Gemfibrozil Tablet
Product Images NDC 68071-2387

NuCare Pharmaceuticals manufactures and distributes Gemfibrozil 600mg tablets in bottles of 180 with Lot number 00000 and NDC number 68071-2387-08. Each tablet contains 600mg Gemfibrozil (USP). The tablets are oval, white to off-white with two partial bisects on one side and the number 1 on the other side. The bottle's expiration date and the manufacturer's identification number are provided. The product is available only by prescription, and patients should contact doctors for medical advice about side effects. FDA should be notified of any side effects, and the medication should be stored at a controlled temperature of 68-77°F and kept out of reach of children.*

This text appears to be a list of possible side effects or symptoms that may occur in relation to a causal relationship with a medication or drug. The focus is on how the central nervous system may be affected, with symptoms such as jaundice, dizziness, paresthesia, decreased libido, depression, headache, blurred vision, and others. It also mentions potential liver and blood abnormalities, bone marrow issues, and skin reactions. There is no indication of what drug is being referred to.*

This is a comparison of adverse reactions between the drug Gemfibrozil and a placebo. The data is presented in a table showing the frequency of gastrointestinal reactions, dyspepsia, abdominal pain, acute appendicitis, atrial fibrillation, and other adverse events reported by over 1% of subjects in both groups. The adverse events listed without significant difference between the groups include diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache.*

The text appears to be a table showing the reduction in Coronary Heart Disease rates in Helsinki Heart Study. The table provides lipid values at baseline, the incidence of events, and the difference in rates between the placebo and Gemfibrozil group. However, the format of the text is not clear to confirm its accuracy.*

The table presents cardiac events and all-cause mortality rates per 1000 patients in the 3.5 year open-label follow-up to the Helsinki Heart Study. The study included six groups designated by the original randomization and by the drug taken in the follow-up period. The cardiac events and all-cause mortality rates are broken down by each group, with the number of patients in each group shown.*

The table shows the statistics of cardiac events, deaths (cardiac and non-cardiac), and mortality rate in the Helsinki Heart Study from years 0 to 8.5. The study includes two groups, Gemfibrozil and Placebo. The intention-to-treat analysis was conducted, neglecting open-label treatment switches and exposure to study conditions. The Hazard Ratio is calculated for the group originally randomized to gemfibrozil compared to the group originally randomized to placebo. The table includes the percentage of confidence intervals. The study covers the incidences of fatal and non-fatal myocardial infarctions plus sudden cardiac deaths over the 8.5 year period.*