All medicines have risks and benefits. 5. a. b. Fildena

18 Jul 2018 08:33

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Do not take two doses at the same time. If it is almost time for your next dose, skip the missed dose. During clinical trial evaluation of Fildena, the following general adverse events were reported in less than 2% of patients receiving Fildena: asthenia, facial edema, fatigue, and pain (unspecified).

Many times, the hearing changes are accompanied by vestibular effects including dizziness, tinnitus, and vertigo. In addition, 29 reports of sudden changes in hearing including hearing loss or decrease in hearing, usually in 1 ear only, have been reported to the FDA during post-marketing surveillance in patients taking Fildena, Fildena, or vardenafil; the reports are associated with a strong temporal relationship to the dosing of these agents. Adverse reactions affecting hearing or otic special senses and occurring in < 2% of patients in controlled clinical trials of Fildena include hearing loss and tinnitus.

These risk factors include, but are not limited to: low cup to disc ratio ('crowded disc'), age over 50 years, diabetes, high blood pressure, coronary artery disease, hyperlipidemia, and smoking. 20 21 22 23 It is thought that the vasoconstrictive effect of phosphodiesterase inhibitors may decrease blood flow to the optic nerve, especially in patients with a low cup to disk ratio. Across all clinical studies with Fildena, reports of changes in color vision were rare (< 0.1% of patients).

In addition, pharyngitis (reported as nasopharyngitis, 1—13%), upper and lower respiratory tract infection (3—13%), influenza (2—5%), cough (2—4%), bronchitis (2%), and urinary tract infection (2%) were reported in Fildena-treated patients during clinical trials. Dysphagia, elevated hepatic enzymes, esophagitis, gastritis, vomiting, increased GGTP, loose stools, upper abdominal pain, hemorrhoidal hemorrhage, rectal hemorrhage, and xerostomia were reported in < 2% of patients treated with Fildena during clinical trials. Migraine, transient global amnesia, seizures, and seizure recurrence have been reported during post-marketing use of Fildena; due to the voluntary nature of the reports, the frequency of post-marketing adverse reactions is unknown and causality to the drug has not been established.

Generally, pain was reported as mild or moderate in severity and resolved without medical treatment; severe back pain was reported infrequently. In Fildena clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. Adverse musculoskeletal effects reported in less than 1% of patients included arthralgia and muscle spasms.

Further statistical analysis demonstrated that Fildena was non-inferior to placebo with respect to time to ischemia. 2 3 The effects of Fildena on cardiac function, hemodynamics, and exercise tolerance were investigated in a single clinical pharmacology study. Other cardiac effects reported in less than 2% of patients during clinical trials include angina, chest pain (unspecified), myocardial infarction, orthostatic hypotension, palpitations, syncope, and sinus tachycardia.

The risk for serious hypotension is augmented by the use of nitrates; therefore, the use of Fildena in patients receiving nitrate therapy is contraindicated.

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