Opsynvi (Macitentan And Tadalafil)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
macitentan and tadalafil
Drug Class
endothelin receptor antagonists and phosphodiesterase type 5 inhibitors
Used For
treatment of pulmonary arterial hypertension in adults
How Taken
oral tablet once a day

What Is Opsynvi Used For?

Opsynvi is a combination medication that helps treat pulmonary arterial hypertension (PAH) in adults.

Primary Uses

Opsynvi is primarily used to manage pulmonary arterial hypertension, a condition characterized by high blood pressure in the arteries that supply blood to the lungs.

How It Works

Opsynvi works by widening the pulmonary arteries, making it easier for the heart to pump blood through them, which lowers blood pressure and may alleviate symptoms.

Good to know: Opsynvi is not considered addictive.

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How to Take Opsynvi

Taking Opsynvi is straightforward, but it's important to follow your doctor's instructions carefully.

Dosage Instructions

The recommended dosage is one tablet taken once daily. It can be taken with or without food.

What If You Miss a Dose?

If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at once.

Important: Never double the dose to make up for a missed one.

Available Tablet Strengths

10 mg/40 mg
10 mg/40 mg Tablet White to almost-white, Oblong • 1040

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • low red blood cell count (anemia)
  • swelling due to fluid retention
  • infections of the nose or throat
  • headaches or migraines
  • flushing
  • sweating
  • nausea
  • indigestion
  • back pain
  • arm or leg pain
  • muscle pain

Seek immediate medical attention if you experience:

  • severe allergic reactions
  • chest pain
  • rapid or irregular heartbeats
  • painful erections lasting longer than usual
  • sudden vision loss
  • sudden hearing loss

Impulse Control Issues

There is no specific mention of impulse control issues related to Opsynvi.

Important Warnings

There are several important considerations before using Opsynvi.

Who Should Not Take Opsynvi

Do not take Opsynvi if you are allergic to macitentan, tadalafil, or any of its ingredients, if you are pregnant or planning to become pregnant, have severe liver problems, or are taking nitrates.

Medical Conditions to Discuss

Discuss with your doctor if you have heart problems, low blood pressure, liver or kidney issues, or any history of vision loss.

Pregnancy and Breastfeeding

Opsynvi may cause birth defects. Do not take it if you are pregnant or planning to become pregnant. Effective contraception is required during treatment and for at least 3 months after stopping. It is not known if Opsynvi is excreted in breast milk; therefore, breastfeeding is not recommended while taking this medication.

Elderly Patients With Dementia: Special caution is advised for elderly patients, particularly those with dementia.

Drug Interactions

Certain medications can interact with Opsynvi, affecting its efficacy.

Grapefruit interaction: Avoid grapefruit juice as it may affect how Opsynvi works.

  • nitrates
  • amyl nitrite
  • rifampicin
  • clarithromycin
  • ciprofloxacin
  • erythromycin
  • phenytoin
  • carbamazepine
  • St. John's Wort
  • ritonavir
  • ketoconazole
  • fluconazole
  • itraconazole
  • miconazole
  • voriconazole
  • amiodarone
  • ciclosporin
  • piperine
  • guanylate cyclase stimulators like riociguat
  • bosentan
  • sildenafil
  • alpha blockers
  • diltiazem
  • verapamil
  • tablets for erectile dysfunction
  • large amounts of alcohol

Alcohol & Driving

Be cautious when consuming alcohol or driving while taking Opsynvi.

Alcohol

Consuming large amounts of alcohol while taking Opsynvi may lead to dizziness.

Driving and Operating Machinery

Opsynvi may cause dizziness and affect your vision, so be careful when driving or using machinery.

Storage

Store Opsynvi below 30°C in its original packaging, away from moisture and heat. Keep out of reach of children.

Overdose Information

If you suspect an overdose of Opsynvi, seek immediate medical attention. Contact the Poisons Information Centre at 13 11 26 or go to the nearest hospital.

Frequently Asked Questions

The time it takes for Opsynvi to show effects can vary by individual, but it is designed to help manage symptoms of pulmonary arterial hypertension.

Yes, Opsynvi can be taken with or without food.

No, Opsynvi is not considered addictive.

Do not stop taking Opsynvi suddenly without consulting your doctor, as it is important for managing your condition.

Be cautious with alcohol consumption, as large amounts may cause dizziness.

Weight gain is not specifically mentioned as a side effect of Opsynvi.

Elderly patients should use Opsynvi with caution, especially those with dementia.

If you miss a dose, take it as soon as you remember but do not double up on doses.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.

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