Medication info
Myungin Tolvaptan 15 mg

Myungin Tolvaptan 15 mg

Prescription medicationTabletOral
Ingredient · strength
Tolvaptan›15mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
Blue round tablet
Packaging
10 tablets/box (10 tablets/PTP X1)
Approval status
Active

MFDS item code 202004774 · Approved 2020.06.30 · Insurance code 651904970

Summary

Main use
Treatment of hyponatremia; inhibition of progression of autosomal dominant polycystic kidney disease
Who takes it
Adults
Adult dose
1. Hyponatremia The recommended initial dose for adults is 15mg once daily. To achieve the target serum sodium concentration, increase the dose to 30mg once daily at intervals of at least 24 hours, and increase up to a maximum of 60mg once daily. Do not administer for more than 30 days to minimize the risk of liver injury. This product is taken mainly in the morning with water, with or without food, and swallowed without chewing. 2. Autosomal dominant polycystic kidney disease (ADPKD) The initial dose is 60mg per day, divided into 2 daily doses: 45mg before breakfast and 15mg 8 hours later. Thereafter, considering tolerability, increase the dose to 90mg per day (60mg+30mg) at intervals of at least 1 week, and then increase to 120mg per day (90mg+30mg). This product must be swallowed with water without chewing. The dose should be reduced in patients taking strong CYP3A inhibitors, and dose adjustment is also required in patients taking moderate CYP3A inhibitors.

Ingredients

Manufacturer
Myungin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hyponatremia; inhibition of progression of autosomal dominant polycystic kidney disease

  • Hypervolemic hyponatremia
  • euvolemic hyponatremia
  • hyponatremia
  • chronic kidney disease
  • autosomal dominant polycystic kidney disease
  • cyst formation
  • decrease in kidney function
View approved original text

This medication is used to treat hypervolemic or euvolemic hyponatremia resulting from conditions such as heart failure or syndrome of inappropriate antidiuretic hormone secretion. It is particularly effective when serum sodium concentration is less than 125 mEq/L or when symptoms are present but correction through fluid restriction is difficult. Additionally, it helps to slow progression of cyst formation and decrease in kidney function in patients with chronic kidney disease stages 1 to 4, particularly those with rapidly progressive autosomal dominant polycystic kidney disease. Thus, it is useful in addressing sodium imbalance and the progression of kidney disease.

How to take

Adult dose

1. Hyponatremia The recommended initial dose for adults is 15mg once daily. To achieve the target serum sodium concentration, increase the dose to 30mg once daily at intervals of at least 24 hours, and increase up to a maximum of 60mg once daily. Do not administer for more than 30 days to minimize the risk of liver injury. This product is taken mainly in the morning with water, with or without food, and swallowed without chewing. 2. Autosomal dominant polycystic kidney disease (ADPKD) The initial dose is 60mg per day, divided into 2 daily doses: 45mg before breakfast and 15mg 8 hours later. Thereafter, considering tolerability, increase the dose to 90mg per day (60mg+30mg) at intervals of at least 1 week, and then increase to 120mg per day (90mg+30mg). This product must be swallowed with water without chewing. The dose should be reduced in patients taking strong CYP3A inhibitors, and dose adjustment is also required in patients taking moderate CYP3A inhibitors.

