Kvarban Tablets 5/80 mg

Adult dose

This medication is administered only to adults, and the dosage should be individualized based on the effectiveness and tolerability of Valsartan/Rosuvastatin for each patient. ◆ Valsartan 1. Essential Hypertension - Take with water during meals or between meals. - It is recommended to take the medication at the same time every day (e.g., in the morning). - The recommended oral dose is 80 mg once daily. - If blood pressure is not well controlled, the dose can be increased to 160 mg once daily. If additional blood pressure reduction is needed, the dose may be increased to a maximum of 320 mg per day. 2. Elderly patients (over 75 years old): Begin treatment at 40 mg once daily. 3. Patients with renal impairment: (1) Creatinine clearance 20 to 50 mL/min: No dose adjustment is necessary. (2) Creatinine clearance 10 to 20 mL/min: Start with 40 mg once daily. (3) Creatinine clearance less than 10 mL/min and dialysis patients: Do not administer this medication. 4. Patients with volume depletion: For patients with volume depletion (e.g., unable to reduce dose due to high-dose diuretic use), start with 40 mg once daily. 5. Patients with liver impairment: For mild to moderate liver impairment, initiate treatment at 40 mg once daily and do not exceed 80 mg per day. This medication should not be given to patients with severe liver impairment, liver cirrhosis, or cholestasis. 6. Pediatric patients: Safety and efficacy have not been established in children (under 18 years of age). 2. Heart Failure Adults: The starting dose is recommended at 40 mg orally twice daily, with the option to increase to 80 mg or 160 mg per dose. When used in conjunction with diuretics, consider reducing the diuretic dose. The maximum daily dose is divided into two doses totaling 320 mg. This medication is not recommended for triple therapy with ACE inhibitors and beta-blockers. 3. Decrease risk of death following myocardial infarction Adults: Treatment may start within 12 hours after the onset of myocardial infarction. The recommended starting dose is 20 mg orally twice daily, which may be increased to 40 mg, 80 mg, or 160 mg twice daily over weeks, considering patient tolerability. Consider dose reduction if symptoms of hypotension or renal failure occur. This medication may also be administered to patients currently being treated with other therapies (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statin medications). However, concurrent use with ACE inhibitors is not recommended. 4. For patients with renal impairment: If creatinine clearance is above 10 mL/min, no dose adjustment is necessary, but there is no experience using in patients with creatinine clearance below 10 mL/min or dialysis patients, and this medication should not be administered. 5. For patients with liver impairment: The daily dosing of this medication in patients with mild to moderate liver impairment should not exceed 80 mg. When doses above 80 mg are administered, the benefits of dosing adjustments should be weighed against the risks. This medication should not be given to patients with severe liver impairment, cirrhosis, or cholestasis. 6. Pediatric patients: Safety and efficacy have not been established in children (under 18 years of age). ◆ Rosuvastatin 1. Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia type IIa), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III) and homozygous familial hypercholesterolemia Patients should follow a standard cholesterol-lowering diet before and during treatment and must maintain it throughout the period. This medication can be administered at any time during the day regardless of meals. The initial dosing is 5 mg once daily, and if further LDL cholesterol reduction is needed, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 mg once daily, and most patients are managed at this dose. The maintenance dose may be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient responses every 4 weeks or longer, with a maximum increase up to 20 mg once daily. 2. Elderly: No dose adjustment is necessary. 3. Patients with renal failure: There is no need to adjust doses in patients with mild to moderate renal failure. Do not administer to patients with severe renal failure. Special care should be taken when administering 20 mg to patients with moderate renal failure. 4. Patients with liver failure: No increased systemic exposure of rosuvastatin has been observed in patients with Child-Pugh scores of 7 or less, but systemic exposure increased in patients with scores of 8 or 9. Renal function testing should be considered in these patients. There is no experience with administration in patients with Child-Pugh scores greater than 9. This medication should not be given to patients with active liver disease. 5. Race: Systemic exposure to this medication is increased in Asian patients, so the recommended starting dose is 5 mg. The 40 mg dosing is contraindicated. 6. Patients susceptible to myopathy: The recommended starting dose for patients prone to myopathy is 5 mg. In some of these patients, the 40 mg dose is contraindicated. For patients taking Valsartan and Rosuvastatin together, this medication (a combination with the same main ingredient content) may be converted for convenience.

Child dose

Safety and efficacy have not been established in children (under 18 years of age), hence it is not administered.

This medication may cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Women of childbearing potential or nursing mothers should not take this medication and should use appropriate contraceptive methods. It is not safe for patients with severely impaired liver or kidney function, muscle diseases, or certain liver diseases to take this medication. Elderly patients or those with high serum potassium levels or impaired liver function should use this medication with particular caution, and regular blood tests and physical condition checks are necessary. This medication may cause muscle pain, muscle weakness, and, rarely, severe muscle damage (rhabdomyolysis), so any unusual symptoms in the muscles should be reported to the medical staff immediately. Furthermore, side effects such as liver dysfunction, allergic reactions, low blood pressure, and hyperkalemia may occur, so immediate consultation with a doctor is advisable if symptoms appear. This medication may interact with other medications, so if you are currently taking any other medicines, be sure to inform your doctor or pharmacist. In case of overdose, severe hypotension or altered consciousness may occur, so you must adhere strictly to the dosage and visit a medical institution immediately if an overdose occurs. Store in a place out of reach of children and do not transfer to another container.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress with coughing + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

Dyspepsia, nausea, chest discomfort, dizziness, headache, conjunctival hemorrhage, constipation, asthenia, chest pain, facial swelling, peripheral edema, nasopharyngitis, urinary tract infection, bruise, increased serum aminotransferases (AST, ALT), increased serum creatinine phosphokinase, increased serum potassium, increased gamma-glutamyl transferase, musculoskeletal stiffness, limb pain, sensory disturbance, anxiety, upper respiratory infection, pharyngitis, tonsillitis,

This medication is sensitive to light, so it should be stored in a special container that blocks light. Additionally, to maintain the effectiveness of the medication, it should be stored at room temperature, between 1°C and 30°C.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP x 3)]