Monograph Details
|
|
Cardiovascular System
> Hyperlipoproteinemias
|
|
LOFIBRA CAPSULES |
| Manufacturer |
|
Gate Pharmaceuticals |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Fibrate. |
| Generic Name |
|
Fenofibrate 67mg, 134mg, 200mg; caps (micronized). |
| Also |
|
• LOFIBRA TABLETS
|
| Indications |
|
Adjunct to diet in hypertriglyceridemia (Types IV and V), and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb). |
| Children |
Not recommended.
|
| Adults |
|
Take with food. Hypertriglyceridemia: 67–200mg/day; adjust in 4–8 week intervals; max 200mg/day. Hypercholesterolemia, dyslipidemia: 200mg/day. Renal impairment (CrCl<50mL/min): initially 67mg/day. Discontinue if inadequate response after 2 months on max dose. |
| Elderly |
|
Initially 67mg/day. |
| Contraindications |
|
Hepatic dysfunction. Primary biliary cirrhosis. Severe renal dysfunction. Gallbladder disease. |
| Precautions |
|
Renal impairment. Monitor CBCs for first year; monitor liver function, discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones occur. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
|
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), other nephrotoxic drugs. |
| Adverse Reactions |
|
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias. |
| How Supplied |
Tabs—90
Caps—100 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
