Medication info

Rotenal 50 mg (Atenolol)

Prescription medicationApproval withdrawn
Ingredient · strength
Atenolol›Strength being verified
Manufacturer / importer
일동제약(주)
Appearance
It is a white round film-coated tablet.
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 198600233 · Notified 1986.12.22

This product's status changed to Approval withdrawn on 2023.07.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypertension and angina
Who uses it
Adults
Adult dosage
1. Hypertension: The initial dose for adults is 50 mg once daily, administered alone or in combination with a diuretic orally. If no effect is observed, the dose may be increased to 100 mg once daily. Do not exceed 100 mg per day. 2. Angina: Administer 100 mg daily in 1-2 divided doses, and do not exceed 100 mg per day. 3. In patients with renal impairment: Depending on creatinine clearance, 15-35 mL/min/1.73 m² is 50 mg daily, 15 mL/min

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement of hypertension and angina

  • Hypertension
  • angina
View approved original text

This medication is used for hypertension and angina.

Dosage and Administration

Adult dosage

1. Hypertension: The initial dose for adults is 50 mg once daily, administered alone or in combination with a diuretic orally. If no effect is observed, the dose may be increased to 100 mg once daily. Do not exceed 100 mg per day. 2. Angina: Administer 100 mg daily in 1-2 divided doses, and do not exceed 100 mg per day. 3. In patients with renal impairment: Depending on creatinine clearance, 15-35 mL/min/1.73 m² is 50 mg daily, 15 mL/min

Precautions

This medication should not be used by individuals allergic to the active ingredient or excipients. It should not be administered to patients with severe bronchial asthma or chronic lung disease. This medication may pose risks to patients with diabetic ketoacidosis or metabolic acidosis. It should not be used in patients with very slow heart rates (bradycardia) or cardiac conduction disorders. Patients with cardiogenic shock or heart failure due to pulmonary hypertension or congestive heart failure should avoid this medication. It is unsuitable for patients with severe hypotension or significant peripheral vascular disease. Caution is required for patients at risk of thyroid storm due to thyroid dysfunction. It should not be used in untreated chromaffin cell tumor patients. In patients with bronchial asthma or those at risk of bronchospasm, bronchodilators should be used concomitantly with this medication, and careful monitoring is necessary. Patients at risk of heart failure should be carefully monitored while on this medication. Diabetic patients must closely manage their blood sugar, as symptoms of hypoglycemia may be masked. Dose adjustments and cautious administration are required for patients with significantly impaired liver or kidney function. Elderly patients should start at a low dose and be monitored closely. This medication can cause various side effects; if rash, itching, dry eyes or vision changes, heart rate changes, mental changes, digestive disturbances, or breathing difficulties occur, notify your provider immediately and discontinue use. Regular monitoring of cardiac function, blood pressure, and pulse is critical during long-term use, as abrupt discontinuation may worsen heart disease; tapering is recommended. Patients scheduled for surgery should stop this medication 24 hours prior and inform the anesthesiologist of its use. Caution is needed when driving or operating machinery due to potential side effects like dizziness. This medication has many interactions with other drugs, especially antihypertensives, antidiabetic drugs, heart medications, and anesthetics; consult with a physician or pharmacist before use. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus or neonate before using this medication. Safety in pediatric patients has not been established; use caution when administering to children. In case of overdose, symptoms like decreased heart rate, heart failure, hypotension, bronchospasm, or hypoglycemia may occur, and immediate medical attention is required. Store this medication out of reach of children and avoid exposure to temperatures above 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • vascular edema
  • chest tightness
  • respiratory distress
  • bronchospasm
  • asthma attacks
  • rare bronchial spasm
  • palpitations
  • bradycardia
  • atrioventricular block
Show 13 more
  • sinus block
  • heart failure
  • hypotension
  • headache
  • disturbances of consciousness
  • confusion
  • visual disturbances
  • paralysis
  • thrombocytopenia
  • respiratory distress
  • hepatotoxicity (including cholestasis)
  • general edema
  • severe edema.

Mild side effects

  • Rash
  • itching
  • decreased tear production
  • blurred vision
  • dry eyes
  • bradycardia
  • cold extremities
  • palpitations
  • increased heart size
  • chest tightness
Show 26 more
  • hypotension
  • cold sensations in limbs
  • orthostatic hypotension
  • leg pain
  • confusion
  • mood changes
  • nightmares
  • mental disturbances
  • hallucinations
  • sleep disorders
  • heavy feeling in the head
  • dizziness
  • orthostatic dysregulation
  • insomnia
  • drowsiness
  • ringing in the ears
  • ear pain
  • fatigue
  • weakness
  • lethargy
  • headache
  • sensory abnormalities
  • gastrointestinal disturbances
  • thirst
  • nausea
  • vomiting

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture ingress. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

It is a white 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

No questions yet.

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.