Medication info

Neotelmiprus Tablet 80/12.5 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›80mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
White or off-white rectangular tablets
Packaging
30 tablets/box (10 tablets/Alu-Alu x 3), 30 tablets/bottle
Approval status
Expired

MFDS item code 201907270 · Approved 2019.10.15

This product's status changed to Expired on 2024.10.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
In patients whose blood pressure is not adequately controlled with telmisartan alone, this medication should be taken once daily with water, regardless of meals. Before switching to this fixed-dose combination, it is recommended to adjust the dosage of each component according to the individual. When clinically appropriate, direct conversion from monotherapy to this combination may also be considered. 1. Telmisartan/Hydrochlorothiazide combination 40/12.5 mg may be administered to patients whose blood pressure is not adequately controlled with 40 mg of telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg may be administered to patients whose blood pressure is not adequately controlled with 80 mg of telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/25 mg may be administered to patients whose blood pressure is not adequately controlled with either 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide administered separately or as a combination. Patients with renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of renal function is recommended. Patients with hepatic impairment This medication should not exceed 40/12.5 mg daily in patients with mild to moderate hepatic impairment. It should not be administered to patients with severe hepatic impairment. Thiazide diuretics should be administered with caution in patients with liver function impairment. Elderly patients No dosage adjustment is necessary. Pediatric patients Safety and efficacy have not been established in children under 18 years of age.
Child dose
This medication is not administered to children under 18 years of age as safety and efficacy have not been established.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively help control blood pressure in patients with essential hypertension who have difficulty controlling their blood pressure with telmisartan alone.

How to take

Adult dose

In patients whose blood pressure is not adequately controlled with telmisartan alone, this medication should be taken once daily with water, regardless of meals. Before switching to this fixed-dose combination, it is recommended to adjust the dosage of each component according to the individual. When clinically appropriate, direct conversion from monotherapy to this combination may also be considered. 1. Telmisartan/Hydrochlorothiazide combination 40/12.5 mg may be administered to patients whose blood pressure is not adequately controlled with 40 mg of telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/12.5 mg may be administered to patients whose blood pressure is not adequately controlled with 80 mg of telmisartan. - Telmisartan/Hydrochlorothiazide combination 80/25 mg may be administered to patients whose blood pressure is not adequately controlled with either 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide administered separately or as a combination. Patients with renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of renal function is recommended. Patients with hepatic impairment This medication should not exceed 40/12.5 mg daily in patients with mild to moderate hepatic impairment. It should not be administered to patients with severe hepatic impairment. Thiazide diuretics should be administered with caution in patients with liver function impairment. Elderly patients No dosage adjustment is necessary. Pediatric patients Safety and efficacy have not been established in children under 18 years of age.

Child dose

This medication is not administered to children under 18 years of age as safety and efficacy have not been established.

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as the components contained in this medication can cause serious harm to the fetus. Patients with allergies to this medication's active ingredients or excipients should not take this medication. Caution is also needed for those allergic to sulfonamide group drugs. Patients with severely impaired liver or kidney function, biliary obstruction, and nursing women should not take this medication. Elderly patients, patients with high potassium levels in the blood, patients with liver impairment, those with cardiac valve disease, and patients with cardiovascular diseases should use this medication cautiously. This medication may cause photosensitivity reactions on the skin, increasing the risk of skin cancer; therefore, it is important to avoid sun exposure and regularly check the condition of the skin. During treatment, dizziness, hypotension, and electrolyte imbalance symptoms (e.g., muscle cramps, weakness) may occur, so caution is necessary. This medication may interact with other antihypertensive drugs, diuretics, lithium, non-steroidal anti-inflammatory drugs, etc., so it is essential to consult with your doctor or pharmacist if you are taking other medications. If pregnancy is confirmed, discontinue use immediately and consult a doctor. It is also safe not to use this medication during nursing. Overdosing may cause hypotension, dehydration, electrolyte imbalances, etc., so it is important to adhere to the prescribed dosage and inform medical personnel immediately of any abnormal symptoms. Safety and efficacy have not been established in children; therefore, it is not recommended to use this medication in pediatric patients. Store this medication out of reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • angioedema
  • rash
  • angioedema (potentially fatal outcome)
  • angioedema
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  • angioedema (potentially fatal outcome)
  • angioedema
  • angioedema (potentially fatal outcome)
  • angioedema
  • angioedema (potentially fatal outcome)
  • angioedema
  • angioedema (potentially fatal outcome)
  • angioedema
  • angioedema (potentially fatal outcome)
  • angioedema
  • angioedema (potentially fatal outcome)

Mild side effects

  • Hypokalemia
  • hyperuricemia
  • hyponatremia
  • anxiety
  • depression
  • dizziness
  • insomnia
  • sleep disturbances
  • visual disturbances
  • temporary blurred vision
Show 25 more
  • lightheadedness
  • tachycardia
  • arrhythmia
  • hypotension
  • orthostatic hypotension
  • diarrhea
  • dry mouth
  • abdominal bloating
  • abdominal pain
  • constipation
  • dyspepsia
  • vomiting
  • gastritis
  • liver function abnormalities
  • hepatic impairment
  • erythema
  • itching
  • rash
  • increased sweating
  • hives
  • back pain
  • muscle cramps
  • myalgia
  • arthralgia
  • limb pain

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius to safely preserve the medication's effectiveness for a long time.

Appearance and packaging

Appearance

White or off-white rectangular tablets

Package unit

30 tablets/box (10 tablets/Alu-Alu x 3), 30 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.

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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.