Precautions

This medication is used for the treatment of hyponatremia, and during initiation and resumption of administration, serum sodium concentrations must be closely monitored in a hospital setting. Rapid increases in serum sodium concentration may lead to serious neurological complications; therefore, regular monitoring of serum sodium levels and fluid volume is necessary. Patients with impaired liver function should avoid using this medication, and administration should be discontinued immediately if liver damage symptoms occur. In treating autosomal dominant polycystic kidney disease, liver function tests should be conducted regularly, and the medication should be discontinued if signs of liver damage are evident. This medication should not be administered to patients with specific allergic reactions, patients requiring urgent elevation of serum sodium levels, or patients who have difficulty managing body fluids. Caution should be exercised in dehydrated or hypovolemic patients, and adequate hydration should be encouraged. Diabetic patients should carefully manage their blood sugar control, and those with cardiovascular diseases or the elderly should use it with caution. This medication may interact with various drugs; therefore, it is essential to consult a healthcare provider regarding concomitant medications. Women who are pregnant or may become pregnant should not take this medication, and breastfeeding women should carefully consider whether to use it. In cases of overdose, appropriate treatment should be sought immediately under medical supervision, as there is no specific antidote for toxicity. This medication may cause drowsiness or muscle weakness when driving or operating machinery, so caution is advised. Overall, this medication requires attention when regulating electrolyte balance in the blood, and regular blood tests and symptom monitoring are essential.

Side effects

  • Dysphonia
  • mutism
  • dysphagia
  • somnolence
  • mood changes
  • incomplete paralysis of limbs
  • seizures
  • coma
  • death
  • fatigue
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  • loss of appetite
  • discomfort in the right upper abdomen
  • black urine
  • jaundice
  • thirst
  • dry mouth
  • weakness
  • constipation
  • frequent urination
  • polyuria
  • hyperglycemia
  • fever
  • decreased appetite
  • nocturia
  • nausea
  • vomiting
  • fever
  • rash
  • itching
  • dark urine
  • headache
  • dizziness
  • taste disturbance
  • fainting
  • palpitations
  • dyspnea
  • diarrhea
  • dry mouth
  • abdominal pain
  • abdominal distension
  • dyspepsia
  • gastroesophageal reflux disease
  • liver dysfunction
  • dry skin
  • rash
  • urticaria
  • arthralgia
  • myalgia
  • fatigue
  • thirst
  • weakness
  • anaphylaxis
  • anaphylactic shock
  • systemic rash symptoms
  • acute liver failure
  • gastrointestinal bleeding
  • disseminated intravascular coagulation
  • cardiac thrombosis
  • ventricular fibrillation
  • prolonged prothrombin time
  • ischemic colitis
  • diabetic ketoacidosis
  • rhabdomyolysis
  • cerebrovascular accidents
  • urethral bleeding
  • vaginal bleeding
  • pulmonary embolism
  • respiratory failure
  • deep vein thrombosis
  • nausea
  • thirst
  • dry mouth
  • polyuria
  • frequent urination
  • gastrointestinal bleeding
  • hyperbilirubinemia
  • azotemia
  • pyelonephritis
  • valvular heart disease
  • heart failure
  • weakness
  • worsening condition
  • fever
  • delirium
  • pneumonia
  • pulmonary edema
  • dyspnea
  • respiratory insufficiency
  • skeletal pain
  • arthralgia
  • myalgia
  • hypokalemia
  • hypocalcemia
  • hyponatremia
  • hyperphosphatemia
  • acidosis
  • hypophosphatemia
  • weight gain
  • infection
  • leukopenia
  • urinary tract infection
  • cystitis
  • urinary difficulty
  • incontinence
  • oliguria
  • myocardial ischemia
  • ventricular tachycardia
  • tachycardia
  • abdominal pain
  • mucosal ulceration
  • hematemesis
  • tongue discoloration
  • hypertension
  • back pain
  • pain
  • leg pain
  • peripheral edema
  • hyperthermia
  • ineffective medication
  • anxiety
  • hyperactivity
  • anemia
  • maculopapular rash
  • skin disease
  • erythematous rash
  • thrombocytopenia
  • cough
  • increased sputum
  • pharyngitis
  • pneumonia
  • postoperative bleeding
  • pressure ulcer
  • hyperglycemia
  • dehydration
  • hypernatremia
  • decreased appetite
  • hyperuricemia
  • gout
  • insomnia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Blue round tablet

Package unit

10 tablets/box (10 tablets/PTP X1)

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.

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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.