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Label: GEMFIBROZIL tablet
- NDC Code(s): 50090-6913-0, 50090-6913-2, 50090-6913-3, 50090-6913-4
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 16714-101
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated December 18, 2023
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Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil USP. Each tablet also contains colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch (botanical source: maize), sodium starch glycolate and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula:
The empirical formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol, and in chloroform. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.
Gemfibrozil is a lipid regulating agent which decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high density lipoprotein (HDL) cholesterol. While modest decreases in total and low density lipoprotein (LDL) cholesterol may be observed with gemfibrozil therapy, treatment of patients with elevated triglycerides due to Type IV hyperlipoproteinemia often results in a rise in LDL-cholesterol. LDL-cholesterol levels in Type IIb patients with elevations of both serum LDL-cholesterol and triglycerides are, in general, minimally affected by gemfibrozil treatment; however, gemfibrozil usually raises HDL-cholesterol significantly in this group. Gemfibrozil increases levels of high density lipoprotein (HDL) subfractions HDL2 and HDL3, as well as apolipoproteins AI and AII. Epidemiological studies have shown that both low HDL-cholesterol and high LDL-cholesterol are independent risk factors for coronary heart disease.
In the primary prevention component of the Helsinki Heart Study, in which 4081 male patients between the ages of 40 and 55 were studied in a randomized, double-blind, placebo-controlled fashion, gemfibrozil therapy was associated with significant reductions in total plasma triglycerides and a significant increase in high density lipoprotein cholesterol. Moderate reductions in total plasma cholesterol and low density lipoprotein cholesterol were observed for the gemfibrozil treatment group as a whole, but the lipid response was heterogeneous, especially among different Fredrickson types. The study involved subjects with serum non-HDL-cholesterol of over 200 mg/dL and no previous history of coronary heart disease. Over the five-year study period, the gemfibrozil group experienced a 1.4 % absolute (34 % relative) reduction in the rate of serious coronary events (sudden cardiac deaths plus fatal and nonfatal myocardial infarctions) compared to placebo, p=0.04 (see Table I). There was a 37 % relative reduction in the rate of nonfatal myocardial infarction compared to placebo, equivalent to a treatment-related difference of 13.1 events per thousand persons. Deaths from any cause during the double-blind portion of the study totaled 44 (2.2%) in the gemfibrozil randomization group and 43 (2.1%) in the placebo group.
Table I Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids1 in the Helsinki Heart Study, Years 0-52
Incidence of Events4All Patients
1 lipid values in mg/dL at baseline
2 P = placebo group; G = Gemfibrozil group
3 difference in rates between placebo and Gemfibrozil groups
4 fatal and nonfatal myocardial infarctions plus sudden cardiac deaths (events per 1000 patients over 5 years)
Among Fredrickson types, during the 5-year double-blind portion of the primary prevention component of the Helsinki Heart Study, the greatest reduction in the incidence of serious coronary events occurred in Type IIb patients who had elevations of both LDL-cholesterol and total plasma triglycerides. This subgroup of Type IIb gemfibrozil group patients had a lower mean HDL-cholesterol level at baseline than the Type IIa subgroup that had elevations of LDL-cholesterol and normal plasma triglycerides. The mean increase in HDL-cholesterol among the Type IIb patients in this study was 12.6% compared to placebo. The mean change in LDL-cholesterol among Type IIb patients was -4.1% with gemfibrozil compared to a rise of 3.9% in the placebo subgroup. The Type IIb subjects in the Helsinki Heart Study had 26 fewer coronary events per thousand persons over five years in the gemfibrozil group compared to placebo. The difference in coronary events was substantially greater between gemfibrozil and placebo for that subgroup of patients with the triad of LDL-cholesterol >175 mg/dL (>4.5 mmol), triglycerides >200 mg/dL (>2.2 mmol), and HDL-cholesterol <35 mg/dL (<0.90 mmol) (see Table I).
Further information is available from a 3.5 year (8.5 year cumulative) follow-up of all subjects who had participated in the Helsinki Heart Study. At the completion of the Helsinki Heart Study, subjects could choose to start, stop, or continue to receive gemfibrozil; without knowledge of their own lipid values or double-blind treatment, 60% of patients originally randomized to placebo began therapy with gemfibrozil and 60% of patients originally randomized to gemfibrozil continued medication. After approximately 6.5 years following randomization, all patients were informed of their original treatment group and lipid values during the five years of the double-blind treatment. After further elective changes in gemfibrozil treatment status, 61% of patients in the group originally randomized to gemfibrozil were taking drug; in the group originally randomized to placebo, 65% were taking gemfibrozil. The event rate per 1000 occurring during the open-label follow-up period is detailed in Table II.
Table II Cardiac Events and All-Cause Mortality (events per 1000 patients) Occurring During the 3.5 Year Open-Label Follow-up to the Helsinki Heart Study1
Group: PDrop
N = 1283GDrop
N = 1207Cardiac
All-Cause Mortality
1The six open-label groups are designated first by the original randomization (P = placebo, G = Gemfibrozil) and then by the drug taken in the follow-up period (N = Attend clinic but took no drug, G = Gemfibrozil, Drop = No attendance at clinic during open-label).
Cumulative mortality through 8.5 years showed a 20% relative excess of deaths in the group originally randomized to gemfibrozil versus the originally randomized placebo group and a 20% relative decrease in cardiac events in the group originally randomized to gemfibrozil versus the originally randomized placebo group (see Table III). This analysis of the originally randomized "intent-to-treat" population neglects the possible complicating effects of treatment switching during the open-label phase. Adjustment of hazard ratios, taking into account open-label treatment status from years 6.5 to 8.5, could change the reported hazard ratios for mortality toward unity.
Table III Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.51
Event Gemfibrozil tablets at
Study StartPlacebo at
Study StartGemfibrozil tablets: Placebo
Hazard Ratio2Cl Hazard
Ratio3Cardiac Events4
0.62 to 1.03
Cardiac Deaths
0.63 to 1.54
0.95 to 2.05
0. 90 to 1.61
1Intention-to-Treat Analysis of originally randomized patients neglecting the open-label treatment switches and exposure to study conditions.
2 Hazard ratio for risk event in the group originally randomized to gemfibrozil tablets compared to the group originally randomized to placebo neglecting open-label treatment switch and exposure to study conditions.
3 95% confidence intervals of gemfibrozil tablets:placebo group hazard ratio
4 Fatal and non-fatal myocardial infarctions plus sudden cardiac deaths over the 8.5 year period.
It is not clear to what extent the findings of the primary prevention component of the Helsinki Heart Study can be extrapolated to other segments of the dyslipidemic population not studied (such as women, younger or older males, or those with lipid abnormalities limited solely to HDL-cholesterol) or to other lipid-altering drugs.The secondary prevention component of the Helsinki Heart Study was conducted over five years in parallel and at the same centers in Finland in 628 middle-aged males excluded from the primary prevention component of the Helsinki Heart Study because of a history of angina, myocardial infarction, or unexplained ECG changes. The primary efficacy endpoint of the study was cardiac events (the sum of fatal and non-fatal myocardial infarctions and sudden cardiac deaths). The hazard ratio (gemfibrozil : placebo) for cardiac events was 1.47 (95% confidence limits 0.88 to 2.48, p=0.14). Of the 35 patients in the gemfibrozil group who experienced cardiac events, 12 patients suffered events after discontinuation from the study. Of the 24 patients in the placebo group with cardiac events, 4 patients suffered events after discontinuation from the study. There were 17 cardiac deaths in the gemfibrozil group and 8 in the placebo group (hazard ratio 2.18; 95% confidence limits 0.94 to 5.05, p=0.06). Ten of these deaths in the gemfibrozil group and 3 in the placebo group occurred after discontinuation from therapy. In this study of patients with known or suspected coronary heart disease, no benefit from gemfibrozil treatment was observed in reducing cardiac events or cardiac deaths. Thus, gemfibrozil has shown benefit only in selected dyslipidemic patients without suspected or established coronary heart disease. Even in patients with coronary heart disease and the triad of elevated LDL-cholesterol, elevated triglycerides, plus low HDL-cholesterol, the possible effect of gemfibrozil on coronary events has not been adequately studied.
