Opsinbihyeong 10/40 mg (Macitentan, Tadalafil)

Adult dose

The recommended dose of this medication in adults aged 18 years and older is 10/40mg (macitentan/tadalafil). One 10/40mg tablet may be taken orally once daily, with or without food. Take this medication with water. Do not chew, cut, or crush it. For patients who have not previously received drug therapy for pulmonary arterial hypertension or who are switching from endothelin receptor antagonist (ERA) monotherapy The recommended starting dose of this medication is 10/20mg (macitentan/tadalafil). One 10/20 mg tablet may be taken orally once daily, with or without food. After one week of treatment, if tolerated, increase the dose to one 10/40mg tablet once daily, with or without food. For patients switching from phosphodiesterase 5 inhibitor (PDE5i) monotherapy The recommended dose of this medication is 10/40mg (macitentan/tadalafil). Take one 10/40mg tablet orally once daily, with or without food.

This medication should not be used by pregnant women due to the risk of congenital defects to the fetus. Women who may become pregnant must verify they are not pregnant before starting treatment, during treatment, and for one month after stopping treatment, and must utilize effective contraception to prevent pregnancy. This medication should not be administered to patients with certain diseases or conditions. For instance, patients allergic to any of the components, those with severe liver impairment, those having recently experienced a myocardial infarction, patients with severe hypotension, and those taking organic nitrate compounds may face risks from this medication. Additionally, patients with liver or kidney function issues, anemia, penile deformities, or certain blood disorders must use this medication with caution. Patients with cardiovascular diseases must consult a doctor before using this medication. When taking this medication, side effects such as edema, anemia, headache, abdominal pain, hypotension, myalgia, nausea, increased uterine bleeding, back pain, flushing, vomiting, palpitations, limb pain, epistaxis, bronchitis, pharyngitis, increased aminotransferase, influenza, urinary tract infections, lower respiratory infections, priapism, gastroesophageal reflux disease, blurred vision, tinnitus, facial swelling, chest pain, dizziness, syncope, varicose veins, cyanosis, and myalgia may occur, so patients should immediately consult healthcare professionals if these symptoms worsen or persist. As liver function may be affected, liver enzyme tests must be conducted before administration of this medication, and regular liver function tests should be carried out during treatment. If symptoms of liver damage (e.g., jaundice, nausea, right upper abdominal pain, etc.) occur, medication should be discontinued immediately. This medication may lower hemoglobin levels, so patients with anemia should undergo blood tests before treatment, and regularly monitor hemoglobin levels during treatment. Serious side effects such as visual disturbances or hearing loss have been rarely reported, so patients should notify healthcare professionals immediately if they experience blurred vision or sudden hearing loss. This medication may interact with other specific drugs, so if patients are taking other medications, they must inform their doctor or pharmacist, especially when using drugs metabolized in the liver. Women who are pregnant or breastfeeding should not use this medication, and if planning to become pregnant, must avoid pregnancy for at least one month after stopping this medication. The safety and efficacy of this medication have not been established in children under 18 years of age, and no special dosage adjustments are needed for patients over 65 years. In cases of overdose, contact a medical institution immediately for appropriate treatment, and the components of this medication are likely not removed by dialysis. This medication should be kept out of reach of children, and it is safer not to transfer it to another container.

Edema, fluid retention, anemia, headache, migraine, abdominal pain, hypotension, myalgia, nasopharyngitis, nausea, increased uterine bleeding, lower back pain, flushing, vomiting, palpitations, limb pain, epistaxis, bronchitis, pharyngitis, increased aminotransferases, influenza, urinary tract infection, lower respiratory tract infection, priapism, gastroesophageal reflux disease, blurred vision, tinnitus, facial swelling, chest pain, hypersensitivity reaction, angioedema, pruritus, rash, nasal congestion, difficulty breathing, pleural effusion, pulmonary arterial hypertension, interstitial lung disease, increased sputum, cough, dyspnea at rest, dyspepsia, diarrhea, toothache, dizziness, syncope, varicose veins, cyanosis, myalgia, increased INR, decreased appetite, otalgia, myocardial infarction, acute cardiac death, stroke, tachycardia, seizure, transient global amnesia, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, visual field defect, non-arteritic anterior ischemic optic neuropathy, retinal vascular occlusion, sudden hearing loss, priapism

This medication must be stored in a tightly closed container to protect it from air and moisture, and should be kept at a temperature between 1 to 30 degrees Celsius, which is safe. Therefore, avoid keeping it in excessively hot or cold places, and maintain it at an appropriate temperature to preserve its efficacy.

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP packaging X 3)]