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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.
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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.
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Overdosage
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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.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Tonact-FN detailed prescribing information
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.
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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.
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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.
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Storage
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Description
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Action
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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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