All the Therapeutic System Drugs
Endothelin A Receptor Antagonist. Ambrisentan 5 mg, 10 mg. FC TABS: 5 mg dly., 10 mg dly. is possible if 5 mg is well tolerated. See lit.
Tmt. of pulmona arterial hypertension (PAH) in adult pts. of WHO Funct. Class (FC) II to III, incl. use in comb. tmt. with tadalafil. Effica. shown in idiopat. PAH and in PAH associat. with connective tissue dis.
C/I: Please refer to the license holder for further details.
Endothelin Receptor Antagonist. Bosentan (as monohydrate) 62.5 mg, 125 mg. F.C. TABS.: 60. The tmt. in adults is usually started with 62.5 mg ×2/d for the first 4 wks. Thereafter, the dose may be incr. to 125 mg×2/d, depend. on the react. of the pt.
Child. and adolesc.: The optimal dosage for child. under the age of 12 who suffer from pulmon. arterial hypertens. is unknown.
Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV.
Reduct. in the number of new digital ulcers in pts. with system. sclerosis with active digital ulcer dis.
C/I: Hypersens. Hepat. impair. Women of child bear. age who are not use. appropr. method of contracep. Preg. Transplant/proriatic pts. who are treated with cyclosporine. See lit.
Prostaglandin. Epoprostenol (as sodium) 0.5 mg, 1.5 mg. VIAL (freeze-dried pwdr.): 1 + 1 sterile
diluent. See lit.
Long-term I.V. tmt. prim. pulm.
hypertens. in NYHA class III and IV.
Endothelin Receptor Antagonist. Macitentan 10 mg. F.C. TABS.: 30. 10 mg ×1/d, with or without food, should be taken every day at the same time.
Tmt. of PAH, who GROUP I to delay dis. progress. Dis. progress. includ.: death, initiat. of IV or subcutan. prostanoids, or clin. worsening of PAH (decreased 6-min. walk distance, worsened PAH sympt. and need for additional PAH tmt.). The drug also reduced hospitaliz. for PAH.
C/I: Hypersens., Soya. Preg., WOCBP who are not using reliable contracep., Lact.
Pts. with severe hep. impair. (with or without cirrhosis).
Baseline values of hep. aminotransferases (AST and/or ALT>3×ULN).
Synthetic Prostacyclin Analog. Treprostinil (as Sodium) 2.5 mg, 5 mg, 10 mg/ml. VIAL: 1, 5 × 20 ml of 50 mg, 100mg,
200mg. SC or IV use contin. infus. The
infus. rate is init. at 1.25 ng/kg/min. If
this init. dose cannot be tolerat., the
infuse. rate should be reduced to 0.625
ng/kg/min. See lit.
Prim. pulmon. arter. hypertens.
Pulmon. arter. hypertens. assoc. with
connect. tissue disord.
Pulmon. arter. hypertens. assoc. with
congen. system. to pulmon. shunts.
C/I: Hypersens. to the drug or structural.
related compound.
PDE5 Inhibitor. Sildenafil (as citrate) 20 mg. F.C. TABS: 90. 20 mg 3 x dly approx.
4-6 hrs apart, with/out food. See lit.
For adult. > 18 yrs.: Tmt. of prim.
pulmon. hypertens. (PPH) pulm.
hypertens. (PH) associated with
connective tissue disease (CTD) or PH
following surgical repair at least 5 yrs.
previous. of atrial septal defect (ASD)
ventric. septal defect (VSD) patent
ductus arteriosus (PDA) or aortopulmon.
window.
C/I: Hypersens; Co-admin. with nitric
oxide donors (such as amyl nitrite) or
nitrates in any form due to the
hypotensive effects of nitrates.
Co-admin. of PDE5 inhib., includ.
sildenafil, with guanylate cyclase
stimulat; Comb. with the most potent of
the CYP3A4 inhib. (eg, ketoconazole,
itraconazole, ritonavir).
Pts. who have loss of vision in one eye
because of non-arteritic anterior
ischaem. optic neuropathy (NAION),
regardless of whether this episode was
in connect. or not with prev. PDE5 inhib.
expos; Sev. hep. impair; Recent history
of stroke or MI; Severe hypotens. (blood
pres.< 90/50 mmHg) at initiat.
