Medication info
Lobatan Tablet 5 mg (Rosuvastatin Calcium)

Lobatan Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201403881 · Approved 2014.08.20 · Insurance code 693201010

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Patients with primary hypercholesterolemia, mixed hyperlipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take it at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and if necessary, it can be adjusted to 10 mg once daily. The dosage can be adjusted at intervals of at least 4 weeks, with a maximum increase to 20 mg once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals with an interval of at least 4 weeks.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is primarily used as a treatment for patients with hypercholesterolemia and hyperlipidemia. It helps as an adjunct to diet in patients with primary hypercholesterolemia, especially those with familial hypercholesterolemia who are not controlled by diet and exercise. It is also used in conjunction with diet or other lipid-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia. This drug lowers total cholesterol and LDL cholesterol and has the effect of slowing the progression of atherosclerosis. It is also used as an adjunct to diet to reduce blood cholesterol levels in children aged 10 to 17 years with heterozygous familial hypercholesterolemia. Moreover, it helps reduce the risk of complications such as stroke, myocardial infarction, and revascularization procedures in high-risk cardiovascular patients with elevated high-sensitivity C-reactive protein levels. In summary, this drug is used to improve various forms of dyslipidemia associated with hypercholesterolemia and reduce the risk of cardiovascular disease.

How to take

Adult dose

Patients with primary hypercholesterolemia, mixed hyperlipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take it at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and if necessary, it can be adjusted to 10 mg once daily. The dosage can be adjusted at intervals of at least 4 weeks, with a maximum increase to 20 mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals with an interval of at least 4 weeks.

Precautions

This medication should not be administered to certain patients. For instance, it should not be used in individuals who are allergic to any of its components, have severely impaired liver function, have muscle disorders, have significantly reduced kidney function, or are pregnant or breastfeeding. Additionally, high doses of this medication are prohibited in patients who are prone to muscle problems. Such patients include those with moderate to severe renal impairment, hypothyroidism, a family history of muscle disorders, and patients with alcohol dependence. This medication contains lactose, so patients with lactose intolerance should not take it. Before taking this medication, regular liver function tests and muscle-related tests should be done, especially in patients who drink heavily or have a history of liver disease. If symptoms such as muscle pain, weakness, cramps, fatigue, or fever appear during treatment, inform a doctor immediately, and if necessary, blood tests should be performed to check for muscle damage. This medication may increase blood concentration when taken with specific other drugs, raising the risk of muscle damage, so if you are taking other medications, inform your doctor or pharmacist. Women of childbearing potential must use appropriate contraception when taking this medication, and if pregnancy is confirmed, they should discontinue use immediately. In case of overdose, there is no specific antidote available; therefore, treatment based on symptoms and regular monitoring of liver function and muscle enzyme levels are necessary. This medication can rarely cause serious skin reactions or liver damage; thus, if any unusual rash develops or jaundice symptoms appear, discontinue use immediately and consult a healthcare professional. Caution should also be taken due to the possibility of dizziness while driving or operating machinery. It is important to monitor liver and muscle function through regular health checks and blood tests during the course of this medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, jaundice, hepatitis, acute renal failure, oliguria, myopathy, severe muscle weakness, oculomotor weakness, severe skin adverse reactions (Stevens-Johnson syndrome, DRESS), fatal and non-fatal liver failure.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, thrombocytopenia, diarrhea, oculomotor weakness, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, cough, hematuria, depression, sleep disorders, sexual dysfunction, gynecomastia, post-marketing cognitive impairment (memory decline, forgetfulness, amnesia)

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture ingress. The storage temperature should be kept between 1 and 30 degrees Celsius at room temperature. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

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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.