Medication info

Tidros 10 mg Tablet (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)티디에스팜
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PTP (15 tablets/PTP (AluAlu)*2) 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201903724 · Approved 2019.06.04

This product's status changed to Expired on 2024.06.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia 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 typically 5 mg once daily, with a maintenance dose of 10 mg once daily being used in most patients. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.
Children's dosage
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), it is administered once daily at a dose range of 5 mg to 20 mg. The dosage should be individually adjusted according to the treatment goals.

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used as an adjunct in patients with hypercholesterolemia and mixed hyperlipidemia who are unable to control their condition with diet and exercise alone. It is particularly effective in patients with primary hypercholesterolemia and familial hypercholesterolemia (heterozygous and homozygous forms), lowering total cholesterol and LDL cholesterol levels to delay the progression of atherosclerosis. It is also used as an adjunct to diet in specific pediatric patients aged 10 to 17 with high LDL cholesterol levels. Additionally, it can be beneficial for patients with dysbetalipoproteinemia. Moreover, in high-risk cardiovascular disease patients, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures. This medication is used to improve blood lipid levels and reduce cardiovascular risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, regardless of meals. The initial dose is typically 5 mg once daily, with a maintenance dose of 10 mg once daily being used in most patients. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), it is administered once daily at a dose range of 5 mg to 20 mg. The dosage should be individually adjusted according to the treatment goals.

Precautions

This medication should not be used in certain patients. Individuals who are allergic to its ingredients should avoid taking it. It should not be administered to persons with severely impaired liver function or active liver disease. Patients with muscle disorders or issues related to muscles should not use this medication. Caution should be exercised to avoid taking it with cyclosporine, which may increase risk. Patients with very poor kidney function, especially those with a creatinine clearance less than 30 mL/min, should not take it. Pregnant or breastfeeding women, as well as fertile women who are not using appropriate contraception, should not use this medication. In patients at high risk of muscle problems, particularly high doses (40 mg) are contraindicated. This medication contains lactose, so individuals with genetic issues like lactose intolerance should avoid using it. Patients who consume large amounts of alcohol or have a history of liver disease should use this medication cautiously. It is essential to perform liver function tests before and during treatment to check liver health. Conditions such as hypothyroidism or nephrotic syndrome should be treated before using this medication. If symptoms such as muscle pain or weakness occur, report them immediately to a doctor for evaluation. If muscle-related symptoms are severe or if muscle enzyme levels rise significantly, discontinuation of the medication may be required. Muscle enzyme test results may be affected after vigorous exercise, so caution is advised. In cases of acute severe illnesses, discontinuation of this medication may be necessary. This medication can rarely cause severe muscle weakness or ocular muscle weakness; discontinue use if such symptoms occur. Caution is needed when taken with certain medications, as the risk of muscle problems may increase. Temporary proteinuria may occur with high doses, so kidney function tests are recommended. Asian patients may have higher drug concentrations, requiring dosage adjustment. In children and adolescents, caution is needed due to potential impacts on growth and sexual characteristics. The side effects of this medication are usually mild and transient, with common symptoms including headache, dizziness, constipation, abdominal pain, muscle pain, etc. Regular check-ups may be needed to monitor liver or kidney function. Rarely, serious side effects such as severe skin reactions, liver damage, or muscle rupture may occur; consult medical personnel immediately if abnormal symptoms appear. This medication is not recommended during pregnancy or breastfeeding, as its safety has not been established, and women of childbearing potential should ensure appropriate contraception. In the case of overdose, no specific antidote exists, so treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels. Symptoms like dizziness may arise when driving or operating machinery, so caution is advised. This medication may interact with other drugs, so inform your health care provider of any other medications being taken. Particularly, risks of muscle problems may increase when used with certain antibiotics, antifungals, immunosuppressants, and fibrates.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, respiratory distress, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptom drug reaction syndrome (DRESS), lupus-like syndrome, immune-mediated necrotizing myopathy, acute kidney injury, oliguria, hematuria

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, muscle pain, weakness, hematuria, diarrhea, chest pain, cough, fatigue, numbness, paresthesia, nausea, abdominal pain, loss of appetite, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory impairment, forgetfulness, amnesia, memory disorders, confusion

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

Storage

Store this medication in a closed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP (15 tablets/PTP (AluAlu)*2) 30 tablets/bottle, 100 tablets/bottle, 300 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.