Allergen Case Study Solution

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A pharmaceutical company called Allergen develops a drug called Byvalson that is fixed combination of nebivolol and valsartan. Byvalson is the first and only fixed-dose combination (FDC) of a beta blocker and angiotensin II receptor blocker available in the U.S. Byvalson provides physician and healthcare providers a new fixed dose combination therapy treatment option for patients with hypertension (Allergan , 2016). Byvalson may cause drowsiness or dizziness. A patient should not drive or operate machinery until they know how this medication affects them. The patient should not sit or stand up too quickly, especially in the elderly population. Also avoid alcoholic beverages when taking this medication. These things help reduce the risk of becoming …show more content…
Valsartan may result in deterioration of renal function, including possible acute renal failure if used in combination with Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors). The use of Byvalson with ACE inhibitors or with aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Lastly Byvalson may cause an increased in serum lithium concentrations and lithium toxicity (Byvalson Interactions, 2016).
Fetal Toxicity
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Byvalson as soon as possible (Byvalson, 2016).
Symptomatic hypotension: may occur because of patients having an activated renin-angiotensin-aldosterone system. This should be corrected before Byvalson therapy is started. If excessive hypotension occurs patient should lay supine and IV fluids may be

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