Medication info
Lipirozet Tablets 10/40 mg

Lipirozet Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate Granule›600mg / 1 tabletEzetimibe Granule›150mg / 1 tablet
Manufacturer / importer
Jong Kun Dang Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP×3], 30 tablets/bottle
Approval status
Active

MFDS item code 202006984 · Approved 2020.10.13 · Insurance code 643308650

Summary

Main use
Improvement of mixed dyslipidemia and primary hypercholesterolemia
Who uses it
Adults
Adult dosage
Administer this medication once daily, regardless of meals. Patients must continue a standard cholesterol-lowering diet before and during treatment with this medication. The dose should be adjusted according to the patient's baseline LDL cholesterol level, recommended treatment goal, and response. Primary hypercholesterolemia The dose range is 10/10 mg to 10/40 mg once daily. The recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients who require a greater reduction in LDL cholesterol, the dose may be adjusted. After starting this medication or adjusting the dose, check blood lipid levels at intervals of at least 2 weeks and adjust the dose accordingly.

Ingredients

Manufacturer
Jong Kun Dang Co., Ltd.

Efficacy & effects

Improvement of mixed dyslipidemia and primary hypercholesterolemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apolipoprotein B
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used to improve blood cholesterol and related lipid levels in patients with primary hypercholesterolemia, particularly those with heterozygous familial and non-familial hypercholesterolemia, or mixed dyslipidemia. Specifically, it helps lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels while raising HDL cholesterol levels, thereby supporting vascular health. This medication is used as an adjunct to dietary measures and should be considered alongside other risk factors in the treatment of dyslipidemia. Additionally, it is important to identify and manage secondary causes that may impact treatment, such as diabetes and hypothyroidism, before initiating therapy. In patients who have experienced acute coronary events, appropriate treatment can be administered with rapid lipid testing. Overall, this medication is used to improve blood lipid levels and reduce the risk of atherosclerotic vascular disease in dyslipidemia treatment.

Dosage and Administration

Adult dosage

Administer this medication once daily, regardless of meals. Patients must continue a standard cholesterol-lowering diet before and during treatment with this medication. The dose should be adjusted according to the patient's baseline LDL cholesterol level, recommended treatment goal, and response. Primary hypercholesterolemia The dose range is 10/10 mg to 10/40 mg once daily. The recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients who require a greater reduction in LDL cholesterol, the dose may be adjusted. After starting this medication or adjusting the dose, check blood lipid levels at intervals of at least 2 weeks and adjust the dose accordingly.

Precautions

This medication is used to lower blood cholesterol levels. Rhabdomyolysis, which can lead to severe muscle abnormalities, may rarely occur, so if symptoms of muscle pain or weakness arise, the physician should be informed immediately. Patients with severe infection, hypotension, major surgery or trauma, metabolic disorders, etc. may need to suspend or discontinue the use of this medication temporarily. Patients with allergies to any ingredients in this medication, liver disease, muscle disorders, pregnant or breastfeeding women, and patients taking certain other medications should not use this medication. Patients with alcohol addiction or liver dysfunction, reduced kidney function, hypothyroidism, the elderly, and those at high risk for muscle problems should use this medication cautiously. Regular monitoring of liver function and muscle-related tests is required while taking this medication, and immediate consultation with healthcare professionals is necessary if liver dysfunction, muscle pain, or muscle weakness occurs. This medication may interact with other drugs, so if any other medications are currently being taken, it is essential to inform the physician or pharmacist. Women who are pregnant or planning to become pregnant should not take this medication, and fertile women should use appropriate contraception during treatment. Safety and effectiveness in children have not been established, so it is not recommended, and caution is required for the elderly due to the risk of muscle problems. In case of overdose, there is no specific antidote, and treatment should be based on symptoms while monitoring liver function tests and muscle enzyme levels. This medication should be kept out of reach of children and not transferred to other containers.

