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admin | Category: What Cause Ed | 13.02.2014
Viagra is typically prescribed in a dosage of 50 mg, taken as needed approximately 1 hour before sexual activity.
Cialis is typically prescribed in a dosage of 10 mg, taken as needed approximately 45 minutes before sexual activity.
Viagra and Cialis have both been shown to be effective in 60-70% of men with erectile dysfunction. With the low-dose version of Cialis for daily use, there is a steady supply of the drug in the bloodstream.
Viagra and Cialis should not be taken by men who take medicines or recreational drugs containing nitrates.
Cialis should not be taken by men who are on medicines called alpha blockers which are sometimes used to treat prostate problems or high blood pressure. Men taking Cialis may experience an unsafe drop in blood pressure if they drink too much alcohol. If you are suffering from erectile dysfunction, a complete physical examination by your doctor or healthcare provider is essential. The persistence of an erection, unassociated with sexual pleasure, that lasts for 6 or more hours.
A medication that is usually taken sublingually (under the tongue) for the relief of angina.
A chemical in the body that stimulates production of cGMP, which is necessary for erectile function. Any change from or interruption of the normal structure or function of any part or organ; system of the body that presents with characteristic symptoms and signs, and whose cause and prognosis may be known or unknown.
Pain in the chest, with a feeling of suffocation, that occurs with decreased blood flow and oxygenation to the heart.
1 for a schematic diagram of the action of drugs such as Viagra on the biochemistry of an erection. Boceprevir is an inhibitor of the hepatitis C virus (HCV) non-structural protein 3 (NS3) serine protease. Inactive ingredients: sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, and magnesium stearate.
Boceprevir is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers. Poorly interferon responsive patients who were treated with boceprevir in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials.
If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen.
Consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW4) with 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of boceprevir 800 mg orally three times daily (every 7 to 9 hours) in combination with peginterferon alfa and ribavirin in order to maximize rates of SVR. Patients with compensated cirrhosis should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks boceprevir 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) in combination with peginterferon alfa and ribavirin. Contraindications to peginterferon alfa and ribavirin also apply to boceprevir combination treatment. Resistance to boceprevir was characterized in biochemical and HCV genotype 1b replicon assays.
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. In case of exposure during pregnancy, a Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment.
No dosage adjustment of boceprevir is required for patients with any degree of renal impairment.
Thromboembolic events have been associated with ESA use in other disease states; and have also been reported with peginterferon alfa use in hepatitis C patients. A randomized, parallel-arm, open-label clinical trial was conducted in previously untreated CHC subjects with genotype 1 infection to compare use of an ESA versus ribavirin dose reduction for initial management of anemia during therapy with boceprevir in combination with peginterferon alfa-2b and ribavirin. Refer to Package Inserts for peginterferon alfa and ribavirin for additional information regarding dose reduction or discontinuation for peginterferon alfa and ribavirin.
See Table 2 for a listing of drugs that are contraindicated for use with boceprevir due to potentially life-threatening adverse events, significant drug interactions or loss of virologic activity [see Contraindications]. HCV-RNA levels should be monitored at Treatment Weeks 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and for other time points as clinically indicated. Refer to the Package Inserts for peginterferon alfa and ribavirin, including pregnancy testing requirements. See peginterferon alfa and ribavirin Package Inserts for description of adverse reactions associated with their use.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of boceprevir cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious and otherwise important adverse drug reactions (ADRs) are discussed in detail in another section of the labeling: Anemia and neutropenia [see Warnings and Precautions].
