Medication info

Intro Minoxidil Tablet

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202103847 · Notified 2021.05.14

This product's status changed to Approval withdrawn on 2024.10.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension (symptomatic, resistant)
Who takes it
Adults · Children
Adult dose
For adults (12 years and older), the dose of minoxidil is 5 mg once daily as the initial dose, and the maintenance dose is 10-40 mg divided into 1-2 doses per day. The maximum dose is 100 mg per day. The frequency of administration depends on the reduction in blood pressure; if the drop is less than 30 mmHg, it can be given once a day, whereas if it is over 30 mmHg, it should be given twice a day. The dosage can be adjusted based on the patient's response.
Child dose
For children (under 12 years), the initial dose is 0.2 mg per kg of body weight once daily, and the dose can be increased by 50-100% until blood pressure is at optimal levels. The maintenance dose is 0.25 mg per kg of body weight.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment of hypertension (symptomatic, resistant)

  • Hypertension
  • resistant hypertension
View approved original text

This medication is used to treat symptomatic hypertension or hypertension caused by specific organ damage, as well as resistant hypertension that does not respond to diuretics and two other antihypertensives.

How to take

Adult dose

For adults (12 years and older), the dose of minoxidil is 5 mg once daily as the initial dose, and the maintenance dose is 10-40 mg divided into 1-2 doses per day. The maximum dose is 100 mg per day. The frequency of administration depends on the reduction in blood pressure; if the drop is less than 30 mmHg, it can be given once a day, whereas if it is over 30 mmHg, it should be given twice a day. The dosage can be adjusted based on the patient's response.

Child dose

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

Precautions

This medication should not be used in patients with certain conditions. For example, it should not be given to patients with pheochromocytoma, a rare tumor, as it may lower blood pressure while increasing the secretion of substances from the tumor. It should also be avoided in patients with pulmonary hypertension due to mitral stenosis, those who have had an acute myocardial infarction, and those who have had allergic reactions to this drug. Caution should be taken in patients with chronic congestive heart failure, severely reduced kidney function, and angina. These patients require closer monitoring of the drug's effects. This medication may commonly cause abnormal hair growth as a side effect. This phenomenon usually starts within 3 to 6 weeks, with hair increasing on the face and body. If the medication is discontinued, new hair growth will stop, but it may take several months to return to baseline. Special care should be given to inform children and women about this side effect in advance. Skin rashes or allergic reactions may also occur, and blood tests may show a decrease in platelet or white blood cell count. Changes may occur in cardiac electrical signals, but most will resolve with continued treatment and will not cause significant cardiac issues. Rarely, pericardial effusion may occur, particularly in patients with poor kidney function. In such cases, additional testing is needed, and if symptoms are severe, discontinuation of the medication may be considered. This medication is typically used alongside diuretics to prevent fluid retention and congestive heart failure. Weight and fluid status should be monitored regularly, and diuretics adjusted as necessary. Because of its vasodilatory effect, it may cause increased heart rate or symptoms of angina, which should be controlled with other medications. Patients with kidney failure or those on dialysis may require a dose reduction, and treatments for myocardial infarction should only be given after the condition stabilizes. Regular examinations such as urinalysis, kidney function tests, ECG, chest X-ray, and echocardiography are required in the early stages of treatment. This medication may interact with other drugs; therefore, caution is advised when used in combination with guanethidine, certain antidepressants, antipsychotics, corticosteroids, and anti-inflammatory pain relievers. The risk of side effects such as hypotension or fluid retention may increase with these medications. Safety during pregnancy has not been established, and use should be avoided. Breastfeeding should also be avoided if possible; if necessary, breastfeeding should be discontinued. There is limited experience with the use of this medication in children or neonates, so caution should be exercised. In case of overdose, intravenous normal saline may be used to support blood pressure maintenance and urination, while sympathomimetics that may put stress on the heart should be avoided. Professional treatment may be necessary as required.

Side effects and when to seek care immediately

Serious side effects

  • Exudative rash
  • vesicular lesions
  • Stevens-Johnson syndrome
  • thrombocytopenia
  • leukopenia
  • pericardial effusion and infarction
  • myocardial infarction
  • worsening heart failure
  • worsening renal failure
  • severe edema
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  • increased blood pressure
  • severe allergic reactions

Mild side effects

Hirsutism, hair growth and thickening, pigmentation increase, headache, frequent menstruation, nausea, vomiting, gastrointestinal disturbances, rash, breast pain, gynecomastia, hemolytic anemia, pulmonary infiltrates, increased antinuclear antibody, changes in ECG T waves, weight gain, peripheral vascular edema, increased heart rate, transient elevations of creatinine and BUN

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

Storage

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. Also, it is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

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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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.