Medication info
Lotrovant 20 mg (Rosuvastatin Calcium)

Lotrovant 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu X3)
Approval status
Active

MFDS item code 201400155 · Approved 2014.01.15 · Insurance code 648103350

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Can be taken at any time of the day, irrespective of meals. The initial dose is typically 5 mg once daily, while the maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg once daily.
Child dose
For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual therapeutic goals at intervals of 4 weeks or more. 10

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct when primary hypercholesterolemia and mixed dyslipidemia cannot be controlled by diet and exercise. It is also effective as an adjunct to diet or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. Furthermore, it helps reduce LDL cholesterol and apo-B protein levels in pediatric patients aged 10 to 17 years with severe hypercholesterolemia. It is used as an adjunct to diet in patients with primary dysbetalipoproteinemia and contributes to reducing the risk of cardiovascular diseases. In particular, it lowers the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged or older patients with high-sensitivity C-reactive protein levels who have risk factors. This medication aims to improve hypercholesterolemia and cardiovascular disease risk.

How to take

Adult dose

Can be taken at any time of the day, irrespective of meals. The initial dose is typically 5 mg once daily, while the maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg once daily.

Child dose

For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual therapeutic goals at intervals of 4 weeks or more. 10

Precautions

This medication should not be used in patients who are allergic to certain components. It should not be administered in the presence of active liver disease or severe hepatic impairment. Patients with muscle disorders or related muscle issues are not suitable for this medication. Patients taking cyclosporine or those with severe renal dysfunction should also avoid this treatment. Pregnant or nursing women should not use this medication, and women of childbearing potential should employ appropriate contraception. Patients at high risk for myopathy or rhabdomyolysis should particularly avoid high-dose administration. This medication contains lactose, so patients with lactose intolerance should be cautious. Patients with a history of hepatic impairment or excessive alcohol consumption should undergo repeated liver function tests before and during treatment. If symptoms of muscle pain or weakness occur, tell your healthcare provider immediately and get tested. Treatment may need to be withheld during severe physical stress or serious illness. There may be interactions with other medications, so any concurrent medications should be disclosed to a healthcare provider. Particular caution is needed when combined with fibrate-class drugs due to the increased risk of muscle-related adverse reactions. This product can occasionally cause serious skin reactions or liver damage, so if rash or jaundice appear, use should be stopped immediately. Clinical trials and post-marketing reported side effects include headache, dizziness, digestive disorders, and myalgia, which are mostly mild and transient. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme tests are required. Dizziness may occur when driving or operating machinery, so caution is advised. In Asian individuals, blood concentrations may be higher, so dosage adjustments may be necessary. There is limited evidence of effects on growth and secondary sexual characteristics in children and adolescents, so cautious use is recommended.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, myopathy, rhabdomyolysis, severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, immune-mediated necrotizing myopathy, cough, dyspnea, respiratory problems, jaundice, hepatitis, hepatic abnormalities, severe muscle weakness, ophthalmoplegia, severe edema, acute renal failure, oliguria, severe liver damage, hyperbilirubinemia, severe skin disorders

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • pruritus
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • transaminase elevation
  • increased ALT
  • increased AST
  • increased CK
  • memory loss
  • peripheral neuropathy
  • cough
  • lupus-like syndrome
  • increased serum creatinine
  • depression
  • lethargy

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu X3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.