Medication info
Lotrovant Tablets 5 mg (Rosuvastatin Calcium)

Lotrovant Tablets 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-AluX3), 30 tablets/bottle
Approval status
Active

MFDS item code 201906545 · Approved 2019.09.18 · Insurance code 648104350

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) improvement and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose. The maintenance dose is usually adjusted to 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, therapeutic goals, and patient response, with a maximum daily dose of 20 mg.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the recommended therapeutic goals for each patient. Dosage adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and dyslipidemia (primary, familial) improvement and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitive C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is primarily used for patients with hypercholesterolemia and hyperlipidemia. It serves as an adjunct to diet and exercise when these are insufficient to control primary hypercholesterolemia and mixed hyperlipidemia, and is also used in conjunction with other treatments for homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL-cholesterol levels, thereby delaying the progression of atherosclerosis. In particular, for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, it acts as an adjunct to dietary therapy. It is used as an adjunct to diet in patients with dysbetalipoproteinemia and helps reduce the risk of cardiovascular disease. In middle-aged patients with high-sensitive C-reactive protein and cardiovascular risk factors, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization. Thus, it is effectively used for various forms of hyperlipidemia and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose. The maintenance dose is usually adjusted to 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, therapeutic goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the recommended therapeutic goals for each patient. Dosage adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to this medication, severe liver dysfunction, muscle disorders, severe renal impairment, women who are pregnant or breastfeeding, and fertile women who do not use adequate contraception should not take this medication. Additionally, patients with muscle problems or risk factors for muscle damage should not take this medication in high doses. This medication contains lactose, so patients with lactose intolerance or specific genetic metabolic disorders should also avoid it. While taking this medication, liver function and muscle condition should be periodically tested, and patients who drink alcohol heavily or have a history of liver disease should be particularly cautious. If symptoms such as muscle pain, weakness, or cramps occur, the physician should be notified immediately, and a blood test should be performed to check for muscle damage. This medication may affect kidney function when taken in high doses, so kidney function tests may also be necessary. This medication may interact with other drugs, so if the patient is taking any other medications, they must inform their doctor or pharmacist. Special caution is needed when taken with certain antiviral drugs, immunosuppressants, antifungals, antibiotics, and fibrate medications. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant should use adequate contraception. If this medication is taken during pregnancy, it should be stopped immediately and the physician consulted. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme tests may be required. This medication is known not to significantly impact driving or machine operation abilities, but caution is advised due to potential dizziness. Rarely, serious skin reactions, liver damage, or muscle damage may occur, so if any unusual symptoms appear, medical personnel should be notified immediately. During the use of this medication, it is important to regularly monitor blood tests and health status as instructed by the physician.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, severe muscle weakness, ophthalmoplegia, thrombocytopenia, fatal and non-fatal liver failure, acute renal failure, oliguria, severe edema, chest tightness, difficulty breathing, severe allergic reactions, severe skin reactions, respiratory difficulties, liver abnormalities (jaundice)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
Show 13 more
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It's best to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-AluX3), 30 tablets/bottle

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.