Medication info

Atovast Jet Tablets 10/40 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)티디에스팜
Appearance
White or whitish elongated film-coated tablets
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Approval withdrawn

MFDS item code 202101539 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2025.03.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipids through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended. For patients requiring a more significant reduction in LDL-cholesterol (greater than 55%), a starting dose of 10/40 mg daily is recommended. After initiation of treatment or dose adjustment, cholesterol and lipid levels should be monitored after intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Improvement of lipids through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medicine helps lower elevated total cholesterol, LDL-cholesterol, and triglycerides in patients with primary hypercholesterolemia or mixed dyslipidemia, while increasing good cholesterol, HDL-cholesterol. It can be used in conjunction with other treatments or as alternative therapy in patients with homozygous familial hypercholesterolemia. This medication is also effective when combined with appropriate dietary and non-drug measures. Prior to therapy, it is important to assess other potential underlying conditions or medication effects, and during treatment, it is essential to periodically check cholesterol and lipid levels. Overall, this medication is used to improve lipid levels in patients with dyslipidemia and to reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dose range is 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended. For patients requiring a more significant reduction in LDL-cholesterol (greater than 55%), a starting dose of 10/40 mg daily is recommended. After initiation of treatment or dose adjustment, cholesterol and lipid levels should be monitored after intervals of more than 2 weeks.

Precautions

This medication has been rarely associated with a serious side effect called rhabdomyolysis, which can result in muscle tissue damage and kidney dysfunction. Therefore, immediate consultation with a physician is necessary if severe muscle pain or weakness symptoms appear, and the use of this medication may need to be temporarily stopped if there are risk factors such as severe infection, hypotension, major surgery or trauma, or uncontrolled seizures. This medication should not be administered to patients with allergies to the active ingredient or other excipients, those with severe liver dysfunction, muscle disorders, women who are pregnant or may become pregnant, nursing mothers, and patients taking certain other medications. Caution should be exercised when administering this medication to patients with a history of alcohol abuse or liver disease, those with severe liver dysfunction, renal impairment, hypothyroidism, a history of genetic muscle disorders, and elderly patients over 70 years old who are at higher risk of muscle damage. Additionally, this medication contains lactose and should not be taken by patients with lactose intolerance or related genetic diseases. During treatment with this medication, if symptoms like muscle pain, weakness, muscle cramps, fatigue, or muscle pain associated with fever develop, immediate notification to a physician is required, and blood tests may be necessary to check for muscle damage. As abnormal liver function may occur, liver function tests should be conducted before and during treatment, and treatment should be stopped if liver damage symptoms arise. This medication may slightly elevate blood sugar levels; however, the cardiovascular disease prevention benefits generally outweigh this concern when considered as a treatment rationale. Women who are pregnant or may become pregnant should not take this medication, and appropriate contraception should be used while on treatment. Nursing mothers are also advised not to take this medication. Safety and efficacy have not been established in children, so it is not recommended for pediatric use. When administering to the elderly, caution should be exercised due to the risk of muscle damage, but no specific dose adjustment is necessary. This medication can interact with several drugs, so patients taking other medications should inform their physician or pharmacist, as dose adjustment or caution may be required when taken concomitantly with certain drugs. Caution is also advised as dizziness may occur when driving or operating machinery. In cases of overdose, there is no specific antidote, and treatment should focus on symptom management and supportive care, while monitoring liver function and potential muscle damage. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • feeling of weakness
  • chest pain
  • malaise
  • headache
  • constipation
  • indigestion
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • abnormal sensation
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain.

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

Storage

This medication can be sensitive to air or moisture, thus it should be stored in a tightly sealed container. A storage temperature between 1 to 30 degrees Celsius at room temperature is recommended. This helps maintain the medication's effectiveness for a prolonged period.

Appearance and packaging

Appearance

White or whitish elongated film-coated tablets

Package unit

30 tablets/box [(10 tablets/Alu-Alu x 3)]

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.