Medication info
Peloden Sustained Release (Felodipine)

Peloden Sustained Release (Felodipine)

Prescription medicationTabletOral
Ingredient · strength
Felodipine›5mg / 1 tablet
Manufacturer / importer
Kips Biopharma Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200503731 · Approved 2005.05.19 · Insurance code 693200430

Summary

Main use
Treatment of hypertension and stable angina
Who takes it
Adults · Children
Adult dose
Swallow this medicine whole with water. Do not divide, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ once daily, taken orally in the morning. Do not exceed a maximum daily dose of 20㎎. This medicine may be administered concomitantly with a β-blocker or diuretic, and may be used as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5㎎ once daily and may be increased to 10㎎ if necessary. This medicine may be used concomitantly when a β-blocker alone does not provide an adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but administer with caution to patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment The plasma concentration of felodipine may increase in patients with hepatic impairment, and they may respond to treatment at lower doses. Therefore, administer with caution to patients with hepatic impairment, considering an initial dose of 2.5mg once daily; do not administer to patients with severe hepatic impairment.
Child dose
The safety and efficacy of this medicine in children have not been established.

Ingredients

Manufacturer
Kips Biopharma Co., Ltd.

Efficacy & effects

Treatment of hypertension and stable angina

  • Hypertension
  • stable angina
View approved original text

This medication is used for the treatment of hypertension and stable angina.

How to take

Adult dose

Swallow this medicine whole with water. Do not divide, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ once daily, taken orally in the morning. Do not exceed a maximum daily dose of 20㎎. This medicine may be administered concomitantly with a β-blocker or diuretic, and may be used as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5㎎ once daily and may be increased to 10㎎ if necessary. This medicine may be used concomitantly when a β-blocker alone does not provide an adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but administer with caution to patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment The plasma concentration of felodipine may increase in patients with hepatic impairment, and they may respond to treatment at lower doses. Therefore, administer with caution to patients with hepatic impairment, considering an initial dose of 2.5mg once daily; do not administer to patients with severe hepatic impairment.

Child dose

The safety and efficacy of this medicine in children have not been established.

Precautions

This medication is not recommended for use by pregnant women or women who may become pregnant. It should also not be administered to patients with cardiogenic shock due to rapidly deteriorating cardiac function or patients with heart valve issues. Patients with severe liver or kidney damage, as well as those with acute myocardial infarction or unstable angina, are also advised against using this medication. Patients with certain genetic metabolic disorders such as lactose intolerance should not take this medication. Elderly patients or those with heart failure, hypotension, or liver and kidney dysfunction should use this medication with extreme caution. Initial administration or when increasing the dose may cause temporary symptoms such as flushing, headache, palpitations, dizziness, and fatigue. This medication has a strong hypotensive effect, so there is a risk of dizziness or fainting due to excessive lowering of blood pressure, and caution should be exercised. Care should be taken while driving or operating dangerous machinery to avoid accidents caused by dizziness. It is preferable to take this medication in the morning, and it can be taken on an empty stomach or after a light meal. Co-administration with other blood pressure medications or certain antibiotics, antifungals, anticonvulsants, etc., may alter the effectiveness of the drugs, so it is crucial to consult with a doctor or pharmacist. Especially, taking it with grapefruit juice can increase drug concentration and a higher risk of side effects, so it should be avoided. Pregnant or breastfeeding women are advised to avoid taking this medication, and if absolutely necessary, it is safest to discontinue breastfeeding. The safety for children has not been established, and there is insufficient experience with its use. In cases of overdose, severe hypotension, cardiac arrhythmias, decreased consciousness, seizures, and other serious symptoms may occur, requiring immediate medical attention. Abruptly discontinuing this medication may worsen symptoms; therefore, doses should be gradually reduced according to a doctor’s instructions.

Side effects

Facial flushing, headache, palpitations, dizziness, fatigue, tachycardia, feeling of suffocation, chest tightness, ankle swelling, hypotension accompanied by tachycardia that causes angina, extrasystoles, heaviness in the head, dizziness, staggering, lethargy, drowsiness, agitation, sensory disturbances, fainting, nausea, constipation, gastric discomfort, heartburn, abdominal pain, loss of appetite, diarrhea, thirst, vomiting, gingival hypertrophy symptoms, gingivitis, elevated AST, elevated ALT, elevated ALP, elevated LDH, elevated BUN, increased creatinine, anemia, rash, itching, exfoliative dermatitis, skin flush erythema, urticaria, photosensitivity reactions, lip swelling, tongue swelling, vascular edema, leukocyte destructive vasculitis, myalgia, arthralgia, hyperglycemia, weight gain, peripheral edema, leg cramps, shoulder stiffness, weakness, finger tremors, cough, throat irritation, sweating, tearing, conjunctival injection, paresthesia, elevated CPK, elevated total cholesterol, elevated triglycerides, decreased serum potassium, gynecomastia, erectile dysfunction, sexual dysfunction, increased urination, angioedema, fever, confusion, sleep disorders, hypothermia, nausea

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

Storage

This medication is sensitive to light, so it should be stored in a tightly sealed container that blocks light. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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.