The most commonly reported adverse reactions (>35% subjects of regardless of investigator's causality assessment) in adult subjects were fatigue, anemia, nausea, headache, and dysgeusia when boceprevir was used in combination with PegIntron and REBETOL. Among subjects (previously untreated subjects or those who failed previous therapy) who received boceprevir in combination with peginterferon alfa and ribavirin, the following adverse drug reactions were reported. Dysgeusia (alteration of taste) was an adverse event reported at an increased frequency in subjects receiving boceprevir in combination with peginterferon alfa and ribavirin compared with subjects receiving peginterferon alfa and ribavirin alone (Table 3). Changes in selected hematological parameters during treatment of adult subjects with the combination of boceprevir with PegIntron and REBETOL are described in Table 4. Daily doses of 3600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects. Table 5 provides recommendations based on established or potentially clinically significant drug interactions. Studies in vitro indicate that boceprevir primarily undergoes metabolism through the aldo-ketoreductase (AKR)-mediated pathway to ketone-reduced metabolites that are inactive against HCV. Drug interaction studies were performed with boceprevir and drugs likely to be coadministered or drugs commonly used as probes for pharmacokinetic interactions. The pharmacokinetics of boceprevir was studied in adult non-HCV infected subjects with normal, mild (Child-Pugh score 5-6), moderate (Child-Pugh score 7-9), and severe (Child-Pugh score 10-12) hepatic impairment following a single 400 mg dose of boceprevir. The pharmacokinetics of boceprevir was studied in non-HCV-infected subjects with end-stage renal disease (ESRD) requiring hemodialysis following a single 800 mg dose of boceprevir.
Population pharmacokinetic analysis of boceprevir indicated that gender had no apparent effect on exposure. Population pharmacokinetic analysis of boceprevir indicated that race had no apparent effect on exposure. Population pharmacokinetic analysis of boceprevir showed that boceprevir exposure was not different across subjects 19 to 65 years old. VICTRELIS 200 mg capsules are comprised of a red-colored cap with the Merck logo printed in yellow ink, and a yellow-colored body with "314" printed in red ink.


Commercials appear on almost every televised sporting event, and men’s magazines are filled with ads to “increase your sexual performance”. Both drugs increase the flow of blood into the penis so that when a man is sexually stimulated, he can get and maintain an erection.
Based on effectiveness and toleration, the dose may be increased to a maximum dose of 100 mg or decreased to 25 mg.
Based on effectiveness and toleration, the dose may be increased to a maximum dose of 20 mg or decreased to 5 mg. The recommended starting dose of Cialis for daily use is 2.5 mg, taken at approximately the same time each day. Because Viagra has been available the longest (since 1998), there is much more research available. Viagra lasts about four to five hours, but with Cialis, the window of opportunity ranges from 24 to 36 hours, which is why it is sometimes called “the weekend drug.” For couples who prize sexual spontaneity, Cialis seems to have a clear competitive edge in this category.
Theoretically, this option makes having sex a possibility without any advance planning at all.
Men who take alpha blockers can use Viagra but must allow at least a six hour gap between taking the alpha blocker and Viagra. The same is true for Viagra, but since Viagra is shorter-acting, this may be less of an issue.
The precise mechanism of Tamoxifen Tablet’s action is unknown, but one possibility is that it binds and blocks estrogen receptors on the surface of cells, preventing estrogens from binding and activating the cell.
Tamoxifen is also used for the treatment of women following surgery and radiation for a less common type of breast cancer called ductal carcinoma in situ (DCIS or intraductal carcinoma).
The dose of boceprevir is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food [a meal or light snack] (see Table 1). Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following Response-Guided Therapy (RGT) guidelines to determine duration of treatment (see Table 1). Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (S139) through an (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells. Among boceprevir-treated subjects who did not achieve a sustained virologic response, and for whom samples were analyzed, 53% had one or more specific post-baseline, treatment-emergent NS3 protease domain amino acid substitutions detected by a population-based sequencing assay.
Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans [see peginterferon alfa Package Inserts].
Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. The addition of boceprevir to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations.
