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What is OPSUMIT?
OPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of CHBrNOS and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:
Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive.
OPSUMIT is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum.
What does OPSUMIT look like?
What are the available doses of OPSUMIT?
Tablets: 10 mg, bi-convex film-coated, round, white, and debossed with "10" on both sides.
What should I talk to my health care provider before I take OPSUMIT?
Nursing mothers: discontinue OPSUMIT or breastfeeding ().
How should I use OPSUMIT?
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH ().
The recommended dosage of OPSUMIT is 10 mg once daily for oral administration. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.
What interacts with OPSUMIT?
Sorry No Records found
What are the warnings of OPSUMIT?
Sorry No Records found
What are the precautions of OPSUMIT?
Sorry No Records found
What are the side effects of OPSUMIT?
Sorry No records found
What should I look out for while using OPSUMIT?
What might happen if I take too much OPSUMIT?
OPSUMIT has been administered as a single dose of up to and including 600 mg to healthy subjects (60 times the approved dosage). Adverse reactions of headache, nausea and vomiting were observed. In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because macitentan is highly protein-bound.
How should I store and handle OPSUMIT?
OPSUMIT tablets are 10 mg white, film-coated, bi-convex debossed with "10" on both sides and supplied as follows:15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15)30 count white high-density polyethylene bottle in carton (NDC 66215-501-30)OPSUMIT tablets are 10 mg white, film-coated, bi-convex debossed with "10" on both sides and supplied as follows:15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15)30 count white high-density polyethylene bottle in carton (NDC 66215-501-30)OPSUMIT tablets are 10 mg white, film-coated, bi-convex debossed with "10" on both sides and supplied as follows:15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15)30 count white high-density polyethylene bottle in carton (NDC 66215-501-30)
Chemical StructureNo Image found
Endothelin (ET)-1 and its receptors (ET and ET) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.
Macitentan is an endothelin receptor antagonist that prevents the binding of ET-1 to both ET and ET receptors. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. One of the metabolites of macitentan is also pharmacologically active at the ET receptors and is estimated to be about 20% as potent as the parent drug .
Non-Clinical ToxicologyPregnancy ()
When given concurrently the following drugs may interact with thiazide diuretics.
OPSUMIT may cause fetal harm when administered during pregnancy and is contraindicated for use in females who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods and obtain monthly pregnancy tests .
OPSUMIT is available for females through the OPSUMIT REMS Program, a restricted distribution program .
Clinically significant adverse reactions that appear in other sections of the labeling include:
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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