SILDENAFIL 20MG 90 TAB
Generic: Sildenafil
SILDENAFIL 20MG 90 TAB
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
Sildenafil
Sildenafil
Macleods Pharmaceuticals Limited
HUMAN PRESCRIPTION DRUG
Administration
TABLET, FILM COATED
ORAL
ANDA203814
Active Ingredients
| Ingredient | Strength |
|---|---|
| SILDENAFIL CITRATE | 20 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS & 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 is a 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 & Administration
2 DOSAGE & ADMINISTRATION Tablet: 20 mg three times a day, 4-6 hours apart ( 2.1 ) 2.1 Sildenafil Tablets The recommended dose of sildenafil tablets is 20 mg three times a day. Administer sildenafil tablets doses 4-6 hours apart. In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling: • Mortality with pediatric use[ see Warnings and Precautions (5.1 ) and Use in Specific Populations (8.4) ] • Hypotension [ see Warnings and Precautions (5.2) ] • Vision loss [ see Warnings and Precautions (5.5) ] • Hearing loss [ see Warnings and Precautions (5.6) ] • Priapism [ see Warnings and Precautions (5.8) ] • Vaso-occlusive crisis [ see Warnings and Precautions (5.9) ] 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. (6.1, 6.2) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil-treated patients with PAH, WHO Group I [see Clinical Studies (14)] . The overall frequency of discontinuation in sildenafil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil-treated patients (20 mg three times a day) and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature. Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil-Treated Patients) Placebo, % (n = 70) Sildenafil tablets 20 mg three times a day, % (n = 69) Placebo-Subtracted, % Epistaxis 1 9 8 Headache 39 46 7 Dyspepsia 7 13 6 Flushing 4 10 6 Insomnia 1 7 6 Erythema 1 6 5 Dyspnea exacerbated 3 7 4 Rhinitis 0 4 4 Diarrhea 6 9 3 Myalgia 4 7 3 Pyrexia 3 6 3 Gastritis 0 3 3 Sinusitis 0 3 3 Paresthesia 0 3 3 At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision. The incidence of retinal hemorrhage with sildenafil 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for sildenafil versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. In a placebo-controlled fixed dose titration study (Study 2) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14) ]. Table 2. Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Sildenafil + Epoprostenol group at least 6% greater than Epoprostenol group) Sildenafil + Epoprostenol (n = 134) Epoprostenol (n = 131) (Sildenafil + Epoprostenol)minus Epoprostenol % Headache 57 34 23 Edema includes peripheral edema 25 13 14 Dyspepsia 16 2 14 Pain in extremity 17 6 11 Diarrhea 25 18 7 Nausea 25 18 7 Nasal congestion 9 2 7 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Events In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors. Nervous system Seizure, seizure recurrence Ophthalmologic NAION [ see Warnings and Precautions ( 5.5 ) and Patient Counseling Information ( 17 ) ].
Information for Patients
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). Inform patients of contraindication of sildenafil tablets 20 mg with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets 20 mg not to take VIAGRA or other PDE-5 inhibitors. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets 20 mg. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets 20 mg. These events may be accompanied by tinnitus and dizziness. VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners. Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceutical Ltd. Baddi, Himachal Pradesh, India Revised: February 2018 PM01596108 PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) Tablets Read this Patient Information before you start taking sildenafil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist. What is the most important information I should know about sildenafil tablets? Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include: • Medicines that treat chest pain (angina) • Nitroglycerin in any form including tablets, patches, sprays, and ointments • Isosorbide mononitrate or dinitrate • Street drugs called “poppers” (amyl nitrate or nitrite) Guanylate cyclase stimulators include: • Riociguat (Adempas) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. What are sildenafil tablets? Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs. Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition. • Sildenafil tablets are not for use in children • Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer ® ), does not result in improvement in your ability to exercise. Sildenafil tablets 20 mg contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets 20 mg with VIAGRA or other PDE-5 inhibitors. Who should not take sildenafil tablets? Do not take sildenafil tablets if you: • take nitrate medicines. See “ What is the most important information I should know about sildenafil tablets?” • take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?” • are allergic to sildenafil or any other ingredient in sildenafil tablets. See “ What are the ingredients in sildenafil tablets? ” at the end of this leaflet. What should I tell my doctor before taking sildenafil tablets? Tell your doctor about all of your medical conditions, including if you • have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack • have a disease called pulmonary veno-occlusive disease (PVOD) • have high or low blood pressure or blood circulation problems • have an eye problem called retinitis pigmentosa • have or had loss of sight in one or both eyes • have any problem with the shape of your penis or Peyronie’s disease • have any blood cell problems such sickle cell anemia • have a stomach ulcer or any bleeding problems • are pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby. • are breastfeeding. Sildenafil passes into your breast milk, it is not known if it could harm your baby. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets. Especially tell your doctor if you take • Nitrate medicines. See “ What is the most important information I should know about sildenafil tablets? ” • Riociguat (Adempas). See “What is the most important information I should know about sildenafil tablets?” • Ritonavir (Norvir®) or other medicines used to treat HIV infection • Ketoconazole (Nizoral®) • Itraconazole (Sporanox) • High blood pressure medicine Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take sildenafil tablets? • Take sildenafil tablets exactly as your doctor tells you. Sildenafil may be prescribed to you as • Sildenafil tablets • Take sildenafil tablet 3 times a day about 4 to 6 hours apart. • Take sildenafil tablets at the same times every day. • If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. • Do not take more than one dose of sildenafil tablets at a time. • Do not change your dose or stop taking sildenafil tablets on your own. Talk to your doctor first. • If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room. What are the possible side effects of sildenafil tablets? • low blood pressure . Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. • more shortness of breath than usual . Tell your doctor if you get more short of breath after you start sildenafil tablets. More shortness of breath than usual may be due to your underlying medical condition. • decreased eyesight or loss of sight in one or both eyes (NAION) . If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. • sudden decrease or loss of hearing . If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors. • heart attack, stroke, irregular heartbeats, and death . Most of these happened in men who already had heart problems. • erections that last several hours . If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis. The most common side effects with sildenafil tablets include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn’t go away. These are not all the possible side effects of sildenafil tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store sildenafil tablets? • Store sildenafil tablets at controlled room temperature, between 20° to 25°C (68° to 77°F). • Keep sildenafil tablets and all medicines away from children. General information about sildenafil tablets Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms you have. It could harm them. This patient leaflet summarizes the most important information about sildenafil tablets. If you would like more information about sildenafil tablets talk with your doctor. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals. For more information call 1-888-943-3210. What are the ingredients in sildenafil tablets? Active ingredients: sildenafil citrate Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, triacetin This Patient Information has been approved by the U.S. Food and Drug Administration. VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners. Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceutical Ltd. Baddi, Himachal Pradesh, India Revised: February 2018
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.