No efficacy in the patients with established coronary heart disease was observed during the Coronary Drug Project with the chemically and pharmacologically related drug, clofibrate. The Coronary Drug Project was a 6-year randomized, double-blind study involving 1000 clofibrate, 1000 nicotinic acid, and 3000 placebo patients with known coronary heart disease. A clinically and statistically significant reduction in myocardial infarctions was seen in the concurrent nicotinic acid group compared to placebo; no reduction was seen with clofibrate.
The mechanism of action of gemfibrozil has not been definitely established. In man, gemfibrozil has been shown to inhibit peripheral lipolysis and to decrease the hepatic extraction of free fatty acids, thus reducing hepatic triglyceride production. Gemfibrozil inhibits synthesis and increases clearance of VLDL carrier apolipoprotein B, leading to a decrease in VLDL production.
Animal studies suggest that gemfibrozil may, in addition to elevating HDL-cholesterol, reduce incorporation of long-chain fatty acids into newly formed triglycerides, accelerate turnover and removal of cholesterol from the liver, and increase excretion of cholesterol in the feces. Gemfibrozil is well absorbed from the gastrointestinal tract after oral administration. Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses.
Gemfibrozil is completely absorbed after oral administration of gemfibrozil tablets, reaching peak plasma concentrations 1 to 2 hours after dosing. Gemfibrozil pharmacokinetics are affected by the timing of meals relative to time of dosing. In one study (ref.4), both the rate and extent of absorption of the drug were significantly increased when administered 0.5 hour before meals. Average AUC was reduced by 14 to 44% when gemfibrozil was administered after meals compared to 0.5 hour before meals. In a subsequent study, rate of absorption of gemfibrozil was maximum when administered 0.5 hour before meals with the Cmax 50 to 60% greater than when given either with meals or fasting. In this study, there were no significant effects on AUC of timing of dose relative to meals (see DOSAGE AND ADMINISTRATION).
Gemfibrozil mainly undergoes oxidation of a ring methyl group to successively form a hydroxymethyl and a carboxyl metabolite. Approximately seventy percent of the administered human dose is excreted in the urine, mostly as the glucuronide conjugate, with less than 2% excreted as unchanged gemfibrozil. Six percent of the dose is accounted for in the feces. Gemfibrozil is highly bound to plasma proteins and there is potential for displacement interactions with other drugs (see PRECAUTIONS). -
Gemfibrozil Tablets are indicated as adjunctive therapy to diet for:
- Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
- Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL- CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.
In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL- cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
- Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
- Preexisting gallbladder disease (see WARNINGS).
- Hypersensitivity to gemfibrozil.
- Combination therapy of gemfibrozil with simvastatin (see WARNINGSand PRECAUTIONS).
- Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS).
- Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS).
- Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS).
1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality between the clofibrate-treated subjects and 3000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond. There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed.
Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the gemfibrozil and placebo groups is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up (see CLINICAL PHARMACOLOGY). Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil primarily due to cancer deaths observed during the open-label extension.
During the five year primary prevention component of the Helsinki Heart Study, mortality from any cause was 44 (2.2%) in the gemfibrozil group and 43 (2.1%) in the placebo group; including the 3.5 year follow-up period since the trial was completed, cumulative mortality from any cause was 101 (4.9%) in the gemfibrozil group and 83 (4.1%) in the group originally randomized to placebo (hazard ratio 1:20 in favor of placebo). Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the gemfibrozil and placebo groups at Year-5 or at Year-8.5 is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up. Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil at the 8.5 year follow-up (65 gemfibrozil versus 45 placebo noncoronary deaths).
The incidence of cancer (excluding basal cell carcinoma) discovered during the trial and in the 3.5 years after the trial was completed was 51 (2.5%) in both originally randomized groups. In addition, there were 16 basal cell carcinomas in the group originally randomized to gemfibrozil and 9 in the group originally randomized to placebo (p=0.22). There were 30 (1.5%) deaths attributed to cancer in the group originally randomized to gemfibrozil and 18 (0.9%) in the group originally randomized to placebo (p=0.11). Adverse outcomes, including coronary events, were higher in gemfibrozil patients in a corresponding study in men with a history of known or suspected coronary heart disease in the secondary prevention component of the Helsinki Heart Study (see CLINICAL PHARMACOLOGY).
A comparative carcinogenicity study was also done in rats comparing three drugs in this class: fenofibrate (10 and 60 mg/kg; 0.3 and 1.6 times the human dose, respectively), clofibrate (400 mg/kg; 1.6 times the human dose, respectively), and gemfibrozil (250 mg/kg; 1.7 times the human dose, respectively). Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with gemfibrozil while testicular interstitial cell (Leydig cell) tumors were increased in males on all three drugs.
2. A gallstone prevalence substudy of 450 Helsinki Heart Study participants showed a trend toward a greater prevalence of gallstones during the study within the gemfibrozil treatment group (7.5% versus 4.9% for the placebo group, a 55% excess for the gemfibrozil group). A trend toward a greater incidence of gallbladder surgery was observed for the gemfibrozil group (17 versus 11 subjects, a 54% excess). This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate. Both clofibrate and gemfibrozil may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Gemfibrozil therapy should be discontinued if gallstones are found. Cases of cholelithiasis have been reported with gemfibrozil therapy.
3. Since a reduction of mortality from coronary heart disease has not been demonstrated and because liver and interstitial cell testicular tumors were increased in rats, gemfibrozil should be administered only to those patients described in the INDICATIONS AND USAGE section. If a significant serum lipid response is not obtained, gemfibrozil should be discontinued.
4. Concomitant Anticoagulants-Caution should be exercised when warfarin is given in conjunction with gemfibrozil. The dosage of warfarin should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been definitely determined that the prothrombin level has stabilized.
5. The concomitant administration of gemfibrozil with simvastatin is contraindicated (see CONTRAINDICATIONS and PRECAUTIONS). Concomitant therapy with gemfibrozil and an HMG-CoA reductase inhibitor is associated with an increased risk of skeletal muscle toxicity manifested as rhabdomyolysis, markedly elevated creatine kinase (CPK) levels, and myoglobinuria, leading in a high proportion of cases to acute renal failure and death. IN PATIENTS WHO HAVE HAD AN UNSATISFACTORY LIPID RESPONSE TO EITHER DRUG ALONE, THE BENEFIT OF COMBINED THERAPY WITH GEMFIBROZIL AND an HMG-CoA REDUCTASE INHIBITORS DOES NOT OUTWEIGH THE RISKS OF SEVERE MYOPATHY, RHABDOMYOLYSIS, AND ACUTE RENAL FAILURE (see PRECAUTIONS, Drug Interactions). The use of fibrates alone, including gemfibrozil, may occasionally be associated with myositis. Patients receiving gemfibrozil and complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myositis, including serum creatine-kinase level determination. If myositis is suspected or diagnosed, gemfibrozil therapy should be withdrawn.
6. Cataracts - Subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3%, of male rats treated with gemfibrozil at 10 times the human dose.
7. CYP2C8 substrates - Gemfibrozil, a strong inhibitor of CYP2C8, may increase exposure of CYP2C8 substrates when administered concomitantly (see PRECAUTIONS, Drug Interactions).
8. OATP1B1 substrates – Gemfibrozil is an inhibitor of organic anion-transporter polyprotein (OATP) 1B1 and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see PRECAUTIONS, Drug Interactions). Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see CONTRAINDICATIONS). -
1. Initial Therapy
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal. Before instituting gemfibrozil therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities.
2. Continued Therapy
Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy.
