHARMACEUTICALS, INC. (052032418)EstablishmentUMEDICA LABORATORIES PRIVATE LIMITED920635096manufacture(75834-272, 75834-240, 75834-241) 50 mg PO ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening Revatio (PO), Liqrev: 20 mg PO TID; may titrate up to 80 mg TID, if required, based on symptoms and tolerability Revatio (IV): 10 mg IV bolus TID 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Do not exceed recommended PO/IV dose Viagra, VibriqueSevere (eg, cirrhosis): Consider initial dose of 25 mg Severe (eg, cirrhosis): Consider initial dose of 25 mg RevatioMild or moderate (Child-Pugh A or B): No dose adjustment requiredSevere (Child-Pugh C): Not studied Mild or moderate (Child-Pugh A or B): No dose adjustment required Viagra, VibriqueMild or moderate (CrCl 30-80 mL/min): No dose adjustment requiredSevere (CrCl <30 mL/min): Consider initial dose of 25 mg Mild or moderate (CrCl 30-80 mL/min): No dose adjustment required Severe (CrCl <30 mL/min): Consider initial dose of 25 mg RevatioAny severity, including severe (CrCl <30 mL/min): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required Indicated in children aged 1-17 years for treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise 20-45 kg: 20 mg PO TID Maximum dose in pediatric patients not identified Based on experience in adults, dose may be titrated up to 40 mg TID, if required, based on symptoms and tolerability Mild or moderate (Child-Pugh A or B): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required ≥65 years: 25 mg PO initially ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening PO: 20 mg PO TID; may titrate up to 80 mg TID, if required , based on symptoms and tolerability 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Recommended PO/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (≥65 years) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively atazanaviratazanavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Never use combination with chronic sildenafil for PAH cobicistatcobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. When used chronically for PAH, sildenafil is contraindicated for use with cobicistat; if used for erectile dysfunction, do not exceed sildenafil 25 mg q48hr cobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
- Do not chew or break the tablet; swallow it whole.
- Avoid taking sildenafil with larger doses of alcohol.
- Regular exercise and a healthy diet can improve erectile function.
- Do not share your medication with others.
Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events; contraindication applies to chronic administration of sildenafil for PAH; for ED, not to exceed 25 mg in 48 hr. nelfinavirnelfinavir will increase the level or effect sildenafil price ireland of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
8.2 Lactation
Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. It is not known if sildenafil tablets caused these problems. Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Usual Adult Dose for:
Keep sildenafil tablets and all medicines out of the reach of children. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsMAGNESIUM STEARATE (UNII: 70097M6I30)HYPROMELLOSES (UNII: 3NXW29V3WO)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeROUNDSize7mmFlavorImprint Code25;SLContainsPackagingNDC:75834-272-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-001000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021Marketing InformationANDAANDA20930206/16/2021Labeler - NIVAGEN PHARMACEUTICALS, INC. (052032418)EstablishmentUMEDICA LABORATORIES PRIVATE LIMITED920635096manufacture(75834-272, 75834-240, 75834-241) 50 mg PO ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening Revatio (PO), Liqrev: 20 mg PO TID; may titrate up to 80 mg TID, if required, based on symptoms and tolerability Revatio (IV): 10 mg IV bolus TID 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Do not exceed recommended PO/IV dose Viagra, VibriqueSevere (eg, cirrhosis): Consider initial dose of 25 mg Severe (eg, cirrhosis): Consider initial dose of 25 mg RevatioMild or moderate (Child-Pugh A or B): No dose adjustment requiredSevere (Child-Pugh C): Not studied Mild or moderate (Child-Pugh A or B): No dose adjustment required Viagra, VibriqueMild or moderate (CrCl 30-80 mL/min): No dose adjustment requiredSevere (CrCl <30 mL/min): Consider initial dose of 25 mg Mild or moderate (CrCl 30-80 mL/min): No dose adjustment required Severe (CrCl <30 mL/min): Consider initial dose of 25 mg RevatioAny severity, including severe (CrCl <30 mL/min): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required Indicated in children aged 1-17 years for treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise 20-45 kg: 20 mg PO TID Maximum dose in pediatric patients not identified Based on experience in adults, dose may be titrated up to 40 mg TID, if required, based on symptoms and tolerability Mild or moderate (Child-Pugh A or B): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required ≥65 years: 25 mg PO initially ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening PO: 20 mg PO TID; may titrate up to 80 mg TID, if required , based on symptoms and tolerability 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Recommended PO/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (≥65 years) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively atazanaviratazanavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Never use combination with chronic sildenafil for PAH cobicistatcobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Revatio Injection
When used chronically for PAH, sildenafil is contraindicated for use with cobicistat; if used for erectile dysfunction, do not exceed sildenafil 25 mg q48hr cobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events; contraindication applies to chronic administration of sildenafil for PAH; for ED, not to exceed 25 mg in 48 hr. nelfinavirnelfinavir will increase the level or effect sildenafil price ireland of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration contraindicated if sildenafil used for pulmonary arterical hypertension. nelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration contraindicated if sildenafil used for pulmonary arterical hypertension. Reduce sildenafil dose if used for erectile dysfunction. nirmatrelvir/ritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
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nitroglycerin rectalsildenafil increases effects of nitroglycerin rectal by additive vasodilation. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.
What side effects can this medication cause?
sildenafil increases effects of nitroglycerin rectal by additive vasodilation.
| Dosage (mg) | Tablet Color | Shape | Typical Usage |
|---|---|---|---|
| 25 | Pink | Round | Mild erectile dysfunction |
| 50 | Blue | Diamond | Moderate ED |
| 100 | Blue | Diamond | Severe ED |
Either increases effects of the other by additive vasodilation.
Sildenafil vs Tadalafil for Erectile Dysfunction
Reduce sildenafil dose if used for erectile dysfunction. nirmatrelvir/ritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nitroglycerin rectalsildenafil increases effects of nitroglycerin rectal by additive vasodilation. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.
Why this range helps:
sildenafil increases effects of nitroglycerin rectal by additive vasodilation. Either increases effects of the other by additive vasodilation. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension; do not administer within 24 hr of each other. Either increases effects of the other by pharmacodynamic synergism. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.
Can I get Sildenafil Citrate without a prescription?
alfuzosinsildenafil increases effects of alfuzosin by pharmacodynamic synergism. sildenafil increases effects of alfuzosin by sildenafil citrate drug pharmacodynamic synergism. apalutamideapalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension; do not administer within 24 hr of each other. Either increases effects of the other by pharmacodynamic synergism. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects. alfuzosinsildenafil increases effects of alfuzosin by pharmacodynamic synergism. sildenafil increases effects of alfuzosin by sildenafil citrate drug pharmacodynamic synergism. apalutamideapalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible.
other ED treatments
Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed. apalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. asenapinesildenafil increases effects of asenapine by pharmacodynamic synergism. sildenafil increases effects of asenapine by pharmacodynamic synergism.
What should I do if I miss a dose of sildenafil?
ceritinibceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicolchloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- The active ingredient, sildenafil citrate, is a white to off-white powder.
- It has a molecular weight of approximately 473.6 g/mol.
- The medication is synthesized through complex chemical processes.
- Pharmaceutical quality control ensures batch consistency.
apalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. asenapinesildenafil increases effects of asenapine by pharmacodynamic synergism. sildenafil increases effects of asenapine by pharmacodynamic synergism. ceritinibceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicolchloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
- People with heart disease should consult their doctor before use.
- Do not use sildenafil if you are taking medications containing nitrates.
- Side effects may include dizziness or vision disturbances.
- Report any persistent or severe side effects to your healthcare provider.
chloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
