Medication info

Rogastin Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)파마킹
Appearance
Pink round film-coated tablet
Packaging
28 tablets/PTP (14 tablets/PTP x 2)
Approval status
Expired

MFDS item code 201400396 · Approved 2014.01.28

This product's status changed to Expired on 2024.01.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
The initial dosage is 5 mg once daily, and if more LDL cholesterol reduction is needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, and may be increased up to a maximum of 20 mg per day.

Ingredients

Manufacturer
(주)파마킹

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication serves as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia who cannot be controlled by diet and exercise alone. Additionally, it is used in conjunction with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication reduces total cholesterol and LDL cholesterol levels to target levels in patients with hypercholesterolemia, slowing the progression of atherosclerosis. It may also be used as an adjunct to diet therapy in patients with primary dysbetalipoproteinemia. In particular, it helps reduce the risk of stroke, myocardial infarction, and revascularization procedures in older men and women at high risk for cardiovascular disease. Overall, this medication is used effectively to improve the risks of dyslipidemia and cardiovascular disease.

Dosage and Administration

Adult dosage

The initial dosage is 5 mg once daily, and if more LDL cholesterol reduction is needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, and may be increased up to a maximum of 20 mg per day.

Precautions

This medication should not be used in certain patients. Patients with an allergy to this drug or severe liver impairment should not take it. It is also contraindicated in those with muscle disorders or who are taking certain medications. Women who are pregnant, nursing, or of childbearing potential without proper contraceptive measures should not take this medication. Furthermore, patients at risk for muscle disorders or rhabdomyolysis should avoid high doses of this medication. Patients with genetic issues such as lactose intolerance should also avoid this treatment. Caution should be exercised in patients with weakened liver function or those who consume alcohol heavily. Liver function tests should be conducted regularly before and during treatment, and conditions such as hypothyroidism or nephrotic syndrome should be addressed before treatment. If symptoms of myalgia or muscle weakness occur, notify a physician immediately, and blood tests may be needed to check for muscle damage. Close attention is required after vigorous exercise, as results from muscle damage tests may be distorted. This medication should be discontinued in acute severe conditions and caution is advised regarding the risk of muscle adverse reactions when used in conjunction with certain medications. Patients taking this medication may experience side effects such as myalgia, weakness, headache, dyspepsia, rash, and other adverse reactions. Most are mild and temporary, but if severe myalgia or muscle damage is suspected, treatment should be stopped immediately. Liver dysfunction has been reported, thus liver function tests are necessary. Rarely, severe skin reactions or neurological abnormalities may occur; if symptoms appear, consult a physician immediately. This medication may cause interstitial lung disease or severe liver damage, so if symptoms of dyspnea or jaundice appear, stop taking it immediately. Blood glucose levels may increase, so patients at risk for diabetes should monitor their blood glucose closely. Genetic factors may result in variable drug responses, thus dose adjustments may be required during treatment. This medication may interact with other drugs, so inform your physician or pharmacist of any other medications you are taking. Particular care should be taken when used with drugs that have a high risk of muscle damage. This medication should not be used during pregnancy or breastfeeding, and women planning to become pregnant should use proper contraceptive measures. In the event of an overdose, there is no specific antidote; treatment should focus on symptomatic care, along with liver function and muscle enzyme tests. Caution is advised as dizziness may occur during driving or operating machinery. This medication may show higher blood concentrations in Asians, thus dosage adjustment may be necessary. It is recommended to use this drug for a limited period in pediatric patients while monitoring growth and development.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including urticaria, angioedema.
  • Chest tightness, dyspnea, respiratory abnormalities accompanied by cough + fever.
  • Severe swelling.
  • Severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes.
  • Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS).
  • Liver abnormalities (jaundice), hepatitis, fatal and non-fatal hepatic failure.
  • Sudden and severe headache, seizures, confusion, visual disturbances.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, diarrhea, thrombocytopenia, increased transaminase, hematuria, edema, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory impairment, forgetfulness, amnesia, memory disturbance, confusion, fatigue, numbness, sensory disturbances, chest discomfort, loss of appetite, abdominal distension, fainting, generalized pain, muscle cramps, gout, erectile dysfunction.

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

Storage

This medication should be kept in a tightly closed container to protect from air and moisture, stored at a temperature between 1 degree Celsius and 30 degrees Celsius. By storing it this way, you can maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/PTP (14 tablets/PTP x 2)

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.