3. Drug Interactions
(A) HMG-CoA Reductase Inhibitors:
The concomitant administration of gemfibrozil with simvastatin is contraindicated ( see CONTRAINDICATIONS and WARNINGS). Avoid concomitant use of gemfibrozil with rosuvastatin. If concomitant use cannot be avoided, initiate rosuvastatin at 5 mg once daily. The dose of rosuvastatin should not exceed 10 mg once daily. The risk of myopathy and rhabdomyolysis is increased with combined gemfibrozil and HMG-CoA reductase inhibitor therapy. Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as three weeks after initiation of combined therapy or after several months (see WARNINGS). There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage.
(B) Anti-coagulants:
(C) CYP2C8 Substrates:
Gemfibrozil is a strong inhibitor of CYP2C8 and may increase exposure of drugs mainly metabolized by CYP2C8 (e.g., dabrafenib, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone). Therefore, dosing reduction of drugs that are mainly metabolized by CYP2C8 enzyme may be required when gemfibrozil is used concomitantly (see WARNINGS).
Repaglinide: In healthy volunteers, co-administration with gemfibrozil (600 mg twice daily for 3 days) resulted in an 8.1-fold (range 5.5- to 15.0- fold) higher repaglinide AUC and a 28.6-fold (range 18.5- to 80.1-fold) higher repaglinide plasma concentration 7 hours after the dose. In the same study, gemfibrozil (600 mg twice daily for 3 days) + itraconazole (200 mg in the morning and 100 mg in the evening at Day 1, then 100 mg twice daily at Day 2-3) resulted in a 19.4- (range 12.9- to 24.7-fold) higher repaglinide AUC and a 70.4-fold (range 42.9- to 119.2-fold) higher repaglinide plasma concentration 7 hours after the dose. In addition, gemfibrozil alone or gemfibrozil + itraconazole prolonged the hypoglycemic effects of repaglinide. Co-administration of gemfibrozil and repaglinide increases the risk of severe hypoglycemia and is contraindicated (see CONTRAINDICATIONS).
Dasabuvir: Co-administration of gemfibrozil with dasabuvir increased dasabuvir AUC and Cmax (ratios: 11.3 and 2.01, respectively) due to CYP2C8 inhibition. Increased dasabuvir exposure may increase the risk of QT prolongation, therefore, coadministration of gemfibrozil with dasabuvir is contraindicated (see CONTRAINDICATIONS).
Selexipag: Co-administration of gemfibrozil with selexipag doubled exposure to selexipag and increased exposure to the active metabolite by approximately 11-fold. Concomitant administration of gemfibrozil with selexipag is contraindicated (see CONTRAINDICATIONS).
Enzalutamide:In healthy volunteers given a single 160 mg dose of enzalutamide after gemfibrozil 600 mg twice daily, the AUC of enzalutamide plus active metabolite (N-desmethyl enzalutamide) was increased by 2.2 fold and corresponding Cmax was decreased by 16%. Increased enzalutamide exposure may increase the risk of seizures. If co-administration is considered necessary, the dose of enzalutamide should be reduced (see WARNINGS).
(D) OATP1B1 substrates:
Gemfibrozil is an inhibitor of OATP1B1 transporter and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see WARNINGS). Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see CONTRAINDICATIONS).
(E) In vitro studies of CYP enzymes, UGTA enzymes and OATP1B1 transporter:
In vitro studies have shown that gemfibrozil is an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, OATP1B1, and UDP-glucuronosyltransferase (UGT) 1A1 and 1A3 (see WARNINGS).
(F) Bile Acid-Binding Resins:
Gemfibrozil AUC was reduced by 30% when gemfibrozil was given (600 mg) simultaneously with resin-granule drugs such as colestipol (5 g). Administration of the drugs two hours or more apart is recommended because gemfibrozil exposure was not significantly affected when it was administered two hours apart from colestipol.
(G) Colchicine
Myopathy, including rhabdomyolysis, has been reported with chronic administration of colchicine at therapeutic doses. Concomitant use of gemfibrozil may potentiate the development of myopathy. Patients with renal dysfunction and elderly patients are at increased risk. Caution should be excercised when prescribing gemfibrozil with colchicine, especially in elderly patients or patients with renal dysfunction.
4. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies have been conducted in rats at 0.2 and 1.3 times the human exposure (based on AUC). The incidence of benign liver nodules and liver carcinomas was significantly increased in high dose male rats. The incidence of liver carcinomas increased also in low dose males, but this increase was not statistically significant (p=0.1). Male rats had a dose-related and statistically significant increase of benign Leydig cell tumors. The higher dose female rats had a significant increase in the combined incidence of benign and malignant liver neoplasms.
Long-term studies have been conducted in mice at 0.1 and 0.7 times the human exposure (based on AUC). There were no statistically significant differences from controls in the incidence of liver tumors, but the doses tested were lower than those shown to be carcinogenic with other fibrates.
Electron microscopy studies have demonstrated a florid hepatic peroxisome proliferation following gemfibrozil administration to the male rat. An adequate study to test for peroxisome proliferation has not been done in humans but changes in peroxisome morphology have been observed. Peroxisome proliferation has been shown to occur in humans with either of two other drugs of the fibrate class when liver biopsies were compared before and after treatment in the same individual.Administration of approximately 2 times the human dose (based on surface area) to male rats for 10 weeks resulted in a dose-related decrease of fertility. Subsequent studies demonstrated that this effect was reversed after a drug-free period of about eight weeks, and it was not transmitted to the offspring.
5. Pregnancy
Gemfibrozil has been shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area). There are no adequate and well-controlled studies in pregnant women. Gemfibrozil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Administration of gemfibrozil to female rats at 2 times the human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate, an increase in stillborns and a slight reduction in pup weight during lactation. There were also dose-related increased skeletal variations. Anophthalmia occurred, but rarely.
Administration of 0.6 and 2 times the human dose (based on surface area) of gemfibrozil to female rats from gestation day 15 through weaning caused dose-related decreases in birth weight and suppressions of pup growth during lactation.
Administration of 1 and 3 times the human dose (based on surface area) of gemfibrozil to female rabbits during organogenesis caused a dose-related decrease in litter size and, at the high dose, an increased incidence of parietal bone variations.
6. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for gemfibrozil in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
7. Hematologic Changes
Mild hemoglobin, hematocrit, and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil therapy. However, these levels stabilize during long-term administration. Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have been reported. Therefore, periodic blood counts are recommended during the first 12 months of gemfibrozil administration.
8. Liver Function
Abnormal liver function tests have been observed occasionally during gemfibrozil administration, including elevations of AST, ALT, LDH, bilirubin, and alkaline phosphatase. These are usually reversible when gemfibrozil is discontinued. Therefore, periodic liver function studies are recommended and gemfibrozil therapy should be terminated if abnormalities persist.
9. Kidney Function
There have been reports of worsening renal insufficiency upon the addition of gemfibrozil therapy in individuals with baseline plasma creatinine >2.0 mg/dL. In such patients, the use of alternative therapy should be considered against the risks and benefits of a lower dose of gemfibrozil.
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group:
Frequency in percent of subjects
Gastrointestinal reactions
Abdominal pain
Acute appendicitis
(histologically confirmed in most
cases where data were available)
Atrial fibrillation
Adverse events reported by more than 1% of subjects, but without a significant difference between groups:
Gallbladder surgery was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil versus 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS).
Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established:
weight loss
cholestatic jaundice
Central Nervous System:
peripheral neuritis
decreased libido
blurred vision
retinal edema
decreased male fertility
renal dysfunction
painful extremities
rhabdomyolysis (see
WARNINGS and
Drug Interactions
under PRECAUTIONS)
Clinical Laboratory:
increased creatine phosphokinase
positive antinuclear antibody
increased bilirubin
increased liver transaminases
increased alkaline phosphatase
bone marrow hypoplasia
laryngeal edema
Lupus-like syndrome
exfoliative dermatitis
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS).
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.
- gemfibrozil
gemfibrozil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6913(NDC:16714-101) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3) GEMFIBROZIL 600 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (Off-white) Score 2 pieces Shape OVAL (elliptical, biconvex) Size 19mm Flavor Imprint Code N111 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-6913-0 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2023 2 NDC:50090-6913-4 180 in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2023 3 NDC:50090-6913-2 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2023 4 NDC:50090-6913-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079072 12/20/2010 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-6913) , REPACK(50090-6913)


text:
This open source icon is named "distraction" and is licensed under the open source CC BY 3.0 license. It's available to be downloaded in SVG and PNG formats (available in 256, 512, 1024 and 2048 PNG sizes).
