Adempas, 1.5 mg 42 pcs

Cronic thromboembolic pulmonary hypertension (CTEH), WHO group 4:

• inoperable CTEH;

• persistent or recurrent CTEHR after surgical treatment;

Pulmonary arterial hypertension (PAH), WHO group 1, WHO class II-III class (either in monotherapy or in combination with endothelin receptor antagonists or prostanoids):

• idiopathic LAH;

• hereditary LAH;

• LAH associated with connective tissue diseases.

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Active ingredient

How to take, the dosage

Overly, at the same time as a meal or regardless of the time of the meal.

The beginning of therapy. The recommended starting dose is 1 mg 3 times daily for 2 weeks. Tablets should be taken 3 times daily about 6-8 hours apart.

If the systolic blood pressure (SBP) is 95 mmHg or higher and the patient has no symptoms of arterial hypotension, the dose should be increased by 0.5 mg every 2 weeks to a maximum daily dose of 2.5 mg 3 times daily.

If the MAP is less than 95 mmHg, the dosage should be left unchanged as long as the patient has no symptoms of arterial hypotension.

If at any time during the dose titration step the MAP is less than 95 mmHg and the patient still has symptoms of arterial hypotension, the current single dose should be reduced by 0.5 mg, i.e., a previously taken and well tolerated dose should be recommended.

The maintenance dose. The adjusted individual dose should be maintained unless symptoms of arterial hypotension develop.

The maximum daily dose of Adempas is 7.5 mg. If another dose of the drug is missed, the next dose should be taken according to the prescribed regimen.

In case of adverse reactions after using the prescribed dose of the drug, the dose may be reduced at any time during treatment.

Cancellation of treatment. If a break in treatment of 3 days or more is necessary, return to the starting dose and resume taking the drug starting at a dose of 1 mg 3 times daily for 2 weeks; continue treatment with subsequent dose titration as described above.

Special Instructions

Children. The safety and efficacy of Adempas has not been studied in patients younger than 18 years of age. Since there are no available data on the use of Adempas in children, it is contraindicated in patients under 18 years of age.

Patients in the elderly. In elderly patients (65 years and older) special caution should be exercised, including with regard to dose selection.

Patients with impaired renal function. In patients with impaired renal function (creatinine Cl less than 80 ml/min but more than 15 ml/min) a more pronounced effect of Adempas has been noted, therefore special caution should be exercised when adjusting the dose in such patients. The use of Adempas is contraindicated in patients with severe renal dysfunction (creatinine Cl less than 15 ml/min) or who are on hemodialysis, since no studies have been conducted in such patients.

Hepatic impairment. Plasma concentrations of ryociguat in patients with mild hepatic impairment (Child-Pugh score 5-6, class A) are similar to plasma concentrations of ryociguat in healthy volunteers. In patients with moderate hepatic impairment (Child-Pugh grades 7-9, class B), a stronger effect of Adempas was observed. Particular caution should be exercised when adjusting the dose in such patients. The use of Adempas in patients with severe hepatic impairment (greater than 9 points by Child-Pugh grade C) is contraindicated since no studies have been conducted in such patients.

Tobacco smoking. Smoking patients are strongly recommended to quit smoking, because plasma concentrations of riociguat in smoking patients are significantly decreased compared to nonsmoking patients. Dose adjustment may be required if the patient starts or stops smoking during treatment with Adempas.

Contraindications

Concomitant use with nitrates or nitric oxide donators (such as amyl nitrite) in any dosage form.

Concomitant use with drugs of the group of FDE inhibitors, including With drugs of the group of FDE-5 inhibitors, such as sildenafil, vardenafil, tadalafil, or drugs of the group of non-specific FDE inhibitors, such as dipyridamole and theophylline;

severe hepatic impairment (greater than 9 Child-Pugh class C, no clinical experience);

severe arterial hypotension at the start of therapy (BP less than 95 mm Hg). systolic blood pressure at the start of therapy (BP less than 95 mm Hg), no clinical experience);

congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption (due to the presence of lactose);

severe renal impairment (creatinine Cl less than 15 ml/min) and patients on hemodialysis (no experience of clinical use);

breastfeeding period;

pregnancy;

Side effects

Blood and lymphatic system disorders: (including relevant laboratory values).

Nervous system disorders: dizziness, headache.

Heart and vascular disorders: palpitations, decreased blood pressure.

Respiratory system, thorax and mediastinum: hemoptysis, nasal bleeding, nasal congestion; pulmonary bleeding*.

Gastrointestinal tract: dyspepsia, diarrhea, nausea, vomiting; gastritis, GERD, dysphagia, pain in different parts of the gastrointestinal tract, constipation, bloating.

General disorders and disorders at the site of administration: peripheral edema.

Infectious and parasitic diseases: gastroenteritis.

Overdose

Symptoms:

Inadvertent overdose of 9-25 mg of riociguat over a period of 2-32 days has been reported. Adverse reactions were similar to those observed with lower doses.

Treatment:

A specific antidote to the drug is unknown. Standard supportive measures should be used according to clinical necessity. Active hemodynamic support may be required if pronounced BP decrease develops. Because ryociguat has a high degree of binding to plasma proteins, the possibility of its excretion by dialysis seems unlikely.

Pregnancy use

The drug Adempas is contraindicated in pregnancy.

The period of breastfeeding.

The drug Adempas should not be used by women while breastfeeding because of the possibility of serious adverse reactions in breastfed children.

The decision to discontinue breastfeeding or to withdraw and/or abstain from the drug during lactation should be based on a risk-benefit assessment.