If ribavirin is permanently discontinued for management of anemia, then peginterferon alfa and boceprevir must also be discontinued [see Dosage and Administration]. With the interventions used for anemia management in the clinical trials, the average additional decrease of hemoglobin was approximately 1 g per dL. Similar SVR rates were reported in subjects who were randomized to receive ribavirin dose reduction compared to subjects who were randomized to receive an ESA. If such an acute reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted [see Contraindications and Adverse Reactions]. Please refer to Table 5 for established and other potentially significant drug interactions [see Drug Interactions]. Use of a sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay for monitoring HCV-RNA levels during treatment is recommended. Complete blood counts should be obtained at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. These events are notable because of their seriousness, severity, or increased frequency in subjects who received boceprevir in combination with peginterferon alfa and ribavirin compared with subjects who received only peginterferon alfa and ribavirin. Adverse events such as dry mouth, nausea, vomiting and diarrhea were also reported at an increased frequency in subjects receiving boceprevir in combination with peginterferon alfa and ribavirin. Treatment of overdosage with boceprevir should consist of general supportive measures, including monitoring of vital signs, and observation of the patient’s clinical status. In drug interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent. In plasma the diastereomer ratio changes to 2:1, favoring the active diastereomer, SCH534128. Steady state AUC, Cmax, and Cmin increased in a less-than-dose-proportional manner and individual exposures overlapped substantially at 800 mg and 1200 mg, suggesting diminished absorption at higher doses. Food enhanced the exposure of boceprevir by up to 65% at the 800 mg three times daily dose, relative to the fasting state. Human plasma protein binding is approximately 75% following a single dose of boceprevir 800 mg. After a single 800-mg oral dose of 14C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4-fold greater than that of boceprevir. The effects of coadministration of boceprevir on AUC, Cmax and Cmin are summarized in Table 6 (effects of coadministered drugs on boceprevir) and Table 7 (effects of boceprevir on coadministered drugs).
The mean AUC of the active diastereomer of boceprevir (SCH534128) was 32% and 45% higher in subjects with moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function. The mean AUC of boceprevir was 10% lower in subjects with ESRD requiring hemodialysis relative to subjects with normal renal function.
The capsules are packaged into a carton with 28 bottles containing 12 capsules (NDC 0085-0314-02). Viagra and Cialis belong to a class of drugs known as PDE5 inhibitors, which enhance the effect of nitric oxide, a chemical that is normally released during stimulation. In addition, it is difficult to make comparisons across studies, since different studies use different measures of efficacy (e.g. Other common side effects include nasal congestion, facial flushing, stomach ache, and urinary tract infections.
However, since Cialis has a longer duration of effectiveness, its side effects tend to last longer, which some men find troubling. The combined effects could cause a dramatic drop in blood pressure, resulting in dizziness, fainting, and sometimes loss of consciousness. Your doctor can determine if any other conditions are involved and help you choose the best and safest therapy. Women who have had DCIS are at high risk for developing invasive breast cancer at a later date, and tamoxifen prevents development of the invasive cancer in almost half of the women during the first five years of treatment.
Nearly all of these substitutions have been shown to reduce boceprevir anti-HCV activity in cell culture or biochemical assays. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Complete blood counts should be obtained pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.


The use of erythropoiesis stimulating agents was permitted for management of anemia, at the investigator’s discretion, with or without ribavirin dose reduction in the Phase 2 and 3 clinical trials.
No definite causality assessment or benefit risk assessment could be made for these events due to the presence of confounding factors and lack of randomization of ESA use.
In this trial, use of ESAs was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and deep vein thrombosis compared to ribavirin dose reduction alone. Decreases in neutrophils or platelets may require a decrease in dosage or interruption of peginterferon alfa, or discontinuation of therapy [see Package Inserts for peginterferon alfa and ribavirin].
Plasma concentrations of boceprevir described below consist of both diastereomers SCH534128 and SCH534129, unless otherwise specified. Boceprevir is administered as an approximately equal mixture of two diastereomers, SCH534128 and SCH534129, which rapidly interconvert in plasma. Following a single 800 mg oral dose of 14C-boceprevir, approximately 79% and 9% of the dose was excreted in feces and urine, respectively, with approximately 8% and 3% of the dosed radiocarbon eliminated as boceprevir in feces and urine. Mean Cmax values for SCH534128 were 28% and 62% higher in moderate and severe hepatic impairment, respectively.
