Medication info
Itax Rosuvastatin Calcium Tablet 20mg

Itax Rosuvastatin Calcium Tablet 20mg

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

MFDS item code 201400288 · Approved 2014.01.22 · Insurance code 698502560

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Adult patients with primary hypercholesterolemia can take the medication at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is adjusted to 10 mg once daily. The maintenance dose should be adjusted based on LDL-cholesterol levels and patient response, with a maximum increase to 20 mg once daily after at least a 4-week interval.
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered a dosage ranging from 5 mg to 20 mg once daily. The dosage should be adjusted individually according to treatment goals with a 4-week interval or longer.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • increased Apo-B protein levels
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
View approved original text

This medication is used as an adjunct to diet for the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia when dietary management and exercise are insufficient. It is also used in conjunction with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug effectively lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia to target levels, delaying the progression of atherosclerosis. For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet to reduce total cholesterol, LDL-cholesterol, and Apo-B protein levels. It is also administered as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, in men over 50 years of age and women over 60 years with elevated high-sensitivity C-reactive protein levels and cardiovascular risk factors, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization. Thus, this medication is effectively used for improving various dyslipidemia and cardiovascular risk conditions.

How to take

Adult dose

Adult patients with primary hypercholesterolemia can take the medication at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is adjusted to 10 mg once daily. The maintenance dose should be adjusted based on LDL-cholesterol levels and patient response, with a maximum increase to 20 mg once daily after at least a 4-week interval.

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered a dosage ranging from 5 mg to 20 mg once daily. The dosage should be adjusted individually according to treatment goals with a 4-week interval or longer.

Precautions

This medication should not be administered to certain patients. For instance, patients who are allergic to any of the components in this medication, those with severe liver dysfunction, muscle disorders, severely impaired kidney function, pregnant or breastfeeding women should not use this medication. Additionally, this medication must be used with special caution in patients at high risk for muscle-related side effects, and such patients should be closely monitored for muscle status and blood tests before and after treatment. Patients with impaired liver function or those who consume alcohol heavily should have frequent liver function tests while using this medication. If symptoms such as muscle pain, weakness, or cramps occur during treatment, healthcare professionals should be notified immediately, and medication may need to be discontinued if necessary. The effects of this medication may vary according to specific genetic factors, so dosage adjustment based on individual patient status may be necessary. Moreover, this medication can interact with other drugs, so it is imperative to inform healthcare providers of any other medications being taken. Women of childbearing potential should use appropriate contraception and should not use this medication if they are pregnant or breastfeeding. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be closely monitored. This medication is known not to have a significant effect on driving or operating machinery, but caution should be exercised due to possible dizziness. Lastly, rare side effects such as interstitial lung disease or serious skin reactions may arise during treatment, so if any unusual symptoms occur, consultation with healthcare professionals should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, respiratory difficulties accompanied by cough, liver abnormalities (jaundice), jaundice, hepatitis, increased transaminases, severe neurological symptoms: severe muscle weakness, ocular muscle weakness, polyneuropathy, peripheral neuropathy, immune-mediated necrotizing myopathy

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, thrombocytopenia, diarrhea, hematuria, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, cognitive impairment, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia

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

Storage

This medication is sensitive to air and moisture and must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature to preserve the medication's efficacy for a longer duration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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.