Medication info
Lotodipine Tablets 10/5 mg (Rosuvastatin, Amlodipine)

Lotodipine Tablets 10/5 mg (Rosuvastatin, Amlodipine)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500593 · Approved 2025.03.18 · Insurance code 648105200

Summary

Main use
Treatment for improvement of hypertension and angina, reduction of hypercholesterolemia and cardiovascular disease risk
Who takes it
Adults
Adult dose
Amlodipine: Administer 5 mg orally once daily, and increase to a maximum of 10 mg daily based on the patient's response. Rosuvastatin: Initial dose is 5 mg orally once daily, adjusted to a maintenance dose of 10 mg once daily. Adjustments should be made at intervals of more than 4 weeks based on treatment goals and patient response, with a maximum dose of 20 mg daily. This medication is administered for adults only.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment for improvement of hypertension and angina, reduction of hypercholesterolemia and cardiovascular disease risk

  • Hypertension
  • fixed obstruction of coronary artery
  • coronary vascular spasm
  • vasoconstriction
  • myocardial ischemia
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • stroke
View approved original text

This medication is used for patients who require the simultaneous administration of amlodipine and rosuvastatin. Amlodipine improves blood supply to the heart in heart-related diseases such as hypertension and stable or variant angina, reduces the risk of hospitalization due to angina, and lowers the risk of vascular intervention. Rosuvastatin helps to control cholesterol levels in dyslipidemia disorders such as hypercholesterolemia and familial hypercholesterolemia, preventing atherosclerosis. Additionally, in patients at high risk for cardiovascular diseases, it reduces the risk of stroke and myocardial infarction, promoting cardiovascular health. This combination of two drugs is used to effectively manage cardiovascular diseases.

How to take

Adult dose

Amlodipine: Administer 5 mg orally once daily, and increase to a maximum of 10 mg daily based on the patient's response. Rosuvastatin: Initial dose is 5 mg orally once daily, adjusted to a maintenance dose of 10 mg once daily. Adjustments should be made at intervals of more than 4 weeks based on treatment goals and patient response, with a maximum dose of 20 mg daily. This medication is administered for adults only.

Precautions

This medication should not be used in people with hypersensitivity to certain ingredients, pregnant women, women who may become pregnant, and breastfeeding mothers. It should also not be used in patients with severe liver dysfunction or active liver disease, severe aortic stenosis, patients in shock, patients with myopathy, and in combination with certain immunosuppressants. The use of this medication is contraindicated in patients with severely impaired kidney function or in those at high risk of muscle-related diseases. Caution should be taken when administering this medication to patients with severe hypotension, those requiring dialysis for renal failure, the elderly, and patients with severe myasthenia gravis. Patients with a history of liver disease or excessive alcohol intake should have regular liver function tests, and patients with hypothyroidism or specific forms of hypercholesterolemia should first have the underlying disease treated before using this medication. This medication may cause muscle-related side effects such as myalgia, myopathy, and in rare cases, rhabdomyolysis, so if symptoms of muscle pain or weakness occur, consult a doctor immediately. Additionally, it is advisable to avoid vigorous exercise or situations that could cause muscle damage while taking this medication. This medication may increase the risk of side effects due to interactions when used with certain drugs, so inform your doctor or pharmacist if you are taking other medications. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should use appropriate contraception. Safety in children has not been established, so this medication should not be used in children. In case of overdose, severe hypotension or heart-related problems may occur, necessitating immediate medical attention and emergency treatment may be required. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or quality degradation.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe edema, severe allergic reactions, chest tightness, difficulty breathing, severe skin reactions, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), generalized malaise, hepatic abnormalities (jaundice), sudden and severe headache, tremor

Mild side effects

  • Headache
  • dizziness
  • peripheral edema
  • chest pain
  • limb pain
  • constipation
  • dental fractures
  • wrist fractures
  • gout
  • urinary difficulties
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  • flushing
  • fatigue
  • edema
  • palpitations
  • drowsiness
  • nausea
  • abdominal pain
  • weakness
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • anxiety
  • sensory loss/paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremors
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • change in bowel habits
  • dry mouth
  • dyspepsia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the effectiveness and safety of the medication for an extended period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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

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

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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.