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subset: commoncrawl


text:
BHR.PRB Advanced Charting
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text:
Despite what has been called a status quo election, life is far from static on Capitol Hill. The 113th Congress will bring with it generational and some historic changes, including the first all-female delegation for a state (New Hampshire), and the fewest number of military veterans in the Senate and House since World War II.
And, as The New York Times notes, "The makeup of Congress has not been this volatile in 20 years, a result of shifting political tides and redistricting. The number of House seats that changed hands in 2010 and this year — 96 and 84, respectively — is the highest since the early 1990s, a period of turnover not seen in nearly half a century."
Some incoming lawmakers have previous federal electoral experience. But others are brand new to the fray of Capitol Hill.
Copyright 2021 NPR. To see more, visit https://www.npr.org.


text:
Discover a variety of UK dating sites tailored to meet your needs. Whether you're searching for singles and interested in mature dating, senior dating, or exploring more options like Plenty of Fish Dating, we have something for everyone.
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Find your perfect match today on our comprehensive platform, designed to connect singles across the world.
To maximise your chances of finding success, we've enhanced the members' area of Single Over 70s to include members with all interests and characteristics. You can still use our search settings to find exactly who you're looking for.


text:
Braker bar & extension included
Welcome to our 2023 PLA Year-End Online Equipment Auction! This auction features items from area farmers, estates, local government and more!
Items are sorted into SALE ORDER. This auction features a "soft close" where an item begins closing every 30 seconds. Any item receiving a bid in the final minute, resets the countdown 45 seconds and continues to reset each time there is a bid. Due to extended bidding, there will be multiple lots closing at the same time. We encourage bidders to place "MAX BIDS" on the items you're most interested in - this way you don't have to worry about missing an item.
Our next consignment auction is June 5, 2024. Contact us early to consign!
Remember...Only at Auction!
Terms & Conditions:
This is an ONLINE ONLY internet auction for the sale of items owned by various consignors. All items sold "AS-IS" without warranty or guarantee of any kind. Please inspect photos and attend inspection date. For questions contact Peterson Land & Auction LLC 605-234-4214.
Preview and Removal Location: Items will be 310 Sorensen, Drive, Chamberlain, SD. Preview is by APPOINTMENT ONLY. See tab for Removal dates & times.
Buyers Premium: 5% (Five Percent) $1000 maximum per item
Payment: Winning bids will be paid by cash, check, wire transfer within 48 hours of auction close. Credit Cards are accepted with an additional 3.5% convenience fee. Any invoices (under $1000) not settled for by December 15, 2023 at 5 pm will be automatically charged to the credit card used at registration unless prior arrangements are made.
Shipping: NO SHIPPING. All items are PICK UP ONLY at the respective item location(s).
Peterson Land & Auction LLC ONLINE AUCTIONS Feature "A MAX BID" Option as well as a "SOFT CLOSE".
"A MAX BID" may be placed on any item and the computer will bid on your behalf, thus eliminating the need to continually watch your bids. This option is highly recommended so you do not miss out on an item you are bidding on. In the event you do not use the MAX BID feature and you are out bid you will be notified via e-mail or text that you have been outbid and will have the opportunity to raise your bid.
"THE SOFT CLOSE" feature means any bid received in the final minutes of the auction will automatically extend bidding on that particular item or lot by 90 seconds to allow another bidder the opportunity to raise their bid.
GENERAL TERMS: The auction will be conducted by Peterson Land & Auction LLC on behalf of the owners of the property, referred to as the Seller. Auctioneer is not responsible for the acts or representations of Seller. The auction shall be governed by the terms set forth herein (the agreement), and any additional terms and conditions that are posted concerning the specific property. The Agreement constitutes a valid, binding contract between individuals participating in the auction with the intent to purchase property, referred to as the Bidder or Buyer, and Seller/Auctioneer. The term Bidder or Buyer shall include, but not limited to, the individual or the company represented by the individual and any and all of its agents, employees, representatives, officers, and directors. Auctioneer is not responsible for statements made by the Bidder, Buyer, or other parties. Auctioneer reserves the right to periodically change the terms and conditions of the Agreement, which shall be effective immediately upon posting. It is the Bidders responsibility to review any and all changes made to these terms and conditions prior to bidding on property. The act of submitting a bid shall constitute Bidder acceptance of each and every term and condition contained herein, any additional terms and conditions posted with the property, and any changes made within the full agreement. All persons attending, inspecting or removing property, assume all risks whatsoever of damage or loss to person and property and specifically release the Auctioneer from all liability. Auctioneer is not liable by reason of any defect in, or condition of, the property or the premises on which the preview/sale is held. Auctioneer is released for any claims to actual damage to the property sold and/or consequential damages that may result from the sale of defective property.
DISCLOSURES/NO WARRANTY: There is no warranty offered, expressed or implied, by Peterson Land & Auction LLC or Sellers for any property. All property is sold AS-IS, WHERE-IS, and with all faults and defects therein. All information provided is believed to be correct but NO warranty as such is either expressed or implied, including but not limited to the merchantability or fitness for a particular purpose. Bidder is solely responsible to determine condition, age, authenticity, value or any other determinative factor. Bidder inspection of the property prior to submitting a bid is strongly recommended. ALL SALES ARE FINAL!!
Auctioneer reserves the right to add or withdraw property from the auction, and/or regroup items. Auctioneer reserves the right to sell property absolute or with reserve, at Sellers discretion. The Seller DOES have the right to make the final bid and the Auctioneer DOES have the right to bid on behalf of the Seller. The auctioneer reserves the right to open the bid as the result of a tie bid or discrepancies in the bid.
Buyer assumes full responsibility of property at time of purchase, and all risk of loss and damage to property. All titles will be assigned to registered buyer unless notification is received by auctioneer at the end of auction. NO TITLES WILL BE ISSUED UNLESS COMPLETELY FILLED OUT.
BIDDER REGISTRATION: Bidder must be 18 years of age or older, and are required to register for the auction. In registration, Bidder must submit information found to be current, complete, and accurate for proper identification. Auctioneer does not sell or rent this information. Auctioneer uses email mailing lists to notify customers about online and live auctions. Customers who do not wish to be notified should contact the office of the Auctioneer and request removal from the email mailing list. Bidder is responsible for security of his/her bidding number/user name and password, and any and all bids placed under the assigned number/ID. Auctioneer should be notified immediately if Bidder believes number and/or password have been compromised. Auctioneer reserves the right to terminate registration, deny any person for any reason permission or access to bid, to reject any and all bids, and to suspend or ban Bidder from bidding, at Auctioneers sole discretion. Bidder registration is not transferable or assignable.
BIDDING: Bidder must register to participate in the auction. Read the descriptions of each lot and view photographs carefully. If you have any questions call 605-234-4214. Should you visit the viewing location, please personally inspect the property on which you intend to bid during the date(s) indicated in the details per item when applicable. Using YOUR knowledge and experience, form your own opinion of the property and bid accordingly. If you are in doubt, DO NOT BID. All items are sold "AS-IS WHERE IS AND WITH ALL FAULTS" this is an AUCTION and all SALES ARE FINAL. Bids cannot be retracted and are binding contracts between Bidder and Auctioneer/Seller. Bidder is accountable to be informed about property and associated costs before bidding. A maximum bid can be placed on property. A maximum bid is kept confidential, and Bidder authorizes Auctioneer to place bids on his/her behalf up to the amount of the maximum bid. Upon sale of property, identifying information and purchase amount will be posted for a designated period of time. All questions or disputes must be resolved immediately; no changes or adjustments will be made at a later date. Auctioneer reserves the right to reopen bidding. Auctioneer decisions will be final.
