Medication info

Medicam Minoxidil Tablets (Minoxidil)

Prescription medicationTabletApproval withdrawn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Approval withdrawn

MFDS item code 202105435 · Notified 2021.07.19

This product's status changed to Approval withdrawn on 2024.01.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension (secondary, 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 ranges from 10 to 40 mg per day divided into 1-2 doses. The maximum dose per day is 100 mg. The frequency of administration may depend on the reduction in supine blood pressure; it can be given once daily or split into two doses depending on the patient's response. If necessary, the dosage can be adjusted every 6 hours.
Children's dosage
For children (12 years and younger), the initial dose is 0.2 mg per kg of body weight once daily, and it can be increased by 50-100% until blood pressure is optimally controlled. For maintenance, the dose is 0.25 mg-1 mg per kg of body weight once daily.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Treatment of hypertension (secondary, refractory)

  • Hypertension
  • refractory hypertension
View approved original text

This medication is used to treat hypertension caused by secondary causes or target organ damage, and refractory hypertension that does not respond to a diuretic and two types of 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 ranges from 10 to 40 mg per day divided into 1-2 doses. The maximum dose per day is 100 mg. The frequency of administration may depend on the reduction in supine blood pressure; it can be given once daily or split into two doses depending on the patient's response. If necessary, the dosage can be adjusted every 6 hours.

Children's dosage

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

Precautions

This medication should not be used in certain patients. For example, patients with pheochromocytoma may experience a dangerous increase in catecholamine secretion from the tumor due to the blood pressure-lowering effects of this medication. Additionally, it should not be taken by patients with pulmonary hypertension due to mitral stenosis, patients who have had an acute myocardial infarction, or those who are hypersensitive to this medication. Patients with chronic congestive heart failure, severe renal failure, and angina should use this medication cautiously, as they may be more sensitive to its effects or side effects. One of the most common side effects of this medication is hypertrichosis, which can occur in about 80% of patients, leading to increased body hair or darkening of hair. This usually starts within 3 to 6 weeks after administration and can spread to other areas of the face and body. Stopping the medication halts new hair growth, but it may take 1 to 6 months to return to the original state. Additionally, skin rashes or blisters may occur, and in severe cases, serious allergic reactions such as Stevens-Johnson syndrome may arise. In the blood, reductions in platelet or white blood cell counts may occur, and hematocrit, hemoglobin, and red blood cell levels may temporarily decrease. Liver function tests may also show changes. Electrocardiograms often show changes in the shape and size of T waves, but these changes generally resolve with continued treatment and do not cause significant issues with heart function. Rarely, pericardial effusion may occur, particularly in patients with poor renal function. In such cases, echocardiography may be required, and discontinuation of the medication or additional treatment may be necessary. Other reported side effects include weight gain, peripheral vascular edema, increased heart rate, gastrointestinal disturbances, rash, breast pain, gynecomastia, antinuclear antibodies (ANA), intermittent claudication, frequent menstruation, peripheral vascular edema, increased heart rate, and temporary elevations in creatinine and BUN.

Side effects and when to seek care immediately

Serious side effects

  • Exudative rash, vesicular lesions, skin-mucosa syndrome (Stevens-Johnson syndrome) → severe skin adverse reactions
  • Thrombocytopenia, leukopenia (WBC < 3000/mm2) → blood abnormalities
  • Pericardial effusion and myocardial infarction → cardiac problems
  • Electrocardiographic abnormalities (T wave direction and amplitude changes, large negative amplitude) → heart abnormalities
  • Severe edema associated with weight gain.

Mild side effects

Hypertrichosis, hair growth, densification, pigmentation, hair growth between eyebrows and between head and eyebrows or on the upper cheeks, headache, nausea, vomiting, gastrointestinal disturbances, rash, breast tenderness, gynecomastia, antinuclear antibodies (ANA), intermittent claudication, frequent menstruation, peripheral vascular edema, increased heart rate, temporary elevations in creatinine and BUN.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature between 1 and 30 degrees Celsius, as this will help maintain its efficacy and safety.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 500 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.