Medication info
Pelodion Sustained Release 5 mg (Pelodipine)

Pelodion Sustained Release 5 mg (Pelodipine)

Prescription medicationTabletOral
Ingredient · strength
Felodipine›5mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201706825 · Approved 2017.08.25 · Insurance code 693902630

Summary

Main use
Treatment of hypertension and stable angina
Who takes it
Adults · Children
Adult dose
Swallow this medicine whole with water; do not split, chew, or crush it. 1. Hypertension The initial dose is 5㎎ orally once daily, and the maintenance dose is 5-10㎎ once daily in the morning, as felodipine. Do not exceed 20㎎ daily. This medicine may be administered concomitantly with a β-blocker or diuretic. If other antihypertensive agents are unsuitable, this medicine may be used as monotherapy. 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 administered concomitantly when a β-blocker does not provide adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Consider an initial dose of 2.5㎎ once daily and administer cautiously while monitoring the patient's condition. 4. Patients with renal impairment Renal impairment does not affect felodipine plasma concentrations. No dose adjustment is required, but administer cautiously in patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment Felodipine plasma concentrations may increase in patients with hepatic impairment, and treatment response may occur at lower doses. Therefore, administer cautiously to patients with hepatic impairment, considering an initial dose of 2.5㎎ once daily; do not administer to patients with severe hepatic impairment.
Child dose
The safety and efficacy in children have not been established.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension and stable angina

  • Hypertension
  • stable angina
View approved original text

This medication is primarily used for hypertension and stable angina.

How to take

Adult dose

Swallow this medicine whole with water; do not split, chew, or crush it. 1. Hypertension The initial dose is 5㎎ orally once daily, and the maintenance dose is 5-10㎎ once daily in the morning, as felodipine. Do not exceed 20㎎ daily. This medicine may be administered concomitantly with a β-blocker or diuretic. If other antihypertensive agents are unsuitable, this medicine may be used as monotherapy. 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 administered concomitantly when a β-blocker does not provide adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Consider an initial dose of 2.5㎎ once daily and administer cautiously while monitoring the patient's condition. 4. Patients with renal impairment Renal impairment does not affect felodipine plasma concentrations. No dose adjustment is required, but administer cautiously in patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment Felodipine plasma concentrations may increase in patients with hepatic impairment, and treatment response may occur at lower doses. Therefore, administer cautiously to patients with hepatic impairment, considering an initial dose of 2.5㎎ once daily; do not administer to patients with severe hepatic impairment.

Child dose

The safety and efficacy in children have not been established.

Precautions

This medication should not be used in women who are pregnant or may become pregnant. It should also not be administered to patients with severely impaired cardiac function or acute myocardial infarction. Furthermore, it is not to be used in patients with a history of allergic reactions to this medication or certain valvular heart diseases. Patients with severe liver or kidney damage should also proceed with caution. Elderly patients or those with heart failure or hypotension should be particularly cautious when using this medication, and it should be administered with caution to patients with a history of allergies. When starting this medication or increasing the dosage, symptoms like facial flushing, headache, or a rapid heartbeat may occur, but these are usually temporary. Occasionally, side effects such as swelling, chest tightness, dizziness, nausea, constipation, or skin rash may present, and any unusual symptoms should be discussed with a doctor. Abruptly stopping this medication can worsen symptoms; thus, it should be tapered off gradually under a physician’s guidance. Since blood pressure may drop too low, it is advisable to avoid driving or operating hazardous machinery during severe dizziness. This medication is recommended to be taken in the morning on an empty stomach or after a light meal. There are many interactions with other medications, so caution is needed when taken with certain antibiotics, antifungals, heart medications, grapefruit juice, etc. Pregnant and breastfeeding women should avoid this medication or discontinue breastfeeding, and safety in pediatrics has not been established. In case of overdose, severe cardiovascular problems and neurological symptoms may occur, and immediate medical attention should be sought.

Side effects

Facial flushing, headache, palpitations, dizziness, fatigue, tachycardia, feeling of suffocation, chest tightness, ankle swelling, hypotension accompanied by tachycardia causing angina, extrasystoles, heaviness in the head, dizziness, unsteadiness, lethargy, drowsiness, anxiety, sensory disturbances, syncope due to hypotension, nausea, constipation, discomfort in the epigastric region, heartburn, abdominal pain, reduced appetite, diarrhea, thirst, vomiting, gingival hyperplasia, gingivitis, elevated AST, elevated ALT, elevated ALP, elevated LDH, elevated BUN, elevated creatinine, anemia, rash, itching, exfoliative dermatitis, skin erythema, urticaria, photosensitivity reactions, vascular edema, leukocyte-lytic vasculitis, myalgia, arthralgia, hyperglycemia, weight gain, peripheral edema, leg cramps, shoulder stiffness, weakness, hand tremors, cough, sensation of throat irritation, sweating, tears, conjunctival injection, paresthesia, elevated CPK, elevated total cholesterol, elevated triglycerides, decreased serum potassium, gynecomastia, erectile dysfunction, sexual dysfunction, frequent urination, vascular edema, fever, confusion, sleep disturbances, bradycardia, atrioventricular block, atrioventricular dissociation, ventricular extrasystoles, inadequate contraction, altered consciousness, coma, seizures, dyspnea, pulmonary edema, apnea, adult respiratory distress syndrome, acidosis, hypocalcemia, 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 an opaque container. Additionally, it is best kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Light pink round film-coated 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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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.