BUYERS PREMIUM: A Buyers premium of 5% -with a $1000 maximum per lot - will be charged on each purchases Unless otherwise stated. A buyer's premium, an advertised percentage of the high bid or flat fee added to the high bid will be added to the high bid and become part of the purchase amount at settlement. Buyer agrees to these provisions and will pay the applicable buyer's premium. Example if an item is sold for $100.00 + 5% buyer's premium = Final bid price $105.00
PAYMENT TERMS: Sales tax, when applicable, will be charged on both the purchase price, buyer's premium and credit card convenience fee. Taxes, fees, shipping, handling, insurance, storage and security charges are Buyers expenses, and will be calculated and rendered due at the sale of the property. Payment will be made in full by the buyer. Upon making payment for property, no stop payment of funds will be honored. Any stop payment order of a check, or giving a check which is returned marked insufficient funds, shall be deemed by the parties to be a prima facie evidence of fraud existing at the time the transaction was consummated and shall be construed by the parties as intent to defraud. If you are from another country other than the US, you must pay in US funds.
REMOVAL OF PROPERTY / SHIPPING TERMS: Buyer assumes full responsibility of property at time of purchase, and all risk of loss and damage to property. Property will not be removed from sale premises until payment in full has been received. Any and all methods of lifting, towing, and/or hauling are the Buyers responsibility. Shipping is not available. The final day of removal will be posted with property information. Any and all property not removed by Buyer by the final day of removal will revert back to the Auctioneer/ Seller, and may be resold at auction or disposed of in any other manner that seems to be suitable.
CHOICE OF LAW: The laws of the State of South Dakota governs this agreement any dispute arising from the terms of this auction shall be brought in a court of Brule County, South Dakota.
ADDITIONAL TERMS: The following are property specific Terms & Conditions that are posted online with the individual property information and will override any likewise terms stated in this Agreement. Buyers Premium - Sale Date and Time (Beginning and Ending) - Inspection Location, Dates, and Times - Final Date of Removal - Shipping Arrangements - Special Notes/Comments/Announcements
ONLINE BIDDING INFORMATION: If you are participating in an online auction, the following additional terms will apply to the Auction Terms & Conditions set forth above: OBTAINING A USER NAME & PASSWORD: Click on BUYER LOGIN on our Home Page and then CREATE NEW ACCOUNT. Follow the instructions. If you need assistance feel free to contact us at 605-234-4214.
BIDDING IN THE ONLINE AUCTION: Once you are registered and have your User Name & Password, you may place bids as soon as a lot opens for bidding. Your bids are FINAL and constitute a binding contract. Please be aware that lots will close at various times and possibly different days and may be extended. You are responsible for monitoring these close times. Please bid early to avoid disappointment. Bidder acknowledges that hardware malfunctions, software malfunctions, viruses, and similar issues do occur and are beyond the knowledge, scope, and control of Auctioneer. We are NOT responsible for your system malfunctions, connection to the internet or your e-mail client stopping any of our e-mails to you in regard to bid confirmations and/or outbid notifications. All lots for the on-line auctions shall be paid in full by Certified Funds prior to pick up. An invoice will be sent to your registered e-mail address within 24 hours following the conclusion of the auction.
United States
December 5, 2023 - 9 am - 5pm
December 6, 2023 - 9am - 5pm
If you cannot make either of the scheduled pick up days, please speak with the auction company-prior to bidding-to make other arrangements. These dates and times pertain to items located at the PLA lot in Chamberlain.
All payments must be made at the Peterson Land & Auction office at 310 Sorensen Dr, Chamberlain, SD.


text:
Stress isn't just a problem for humans; your pet can experience the negative effects too. Illness, changes in the usual routine or the death of another pet can lead to an increase in your pet's anxiety level. Luckily, there are a few things you can do to help your furry friend relax.
Signs of Stress
Your pet may not be able to tell you that it feels stressed, but you will probably notice some behavioral changes, including:
- Bathroom accidents, particularly if your pet has been successfully house or litter trained
- Excessive grooming, licking or scratching
- Irritability
- Chewing walls, couches or other items in your home (dogs)
- Scratching furniture, doors and walls (cats)
- Vomiting and diarrhea
- Excessive barking or howling
- Hiding (cats)
Identifying the Cause
In some cases, the cause of your pet's stress is obvious. Perhaps you got a new puppy or kitten, and your pet is having trouble adjusting to the new addition. In other cases, the cause might be less obvious. Something that you view as a minor event, such as rearranging furniture, can be stressful for some animals. Other potential causes of stress are:
- Travel
- Moving to a new home
- Holiday celebrations, which may include scary Halloween costumes, 4th of July fireworks or loud parties
- The death of a person or pet
- The addition of a new person to the home
- Being left at home alone
- Changes in the usual family routine
- The absence of a family member
- Car trips
- Visits to the veterinarian or groomer
Reducing Stress
Once you have identified the stressor, you can make changes to help your pet feel more relaxed. For example, the start of a new school year obviously means that your family must make changes to its normal routine. If you notice that your cat or dog seems to be stressed by the flurry of early morning activity in your home, offer a quiet refuge far from the chaos. Provide a crate with several toys for your dog or put your cat in a quiet room with a few favorite things.
Your dog may become stressed about riding in the car if he only associates car trips with visits to the vet. Take him on a few short trips to a place he enjoys, such as a local park, and provide treats at the end of the trip. Turning a car ride into a pleasant experience means that short and long trips will be more enjoyable for both you and your pet.
Treatments That Can Help
A variety of treatments may help reduce your pet's stress level, including:
- Pheromone-based sprays, collars and diffusers. Pheromones are scents animals produce to communicate with each other. Pheromone products mimic scents that help calm your pets.
- Herbal products. Some pets react well to herbal products; others do not experience any decrease in stress levels. Catnip and valerian may be helpful in relaxing your cat while oat seed or California poppy might help your dog.
- Natural supplements. Your pet may experience less stress after taking supplements containing vitamin B1, colostrum and L-theanine. Before you give your pet any herbal or natural product, check with your veterinarian to make sure it is safe.
- Massage. Many pets enjoy a good massage just as we do. If you have any questions about pet massage, contact our office today.
When to Call Your Vet
If home remedies and removing stressors do not help your pet, it's time for a visit to the veterinarian. Your veterinarian may recommend anti-anxiety medication or suggest that you consult with an animal behaviorist. The behaviorist will evaluate your pet's behavior and suggest strategies that will help him or her cope with stress.


text: Machine learning is the study that allows computers to adaptively improve their performance with experience accumulated from the data observed. Our two sister courses teach the most fundamental algorithmic, theoretical and practical tools that any user of machine learning needs to know. This second course of the two would focus more on algorithmic tools, and the other course would focus more on mathematical tools. [機器學習旨在讓電腦能由資料中累積的經驗來自我進步。我們的兩項姊妹課程將介紹各領域中的機器學習使用者都應該知道的基礎演算法、理論及實務工具。本課程將較為著重方法類的工具,而另一課程將較為著重數學類的工具。]


text:
Slate Grey
Cotton Pastel Green Colour Floral Jaal Print 42 Inches Width Fabric
1 Colour Options Available
Description |
Cotton Pastel Green Colour Floral Jaal Print 42 Inches Width Fabric |
Material | Cotton |
Colour | Pastel Green |
Usage | Female Shirt , Anarkali , Blouse , Chudidar , Crop Top , Gown , Jacket , Kurta , Kurti , Palazzo , Salwar Suit , Skirt , Top |
Dimension | Width 1.07 Meter (42 Inches) |
Type | Printed |
Minimum Weight | 75 Gram Per Unit |
Lining Suggested | No |
Washing Care | Gentle Wash in Cold Water |
Disclaimer | We make every effort to photograph the fabrics so as to capture their natural colour. However, due to factors not in our control, the colour that you see on your screen may vary from the real colour of the fabric. Minor variation in colour is unavoidable |
Marketed By | Sourceitright Pvt Ltd |
Country of Origin | India |
Shipping Charges for Orders within India:
Order Value |
Pre-Paid Payment |
COD Payment |
Upto ₹1398.99 |
₹89 |
₹89 |
₹1399 & Above |
Free |
Free |
Generally, we dispatch orders within 48-72 working hours.
