Medication info

Uniminoxidil Tablet

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Minoxidil›5mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White round tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202102018 · Notified 2021.03.04

This product's status changed to Approval withdrawn on 2024.09.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension (symptomatic and refractory)
Who uses it
Adults · Children
Adult dosage
For adults (12 years and older), the initial dose is 5 mg of minoxidil taken orally once daily, and the maintenance dose is divided into 10-40 mg once daily. The maximum daily dose can be up to 100 mg.
Children's dosage
For children (under 12 years old), the initial dose is 0.2 mg per kg of body weight once daily and can be increased by 50-100% until blood pressure is optimally controlled. The maintenance dose is 0.25 mg-1 mg per kg daily.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of hypertension (symptomatic and refractory)

  • Hypertension
  • refractory hypertension
View approved original text

This drug is used in the treatment of hypertension caused by symptomatic or specific organ damage, and in refractory hypertension that cannot be controlled with diuretics and two other antihypertensive agents.

Dosage and Administration

Adult dosage

For adults (12 years and older), the initial dose is 5 mg of minoxidil taken orally once daily, and the maintenance dose is divided into 10-40 mg once daily. The maximum daily dose can be up to 100 mg.

Children's dosage

For children (under 12 years old), the initial dose is 0.2 mg per kg of body weight once daily and can be increased by 50-100% until blood pressure is optimally controlled. The maintenance dose is 0.25 mg-1 mg per kg daily.

Precautions

This drug should not be administered to certain patients. In patients with pheochromocytoma, this drug may increase the amount of hormones secreted by the tumor due to its blood pressure-lowering effects, therefore it should be avoided. Patients with pulmonary hypertension due to mitral stenosis, patients with acute myocardial infarction, and those who have experienced allergic reactions to this drug should also not be administered this medication. In patients with chronic congestive heart failure, severe renal impairment, and angina, additional caution is necessary when using this drug. Using this drug may commonly lead to abnormal hair growth as a side effect. This phenomenon typically begins around the face and head and may spread to other areas of the body; when the medication is discontinued, new hair growth stops, but it takes time to return to the original condition. Also, skin rashes or blisters may occur, and severe allergic reactions should be watched for skin changes. Blood tests may show a decrease in platelet or white blood cell counts, and liver function test results may change. Electrocardiograms may show changes in the electrical signals of the heart, but in most cases, these return to normal with continued treatment. Pericardial effusion may rarely occur, particularly in patients with poor renal function. In such cases, the condition should be monitored via echocardiography, and additional treatment may be necessary as needed. Other rare side effects may include weight gain, peripheral edema, increased heart rate, gastrointestinal disturbances, breast pain, anemia, headache, nausea, and vomiting. Typically, this drug is used in conjunction with diuretics to prevent fluid retention and symptoms of heart failure, and weight and electrolyte status should be monitored regularly. Due to its vasodilatory effects, increased heart rate or angina symptoms may occur; therefore, it is common to use beta-blockers together to prevent these symptoms. Patients with decreased renal function or those undergoing dialysis may require dosage adjustments, and myocardial infarction patients should be administered after their condition is stabilized. At the beginning of treatment, it is important to regularly perform urine tests, renal function tests, electrocardiograms, chest X-rays, and echocardiograms. Caution is required when using this drug with others. In particular, concomitant use with guanethidine may cause severe hypotension; therefore, it should be avoided if possible, and if unavoidable, should be managed safely in a medical facility. Antidepressants or antipsychotics can increase the risk of hypotension, and concomitant use with corticosteroids or certain anti-inflammatory analgesics may increase fluid retention or reduce blood pressure-lowering effects. Safety has not been established during pregnancy, so use is not recommended, and during breastfeeding, there is a possibility that the drug may be passed into breast milk, so administration should be avoided or breastfeeding should be discontinued. There is limited experience with use in children, especially infants, so caution should be taken in administration. In the case of overdose, blood pressure may drop severely, so immediate medical assistance should be sought, and appropriate measures to stabilize blood pressure are necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, exudative rash, vesicular lesions, Stevens-Johnson syndrome, thrombocytopenia, leukopenia, pericardial effusion, myocardial infarction due to pericardial effusion

Mild side effects

  • Hirsutism
  • weight gain
  • peripheral vascular edema
  • increased heart rate
  • increased creatinine
  • increased BUN
  • gastrointestinal disturbances
  • rash
  • breast pain
  • gynecomastia
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  • hemolytic anemia
  • pulmonary infiltrates
  • antinuclear antibody (ANA)
  • headache
  • intermittent claudication
  • frequent menstrual cycle
  • nausea
  • vomiting

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

Storage

This drug should be stored in a tightly closed container to prevent exposure to air or light and should be kept at room temperature between 1°C and 30°C. Proper storage like this can maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 300 tablets/bottle, 500 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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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.