For patient use, refrigerated capsules of VICTRELIS can remain stable until the expiration date printed on the label. It has been endorsed by celebrities such as NASCAR star Mark Martin, baseball all-star Rafael Palmeiro, and even former Republican presidential candidate Bob Dole. Nitric oxide opens and relaxes blood vessels in the penis, thereby increasing inflow and allowing erections to last longer. Viagra is best taken on an empty stomach, since its action may be delayed or impaired when taken with food (especially high-fat foods). But Cialis (which entered the market 5 years later) seems to have a very similar efficacy profile. Nitrate medicines include nitroglycerin and isosorbide (both used to treat the chest pain associated with angina).
However, the side effects of Cialis can be prolonged and there can be an increased risk for drug interactions. If peginterferon alfa or ribavirin is permanently discontinued, boceprevir must also be discontinued.
The fold decrease in boceprevir anti-HCV activity conferred by double resistance-associated substitutions was approximately equal to the product of that for the individual substitutions. Cross-resistance is not expected between boceprevir and interferons, or boceprevir and ribavirin.
Therefore, two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with boceprevir and concomitant ribavirin [see Warnings and Precautions].
Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. The treatment discontinuation rate due to anemia was similar in subjects randomized to receive ribavirin dose reduction compared to subjects randomized to receive ESA (2% in each group). Complete blood counts should be obtained at Treatment Weeks 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. For the purposes of assessing Response-Guided Therapy milestones, a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result. The population studied had a mean age of 49 years (3% of subjects were >65 years of age), 39% were female, 82% were white and 15% were black.
Only anemia and fatigue were reported as events that led to discontinuation in >1% of subjects in any arm.
The predominant diastereomer, SCH534128, is pharmacologically active and the other diastereomer is inactive. Subjects with mild hepatic impairment had similar SCH534128 exposure as subjects with normal hepatic function.
No dosage adjustment of boceprevir is required in patients with any degree of renal impairment. Cialis, another of the dominant erectile dysfunction drugs, has also become a household word. People aren’t all alike, and the treatment that is successful for one man might not be ideal for another. The least amount of data is available on the low-dose version of Cialis, although one small study showed that efficacy varied greatly depending on the level of erectile dysfunction (73%-82% efficacy in patients with mild erectile dysfunction, 56%-61% efficacy in men with moderate erectile dysfunction, and 27%-33% efficacy in men with severe erectile dysfunction).
In some cases, men taking Viagra and Cialis experience temporary vision problems – mainly a blue tinge to the vision or difficulty in distinguishing the colors blue and green. Nitrates are also contained in street drugs called “poppers” and in some air fresheners which are inhaled to enhance sexual pleasure. The red ink contains shellac and red iron oxide, while the yellow ink consists of shellac, titanium dioxide, povidone and D&C Yellow #10 Aluminum Lake.
In cell-based protease assays, an NS3 Q80K substitution did not reduce HCV sensitivity to boceprevir.
Clear patterns of boceprevir treatment-emergent substitutions in the NS3 helicase domain or NS4A coding regions of the HCV genome were not observed. One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. The transfusion rate was 4% in subjects randomized to receive ribavirin dose reduction and 2% in subjects randomized to receive ESA. Decreases in neutrophil counts may require dose reduction or discontinuation of peginterferon alfa and ribavirin.
Therefore, boceprevir may be taken without regard to either meal type or timing of the meal. The image of a man and a woman relaxing in separate bathtubs has become as universally recognized as the McDonalds golden arches. An extremely rare but very serious side effect associated with both Viagra and Cialis is priapism, an abnormally long and painful erection.
Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated.
If peginterferon alfa and ribavirin are permanently discontinued, then boceprevir must also be discontinued [see Dosage and Administration]. No dosage adjustment of boceprevir is recommended for patients with hepatic impairment [see Use in Specific Populations]. With this knowledge, you and your health care provider should be able to make an informed decision about which drug is right for you. Routine monthly pregnancy tests must be performed during this time [see Contraindications and Drug Interactions]. See peginterferon alfa Package Insert for contraindication in patients with hepatic decompensation.



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