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Adempas

Generical name: riociguat] RYE-oh-SIG-uat RYE-oh SIG-ue-at [ RYE-oh-SIG-ue-at
Drug class: vasodilators

What is Adempas?

Adempas reduces blood pressure in your lungs, helping to circulate blood effectively.

Adempas can be used for treating chronic thromboembolic hypertension pulmonary (CTEPH) in those who are unable to be treated by surgery or who have had surgery but are still experiencing symptoms. Riociguat may treat some symptoms of CTEPH and enhance your fitness.

Adempas can also be utilized to treat the symptoms of pulmonary arterial hypertension (PAH). Riociguat could improve your ability to exercise and prevent PAH from getting worse.

Adempas is only available to women under an exclusive program. It is necessary to be enrolled in the program and know the risks and benefits associated with this medication.

Warnings

Adempas may result in birth defects. Do not take it if your pregnancy is imminent. You must use high-quality birth control when you are taking Adempas in the first month following your last dose. Do not engage in sexual relationships that are not protected.

Inform your doctor about all the medications you currently take as well as any new medications you decide to start or stop taking. Numerous drugs are incompatible with Riociguat, and certain medications should not be taken together.

Before you Take this Drug 

Adempas are not recommended for use in the event that you are allergic to riociguat. Also, if:

  • You are expecting or may be pregnant if you undergo treatment; or

  • You suffer from PAH due to a condition known as idiopathic interstitial pulmonary (PH-IIP).

Certain medicines may cause undesirable or hazardous effects when used in conjunction with Adempas. Your doctor could alter the treatment plan when you are also using:

  • Dipyridamole;

  • Theophylline;

  • Erectile dysfunction medications like Viagra, Cialis, Levitra, and many more

  • other medications that treat the symptoms of PAH (Adcirca or Revatio).

Please do not consume Adempas for 24 hours prior to or following the use of sildenafil (Revatio, Viagra) or for 24 hours prior to or after having taken tadalafil (Adcirca, Cialis).

To ensure that Adempas is safe for you, inform your doctor if you've ever experienced:

  • Heart illness, blood circulation issues;

  • Lower blood pressure;

  • A condition referred to as pulmonary-veno-occlusive disorder (PVOD);

  • A cough that is bloody or bleeding from your lungs

  • Liver disease;

  • Kidney diseases (or if you're taking dialysis)

  • If you smoke.

Do not take Adempas if you are expecting. It could harm the unborn baby or cause birth defects. Make sure you use effective birth control methods to stop pregnancy while using this medication and for at least one month following the end of your treatment. Inform your doctor promptly if you don't have menstrual cycles or suspect you might be pregnant while taking treatment.

It is necessary to take an unconfirmed pregnancy test prior to beginning this treatment. It is also recommended to test each month throughout your treatment and once per month after stopping using this medication. Do not engage in unprotected sexual relationships.

When taking Adempas, women and girls who have the potential to become pregnant should use the most effective birth control methods, or two methods in combination.

Even if you're not planning to become pregnant, you are considered to have the possibility of becoming pregnant in the event that:

  • you've entered the puberty stage (even if you haven't yet begun having menstrual cycles);

  • You've never had a hysterectomy, had your ovaries removed, or

  • You haven't gone through menopausal changes (you haven't ever gone for more than 12 months without a menstrual cycle).

Adempas includes patient guidelines regarding acceptable birth control that you can use while using this medication. Follow these guidelines carefully. Consult your physician or pharmacist for more information.

Even if your partner had a vasectomy, you should nevertheless use a different method to control births, either the barrier method or the hormonal method (birth control pills, injections, patches for the skin, the vaginal ring).

If you're the caregiver or parent of a girl on this medication, consult the doctor if you see any signs of puberty (breast growth and pubic hair), even if menstrual cycles haven't yet been established.

It is not recommended to breastfeed during the course of this medication.

How to Take Adempas?

You should take Adempas exactly as directed by your physician. Follow the directions on the prescription label and study the entire medication guide or instruction sheet. Your doctor may alter your dosage. Follow the medication precisely as directed.

It is possible to consume Adempas in combination with food or not.

If you are unable to swallow the tablet completely, then you can smash the tablet and then mix it into water or other soft meals (such as applesauce). Take the mixture in one go, without chewing. Don't store it for a later time.

Your blood pressure needs to be monitored regularly.

Keep at room temperature, free of heat and moisture.

Details on Dosage 

Usual Adult Dose for Pulmonary Hypertension:

Initial dosage: 1 mg orally three times per day.

Maximum dosage: 2.5 mg orally, three times per day.

Comments:

If patients are not able to take the hypotensive effects, think about an initial dose of 0.5 mg taken orally three times per day. If the systolic blood pressure is higher than 95 mmHg and the patient does not show symptoms of hypotension, The dose can be increased by 0.5 mg taken orally three times per day.

Dose increases should not occur more frequently than every two weeks.

Uses:

persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.

As a monotherapy or in combination with endothelin receptor antagonists and prostanoids for the treatment of the condition of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve fitness capacity, increase WHO functional class, and prevent clinical worsening.

What Happens If I Miss the Dose?

Do not miss the missed dose, and take your next dose at your regular time. Don't use two doses at the same time.

Contact your physician in the event that you do not receive your medication for three consecutive days or more.

What Happens If I Overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line at 1-800-222-1222.

What Should be Avoided?

Do not engage in unprotected sex while you are taking Adempas. It is essential to take birth control in order to avoid pregnancy during treatment and for a minimum of 30 days after stopping using this medicine.

Do not take an antacid for at least one hour prior to or one hour after taking Adempas. Certain antacids may make it difficult for your body to take in the riociguat.

Smoking can cause riociguat to become less efficient. Talk to your doctor if you're smoking when you're taking this medication. The dosage you are taking may need to be altered.

Avoid driving and other hazardous activities until you are aware of the effects of this medication on your body. Your reaction may be impaired. Do not get up too quickly from a lying or sitting position, as you could get dizzy.

Side Effects of Adempas

Get immediate medical attention. If you are experiencing symptoms that you are experiencing an allergic reaction, such as hives, breathing difficulties, or swelling of your lips, face, and tongue,

Stop taking Adempas and consult your physician immediately if you are suffering from:

  • A lightheaded sensation, similar to passing out;

  • unusual vaginal bleeding, or any other bleeding that is unusual;

  • Vomit or vomiting blood that is bright red or vomit that looks like coffee grounds

  • Low red blood cells (anemia): pale skin, unusual fatigue, feeling lightheaded or Breathless, cold feet and hands,

  • The build-up of fluids in your lungs. The lungs are filled with fluid. anxiety, the appearance of pale skin, extreme shortness of breath, and wheezing. You may also be struggling to breathe, coughing with mucus that foams, having chest pain, or having a rapid or irregular heart rate.

Common Adempas side effects may include:

  • Headache,

  • Dizziness;

  • Indigestion, 

  • Nausea,

  • Vomiting, 

  • Diarrhea

  • Swelling in your legs, hands, or feet

This isn't an exhaustive list of all the side effects. Other effects may also be present. Consult your physician to seek medical advice on the effects. You can report any side effects to the FDA at 1-800-FDA-1088.

Interaction with Other Drugs 

Other medications can interfere with riociguat, such as prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your physician your current medications and any medications you begin or stop taking.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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