Trinex Tablets / Film-coated
Fenofibrate
145mg
Nexgen Pharma FZ LLC
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | ARABIAN ETHICALS CO. |
| Retail Price | 27.00 AED |
Available as:
Indications
Trinex Tablets / Film-coated is used for:
Hyperlipidemia, Hypercholesterolaemia, Hypertriglyceridaemia
Adult Dose
Oral
Hypercholesterolemia, Mixed dyslipidemia, Hypertriglyceridemia
Tablet: 40-160mg once daily.
Capsule: 200mg once daily.
Hepatic impairment: Contraindicated.
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild-Moderate: Initial: lower dose
Severe: contraindicated
Administration
Should be taken with food.
Contra Indications
Hypersensitivity; severe hepatic and renal impairment. Unexplained persistent liver function abnormality and primary biliary cirrhosis; preexisting gall bladder disease. Pregnancy, lactation.
Precautions
Renal or hepatic impairment. Monitor LFTs and blood counts regularly. Increased risk of cholelithiasis, pancreatitis, skeletal muscle effects. Withdraw treatment if no adequate response after 2 mth of treatment at max recommended dose.
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy-Lactation
Pregnancy
Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 120 mg daily, based on body surface area (mg/m2)
Adverse reproductive outcomes occurred at higher doses in presence of maternal toxicity; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Lactation
There is no available information on presence of drug in human milk, effects on the breastfed infant, or on milk production; drug is present in milk of rats, and likely to be present in human milk; because of potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment and for 5 days after final dose
Interactions
Decreased absorption w/ bile acid sequestrants (e.g. colestyramine). May increase risk of ciclosporin-induced nephrotoxicity. Increased risk of muscle toxicity w/ HMG-CoA reductase inhibitors (e.g. simvastatin). May increase risk of bleeding w/ oral anticoagulants.
Adverse Effects
Side effects of Fenofibrate :
1-10%
Abdominal pain (4.6%), Back pain (3.4%), Increased AST (3.4%), Headache (3.2%), Increased ALT (3%), Increased CPK (3%), Nausea (2.3%), Constipation (2.1%)
Potentially Fatal: Hepatitis, cholecystitis.
Mechanism of Action
Fenofibrate, a fibric acid derivative, lowers plasma triglyceride by activating lipoprotein lipase thus increasing catabolism of VLDL w/ consequent increase in HDL levels.
Note
Trinex 145mg Tablets / Film-coated manufactured by Nexgen Pharma FZ LLC. Its generic name is Fenofibrate. Trinex is availble in United Arab Emirates.
Farmaco UAE drug index information on Trinex Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.