Medication info
Sardipin Tablets 5/80 mg

Sardipin Tablets 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Dark yellow round film-coated tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201506507 · Approved 2015.09.11 · Insurance code 649506940

Summary

Main use
Improvement in blood pressure control of essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, to be taken with water, regardless of meals. It is advisable to take this at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, dosage adjustment is not necessary; however, it should not be administered to patients with severe renal impairment or those on dialysis. For patients with mild to moderate hepatic impairment, the daily dosage of valsartan should not exceed 80 mg.
Child dose
The safety and efficacy for pediatric patients under 18 years of age have not been established; therefore, the use of this drug is not recommended.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement in blood pressure control of essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension who are not adequately controlled on monotherapy with amlodipine or valsartan. It effectively lowers blood pressure, helping to reduce the risk of complications and improve health.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, to be taken with water, regardless of meals. It is advisable to take this at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, dosage adjustment is not necessary; however, it should not be administered to patients with severe renal impairment or those on dialysis. For patients with mild to moderate hepatic impairment, the daily dosage of valsartan should not exceed 80 mg.

Child dose

The safety and efficacy for pediatric patients under 18 years of age have not been established; therefore, the use of this drug is not recommended.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be used in patients with allergies to any of its ingredients or similar substances, pregnant or nursing women, and patients with severe renal or liver impairment. Patients with low sodium or fluid levels in the body should optimize their condition before starting this medication, and careful monitoring is required as hypotension may occur. In patients with high potassium levels or those taking medications that can raise potassium levels, potassium levels should be frequently monitored. Patients with renal vascular problems or those who have recently received a kidney transplant should closely monitor kidney function while using this medication. If symptoms of angioedema, such as swelling of the face, lips, or tongue occur during treatment, the medication should be discontinued immediately. Patients with heart failure or post-myocardial infarction should closely observe kidney function during treatment with this medication, as hypotensive symptoms may occur, requiring cautious use. This medication may cause dizziness or fatigue when driving or operating machinery; caution is advised during such activities. If blood pressure drops too low suddenly during treatment, the patient should be laid down and emergency treatment such as administering saline may be required. When combined with certain other medications, the effectiveness of blood pressure control may be reduced or kidney function may be affected; discuss any medications being taken with a physician. Women who are pregnant or planning to become pregnant should avoid this medication, and nursing mothers are advised to avoid its use as well. Its safety and efficacy in children under 18 years old have not been sufficiently established, thus it is not recommended for use in this population. For the elderly, it can be administered at the same dosage as adults, but careful monitoring of their physical status is necessary. In the event of overdose, dizziness and severe hypotension may occur. Immediate medical attention should be sought if these symptoms develop.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound fatigue, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbance
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasopharyngitis
  • influenza

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

Storage

This medication should be stored in a tightly closed container to protect it from air or moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

Dark yellow round film-coated tablets

Package unit

30 tablets (10 tablets/PTP 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.