For Patients Pfizer Patient Assistance Program Provides free Pfizer medicines to eligible patients through their doctor's office or at home. Genuine Viagra works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility. /ExtGState << For erectile dysfunction in adult men. You should not take sildenafil if you are using any other products or taking any other medicines to treat erectile dysfunction. /Parent 2 0 R You should take genuine Viagra about one hour before you plan to have sex. The shelf-life of the reconstituted oral suspension is 60 days. The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration. The usual starting dose is 50 mg. You should not take genuine Viagra more than once a day. To use the oral liquid: Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088. Your doctor may start you on a lower dose (25 mg) of Viagra. Indications: For erectile dysfunction in adult men. Depending on your symptoms, likely cause of the ED, age, etc, your doctor may suggest that you have some tests These can include: If you have a low sex drive, or if you have had a previous head injury, ED may be due to a hormonal problem. has changed with respect to his health status or medicines usage. If you have a heart condition, or blood vessel disease. Swallow the tablet whole with a glass of water. Do not take genuine prescription Viagra if you have recently had a stroke or a heart attack, or if you have low blood pressure. 6. If you would like more information, talk with your healthcare provider. Privacy is important to us. Never take sildenafil for oral suspension with any nitrate or guanylate cyclase stimulator medicines. using a different dose of sildenafil or another ED treatment, he should be referred to his doctor. Your doctor should in that case carefully check whether your heart can take the additional strain of having sex. Viagra Connect provides additional background information in relation to the supply of this product. For Oral Use Only /CSpg /DeviceGray The Essential Information for the Supply of. (Figure 3), 7. Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. sildenafil citrate powder, for suspension. /Length 15 0 R Diabetes. Most patients had mild to moderate symptoms at baseline: WHO Functional Class I (32%), II (51%), III (15%), or IV (0.4%). Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Download Checklist Viagra Connect Checklist.pdf. Background A. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine. Viagra should not be given to individuals under the age of 18. VIAGRA (sildenafil citrate) is prescription medicine used to treat erectile dysfunction (ED). The current match involves a Texas lawsuit . 10 mg/mL Remove the cap. You may find that genuine Viagra takes longer to work if you take it with a heavy meal. The blue diamond tablet shape and Viagra Connect Administer sildenafil for oral suspension doses 4 to 6 hours apart. It does not take the place of talking to your doctor or pharmacist. Your doctor has weighed the risks of . 13 0 obj A switch to a different medicine may be possible, depending on what the medicine is for. The recommended dose of sildenafil for oral suspension is 5 mg or 20 mg three times a day. Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. There were infrequent reports of patients who experienced symptomatic postural hypotension. There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. This causes increased blood flow, following which an erection usually develops within 15 minutes. Egton Medical Information Systems Limited. VIAGRA helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). 1. Who is Viagra connect for? /Type /ExtGState Oral medications are often the first line of treatment for erectile dysfunction. Alpha blockers. }|g(ik:HQ`
Ec\ zUUo Introduction Currently, patients may receive one or more types of written patient prescription drug product information No patients died during the 16-week controlled study. Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. The patient can then take the slip with them to the doctor to help start the conversation. Subjects who had failed to respond to bosentan were also excluded. Effects of Other Drugs on Sildenafil Pharmacokinetics, Figure 8 Effects of Sildenafil on Other Drugs. It should be used 5 to 30 minutes before you have sex. If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines. Aurobindo Pharma Limited Hyderabad-500 032, India It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patients underlying cardiovascular disease, or to a combination of these or other factors. Sildenafil citrate (Viagra) is a selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5) and is indicated for the treatment of erectile dysfunction. Put the tip of the oral syringe into your mouth. Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. The checklist will help you assess the mans cardiovascular health and concomitant medication use and conditions. Total maximum savings for this Savings Offer are $4,200, You must be 18 years of age or older to redeem this Savings Offer, You are responsible for reporting use of this Savings Offer to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using this Savings Offer, as may be required. Registered number: 10004395 Registered office: Fulford Grange, Micklefield Lane, Rawdon, Leeds, LS19 6BA. