Parmodia Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Pemafibrate

Indications/Uses

Adjunctive therapy to diet to reduce triglyceride in patients w/ dyslipidemia, including familial hyperlipidemia.

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Dosage/Direction for Use

Adult Usual dose: 0.1 mg bid. Max: 0.2 mg bid. Renal impairment (estimated GFR <30 mL/min/1.73 m²) Max: 0.2 mg daily.

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Overdosage

View Parmodia overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: May divide tab into equal halves.

Contraindications

Hypersensitivity. Cholelithiasis. Concomitant use w/ cyclosporine or rifampicin. Severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction. Pregnancy.

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Special Precautions

Discontinue treatment in patients w/ muscle toxicity presenting diffuse myalgia, myositis, muscle cramps & weakness, &/or marked increases in creatine kinase (>5x ULN). Consider dose reduction or prolonged dosing intervals if estimated GFR is <30 mL/min/1.73 m². Muscle toxicity including rhabdomyolysis w/ & w/o acute renal failure. Abnormal LFTs. History of hepatic disorder; cholelithiasis. Periodically monitor liver & renal function; LDL-cholesterol levels during treatment. Concomitant use w/ HMG-CoA reductase inhibitor. Hepatic disorder (Child-Pugh grade A cirrhosis). Discontinue breastfeeding during treatment. Low birth wt infants, newborns, infants. Childn. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Cholelithiasis; DM including aggravated DM.

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Drug Interactions

Increased plasma conc w/ cyclosporine; rifampicin; clopidogrel sulfate, clarithromycin, HIV PIs eg, ritonavir; fluconazole. Muscle toxicity w/ HMG-CoA reductase inhibitors eg, pravastatin Na, simvastatin, fluvastatin Na. Decreased plasma conc w/ anion exchange resins eg, cholestyramine, colestimide; strong CYP3A inducers eg, carbamazepine, phenobarb, phenytoin, food containing Hypericum perforatum (St. John's wort).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Parmodia detailed prescribing information

Storage

View Parmodia storage conditions for details to ensure optimal shelf-life.

Description

View Parmodia description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AB12 - pemafibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

Thai FDA Category

Presentation/Packing

Form

Parmodia FC tab 0.1 mg

Packing/Price

10 × 10's

Parmodia

Manufacturer:

Kowa

Distributor:

Biopharm

Marketer:

Kowa