Opsinbi Tablet 10/20mg (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 administered to pregnant women due to the risk of congenital defects in the fetus. Women of childbearing potential must use reliable contraceptive methods before starting treatment, during treatment, and for one month after discontinuation. Monthly pregnancy tests during treatment are recommended. This medication should not be given to patients with certain diseases or conditions. For example, patients who are allergic to this medication or its components, those with severe liver impairment, those who have recently had a myocardial infarction, those with severe hypotension, and those with certain cardiovascular diseases should not receive it. Also, it should not be used in conjunction with organic nitrates or certain drugs due to potential risks. Patients with poor liver function, impaired kidney function, anemia, penile deformities, or cardiovascular disease should use this medication cautiously. Regular monitoring is required before and during treatment as it may affect liver and kidney conditions. While taking this medication, side effects such as edema, anemia, headache, abdominal pain, hypotension, myalgia, and nausea may occur. If these symptoms are severe or persist, immediate consultation with a healthcare professional is necessary. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should ensure they are not pregnant and use contraception thoroughly. This medication is not to be used in pediatric patients under 18 years of age, as safety and efficacy have not been established. It can be used in elderly patients over 65 without special dosage adjustments, but caution is needed for those with impaired kidney or liver function. In case of overdose, there is no specific antidote, and appropriate treatment and supportive therapy should be provided based on symptoms. Dialysis may not be effective in removing the components of this medication. This medication may interact with other drugs, so it is essential to inform healthcare professionals if taking medications metabolized in the liver or cardiovascular drugs, and not to discontinue or combine medications on one's own. Symptoms such as headache or hypotension may occur when driving or operating machinery, so it is important to check one's reaction when first taking the medication. This medication should be kept out of reach of children and should not be transferred to another container for safety.

Edema, fluid retention, anemia, headache, migraine, abdominal pain, hypotension, myalgia, nasopharyngitis, nausea, increased uterine bleeding, lumbago, flushing, vomiting, palpitations, limb pain, epistaxis, bronchitis, pharyngitis, increased amino transferase, 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, dyspnea, pleural effusion, pulmonary hypertension, interstitial lung disease, increased sputum, cough, dyspnea at rest, dyspepsia, diarrhea, toothache, ineffective medication, pain, 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 loss, non-arteritic anterior ischemic optic neuropathy, retinal vascular occlusion, sudden sensorineural hearing loss, priapism

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance

Pink oval film-coated tablet

Package unit

7 tablets/box [(7 tablets/PTP packaging x 1)]