Shipping Charges for International Orders:
For international orders, shipping charges calculates dynamically based on actual weight at the checkout page.
Return of Domestic Orders:
All products except for the products bought at discounted and bulk prices are eligible for return. The customer must raise a return request within seven days of delivery, failing which return will not be accepted.
The customer will be responsible for shipping the product back to us. If the customer wants us to arrange a reverse pick up, a token charge of ₹100 is applicable. Reverse pickup is subject to PINCODE serviceability by our courier partner.
Taxes and Return of International Orders:
Orders with a delivery location outside India are considered international orders, unconditional to the payment method. We do not accept the return of international orders. In unlikely conditions, if a customer receives a damaged product, the refund will only be for the product cost, and shipping charges will not be refunded. Custom charges, brokerage fees or any other taxes applicable at the destination country are to be paid by customers directly to our courier company. In no condition, Sourceitright Private Limited will be responsible for any taxes payable to the destination country.
Some of our products with natural dye and hand processes tend to colour bleed while washing. Therefore, we request International customers to read details before buying fabric to avoid any issues.
For more detail on shipping, return and refund, please visit the dedicated page here.
For boutiques and bulk buying, please contact our business manager. (available from 10:30 AM to 6 PM on all working days).
1 Colour Options Available
Designer Combos Showing 1 of 3
Mix and Match


text:
FP-DR-03 Festiport 7
PO Box 23656
Baltimore, MD 21203
Monday through Saturday
11:30 am - 8:00 pm EST
Closed on Sunday
Festiport © 2018
All product names, logos, and brands are the property of their respective owners. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.
Brand & Marketing Strategy by PerceptionInk, LLC


text:
Following are the steps you need to take within your Control Panel to setup your Domain Registration Product for your Customers and Sub-Resellers:
Select which TLDs you want to sell. See details
Set your Selling Price for different TLDs that you are selling. See details
Specify your Default Settings for the Domain Names Service: You may specify which Name Servers are pre-filled every time your Customers register a domain name. See details
Understanding Tax and how you may use the Tax Engine to collect it from your Customers and Sub-Resellers. See details
If you choose to integrate the domain name registration buy process with your website using our API Kit, then you need to ensure that you display the Registrar Registrant Agreement for Domain Names Legal document within the domain name registration buy process on your website.
It is compulsory to display this document as is to your Customers and get them to agree to the terms mentioned therein, before buying domain names through you. You can view this agreement from within your Reseller Control Panel by going to Help -> Legal Agreements in the Menu.


text:
You are @ Home
Hello writers and readers! You have landed on 'The Best of writebuzz.com' - the official tribute site of writebuzz.com. writebuzz.com was open to contributions from amateur and professional writers for seven years - from June 2005 to May 2012. Writers were invited to publish sound-bites of their work for feedback and review. There were over 8,000 publications on the former interactive site. This (Best of writebuzz.com) site is a scaled-down version of the original site, showcasing a subset of the publications concerned. The selection criteria was based on popularity (via reviews) and readership (via clicks). If you have time to spend browsing and reading we are sure that you will find something that interests and inspires you. Navigation is easy - we have displayed a random sample of publications below. To refresh this and see a new random sample simply click on the 'See new sample' option below. You can also browse by categories - the menu on the left - or by channels - the menu at the top. We would like to thank all contributors for their support and this wonderful legacy of writing in all genres - poetry, short-stories, lyrics and more…. Enjoy! Fame is a bee. / It has a song / It has a sting / Ah, too, it has a wing. Emily Dickinson © writebuzz® 2012. All rights reserved. Sample of work from site See new sample The prefixes, in the references above, indicate the category. e.g. F = features, M = memorials, Po = poetry, P = plots (i.e. sound-bites of current plots), WW = words of wisdom, etc. |
writebuzz®... the word is out!


text:
Every so often, new tools are added to a designer or engineer's tool belt that cause a dramatic shift in what is possible. These tools fundamentally transform how someone might interact with a product or service. In recent years, there has been a lot of attention given to mobile apps and, more specifically, location-based apps. Some see this trend as a fad, and I agree insofar as the check-in model of geolocation will only be popular in the short term.
But beyond the check-in, there are many other possibilities for improving a user's experience using location data.
In the age of smartphones, the map seems to be taken for granted; we power up our navigation systems in our automobiles and speed off without any worry that we'll get lost. But location is more than maps and navigation. It can be a communication tool, a filtering mechanism, and an aid to socializing. It's important to think of it in this way.
The use of location in our daily lives is increasing rapidly, with positive effect. Location data will become increasingly important as a required addition to nearly every app, website, or bit of data. I define "location data" (or "geodata," as some may refer to it) as any piece of information that has a location attached to it. This might be a photo that has been geotagged, or something as simple as a receipt from a grocery store on which a store address is associated with that purchase. The location can be as specific as a coordinate, or as general as a polygon or "area of interest" that draws the boundary of a state or province.
Redefining Existing Experiences
Hotel search has long been quite stagnant. Even with the advent of the Internet, many sites just replicated online what travel agents had done for clients for years. Seeing this as an opportunity, a company called Hipmunk decided they'd try to innovate within the stale space. They wanted to go beyond just listings of hotels ranked by price, rating, or distance from some landmark; they wanted to fundamentally change how people visualized what their options were.
Hipmunk came up with a series of data sets that might be interesting to users as they're searching for their hotels. A map of hotel locations can be overlaid with a heatmap of points of interest related to food, tourism, shopping, nightlife, and "vice." Now, instead of picking a hotel solely based on price, features, or distance from a location, users are able to choose a hotel near a concentration of restaurants, bars, shopping, etc. This use of location is about helping people make more informed decisions about where they stay.
The most interesting aspect of the Hipmunk story is their use of points of interest (POIs). In a time where POIs tend to only get used for check-ins, Hipmunk went after a radically different approach. They use POI data to provide visual cues to assist users in their searches. It's a great example of how raw location data—in this case, an address or coordinate associated with a set of POIs—can be used in new and compelling ways.
Location Can Make For Simple Features As Well
The use of location data doesn't always need to be imaginative. Who would have thought that just by adding some coordinates to a photo, the experience around organizing photos could be dramatically improved? The simple addition of a latitude and longitude to most anything can open up a world of possibilities.
As an example, products that have helped people organize their to-do lists have had pretty much the same feature list for a long time. But recently, location has become a new way of defining the items in a to do list. In conjunction with a smartphone's acquisition of a user's location, the to do application can now automatically notify you when you're near the place where you're supposed to accomplish a particular task.
Knowing where a user is standing can also eliminate some work for him. Whenever I would visit Weather.com, I always found it tedious to have to enter my ZIP code each time. I know this is a small complaint, but I figure that the site should be smart enough to know where I am. It's taken a long time, but Weather Underground had finally added location detection to its mobile site. The site is able to capture the location of whatever device is accessing it and automatically display that location's weather. This kind of automatic data entry could extend to any kind of form that deals with location. Imagine a future where signing up for an account somewhere didn't require typing in your address anymore, but filled out for you instead.
These examples may seem simplistic, but that's mostly the point. By virtue of knowing just one new piece of information—a user's location—an application or service can make users' lives a bit easier.
Location Is Context
There are two major types of location information that can be associated with data: points and areas. A point might be a coordinate, address, or business, whereas an area might be a neighborhood, park, census district, or many others. Understanding the relationship between these different location types can open up new possibilities in UX.
Uses for individual points have been played out pretty well already in the form of check-ins, geotagged photos, etc. But the use of points in aggregate, such as Hipmunk does, is an wide-open playing field at the moment. Aggregated point data has many interesting potential uses such as localized sentiment analysis, aiding in disaster relief, and massive sensor networks based on mobile devices.
