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that remain at selected time intervals after the time of calibration are shown in Table 3 Table 3 Physical Decay Chart Gallium Ga 67 Half-Life Hours Calibration Time Hours Fraction Remaining Hours Fraction Remaining 000 72 3d 6 78 12 84 18 90 24 1d 96 4d 30 108 36 120 5d 42 132 48 2d 144 6d 54 156 60 168 7d 66 Gallium - Clinical Pharmacology Gallium Citrate Ga 67 with no carrier added has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of infection The mechanism of concentration is unknown but investigational studies have shown that Gallium Ga 67 accumulates in lysosomes and is bound to a soluble intracellular protein It has been reported in the scientific literature that following intravenous injection the highest tissue concentration of Gallium Ga 67 - other than tumors and sites of infection - is the renal cortex After the first day the maximum concentration shifts to bone and lymph nodes and after the first week to liver and spleen Gallium Ga 67 is excreted relatively slowly from the body The average whole body retention is 65 percent after seven days with 26 percent having been excreted in the urine and 9 percent in the stools Indications and Usage for Gallium Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin s disease lymphoma and bronchogenic carcinoma Positive Gallium Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions Contraindications None Warnings None known Precautions General A thorough knowledge of the normal distribution of intravenously administered Gallium Citrate Ga 67 Injection is essential in order to accurately interpret pathologic states The finding of an abnormal Gallium Ga 67 concentration usually implies the existence of underlying pathology but further diagnostic studies should be done to distinguish benign from malignant lesions Gallium Citrate Ga 67 Injection is intended for use as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection Certain pathologic conditions may yield up to 40 percent false negative Gallium Ga 67 studies Therefore a negative study cannot be definitely interpreted as ruling out the presence of disease Lymphocytic lymphoma frequently does not accumulate Gallium Ga 67 sufficiently for unequivocal imaging and the use of Gallium with this histologic type of lymphoma is not recommended at this time Gallium Ga 67 localization cannot differentiate between tumor and acute inflammation and other diagnostic studies must be added to define the underlying pathology As in the use of any radioactive material care should be taken to minimize radiation exposure to the patient consistent with proper

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follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 25 mg Supine -0 7 Standing -0 8 Figure 5 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured immediately pre-dose and at 45 minutes and 5 5 6 and 8 hours after Viagra or matching placebo Outliers were defined as subjects with a standing systolic blood pressure of 85 mmHg or a decrease from baseline in standing systolic blood pressure of 30 mmHg at one or more timepoints There were no subjects treated with Viagra 25 mg who had a standing SBP 85mmHg There were three subjects with a decrease from baseline in standing systolic BP 30mmHg following Viagra 25 mg one subject with a decrease from baseline in standing systolic BP 30 mmHg following placebo and two subjects with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra and placebo No severe adverse events potentially related to blood pressure effects were reported in this group Of the four subjects who received Viagra 100 mg in the first part of this study a severe adverse event related to blood pressure effect was reported in one patient postural hypotension that began 35 minutes after dosing with Viagra with symptoms lasting for 8 hours and mild adverse events potentially related to blood pressure effects were reported in two others dizziness headache and fatigue at 1 hour after dosing and dizziness lightheadedness and nausea at 4 hours after dosing There were no reports of syncope among these patients For these four subjects the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were mmHg and mmHg respectively Two of these subjects had a standing SBP 85mmHg Both of these subjects were protocol violators one due to a low baseline standing SBP and the other due to baseline orthostatic hypotension In the second study a single oral dose of Viagra 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH Following at least 14 consecutive days of doxazosin Viagra 50mg or matching placebo was administered simultaneously with doxazosin 4 mg 17 subjects or with doxazosin 8 mg 3 subjects The mean subject age in this study was years Twenty subjects received Viagra 50 mg but only 19 subjects received matching placebo One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with Viagra 50 mg This patient had been taking minoxidil a potent vasodilator during the study For the 19 subjects who received both Viagra and matching placebo the placebo-subtracted mean maximum decreases from baseline 95 CI in systolic blood pressure

