Diroprozijung 5/80mg (Amlodipine Besylate, Valsartan)

Adult dose

The recommended dose is 1 tablet once daily, taken with water regardless of meal. It is recommended to take it at the same time every day (e.g., in the morning). 5/80mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5mg or Valsartan 80mg. 5/160mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5mg or Valsartan 160mg.

Child dose

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

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately if pregnancy is confirmed. It should not be used in patients who are allergic to its components or in pregnant or breastfeeding women, as well as in patients with severe kidney or liver diseases. Caution should be exercised in patients with sodium or fluid depletion as there is a risk of hypotension; blood pressure and symptoms should be carefully monitored before and during treatment. If there is hyperkalemia or if concomitant medications that may increase potassium levels are being taken, potassium levels should be frequently checked. Special attention is required for patients with renal artery stenosis, kidney transplant recipients, those with a history of angioedema, and patients after heart failure or myocardial infarction. Due to its blood pressure-lowering effects, this medication may cause side effects such as dizziness, headache, hypotension, edema, and cough; consult a doctor immediately if any unusual symptoms occur. Caution is needed when driving or operating machinery as dizziness or fatigue may occur. This medication may interact with other blood pressure medications, potassium supplements, diuretics, and non-steroidal anti-inflammatory drugs (NSAIDs), so all current medications should be disclosed to a doctor or pharmacist. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women are also advised to avoid its use. Safety and efficacy have not been established for children under 18 years of age, so its use is not recommended in this population. Elderly patients can take the same dose as adults, but careful observation for symptoms or side effects is necessary. In the case of overdose, severe hypotension, dizziness, or increased heart rate may occur, so immediate medical attention should be sought.

Serious side effects

Hives, 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 cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

• Headache
• dizziness
• drowsiness
• sensory abnormalities
• lightheadedness
• tinnitus
• tachycardia
• palpitations
• syncope
• orthostatic hypotension

This medication should be stored in a tightly sealed container to protect it from air and moisture. It’s important to maintain the storage temperature between 1 to 30 degrees Celsius. This helps to ensure the medication's efficacy and safety.

Appearance

Dark yellow round film-coated tablets

Package unit

28 tablets (14 tablets/Alu-Alu pack ×2)