Tonact-FN

Tonact-FN

Manufacturer:

Lupin (Inventia)

Distributor:

Maxxcare

Marketer:

Lupin
Concise Prescribing Info
Contents
Atorvastatin 10 mg, fenofibrate 160 mg
Indications/Uses
Adjunct to diet to reduce elevated total-C, LDL-C, apo B & TG levels & to increase HDL-C.
Dosage/Direction for Use
1 tab once daily. Concomitant use w/ cyclosporine Atorvastatin 10 mg once daily. Concomitant use w/ clarithromycin or in patients w/ HIV taking a combination of ritonavir+saquinavir or lopinavir+ritonavir Max atorvastatin dose: 20 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Preexisting gallbladder disease. Hepatic or severe renal dysfunction, including primary biliary cirrhosis, & patients w/ unexplained persistent liver function abnormality. Pregnancy & lactation.
Special Precautions
Conduct liver function test prior to initiation of therapy, at 12 wk after initiation of therapy & periodically thereafter semiannually. Patients w/ an acute, serious condition suggestive of myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Pancreatitis. Concomitant use w/ ketoconazole, spironolactone & cimetidine. Not recommended in renal impairment. Patients w/ substantial quantities of alcohol consumption &/or w/ history of liver disease. Fenofibrate: Discontinue or replace the concomitant use of β-blockers, thiazides, estrogens prior to consideration of treatment. May increase cholesterol excretion into the bile, leading to cholelithiasis.
Adverse Reactions
Gastritis, leg pain, burning feet, body ache, numbness in legs, joint pain, pruritus, hyperglycemia & dizziness. Nausea, headache, abdominal pain, constipation, dyspepsia, flatulence, diarrhea, dizziness, insomnia, hepatitis, cholelithiasis, cholecystitis, hepatomegaly, photosensitivity, myopathy, rhabdomyolysis & eczema.
Drug Interactions
May decrease the levels or activity of endogenous steroid hormones w/ ketoconazole, spironolactone & cimetidine. Increased plasma conc w/ strong inhibitors of CYP3A4 (clarithromycin, combination of protease inhibitors, itraconazole, diltiazem HCl; erythromycin. Reduced plasma conc w/ inducers of CYP3A4 (eg, efavirenz, rifampin); colestipol. Increased plasma conc of digoxin; norethindrone & ethinyl estradiol. Frequent prothrombin time/INR determinations & reduced anticoagulant (coumarin) dosage. Potential nephrotoxicity w/ cyclosporine. Increased risk of myopathy w/ azole antifungals/niacin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10BA - Combinations of various lipid modifying agents ; Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Tonact-FN tab
Packing/Price
10 × 10's
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