Medication info
Telmisartan and Amlodipine Tablets 80/5 mg

Telmisartan and Amlodipine Tablets 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
오스틴제약(주)
Appearance
Biconvex oval double tablet in white and light blue color
Packaging
30 tablets/box [10 tablets/TPP × 3]
Approval status
Active

MFDS item code 202000462 · Approved 2020.01.29 · Insurance code 654305320

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage is one tablet once daily, taken with water regardless of meals. It is preferable to take it at the same time each day (e.g., in the morning). - 40/5 mg: Administer to patients in whom blood pressure is not adequately controlled with amlodipine 5 mg or telmisartan 40 mg. - 80/5 mg: Administer to patients in whom blood pressure is not adequately controlled with amlodipine 5 mg or this medication, 40/5 mg.
Child dose
Safety and efficacy have not been established for pediatric patients under the age of 18, so the use of this medication is not recommended.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Used for the treatment of essential hypertension when blood pressure is not adequately controlled with telmisartan or amlodipine monotherapy.

How to take

Adult dose

The recommended dosage is one tablet once daily, taken with water regardless of meals. It is preferable to take it at the same time each day (e.g., in the morning). - 40/5 mg: Administer to patients in whom blood pressure is not adequately controlled with amlodipine 5 mg or telmisartan 40 mg. - 80/5 mg: Administer to patients in whom blood pressure is not adequately controlled with amlodipine 5 mg or this medication, 40/5 mg.

Child dose

Safety and efficacy have not been established for pediatric patients under the age of 18, so the use of this medication is not recommended.

Precautions

This medication may cause serious damage to the fetus during pregnancy, especially in the second and third trimesters, so pregnant women or those who may become pregnant should not take it. Do not administer this medication to patients with certain diseases, such as severe liver impairment, severe hypotension, cardiogenic shock, or unstable heart failure following acute myocardial infarction. Patients with primary aldosteronism, valvular heart diseases, liver impairment, gastrointestinal disorders, renal artery hypertension, patients on dialysis, and the elderly should use this medication with caution and may need dose adjustment or monitoring of their condition. This medication can commonly cause side effects such as dizziness and peripheral edema, and serious side effects such as syncope have also been reported in rare cases. Therefore, if unusual symptoms occur, immediate consultation with healthcare professionals is required. The administration of this medication should be avoided during pregnancy, and when pregnancy is confirmed, it should be discontinued as soon as possible and changed to another safe treatment. It is also advisable for breastfeeding women not to take this medication. Since this medication lowers blood pressure, hypotension may occur upon initial administration; in such cases, patients should be laid down and infused with fluids if necessary. Patients taking this medication may have increased potassium levels in their blood, so those at risk of hyperkalemia should have their potassium levels regularly checked through blood tests. Patients with impaired renal function should periodically monitor their renal function and electrolyte status before and during treatment with this medication. This medication can interact with other drugs, so patients should inform healthcare professionals of any medications they are currently taking, especially when used concurrently with digoxin, lithium, warfarin, non-steroidal anti-inflammatory drugs, etc. This medication may cause drowsiness or dizziness, so caution should be taken when driving or operating hazardous machinery. In case of overdose, severe hypotension, tachycardia, dizziness, and acute renal failure may occur, requiring immediate emergency treatment, and in severe cases, intensive monitoring of blood pressure and cardiac function is required. This medication is not recommended for children as its safety and efficacy have not been adequately established, and older adults should adjust the dose, increasing it slowly as needed. Finally, this medication should be stored out of reach of children, and it is important to maintain its sealed state until just before use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attacks, cough with fever accompanying respiratory distress, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis

Mild side effects

Dizziness, peripheral edema, syncope, drowsiness, headache, sensory disturbance, taste disturbance, tremor, visual disturbance (including double vision), vertigo, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia, nausea, vomiting, dry mouth, gingival enlargement, liver function abnormalities, liver impairment, itching, sweating, rash, hair loss, purpura, skin discoloration, eczema, erythema, joint swelling, muscle cramps, arthralgia, myalgia, urination

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

Storage

This medication is sensitive to light and should be stored in a container that protects it from light. Additionally, it is recommended to store the medication at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Biconvex oval double tablet in white and light blue color

Package unit

30 tablets/box [10 tablets/TPP × 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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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.