Medication info
Tobika Tablet 5/40 mg

Tobika Tablet 5/40 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pale yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201903520 · Approved 2019.05.29 · Insurance code 073000030

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Give to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Give to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg monotherapy.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Amlodipine or Olmesartan Medoxomil is used when blood pressure is not sufficiently controlled with monotherapy for patients with essential hypertension. These drugs work by dilating blood vessels to lower blood pressure and help reduce the risk of cardiovascular disease. They play an important role in effectively managing a patient's blood pressure to prevent complications. Therefore, they are actively used in the treatment of hypertension to improve blood pressure control.

How to take

Adult dose

This medication is administered once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Give to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Give to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg monotherapy.

Child dose

Safety and efficacy have not been established in pediatric patients under 18 years of age.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to this medication or severe liver disease, severe aortic stenosis, bile duct obstruction, those on dialysis, patients in shock, and certain diabetic patients should not take this medication. When this drug is first administered to patients who are depleted of fluids or salt, hypotension may occur, so their condition should be closely monitored, and appropriate measures should be taken if hypotension develops. This drug has a vasodilating effect, and acute hypotension may occur in some patients, so caution is advised. Patients with severe heart disease should use caution as cardiac symptoms may worsen during the use of this medication. Patients with weakened kidney function or kidney disease should be cautious as this medication may further worsen kidney function. Patients with reduced liver function should take this medication with consideration of their liver function status since it is metabolized in the liver. During treatment, side effects like dizziness, headache, hypotension, swelling, digestive disturbances, and rash may occur; persistent symptoms should be discussed with healthcare professionals. This medication may interact with other medications, so patients should inform their healthcare providers of any other medications they are taking. In particular, taking this medication with grapefruit juice may enhance its effect, so it is recommended to avoid it. Women who are pregnant or breastfeeding should avoid taking this medication; if breastfeeding, they should consider whether to discontinue the medication or breastfeeding carefully. It is not recommended for children as safety and efficacy have not been established in pediatric patients under 18 years of age. Elderly patients may have reduced kidney and liver function, so treatment should start at a low dose with careful monitoring. In cases of overdose, symptoms such as hypotension or arrhythmia may occur, requiring immediate medical attention. This medication should be stored in a tightly sealed container to avoid exposure to light and moisture and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, severe allergic reactions, urticaria, severe skin reactions, yellowing of the skin or eyes (jaundice), liver dysfunction (jaundice), severe swelling or urinary abnormalities, significantly decreased urine output, increased blood pressure, sudden and extremely severe headaches, seizures, confusion, vision disturbances, paralysis, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties associated with cough and fever

Mild side effects

  • Hyperkalemia
  • decreased libido
  • dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • dysesthesia
  • decreased sensation
  • syncope
  • lightheadedness
Show 26 more
  • palpitations
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • frequency of urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • dependent edema
  • fatigue
  • weakness
  • facial edema
  • decreased plasma potassium
  • decreased serum creatinine

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to keep its efficacy and safety well preserved.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)

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.