TGR Tablets by Intas (Generic Fenofibrate Tablets)

1. TGR Tablets by Intas (Generic Fenofibrate Tablets) © Clearsky Pharmacy

2. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR (Generic Fenofibrate Tablets)is a peroxisome proliferator receptor alpha (PPARa) activator which is used as adjunctive therapy to diet to lower the amount of low- density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. TGR tablets are also used as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. © Clearsky Pharmacy

3. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets are manufactured by Intas Pharmaceuticals Limited, India in the strength of 160mg. (Website: www.intaspharma.com www.intaspharma.com) © Clearsky Pharmacy

4. TGR Tablets by Intas (Generic Fenofibrate Tablets) Fenofibrate Tablets – Brand Names Fenofibrate tablets are available as Tricor, Fenolip, Lipicard, Tgr, Antara, Fenoglide, Lipofen, Lofibra, Triglide, Fenocor, Finate and Tififib. © Clearsky Pharmacy

5. TGR Tablets by Intas (Generic Fenofibrate Tablets) Active Ingredient The active ingredient contained in TGR tablets is Fenofibrate. Each TGR tablet contains 160 mg of Fenofibrate. © Clearsky Pharmacy

6. TGR Tablets by Intas (Generic Fenofibrate Tablets) Chemical Structure The structure of Fenofibrate is given below: © Clearsky Pharmacy

7. TGR Tablets by Intas (Generic Fenofibrate Tablets) Uses of TGR Tablets TGR (Generic Fenofibrate Tablets) is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. In addition to eating a proper diet (such as a low-cholesterol/low- fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

8. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets Dosage TGR tablets (Generic Fenofibrate Tablets) is given below: Patients should be placed on an appropriate lipid-lowering diet before receiving TGR (Generic Fenofibrate tablets), and should continue this diet during treatment with Fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication. Primary Hypercholesterolemia or Mixed Dyslipidemia: Primary Hypercholesterolemia or Mixed Dyslipidemia: The initial dose of Fenofibrate tablets are 160 mg once daily. The dosage of TGR tablets URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

9. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets Dosage The dosage of TGR tablets given below: Severe Hypertriglyceridemia: Severe Hypertriglyceridemia: The initial dose is 54 mg to 160 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg once daily. Impaired Renal Function: Impaired Renal Function: Treatment with Fenofibrate tablets should be initiated at a dose of 54 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Fenofibrate tablets should be avoided in patients with severe renal impairment. TGR tablets (Generic Fenofibrate Tablets) is URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

10. TGR Tablets by Intas (Generic Fenofibrate Tablets) Contraindications TGR tablets are contraindicated in patients with a hypersensitivity to Fenofibrate, Fenofibric Acid or any other component of this medication. This medicine is also contraindicated in: patients with severe renal impairment, including those receiving dialysis, patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities, patients with preexisting gallbladder disease and nursing mothers. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

11. TGR Tablets by Intas (Generic Fenofibrate Tablets) Storage Instructions TGR (Generic Fenofibrate Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. © Clearsky Pharmacy

12. TGR Tablets by Intas (Generic Fenofibrate Tablets) Warnings Myopathy and rhabdomyolysis have been reported in patients taking Fenofibrate (TGR tablets). Risks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism. TGR can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy. TGR tablets can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal impairment. TGR increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

13. TGR Tablets by Intas (Generic Fenofibrate Tablets) Warnings Use caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment. Discontinue Fenofibrate and treat patients appropriately if reactions occur. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

14. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets and Alcohol You should avoid drinking alcohol before and during treatment with Fenofibrate (TGR Tablets). Alcohol can raise triglyceride levels and increase your risk of liver damage. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

15. TGR Tablets by Intas (Generic Fenofibrate Tablets) Side Effects The most common side effects that occur in more than 2% of the patients undergoing therapy with Fenofibrate Tablets (TGR Tablets) and at least 1% greater than placebo are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

16. TGR Tablets by Intas (Generic Fenofibrate Tablets) Side Effects Additional Fenofibrate (TGR tablets) side effects observed in clinical trials and postmarketing experience include: Immune system disorders: hypersensitivity Vascular disorders: thromboembolism (pulmonary embolism, deep vein thrombosis) Hepatobiliary disorders: cholelithiasis, complications of cholelithiasis (e.g. cholecystitis, cholangitis, biliary colic etc.) Skin and subcutaneous tissue disorders: severe cutaneous reactions (e.g erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.), cutaneous hypersensitivity (e.g. rash, pruritus, urticaria), alopecia, photosensitivity reactions Reproductive system and breast disorders: sexual dysfunction Investigations: blood homocysteine level increased, blood urea increased. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

17. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets Overdose There is no specific treatment for overdose with Fenofibrate (TGR tablets). General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because Fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

18. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets During Pregnancy Fenofibrate (TGR tablets) has been classified by the US FDA as Pregnancy Category C. Safety in pregnant women has not been established. There are no adequate and well controlled studies of Fenofibrate in pregnant women. During animal reproduction studies, no evidence of embryo- fetal toxicity was observed with oral administration of Fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 160 mg daily, based on body surface area (mg/m2). Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

19. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets During Nursing There is no available information on the presence of Fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. Fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk. Because of the potential for serious side effects in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with TGR tablets and for 5 days after the final dose. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy

20. TGR Tablets by Intas (Generic Fenofibrate Tablets) TGR Tablets TGR Tablets (Generic Fenofibrate Tablets) by Intas Pharmaceuticals Limited, India. URL: URL: https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html https://www.clearskypharmacy.biz/generic-fenofibrate-tablets.html © Clearsky Pharmacy