Medication info
Mizartan Plus Tablet 80/12.5 mg (Telmisartan, Hydrochlorothiazide)

Mizartan Plus Tablet 80/12.5 mg (Telmisartan, Hydrochlorothiazide)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
White or off-white elongated tablet
Packaging
30 tablets (10 tablets/Alu-Alu * 3)
Approval status
Active

MFDS item code 201903559 · Approved 2019.05.29 · Insurance code 658604660

Summary

Main use
Effect of controlling blood pressure in essential hypertension
Who takes it
Adults · Children
Adult dose
For patients whose blood pressure is not adequately controlled with Telmisartan alone, take one tablet once daily with water, regardless of meals. Before switching to this fixed-dose combination medication, it is recommended to adjust the doses of the individual components based on individual needs. If clinically appropriate, a direct switch from monotherapy to this medication may be considered. - Telmisartan/Hydrochlorothiazide combination 40/12.5 mg can be given to patients whose blood pressure is not adequately controlled with Telmisartan 40 mg. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg can be given to patients whose blood pressure is not adequately controlled with Telmisartan 80 mg. - Telmisartan/Hydrochlorothiazide combination 80/25 mg can be given to patients whose blood pressure is not controlled either with Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg alone or in combination. Before starting this medication, sodium or blood volume depletion should be corrected. Patients with renal impairment Patients with mild to moderate renal impairment do not require dose adjustment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of kidney function is recommended. Patients with liver impairment Patients with mild to moderate liver impairment should be given this medication with caution. The daily dose should not exceed 40/12.5 mg. This medication should not be given to patients with severe liver impairment (refer to precautions on use). Thiazide diuretics require careful administration in patients with liver function disorders. Elderly population No dose adjustment is necessary. Pediatric population Safety and efficacy of this medication have not been established in children under the age of 18.
Child dose
Safety and efficacy of this medication have not been established in children under the age of 18.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Effect of controlling blood pressure in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for the treatment of essential hypertension. It helps to more effectively control blood pressure when added to patients whose blood pressure is not sufficiently controlled by Telmisartan alone. It manages blood pressure safely and effectively, reducing the risk of complications.

How to take

Adult dose

For patients whose blood pressure is not adequately controlled with Telmisartan alone, take one tablet once daily with water, regardless of meals. Before switching to this fixed-dose combination medication, it is recommended to adjust the doses of the individual components based on individual needs. If clinically appropriate, a direct switch from monotherapy to this medication may be considered. - Telmisartan/Hydrochlorothiazide combination 40/12.5 mg can be given to patients whose blood pressure is not adequately controlled with Telmisartan 40 mg. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg can be given to patients whose blood pressure is not adequately controlled with Telmisartan 80 mg. - Telmisartan/Hydrochlorothiazide combination 80/25 mg can be given to patients whose blood pressure is not controlled either with Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg alone or in combination. Before starting this medication, sodium or blood volume depletion should be corrected. Patients with renal impairment Patients with mild to moderate renal impairment do not require dose adjustment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of kidney function is recommended. Patients with liver impairment Patients with mild to moderate liver impairment should be given this medication with caution. The daily dose should not exceed 40/12.5 mg. This medication should not be given to patients with severe liver impairment (refer to precautions on use). Thiazide diuretics require careful administration in patients with liver function disorders. Elderly population No dose adjustment is necessary. Pediatric population Safety and efficacy of this medication have not been established in children under the age of 18.

Child dose

Safety and efficacy of this medication have not been established in children under the age of 18.

Precautions

This medication can pose a significant risk to the fetus, especially during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. This medication should not be administered to patients with an allergy to the active ingredients or additives, pregnant or nursing women, or patients with severe liver or kidney diseases. Elderly patients, those with elevated potassium levels, or patients with weakened liver function, valvular heart disease, or ischemic heart disease should use this medication cautiously. The Hydrochlorothiazide component may sensitize the skin to sunlight, increasing the risk of skin cancer; therefore, sun exposure should be avoided during use, and the skin should be monitored periodically. This medication lowers blood pressure, and symptoms such as dizziness, hypotension, and fainting may occur. Electrolyte imbalances can occur, making it important to regularly check the levels of potassium, sodium, and other electrolytes through blood tests. Particular caution is essential for patients with impaired kidney function or those who are dehydrated or sodium deficient, as there is a risk of hypotension or kidney failure; improving these conditions before taking the medication is crucial. This medication may interact with other antihypertensives, diuretics, lithium, and non-steroidal anti-inflammatory drugs; it is essential to inform healthcare professionals of any medications being taken. Dizziness or drowsiness may occur when driving or operating machinery, so caution is advised, and such activities should be avoided if symptoms are present. Overdose may result in hypotension, electrolyte abnormalities, dehydration, and it is vital to adhere to the recommended dosage; seek immediate medical attention if adverse symptoms occur. This medication is not recommended for use in children under 18 years of age, as its safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory anomalies accompanying cough and fever, respiratory issues, jaundice (yellowing of the skin or eyes), generalized lethargy, liver abnormalities (jaundice), sudden

Mild side effects

Dizziness, diarrhea, cough, pharyngitis, sinusitis, hypokalemia, hyperuricemia, hyponatremia, anxiety, depression, insomnia, sleep disturbances, fainting, paresthesia, visual disturbances, blurred vision, vertigo, tachycardia, arrhythmia, hypotension, orthostatic hypotension, dyspnea, respiratory distress, pneumonia, pulmonary edema, diarrhea, dry mouth, abdominal distension, abdominal pain, constipation, indigestion, vomiting, liver function abnormalities/liver disorders, erythema, pruritus, rash

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. The storage temperature should be maintained between 1 to 30 degrees Celsius (room temperature). Proper storage will help maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

White or off-white elongated tablet

Package unit

30 tablets (10 tablets/Alu-Alu * 3)

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.