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            The  first  dose  syncope  (sudden  loss  of          interferon  or  ribavirin,  two  FDA-approved  drugs
            consciousness) is generally associated with alpha-1   also used to treat HCV infection.
            blockers.  The  vasodilation  produced  by  Minipress
            (Prazosin) leads to reflex tachycardia. The first dose   Harvoni (Ledipasvir  and  Sofosbuvir)  is  a once-daily
            syncope sometimes leads to tachycardia with heart     NS5A  inhibitor  and  nucleotide  analog  polymerase
            rates of 120-160 beats per minute.                    inhibitor fixed-dose combination for the treatment
                                                                  of  chronic  hepatitis  C  genotype  1  infection.  Both
            109.(e)  The  first  dose  syncope  generally  occurs   drugs in Harvoni interfere with the enzymes needed
            within  30  to  90  minutes  after  the  initial  dose  of   by  HCV  to  multiply.  Sofosbuvir  is  a  previously
            Minipress.  The  incidence  of  syncope  increases    approved  HCV  drug  marketed  under  the  brand
            significantly  when  the  initial  dose  of  Minipress  is   name  Sovaldi.  Harvoni  also  contains  a  new  drug
            greater than 2 mg. It can be minimized by limiting    called Ledipasvir.
            the  initial  dose of the  drug  to  1mg,  and  by  taking
            the dose at bed time.                                 Harvoni (Ledipasvir and Sofosbuvir) is the third drug
                                                                  approved  by  the  FDA  in  the  past  year  to  treat
            110.(e) Tyzeka   (Telbivudine)   is   a   synthetic   chronic  HCV  infection.  The  FDA  approved
            thymidine nucleoside analogue with activity against   Simeprevir  (Olysio)  in  November  2013  and
            hepatitis  B  virus  (HBV).  Each  film-coated  tablet   Sofosbuvir (Sovaldi) in December 2013.
            contains 600 mg Telbivudine. Tyzeka oral solution is
            available  for  oral  administration  in  100mg/5mL   The most common side effects reported in clinical
            strength.                                             trial participants were fatigue and headache.

            Tyzeka  is  indicated  for  the  treatment  of  chronic   112.(e) Minipress (Prazosin), Hytrin (Terazosin) and
            hepatitis  B  in  adult  patients with evidence  of viral   Cardura  (Doxazosin)  are  specific  alpha-1  blockers.
            replication  and  either  evidence  of  persistent    They may cause first dose syncope.
            elevations in serum aminotransferases (ALT or AST)
            or histologically active disease.                     113.(c)  Hytrin  (Terazosin)  is  classified  as  a  specific
                                                                  alpha-1 blocker. It is indicated for the treatment of
            The  recommended  dose  of  Tyzeka  for  the          hypertension   and   B.P.H.   (Benign   Prostatic
            treatment  of  chronic  hepatitis  B  is  600  mg  once   Hyperplasia). The symptoms related to BPH are due
            daily,  taken  orally,  with  or  without  food.  Tyzeka   to bladder outlet obstruction.
            may be used for the treatment of chronic hepatitis
            B  in  patients  with  impaired  renal  function.  No   The dynamic component of the body may increase
            adjustment to the recommended dose of Tyzeka is       the  smooth  muscle  tone  in  the  bladder,  neck  and
            necessary in patients whose creatinine clearance is   prostate  gland,  which  constricts  the  bladder  by
            > 50 mL/min.                                          stimulating   alpha-1   adrenoreceptors.   Hytrin
                                                                  (Terazosin)  is  an  alpha-1  receptor  blocker  which
            Lactic  acidosis  and  severe  hepatomegaly  with     reduces  the  symptoms  associated  with  bladder
            steatosis, including fatal cases, have been reported   obstruction  and  improves  urinary  flow  by  relaxing
            with the use of Tyzeka (Telbivudine). Severe acute    smooth muscles of the bladder, neck and prostate
            exacerbations of hepatitis B have been reported in    gland.
            patients  who  have  discontinued  anti-hepatitis  B
            therapy, including Tyzeka.                            The dose should be increased in a stepwise fashion
                                                                  to 2 mg, 5 mg, or 10 mg once daily to achieve the
            111.(d)  Harvoni  (Ledipasvir  and  Sofosbuvir)  is  the   desired  improvement  of  symptoms  and/or  flow
            first combination pill approved to treat chronic HCV   rates.  Doses  of  10  mg  once  daily  are  generally
            genotype  1  infection.  It  is  also  the  first  approved   required  for  the  clinical  response.  Therefore,
            regimen that does not require administration with     treatment with 10 mg for a minimum of 4–6 weeks


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