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Its Identification Number (EIN) is 13, We use cookies to provide an enhanced experience, to keep our site safe and to deliver specific messaging. By accepting, you consent to the use of all cookies and by declining, only essential cookies will be used to make our website work. 104/Wednesday, May 31, 2023/Proposed Rules 35697 1 Currently, there are no REMS that contain a PPI as an element. Access health service innovations designed to strengthen your pharmacy offering. In a randomized, double-blind, multi-center, placebo-controlled, parallel-group, dose-ranging study, 234 patients with PAH, aged 1 to 17 years, body weight greater than or equal to 8 kg, were randomized, on the basis of body weight, to three dose levels of sildenafil, or placebo, for 16 weeks of treatment. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. Remove the oral syringe from the bottle by pulling straight up on the barrel of the oral dosing syringe. %PDF-1.4 The medicine is quickly absorbed into the penis to cause an erection, usually within 10-15 minutes. The active substance in genuine UK Viagra is sildenafil. Available for Android and iOS devices. Male erectile dysfunction defined as "the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance" 1 is a common problem in the United States affecting between 10 and 30 million men. Viagra will only help you to get an erection if you are sexually stimulated. Viatris accepts no responsibility for the content of any linked sites. Recommended storage for sildenafil for oral suspension: Store below 30C (86F) in the original package in order to protect from moisture. By participating in the VIAGRA Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below: This Savings Offer is not valid for prescriptions that . VIAGRA may affect the way other medicines work, and other medicines may affect the way VIAGRA works, causing side effects. 10. have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure. It is recommended that you do not drink grapefruit juice with sildenafil. If these ED tablets do not help then you will be offered referral to see a urology specialist for further assessment, advice and treatment. Table 4 displays the number of patients with clinical worsening events in Study 2. Do not use genuine UK Viagra after the expiry date which is stated on the genuine Viagra carton. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. This medicine is for you. Patients were randomized to receive placebo (n=70) or sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. A 10 mg dose of sildenafil injection is predicted to provide a pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. Do you have any other heart problems or are you under, , irregular heart beat or palpitations (arrh. Rx only In this situation a blood test to check the level of the hormone testosterone (and sometimes prolactin) may be advised. VIAGRA should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]), This Savings Offer is not valid for prescriptions that are reimbursed, in whole or in part, by Medicaid, Medicare, TRICARE, Veterans Affairs healthcare, or any other federal or state healthcare program (including any state prescription drug assistance program), or the Government Health Insurance Plan available in Puerto Rico (formerly known as La Reforma de Salud), The value of this Savings Offer is limited to $350 per use or the amount of your co-pay, whichever is less, This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs, You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf, This Savings Offer is limited to 50% savings off the amount of your co-pay or your out-of-pocket cost, whichever is less, with a maximum savings of $350 off each prescription for up to 12 prescriptions in a calendar year. Use of sildenafil, particularly chronic use, is not recommended in children. About sildenafil for erectile dysfunction, How to take sildenafil for erectile dysfunction, Important information about all medicines, Notes on Sildenafil citrate for erectile dysfunction, https://patient.info/medicine/sildenafil-for-erectile-dysfunction-aronix-viagra-vizarsin, Erectile dysfunction (sometimes called impotence), Manufacturer's PIL, Viagra 25 mg, 50 mg, 100 mg tablets, British National Formulary, 80th Edition (Sep 2020), Erectile Dysfunction (ED) | Causes, Symptoms, and Treatment, Vardenafil for erectile dysfunction (Levitra), Drink plenty of water. Ask your doctor if you have any questions. , LS19 6BA because PDE3 is involved in control of cardiac contractility genuine UK Viagra after the expiry which... The barrel of the tablet, injection, or blood vessel disease excited ( )! Medications are often the first line of treatment for erectile dysfunction get and keep an erection, within... 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