Staphorize 10/160 mg

Adult dose

The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time daily (e.g., morning) if possible. Dose adjustments can be considered for individual components (amlodipine or valsartan) when blood pressure is not adequately controlled. The administration of dosages can be made in 5/80 mg, 5/160 mg, or 10/160 mg forms depending on the case. Patients with kidney impairment: For those with mild to moderate kidney impairment (creatinine clearance above 10 mL/min), no dose adjustment is necessary, but severe kidney impairment (creatinine clearance below 10 mL/min) and dialysis patients should not take this medication. Moderate kidney impairment patients are recommended to monitor potassium and creatinine levels.

Child dose

Safety and efficacy in patients under 18 years of age have not been established, so administration of this medication is not recommended.

This medication can cause serious damage to the fetus and newborn if taken during the second and third trimester of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Individuals allergic to the active ingredients or similar class medications should not use this product. This medication should not be taken by women who are pregnant or may become pregnant, or by nursing mothers. Patients with severe kidney impairment or very poor liver function should not take this medication. Diabetic patients or individuals with moderate to severe kidney impairment are advised against using this medication in conjunction with specific drugs. Patients with a history of angioedema or those who have had symptoms of angioedema should also avoid this medication. This medication is not administered to patients with severe aortic stenosis or in a state of shock. Patients who are deficient in sodium or fluids should restore their condition before taking this medication, and blood pressure and symptoms should be closely monitored during treatment. Patients with high potassium levels should frequently check their potassium levels when taking this medication with potassium supplements or drugs that can increase potassium levels. Patients with renal artery stenosis should be cautious, as kidney function may deteriorate during treatment with this medication. Recently transplanted kidney patients should not take this medication as its safety has not been confirmed. If symptoms of angioedema occur during treatment with this medication, it should be discontinued immediately and not readministered. Patients who have had heart failure or myocardial infarction should regularly monitor kidney function and blood pressure while taking this medication, as there is a risk of heart failure worsening. In cases of acute myocardial infarction, caution is advised as symptoms of angina or myocardial infarction can worsen upon starting or increasing the dose of this medication. Patients with aortic and mitral valve stenosis and hypertrophic obstructive cardiomyopathy require special caution when taking this medication. This medication is not recommended to be used in combination with other renin-angiotensin-aldosterone system drugs, as the risk of hypotension, hyperkalemia, and kidney function deterioration significantly increases. Patients with mildly impaired liver function may need dose adjustments for this medication. Various side effects, including headaches, dizziness, drowsiness, sensory disturbances, vertigo, tinnitus, tachycardia, palpitations, orthostatic hypotension, hypotension, cough, throat and larynx pain, diarrhea, nausea, abdominal pain, constipation, thirst, rashes, erythema, sweating, itching, joint swelling, back pain, arthritis, muscle cramps, lethargy, polyuria, diuresis, erectile dysfunction, swelling, lymphedema, facial swelling, peripheral edema, fatigue, flushing, weakness, and facial flushing, may occur while taking this medication; if symptoms are severe or persistent, consult with a doctor. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised. In cases of overdose, severe hypotension or cardiac dysfunction may occur, and immediate medical attention is required. This medication is not recommended for patients under 18 years of age, as its safety and efficacy have not been sufficiently confirmed.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling of the skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and changes in urination.

Mild side effects

• Headache
• dizziness
• drowsiness
• sensory disturbances
• vertigo
• tinnitus
• tachycardia
• palpitations
• orthostatic hypotension
• hypotension

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication and prevents degradation.

Appearance

Bright yellow rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 2)