Medication info
Sintexpin Tablet 5 mg (Amlodipine Besilate)

Sintexpin Tablet 5 mg (Amlodipine Besilate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201905298 · Approved 2019.07.25 · Insurance code 623005260

Summary

Main use
Treatment of myocardial ischemia due to hypertension and angina (stable and variant) and reduction of hospitalization risk for angina
Who takes it
Adults
Adult dose
Adults: Amlodipine 5 mg orally once daily, can be increased up to a maximum of 10 mg per day based on the patient's response. Adjust according to age and symptoms.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and angina (stable and variant) and reduction of hospitalization risk for angina

  • Hypertension
  • fixed occlusion of coronary arteries
  • coronary artery spasm
  • vasoconstriction
  • myocardial ischemia
  • angina
View approved original text

This medication is used for hypertension and stable angina, as well as myocardial ischemia due to variant angina caused by vascular spasms. Additionally, it helps reduce the risk of hospitalization due to angina in patients confirmed with coronary artery disease who do not have heart failure and have a cardiac output of 40% or more, as well as reducing the risks associated with coronary artery revascularization. This medication is effectively used to improve cardiovascular diseases.

How to take

Adult dose

Adults: Amlodipine 5 mg orally once daily, can be increased up to a maximum of 10 mg per day based on the patient's response. Adjust according to age and symptoms.

Precautions

This medication should not be administered to certain patients. It should not be used in individuals who are allergic to this medication or similar drugs, those who are breastfeeding, patients with severe liver dysfunction, those with severe heart valve disease, and patients in a state of shock. Furthermore, it should be used with caution in patients with severe hypotension, those with very poor kidney function requiring dialysis, elderly patients, and women who are pregnant or may become pregnant. Various side effects may occur when taking this medication. The most common side effects include flushing, fatigue, swelling, palpitation, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, very low blood pressure, vasculitis, neurological abnormal symptoms, erectile dysfunction, gynecomastia, dyspepsia, weight changes, skin rash, hair loss, and allergic reactions may occur. Cardiac-related adverse reactions have also been reported rarely, and there may be blood pressure drop or cardiac rhythm irregularities, so caution is required. Patients with heart failure and poor liver function must be more careful when using this medication, and after discontinuation, blood pressure may drop gradually, so caution is needed when used with other antihypertensives. This medication is unlikely to significantly impair driving or machine operation abilities. Interactions may occur when taken with other medications, particularly when combined with specific antibiotics, antihypertensives, analgesics, grapefruit juice, etc.; consultation with a physician or pharmacist is advised. The safety of this medication during pregnancy or lactation has not been established, so it should be avoided if possible or used only when necessary, and breastfeeding should be discontinued. In children, some doses have shown hypotensive effects, but the safety and efficacy in children under 6 years of age are not known. In case of overdose, severe hypotension and heart problems may occur; immediate medical treatment is necessary. In emergency situations, continuous monitoring of blood pressure and heart condition and appropriate action should be taken. This medication is known to pose no risk of carcinogenicity or genetic mutations and is considered safe for long-term use.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • yellowing of the skin or eyes (jaundice)
  • extreme lethargy
  • toxic epidermal necrolysis
  • angioedema
  • erythema multiforme
  • hepatitis
  • jaundice
Show 3 more
  • severe allergic reactions
  • severe skin reactions
  • liver abnormalities (jaundice)

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitation
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 25 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • syncope
  • taste alterations
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia (gastritis)
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • weakness

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 300 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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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.