Side effects

  • Acute renal failure due to myoglobinuria
  • rhabdomyolysis
  • decreased sensation
  • abnormal sensation
  • hypertension
  • increased ALT
  • increased GGT
  • nasopharyngitis
  • cough
  • itching
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  • dizziness
  • diabetes
  • intracranial aneurysm
  • restless legs syndrome
  • depression
  • bronchiolitis
  • dental abscess
  • vestibular neuritis
  • bradycardia
  • hypotension
  • anemia
  • hernia
  • hyperkalemia
  • vitamin D deficiency
  • gastric polyp
  • duodenal polyp
  • duodenitis
  • jaundice
  • erectile dysfunction
  • breast mass
  • skin mass
  • ingrown toenail
  • thyroid adenoma
  • weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • complications due to rupture
  • myopathy
  • myositis
  • tendon disorders
  • muscle rupture
  • lupus-like syndrome
  • immune-mediated necrotizing myopathy
  • thrombocytopenia
  • allergic reaction
  • anaphylaxis
  • hepatitis
  • cholestasis
  • liver failure
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • urticaria
  • skin rash
  • hair loss
  • angioedema
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • gynecomastia
  • abnormal liver function test
  • increased serum creatine kinase
  • positive leukocytes in urine
  • nightmares
  • blurred vision
  • tinnitus
  • vomiting
  • abdominal abnormalities
  • hepatitis
  • pancreatitis
  • cholestasis
  • cholestatic jaundice
  • abnormal liver function test results
  • gastroenteritis
  • enteritis
  • dry mouth
  • rectal bleeding
  • esophagitis
  • belching
  • glossitis
  • oral ulcer
  • stomatitis
  • gallbladder pain
  • cheilitis
  • gastric and duodenal ulcer
  • dysphagia
  • melena
  • gingival bleeding
  • hyperemesis gravidarum
  • bronchitis
  • rhinitis
  • pneumonia
  • dyspnea
  • asthma
  • nosebleed
  • sensory disturbances
  • peripheral neuropathy
  • dizziness
  • phototoxic reaction
  • drowsiness
  • forgetfulness
  • abnormal dreams
  • decreased libido
  • emotional instability
  • ataxia
  • torticollis
  • facial paralysis
  • hyperkinesia
  • depression
  • tension dysregulation
  • muscle cramps
  • muscle fatigue
  • myositis
  • muscular disease
  • arthritis
  • bursitis
  • tenosynovitis
  • myasthenia gravis
  • neck pain
  • contractures
  • elevated CK
  • increased serum myoglobin
  • itching
  • rash
  • alopecia
  • contact dermatitis
  • dry skin
  • sweating
  • acne
  • urticaria
  • eczema
  • seborrhea
  • skin ulcer
  • impotence
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis
  • breast fibrocystic disease
  • vaginal bleeding
  • albuminuria
  • breast enlargement
  • cervical discharge
  • nephritis
  • urinary incontinence
  • urinary retention
  • urgency
  • abnormal ejaculation
  • uterine bleeding
  • colored urine
  • hypoglycemia
  • hyperglycemia
  • increased appetite
  • fatigue
  • vasomotor edema
  • chest pain
  • angina
  • facial edema
  • fever
  • neck stiffness
  • generalized edema
  • amblyopia
  • xerophthalmia
  • refractive errors
  • eye bleeding
  • hearing loss
  • glaucoma
  • lens opacity
  • taste loss
  • taste distortion
  • leukopenia
  • decreased testosterone
  • increased cholinesterase
  • elevated TSH
  • elevated ACTH
  • decreased aldosterone
  • cerebral infarction
  • palpitations
  • tachycardia
  • positive leukocytes in urine
  • hyperlipidemia
  • facial flushing
  • increased non-protein nitrogen
  • hyperuricemia
  • gingival hypertrophy
  • hypothermia
  • sleep disorders
  • memory loss
  • interstitial lung disease
  • sexual dysfunction
  • cognitive impairment
  • severe myasthenia gravis
  • ocular myasthenia gravis
  • anaphylaxis
  • urticaria
  • rash
  • angioedema
  • arthralgia
  • myalgia
  • elevated creatine phosphokinase
  • myopathy
  • increased liver aminotransferase levels
  • hepatitis
  • abdominal pain
  • thrombocytopenia
  • nausea
  • pancreatitis
  • dizziness
  • sensory disturbances
  • depression
  • headache
  • cholelithiasis
  • cholecystitis
  • drug-induced liver damage
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • eosinophilia
  • systemic drug response
  • erythema multiforme
  • fatigue
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • generalized edema
  • diabetic neuropathy
  • tremors
  • epigastric pain
  • vomiting
  • gastritis
  • dry mouth syndrome
  • discomfort in the epigastric region
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flush
  • cough
  • sputum
  • runny nose
  • limb pain
  • anemia
  • splenomegaly
  • urticaria
  • hyperhidrosis
  • rash
  • itching
  • upper respiratory infection
  • conjunctival injection
  • renal failure
  • abnormal liver function
  • increased serum creatinine
  • elevated blood pressure
  • increased blood urea nitrogen
  • elevated CPK
  • abnormal liver function test results

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best stored at room temperature, which is between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP×3], 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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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.