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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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