Lustatin-10/Lustatin-20/Lustatin-40 Dosage & Drug Information

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

Concise Prescribing Info

Contents

Rosuvastatin Ca

Indications/Uses

Reduce LDL-C, apo B, & triglycerides, & to increase HDL-C in the management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), & hypertriglyceridaemia (type IV), as well as in patients w/ homozygous familial hypercholesterolaemia. Reduce the progression of atherosclerosis.

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Dosage/Direction for Use

Individualized dosage. Adult Hypercholesterolaemia Initially 5 or 10 mg orally once daily. Adjustment of dose to next level can be made after 4 wk, if necessary. Only consider final titration to the max dose of 40 mg in patients w/ severe hypercholesterolaemia at high CV risk (in particular those w/ familial hypercholesterolaemia), who do not achieve treatment goal on 20 mg, & in whom routine follow-up will be performed. Prevention of CV events 20 mg daily. Childn & adolescents 6-17 yr (Tanner Stage <II-V) w/ heterozygous familial hypercholesterolaemia Initially 5 mg daily, 10-17 yr w/ heterozygous familial hypercholesterolaemia 5-20 mg orally once daily, 6-9 yr w/ heterozygous familial hypercholesterolaemia 5-10 mg orally once daily. Elderly >70 yr Initially 5 mg.

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Overdosage

View Lustatin-10/Lustatin-20/Lustatin-40 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Active liver disease or unexplained persistent elevated LFTs. Pregnancy & lactation.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Lustatin-10/Lustatin-20/Lustatin-40 detailed prescribing information

Special Precautions

Perform LFTs before & at 12 wk after initiation of therapy or any increase in dosage & periodically (eg, semiannually) thereafter. Myopathy, rhabdomyolysis w/ or w/o acute renal failure secondary to myoglobinuria. Institute appropriate dietary regimens, wt reduction, exercise & treatment of any underlying disorder that may cause lipid abnormality prior to initiation of therapy. Not recommended in childn <6 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia. Pruritus, rash, urticaria.

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Drug Interactions

Decreased plasma conc w/ Al-Mg hydroxide antacids. Enhanced effect on total cholesterol & LDL-C w/ bile acid sequestrants. Increased peak plasma conc & AUC w/ cyclosporine.

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Storage

View Lustatin-10/Lustatin-20/Lustatin-40 storage conditions for details to ensure optimal shelf-life.

Description

View Lustatin-10/Lustatin-20/Lustatin-40 description for details of the chemical structure and excipients (inactive components).

Action

View Lustatin-10/Lustatin-20/Lustatin-40 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Regulatory Classification

Presentation/Packing

Form

Lustatin-10 tab 10 mg

Packing/Price

30's (P600/box, P20/tab)

Form

Lustatin-20 tab 20 mg

Packing/Price

30's (P25/tab, P750/box)

Form

Lustatin-40 tab 40 mg

Packing/Price

30's (P47/tab, P1,410/box)

Lustatin-10/Lustatin-20/Lustatin-40

rosuvastatin

Manufacturer:

Simpex Pharma

Distributor:

Bell-Kenz Pharma

Marketer:

SRS Life Sciences