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Orenitram
Overview
What is Orenitram?
Orenitram is an extended release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1,2,3a,9a)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3)-3-hydroxyoctyl]-1-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is CHO.CHNO, the molecular weight is 495.65, and it has the following structural formula:
Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine) or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprinting ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol.
Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug out through the tablet at a controlled rate.
What does Orenitram look like?
What are the available doses of Orenitram?
Extended-Release Tablets: 0.125 mg, 0.25 mg, 1 mg, 2.5 mg and 5 mg. ()
What should I talk to my health care provider before I take Orenitram?
How should I use Orenitram?
Orenitram is a prostacyclin vasodilator indicated for:
As the sole vasodilator, the effect on exercise is small. Orenitram has not been shown to add to other vasodilator therapy. ()
Take Orenitram with food. Swallow Orenitram tablets whole; do not crush, split, or chew.
The recommended starting dose of Orenitram is 0.25 mg twice daily (BID) with food, taken approximately 12 hours apart or 0.125 mg three times daily (TID) with food, taken approximately 8 hours apart. Increase the dose to the highest tolerated dose. The recommended increment is 0.25 or 0.5 mg BID or 0.125 mg TID every 3-4 days. If dose increments are not tolerated consider titrating slower.
The appropriate maintenance dose is determined by tolerability.
If intolerable pharmacologic effects occur, decrease the dose in increments of 0.25 mg.
.
What interacts with Orenitram?
Sorry No Records found
What are the warnings of Orenitram?
Sorry No Records found
What are the precautions of Orenitram?
Sorry No Records found
What are the side effects of Orenitram?
Sorry No records found
What should I look out for while using Orenitram?
Severe hepatic impairment (Child Pugh Class C) .
What might happen if I take too much Orenitram?
Signs and symptoms of overdose with Orenitram during clinical trials reflect its dose-limiting pharmacologic effects and include severe headache, nausea, vomiting, diarrhea, and hypotension. Treat supportively.
How should I store and handle Orenitram?
Store at 25°C (77°F); excursions 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Keep out of reach of children.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows:Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows:StorageStore montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.Storage for Bulk BottlesStore bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
Non-Clinical Toxicology
Severe hepatic impairment (Child Pugh Class C) .Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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