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Riociguat

ریوسیگوات

⚠ Unverified

❤️ Cardiovascular SystemSoluble guanylate cyclase stimulator

🤰 Pregnancy:Contraindicated 🤱 Breastfeeding:Dangerous / avoid 👶 Children:Safety not established 👴 Older adults:Use with caution ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran ⛔ 4 contraindications 🇺🇸 FDA approved (NDA) NDA204819 ATC C02KX05

Market / country: 🇺🇸 USA

Adempas (US)

🧮 Dose calculator

Disease / regimen

Pulmonary arterial hypertension (PAH) · Regimen source: FDA Adempas · 2.1

• Increase only if systolic BP stays >95 mmHg without hypotension. Start 0.5 mg if at risk of hypotension or with strong CYP/P-gp inhibitors. Stop sildenafil 24 h and tadalafil 48 h before. FDA Adempas · 2.1 FDA Adempas · 2.5 FDA Adempas · 2.6

Formulation

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🛡️ Safety & information

Contraindications

⛔ Pregnancy. FDA Adempas · 4.1
⛔ Nitrates or nitric oxide donors in any form. FDA Adempas · 4.2
⛔ PDE-5 inhibitors (sildenafil, tadalafil, vardenafil) or non-specific PDE inhibitors (dipyridamole, theophylline); other sGC stimulators. FDA Adempas · 4.3 FDA Adempas · 4.4
⛔ Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). FDA Adempas · 4.5

Warnings

• Boxed warning: embryo-fetal toxicity — contraindicated in pregnancy; pregnancy test before and monthly, effective contraception until 1 month after stopping (REMS). FDA Adempas · Boxed Warning
• Hypotension; bleeding (including haemoptysis); pulmonary oedema with veno-occlusive disease. FDA Adempas · 5

Formulations

0.5 mg tablet — tablet 🇺🇸 USA FDA Adempas · 3
1 mg tablet — tablet 🇺🇸 USA FDA Adempas · 3
1.5 mg tablet — tablet 🇺🇸 USA FDA Adempas · 3
2 mg tablet — tablet 🇺🇸 USA FDA Adempas · 3
2.5 mg tablet — tablet 🇺🇸 USA FDA Adempas · 3

👥 Special populations

🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Adempas · 4
“( 4.4 , 7.1 ) • Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) ( 4.5 ) 4.1 Pregnancy Use of Adempas is contraindicated in patients who are pregnant [see Warnings and Precautions (5.1) , Use in Specific Populations ( 8.1 )] . 4.2 Nitrates and Nitric Oxide Donors Co-administration of …”
🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Adempas · 8.2
“Because of the potential for serious adverse reactions from Adempas, such as hypotension, in breastfed infants, advise women not to breastfeed during treatment with Adempas.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Adempas · 8.4
“Safety and effectiveness of Adempas in pediatric patients have not been established [see Nonclinical Toxicology (13.2) ] .”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Adempas · 8.5
“Of the total number of subjects in clinical studies of Adempas, 23% were 65 and over, and 6% were 75 and over [see Clinical Studies (14) ].”
⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Adempas · 8.3
“Contraception Females Female patients of reproductive potential should use effective contraception prior to initiation of treatment, during treatment with Adempas and for 1 month after treatment with Adempas to prevent pregnancy [see Boxed Warning ].”

🔗 Reference links

FDA (approval record)NDA204819
DailyMed (FDA label)FDA Adempas
MedlinePlus (NIH)Riociguat
WHO ATC/DDDC02KX05
Darooyab (Iran)Riociguat

🇮🇷 Registered in Iran Darooyab · G-5522/Riociguat

Dosage forms with Iranian generic codes, per Darooyab.

52716 · RIOCIGUAT TABLET ORAL 1 mg · قرص ریوسیگوات ۱ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Adempas · 3 FDA Adempas · 2.1 FDA Adempas · 2.5 FDA Adempas · 2.6 FDA Adempas · 4.1 FDA Adempas · 4.2 FDA Adempas · 4.3 FDA Adempas · 4.4 FDA Adempas · 4.5 FDA Adempas · Boxed Warning FDA Adempas · 5 FDA Adempas · SPL approval / marketing category FDA Adempas · 4 FDA Adempas · 8.2 FDA Adempas · 8.4 FDA Adempas · 8.5 FDA Adempas · 8.3
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-5522/Riociguat
Clinical review⚠ Unverified