One specific use of aggregated point data is Skyhook's SpotRank dataset. Skyhook provides a way for mobile devices to acquire location using a combination of cell tower triangulation, GPS, and WiFi network triangulation. Using the acquired location of a large number of anonymized individuals, aggregated together into one dataset, Skyhook is able to determine the near real-time density of a given area. There is a wide range of uses for this data. For example, imagine a Yelp-like restaurant recommendation app where users could set their preferences to find restaurants that have high ratings but are not in neighborhoods that are currently crowded. The aggregation of all of the location acquisition information by mobile devices makes this possible.
Additionally, there are types of location data that can provide context that might not immediately be apparent. Weather is one of those types. Even though it may not seem like it, weather is inherently location data because it's attached to physical areas. Using this information, one could imagine an app that simply reminds me to pick up my umbrella as I'm walking out of the house, or a game where a fire monster's abilities became stronger on a hot day.
Some of the data that's available for such things as neighborhoods, postal codes, and other boundaries, could provide a way for any bit of data to be automatically geotagged. With those tags in mind, many different ways of filtering, categorizing or presenting data can be implemented. Music apps that could show what's popular in the user's neighborhood, camera apps might re-sort photos based on the city they were taken in, or in-app language can be changed based on the country the user is logging in from.
Even in the absence of externally contributed data, a product can still use location to create new and interesting experiences. A simple news website or app could track where users are reading the articles and prioritize particular articles for other people in areas where are they tend to be popular. This same premise could be brought to coupons, concerts, restaurants and more.
Location data is abundant these days. Just about anything can be assigned a location to make the resulting data more powerful. From Twitter to Facebook to census data to news, the places where location can be introduced are endless. There are many companies, including mine, SimpleGeo, that are on a mission to make this data and the services that surround it more accessible to web and app developers. There are many possibilities with the treasure trove of data that exists today. Just keep in mind that it's just another tool in your belt. That is, an incredible power tool that has the potential of making yours and your users' lives better and easier.


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Yuri Grigorovich is considered to be the greatest living choreographer in the world of ballet today. His ballets dominate the repertory of contemporary works, and his stagings of the classic ballets reflect his personal taste arid his often-stated conviction that drama must always infuse and be expressed through dancing. He breaks with tradition, yet he himself is rooted in the traditions of classic ballet, by birth and upbringing. He has acute awareness of his inheritance, and of the vital contribution that is made to the performances of today by the guidance of great artists of an earlier generation. On all the Bolshoi's many tours, they are accompanied by such guardians of the classic school as the ballerinas Marina Semyonova (born 1908), Galina Ulanova (born 1910) and Raissa Struchkova (born 1925). To them is entrusted the coaching of young ballerinas, and even established dancers return for help and advice. Yuri Nikolaievich Grigorovich was born in what was then Leningrad on January 2nd, 1927. His uncle George Rozai, was a character dancer who appeared with Diaghilev's Ballet Russe and his mother, Klaudia Rozai, trained at the ballet school with Semvonova. Many of his family were circus artists and young Yuri was fascinated by the world of the circus, but soon lost his heart to the dance. He describes it as "a love affair that has lasted all my life." He trained at the Leningrad Choreographic School and along with the other pupils was evacuated to Perm during World War II. He tried to run away (by canoe!) to get to the front but was brought back and eventually graduated in 1946. He joined the Kirov Ballet where he excelled in character roles. His favorite was that of the virtuoso warrior leader Nurali, who can be so sensational in the last act of The Fountain of Bakhchisarai. But he was already, in his formative years, keen to try his hand at choreography and in 1956 was allowed to arrange a ballet to Glinka's Valse-Fantasie for a graduation performance at the Kirov School. His first major work, undertaken despite the fact that another version already existed in Moscow, was The Stone Flower, to the Prokofiev score which was first performed at the Kirov on April 27, 1957. It marked the first collaboration between Grigorovich and the artist Simon Virsaladze, a man of great culture from Tbilisi, who was to design all his subsequent ballets. In addition to their working partnership they also were the greatest of friends, a relationship that was only broken by Virsaladze's death in 1989, at the age of eighty. Grigorovich was named ballet master at the Kirov in 1962 but subsequently transferred to Moscow and to the Bolshoi in 1964. Grigorovich was Artistic Director of the Bolshoi Ballet for the following 30 years, a tenure in ballet rivaled only by the founding director of the New York City Ballet, George Balanchine. During Grigorovich's term at the Bolshoi, he staged Spartacus by Khachaturian (1968), Ivan the Terrible by Prokofiev (Moscow, 1975; Paris, 1977), Angara by Eshpai (1876), Romeo and Juliet bv Prokofiev (Paris, 1978; Moscow, 1979), The Golden Age by Shostakovich (1982). Yuri Grigorovich revised classical masterpieces for the Bolshoi Ballet: The Sleeping Beauty (1963), The Nutcracker (1966), Swan Lake (1969) by Tchaikovsky; Raymonda by Glazunov (1984), La Bayadere (1991), La Fille Mal Gardee (1993) by Hertel, Don Quixote (1995) by Minkus.
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1At that time—oracle of the LORD—the bones of the kings and princes of Judah, the bones of the priests and the prophets, and the bones of the inhabitants of Jerusalem will be brought out of their gravesa 2and spread out before the sun, the moon, and the whole host of heaven,* which they loved and served, which they followed, consulted, and worshiped. They will not be gathered up for burial, but will lie like dung upon the ground.b 3Death will be preferred to life by all the survivors of this wicked people who remain in any of the places to which I banish them—oracle of the LORD of hosts.
Israel's Conduct Incomprehensible
4Tell them: Thus says the LORD:
When someone falls, do they not rise again?
if they turn away, do they not turn back?
5Why then do these people resist
with persistent rebellion?
Why do they cling to deception,
refuse to turn back?c
6I have listened closely:
they speak what is not true;
No one regrets wickedness,
saying, "What have I done?"
Everyone keeps on running their course,
like a horse dashing into battle.d
7Even the stork in the sky
knows its seasons;
Turtledove, swift, and thrush
observe the time of their return,
But my people do not know
the order of the LORD.e
8How can you say, "We are wise,f
we have the law of the LORD"?
See, that has been changed into falsehood
by the lying pen of the scribes!*
9The wise are put to shame,
terrified, and trapped;
Since they have rejected the word of the LORD,
what sort of wisdom do they have?g
Shameless in Their Crimes
10Therefore, I will give their wives to other men,
their fields to new owners.
Small and great alike, all are greedy for gain,
prophet and priest, all practice fraud.h
11They have treated lightly
the injury to the daughter of my people:*
"Peace, peace!" they say,
though there is no peace.i
12They have acted shamefully; they have done abominable things,
yet they are not at all ashamed,
they do not know how to blush.
Hence they shall be among those who fall;
in their time of punishment they shall stumble,
says the LORD.j
Threats of Punishment
13I will gather them all in—oracle of the LORD:
no grapes on the vine,
No figs on the fig trees,
foliage withered!
Whatever I have given them is gone.
14Why do we remain here?
Let us assemble and flee to the fortified cities,
where we will meet our doom;
For the LORD our God has doomed us,
he has given us poisoned water to drink,
because we have sinned against the LORD.k
15We wait for peace to no avail;
for a time of healing, but terror comes instead.l
16From Dan is heard
the snorting of horses;
The neighing of stallions
shakes the whole land.
They come to devour the land and everything in it,
the city and its inhabitants.
17Yes, I will send against you
poisonous snakes.
Against them no charm will work
when they bite you—oracle of the LORD.m
The Prophet's Grief over the People's Suffering
18My joy is gone,
grief is upon me,
my heart is sick.
19Listen! the cry of the daughter of my people,
far and wide in the land!
"Is the LORD no longer in Zion,
is her King no longer in her midst?"
Why do they provoke me with their idols,
with their foreign nonentities?n
20"The harvest is over, the summer ended,
but we have not yet been saved!"
21I am broken by the injury of the daughter of my people.