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were as follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 50 mg 95 CI Supine 5 68 Standing 7 90 Figure 6 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of Viagra at the same times as those specified for the first doxazosin study There were two subjects who had a standing SBP of 85 mmHg In these two subjects hypotension was reported as a moderately severe adverse event beginning at approximately 1 hour after administration of Viagra 50 mg and resolving after approximately hours There was one subject with a decrease from baseline in standing systolic BP 30mmHg following Viagra 50 mg and one subject with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra 50 mg and placebo There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study In the third study a single oral dose of Viagra 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH In dose period 1 subjects were administered open-label doxazosin and a single dose of Viagra 50 mg simultaneously after at least 14 consecutive days of doxazosin If a subject did not successfully complete this first dosing period he was discontinued from the study Subjects who had successfully completed the previous doxazosin interaction study using Viagra 50 mg including no significant hemodynamic adverse events were allowed to skip dose period 1 Treatment with doxazosin continued for at least 7 days after dose period 1 Thereafter Viagra 100mg or matching placebo was administered simultaneously with doxazosin 4 mg 14 subjects or doxazosin 8 mg 6 subjects in standard crossover fashion The mean subject age in this study was years Twenty-five subjects were screened Two were discontinued after study period 1 one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label Viagra 50 mg Of the twenty subjects who were ultimately assigned to treatment a total of 13 subjects successfully completed dose period 1 and seven had successfully completed the previous doxazosin study using Viagra 50 mg For the 20 subjects who received Viagra 100 mg and matching placebo the placebo-subtracted mean maximum decreases from baseline 95 CI in systolic blood pressure were as follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 100 mg Supine 4 1 Standing -1 3 Figure 7 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of Viagra at the same times as those specified for the previous doxazosin studies There were three subjects who had a standing SBP of 85 mmHg All three were taking Viagra 100 mg and all three reported mild adverse events at the time of reductions in standing SBP including vasodilation and lightheadedness There were four subjects with a decrease from baseline in standing systolic BP 30mmHg following Viagra 100 mg one subject with a decrease from baseline in standing systolic BP 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra and placebo While there were no severe adverse events potentially related to blood pressure reported in this study one subject reported moderate vasodilatation after both Viagra 50 mg and 100 mg There were no episodes of syncope reported in this study When Viagra 100 mg oral was coadministered with amlodipine 5 mg or 10 mg oral to hypertensive patients the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic No significant interactions were shown with tolbutamide 250 mg or warfarin 40 mg both of which are metabolized by CYP2C9 Viagra 50 mg did not potentiate the increase in bleeding time caused by aspirin 150 mg Viagra 50 mg did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of In a study of healthy male volunteers sildenafil 100 mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors saquinavir and ritonavir both of which are CYP3A4 substrates Sildenafil at steady state 80 mg t i d resulted in a 50 increase in AUC and a 42 increase in Cmax of bosentan 125 mg b i d Carcinogenesis Mutagenesis Impairment of Fertility Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure AUCs for unbound sildenafil and its major metabolite of 29- and 42-times for male and female rats respectively the exposures observed in human males given the Maximum Recommended Human Dose MRHD of 100 mg Sildenafil was not carcinogenic when administered to mice for months at dosages up to the Maximum Tolerated Dose MTD of 10 mg kg day approximately times the MRHD on a mg m2 basis Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity There was no impairment of fertility in rats given sildenafil up to 60 mg kg day for 36 days to females and 102 days to males a dose producing an AUC value of more than 25 times the human male AUC There was no effect on sperm motility or morphology after single 100 mg oral doses of Viagra in healthy volunteers Pregnancy Nursing Mothers and Pediatric Use Viagra is not indicated for use in newborns children or women Pregnancy Category B No evidence of teratogenicity embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mg kg day during organogenesis

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