What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Opsynvi (Macitentan/Tadalafil)

Brand

Opsynvi (Macitentan/Tadalafil)

Prescription Required

Strength
Qty
10mg / 40mg

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  • Product Details

    Description

    Opsynvi (macitentan/tadalafil) is a long-term combination prescription medication used to treat high blood pressure in the lung arteries (pulmonary arterial hypertension).

    This medication works by applying two mechanisms. Macitentan blocks endothelin, a protein that usually causes blood vessels in the lungs to narrow. In doing so, this allows blood vessels to relax and widen.

    Meanwhile, tadalafil helps improve blood flow through the lung arteries by enhancing the nitric oxide pathway, which relaxes blood vessels. Combined, this makes Opsynvi effective at reducing pressure in the lung arteries, easing the heart's workload and helping to preserve long-term lung and heart function.

    Fact Table

    Formula

    Macitentan: C19H20Br2N6O4S; Tadalafil: C22H19N3O4

    License

    US FDA, Health Canada, EMA, TGA

    Bioavailability

    Macitentan: not known; Tadalafil: not determined

    Legal status

    Rx-only; Schedule 4 (AU)

    Chemical Name

    Macitentan: N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; Tadalafil: (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    Elimination half-life

    Macitentan: approximately 16 hours; active metabolite: approximately 48 hours; Tadalafil: approximately 11 hours

    Dosage (Strength)

    Macitentan 10 mg/tadalafil 20 mg or macitentan 10 mg/tadalafil 40 mg tablet once daily; maintenance dose usually 10 mg/40 mg once daily

    Pregnancy

    Contraindicated in pregnancy; may cause fetal harm

    Brands

    Opsynvi, Yuvanci

    Protein binding

    Macitentan: greater than 99%; Tadalafil: 94%

    PubChem CID

    Macitentan: 16004692; Tadalafil: 110635

    MedlinePlus

    a624029

    ChEBI

    Macitentan: 76607; Tadalafil: 71940

    ATC code

    C02KX54

    DrugBank

    Macitentan: DB08932; Tadalafil: DB00820

    KEGG

    D12963

    Routes of administration

    Oral

    Directions

    Buy Opsynvi at a low cost here at Canada Pharmacy with a valid prescription from your doctor. This medication is available in oral tablet form, containing 10 mg of macitentan and 40 mg of tadalafil.

    Healthcare providers typically prescribe one daily tablet that should be taken at the same time each day. This medication is meant for long-term use, should be swallowed whole with water, and can be taken with or without food.

    If you miss a dose, take it as soon as you remember. If it’s the next day, do not take an additional tablet and continue with your next scheduled dose as usual. Never take two tablets at the same time. If you vomit shortly after taking a dose, do not take an extra tablet but take your next dose at the usual time.

    Always follow your doctor’s instructions carefully and never adjust your dose or stop using it on your own, even if your symptoms have improved.

    Ingredients

    The two active ingredients in Opsynvi are?macitentan and tadalafil.

    Cautions

    Inform your healthcare provider if you have any medical conditions, including liver or heart problems (e.g. a history of heart attacks or heart failure), low blood pressure, or a rare lung condition called PVOD. Your doctor may monitor your treatment closely or decide that it’s not appropriate for you.

    Your healthcare provider will check your blood pressure and schedule blood tests to monitor your health and your body’s response to treatment.

    Let your doctor know of any medications, vitamins, or herbal supplements you are taking, to avoid potentially dangerous drug interactions.

    If you are a female who can become pregnant, you must use effective birth control during treatment and for 1 month after the last dose to avoid birth defects from Opsynvi.

    Keep in mind that this medication can reduce red blood cells, especially if you have just started treatment. Regular blood tests help ensure that you remain in a healthy range.

    Consult your doctor if you experience fluid retention, characterized by rapid weight gain, swelling in legs or ankles, or new trouble breathing.

    Opsynvi may increase the risk of sudden vision as well as hearing changes, including hearing loss, ringing, or dizziness. Tell your provider if you have a history of eye problems, especially a type of optic nerve issue called NAION.

    This medication may not be suitable for you if you have kidney disease or are on dialysis. Inform your doctor so that they can decide on the best course of action for you.

    For male patients: Tell your provider if you have conditions that make prolonged erections more likely, including Peyronie’s disease or certain blood conditions. This allows them to assess and explain your risk, determine whether treatment is suitable, and decide if the medication should be modified or stopped if symptoms arise.

    Avoid drinking more than four alcoholic beverages at once while taking Opsynvi, as it can increase the chance of dizziness, low blood pressure, and headache.

    Opsynvi is currently not approved for use in children due to a lack of knowledge regarding safety and effectiveness.

    Contraindications

    Opsynvi can cause significant birth defects. Do not take this medication during pregnancy or when planning to become pregnant. If you become pregnant during treatment, inform your doctor immediately.

    Do not take Opsynvi if you are allergic to macitentan, tadalafil, or any of the drug’s inactive ingredients.

    Do not take this medication if you use nitrate medicines or guanylate cyclase stimulators (e.g. riociguat).

    Side Effects

    Individuals taking Opsynvi commonly report fluid retention or swelling, anemia, headache, migraine, nausea, abdominal pain, and dizziness.

    Additionally, serious side effects include liver problems, low blood pressure, vision or hearing loss, severe fluid retention, prolonged erection, and decreased sperm count in male patients.

    These are not all Opsynvi side effects. Consult your healthcare provider if you notice any persistent or concerning side effects of Opsynvi.

    Buy Opsynvi today at Canada Pharmacy at a low cost!

    References

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 15490

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