Medication info

Minoxidil Tablet (Minoxidil)

Prescription medicationTabletApproval withdrawn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Approval withdrawn

MFDS item code 202103531 · Notified 2021.04.30

This product's status changed to Approval withdrawn on 2024.10.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension (secondary and resistant)
Who uses it
Adults · Children
Adult dosage
Adults (12 years and older): For initial dosage, administer 5 mg of minoxidil orally once a day and for maintenance dosage, administer 10-40 mg once or twice daily. The maximum daily dosage can be up to 100 mg. Dosing frequency: If the guided pressure reduction is less than 30 mmHg, one administration per day is acceptable; if it is 30 mmHg or more, split the dose into two administrations daily. Dosing adjustment: The dosage should be adjusted based on patient response.
Children's dosage
Pediatric (under 12 years old): For initial dosage, administer 0.2 mg per kg of body weight once a day and may increase by 50-100% until blood pressure is adjusted to the optimal state. For maintenance dosage, administer 0.25 mg-1 mg per kg of body weight once daily.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Treatment of hypertension (secondary and resistant)

  • Hypertension
  • resistant hypertension
View approved original text

This medication is used for hypertension caused by symptoms or specific organ damage. It also helps in the treatment of resistant hypertension that does not respond to the combination of two or more diuretics and antihypertensives. Therefore, this drug is effectively utilized in the management of complex hypertension.

Dosage and Administration

Adult dosage

Adults (12 years and older): For initial dosage, administer 5 mg of minoxidil orally once a day and for maintenance dosage, administer 10-40 mg once or twice daily. The maximum daily dosage can be up to 100 mg. Dosing frequency: If the guided pressure reduction is less than 30 mmHg, one administration per day is acceptable; if it is 30 mmHg or more, split the dose into two administrations daily. Dosing adjustment: The dosage should be adjusted based on patient response.

Children's dosage

Pediatric (under 12 years old): For initial dosage, administer 0.2 mg per kg of body weight once a day and may increase by 50-100% until blood pressure is adjusted to the optimal state. For maintenance dosage, administer 0.25 mg-1 mg per kg of body weight once daily.

Precautions

This medication should not be used in patients with specific diseases. For example, patients with a rare tumor called pheochromocytoma, those with pulmonary hypertension due to mitral stenosis, acute myocardial infarction patients, and those with hypersensitivity to the drug should not be treated with it. Use with caution in patients with chronic congestive heart failure, severe renal failure, and angina pectoris, as these patients should be administered under strict medical supervision. This medication may cause abnormal excessive hair growth (hypertrichosis), which primarily starts around the face and scalp and may spread throughout the body. This phenomenon gradually disappears after discontinuation of the drug but may take several months for complete recovery. Children and women, in particular, should be adequately informed about these side effects. Skin rashes or allergic reactions may occur, and blood tests may reveal reduced platelet or white blood cell counts. Electrocardiograms may show changes in the heart's electrical signals, but this rarely results in significant clinical issues. Rarely, pericardial effusion, which is the accumulation of fluid around the heart, may occur and is more frequent in patients with reduced kidney function and should be observed carefully. This drug is often used in combination with diuretics to prevent the accumulation of body fluids and salts; as heart rate may increase, it can be combined with heart medications as needed. In patients with impaired kidney function, dosage adjustment is necessary, and it is safe to administer only when stabilized after myocardial infarction. In the initial stages of treatment, regular monitoring through urinalysis, renal function tests, ECG, chest X-rays, and echocardiograms is required. This drug can interact with other medications; therefore, caution is needed when used concurrently with guanethidine, antidepressants, antipsychotics, corticosteroids, and non-steroidal anti-inflammatory drugs. During pregnancy, safety has not been established, so it should be avoided, and while breastfeeding, either administration should be avoided or breastfeeding should be discontinued. There is limited experience using this medication in children or newborns, and it should be administered with extra caution. If this drug is overdosed, immediate consultation with healthcare professionals is necessary, and interventions to maintain blood pressure and facilitate urine excretion may be required. Some sympathomimetics should be avoided as they can stress the heart if overdosed.

Side effects and when to seek care immediately

Serious side effects

  • Vesicular lesions and mucocutaneous syndrome (Stevens-Johnson syndrome) → severe skin adverse reactions
  • Pericardial effusion and ischemia → severe swelling or urinary abnormalities

Mild side effects

Hypertrichosis, exudative rashes, vesicular lesions, mucocutaneous syndrome, thrombocytopenia, leukopenia, decreased hematocrit, decreased hemoglobin, decreased red blood cells, increased ALP, changes in ECG T wave direction and amplitude, pericardial effusion, increased heart rate, elevated creatinine, elevated BUN, gastrointestinal disturbances, rash, breast pain, gynecomastia, hemolytic anemia, pulmonary infiltration, increased antinuclear antibodies, headache, intermittent claudication, frequent menstruation, nausea

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is best to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White round tablets

Package unit

30 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.