I am in mourning; horror has seized me.o
22Is there no balm in Gilead,*
no healer there?
Why does new flesh not grow
over the wound of the daughter of my people?p
23Oh, that my head were a spring of water,
my eyes a fountain of tears,
That I might weep day and night
over the slain from the daughter of my people!
* [8:2] Host of heaven: the stars, worshiped by other nations and even by the inhabitants of Jerusalem, particularly during the reigns of Manasseh and Amon.
* [8:8] Lying pen of the scribes: because the teachings and interpretations of the scribes ran counter to the word of the Lord.
* [8:11] Daughter of my people: see note on 4:11.
* [8:22] Gilead: a region southeast of the Sea of Galilee noted for its healing balm.
f. [8:8] Mal 2:8; Rom 2:17–23.
g. [8:9] 1 Cor 3:20.
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text: Overview and HistoryNew York was invented by time-traveling punks from across the galaxy so they could show up there in 1977, smash some guitars and then overdose on heroin to die in the East Village, according to prophecy.The historic origins of the city go back to long before the American Revolution. Let's take a quick look at what it is before we look at what it looks like in panoramas.New York City sits on the island of Manhattan. Manhattan, you will notice, is not only an island situated between two rivers perfect for easy transportation to the Atlantic Ocean -- it's also an Indian word!Like lots of New England states and towns, its lineage comes from the "Indians" who lived there first. White people learned those names and kept them, for example Massachusetts, Connecticut, Manhattan, Chesapeake. Go out to the small towns in the greater New York or Tri-State area and you'll find even more names like Massapequa, Hammonasset, Ronkonkoma, Montauk, Quinnipiac, etc. And of course Mohawk, which comes into play later around 1977.So, let's keep it sanitized for posterity. The white people came and the Indians left. How do you like that? Legend has it that white settlers bought the island of Manhattan for $26; obviously the contracting party on the other end had no idea what real estate connections were all about. Early pilgrims cited the Bible as their mandate for taking over what lands they found in "the new world". (They decided that, since "the Indians" had not subdued the land, it was free for the taking. File this away in the "karmic repurcussions" folder.)The point is, New York City sits on a bunch of islands. An archipelago, if you will. An island just off the coast of Europe, if you want to comment on how different NYC is from the rest of the United States. Bird's eye view: you've got Manhattan, Staten Island and Long Island, which hosts both Brooklyn and Queens.The south end of Manhattan is where New York City started. Once upon a time there were deer, owls, hawks and trees covering the entire island. Gradually it filled in with farms and, much later, low-income apartment buildings. Manhattan is now bridged to the western end of Long Island by the Brooklyn Bridge, the Manhattan Bridge, the Williamsburg bridge and the Brooklyn Battery Tunnel. Take the Williamsburg bridge across from the east village to find where the artists went after the East Village got to be too. friggin. expensive. for. anybody. to. really. live. here. dammit. Go ahead!, check out the cost of living in New York yourself if you want.Anyway, as European settlers filled in the space, New York City grew up and took over the entire Hudson Bay area including Connecticut and New Jersey (Tri-State area).Contrary to intuitive belief, NYC is not the capital of New York State. Albany is the capital but nobody ever goes there except to do realllly big deals, so don't worry about it. New York's nickname is "The Empire State" and for all purposes, NYC is the jewel in the Empire's crown.Back to downtown in Tribeca (Triangle Below Canal Street) -- you will find two distinctly different layouts. One side of this southern tip of the island was built by the Dutch, the other half by the English.The Dutch side has twisting streets with lots of triangular central, um, squares that are hell on the novice bike messenger to find. The English side sports long avenues connecting evenly spaced parallel streets, a grid like what you see in midtown among the "number streets." What does that say about the worldview of these two groups at the time? See, already New York is intriguing. What else is going on there?Here are the essential neighborhoods to cover, if you want to have even the most awkwardly cursory view of the city. This is going from south to north. For scale, it's about five miles from the southern tip to the south edge of Central Park at 59th street.The financial district (Wall Street, etc), Tribeca, Chinatown.SoHo, Greenwich Village, East Village, Meat Packing District.Flatiron and Murray Hill merge upwards into Hell's Kitchen (best food in midtown), and Times Square and then Central Park.From there it's all Upper East Side and Upper West Side until you get to Spanish Harlem, Harlem, and The Bronx.Off to the East of Manhattan there's Brooklyn and Queens, both of which could take up a thousand pictures, and to the west side there's New Jersey. The East River and Hudson River border Manhattan to either side and if you can't figure out which side the Hudson is on, I can't help you.If you just go to New York City and eat one meal in each of the above neighborhoods, you will have done an excellent job of seeing what this megalopolis has to offer. Many people make the mistake of going to NYC for a week and spending five days in Times Square. Don't let this be you. You can find food from anywhere in the world in New York and it's a crime against modern civilization not to do so.Getting ThereOh boy. Three airports, which are all connected to a greater or lesser degree by taxi drivers who are completely cool and professional on the inside, and you can't tell that by looking. It's a yellow river of taxis but you are not at their mercy if you can afford a helicopter ride to where you're going! Ha ha! You can't! And get used to it!!!Everything about NYC is either a celebration of your wealth, or a celebration of not having any. Not to worry, there's an equal amount of fun to be had regardless of which end of the spectrum you're on. (That amount=MORE THAN YOU HAVE TIME FOR...)Okay, the airports are JFK (John F. Kennedy International), LaGuardia and Newark International. Getting between Manhattan and JFK airport usually means a private limousine or a taxi, because the public transportation is not so hot there. There is the Airtrain on the subway line that goes there, just make sure you get on the right train.LaGuardia airport is closer to the city center and you can get there on a bus without much trouble, if you have learned how to move around on the subway system and you don't mind standing on the street up in Harlem with all your stuff.Newark International Airport is the easiest to get to because you can take a train right from the subway system at 34th Street in Manhattan and get off inside the airport at your departure terminal, and it looks high-tech the whole way. Check here for prices and schedules.TransportationThe subway (MTA) is a great way to get around New York when you're on foot for day trips, commuting, whatever.The only caution is to remember that you can walk ten blocks a lot more easily than waiting underground. One ride costs $2 with the mandatory Metrocard. Tokens are in the museum now, next to the dinosaur teeth. No more tokens. Here's a subway map, have fun!People and CultureAre you kidding? People and Culture in New York might as well be "People and Culture of Planet Earth". Somebody from everywhere lives here and they all keep their native languages and recipes, then learn English so they can open a restaurant, all to YOUR benefit as soon as you figure out which neighborhood you want to go explore tonight.There are a few sayings about people in NYC. First, "people in new york are either 100% real or 100% fake." This might be true, depending who you ask.Second, "New Yorkers are the nicest people in the world.. you just have to force them to be nice." (because they're always in a hurry). This is definitely true.Culture here? You've got film, fashion, music, food, fine art, dance, theater, you name it. Every art form you can think of, including the art of making lots of money, is flaunted on the city streets. Also fun stuff like sex, drugs, arson, murder and stealing are thriving here at the apex of their popularity. Think class division and you'll be standing tip-toe on the ice berg's lurking point.Things to do & RecommendationsNo swimming buddy, not in the rivers. Check out the beaches on Long Island for that, get there by train LIRR. Robert Moses State Park is my recommendation.A great "new yorky" thing to do is to walk across the Brooklyn Bridge and get an amazing view of the Statue of Liberty, Manhattan skyline and Brooklyn.There's really no way to encapsulate the life of this city in a few recommendations but I'll try.Grimaldi's Pizza in Brooklyn's DUMBO neighborhood: Down Under Manhattan Bridge Overpass. Go there. Eat pizza. Die happy.3rd Ward Art Space for Brooklyn wareouse type parties and also studio space.In Times Square, take a bicycle taxi to get around, see things and hear a real insider's report on where to go not to get ripped off.Meat Packing District for nightlife, start here.Curry In A HurryMiss Mamie's Spoonbread TooIt's abominable how much I am leaving out. Please forgive me, New York!!! Text by Steve Smith.