Bosentan (Bosentan)

Trade Name : Bosentan

West-Ward Pharmaceuticals Corp.

TABLET

Strength 62.5 mg/1

BOSENTAN Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bosentan (Bosentan) which is also known as Bosentan and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 62.5 mg/1 per ml. Read more

Bosentan (Bosentan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Because of the risks of hepatotoxicity and birth defects, Bosentan is available only through a restricted program called the Bosentan REMS Program. Under the Bosentan REMS Program, prescribers, patients, and pharmacies must enroll in the program [].
Arrayn- Hepatotoxicity
In clinical studies, bosentan caused at least 3-fold upper limit of normal (ULN) elevation of liver aminotransferases (ALT and AST) in about 11% of patients, accompanied by elevated bilirubin in a small number of cases. Because these changes are a marker for potential serious hepatotoxicity, serum aminotransferase levels must be measured prior to initiation of treatment and then monthly [n n- Arrayn- Array
In the postmarketing period, in the setting of close monitoring, rare cases of unexplained hepatic cirrhosis were reported after prolonged (> 12 months) therapy with bosentan in patients with multiple comorbidities and drug therapies. There have also been reports of liver failure. The contribution of bosentan in these cases could not be excluded.
In at least one case, the initial presentation (after > 20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by non-specific symptoms, all of which resolved slowly over time after discontinuation of bosentan. This case reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment and the treatment algorithm, which includes stopping bosentan with a rise of aminotransferases accompanied by signs or symptoms of liver dysfunction [].
Elevations in aminotransferases require close attention []. Bosentan should generally be avoided in patients with elevated aminotransferases (> 3 x ULN) at baseline because monitoring for hepatotoxicity may be more difficult. If liver aminotransferase elevations are accompanied by clinical symptoms of hepatotoxicity (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin u22652 x ULN, treatment with bosentan should be stopped. There is no experience with the reintroduction of bosentan in these circumstances.
Arrayn- Embryo-Fetal Toxicity
Bosentan is likely to cause major birth defects if used by pregnant females based on animal data []. Therefore, pregnancy must be excluded before the start of treatment with bosentan. Throughout treatment and for one month after stopping bosentan, females of reproductive potential must use two reliable methods of contraception unless the patient has an intrauterine device (IUD) or tubal sterilization, in which case no other contraception is needed. Hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives should not be used as the sole means of contraception because these may not be effective in patients receiving bosentan []. Obtain monthly pregnancy tests.
WARNING: RISK OF HEPATOTOXICITY and EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
Bosentan is available only through a restricted distribution program called the Bosentan REMS Program because of these risks (): Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with bosentan ().
Based on animal data, bosentan is likely to cause major birth defects if used during pregnancy (, , ).

Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

u2022
1

No data

Bosentan Tablets contain either 64.541 mg or 129.082 mg of bosentan monohydrate equivalent to 65 mg or 125 mg of bosentan and are available as film-coated tablets for oral administration.
62.5 mg Tablets:
125 mg Tablets:

u2022
3

No data

No data

The following important adverse reactions are described elsewhere in the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact
West-Ward Pharmaceuticals Corp. at 1-800-962-8364
or FDA at 1-800-FDA-1088 or n

u2022
6.1

No data

4.2n- 4.3n- 7.1

No data

u2022
8.2

Bosentan has been given as a single dose of up to 2400 mg in normal volunteers, or up to 2000 mg/day for 2 months in patients, without any major clinical consequences. The most common side effect was headache of mild to moderate intensity. In the cyclosporine A interaction study, in which doses of 500 and 1000 mg twice daily of bosentan were given concomitantly with cyclosporine A, trough plasma concentrations of bosentan increased 30-fold, resulting in severe headache, nausea, and vomiting, but no serious adverse events. Mild decreases in blood pressure and increases in heart rate were observed.
In the postmarketing period, there was one reported overdose of 10,000 mg of bosentan taken by an adolescent male patient. He had symptoms of nausea, vomiting, hypotension, dizziness, sweating, and blurred vision. He recovered within 24 hours with blood pressure support.
Bosentan is unlikely to be effectively removed by dialysis due to the high molecular weight and extensive plasma protein binding.

Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy ethoxy)-5-(2-methoxy phenoxy) 2-(pyrimidine-2-yl) pyrimidine-4-yl] benzene sulfonamide monohydrate] and has the following structural formula:
Bosentan has a molecular weight of 569.64 and a molecular formula of CHNOSu2022HO. Bosentan is an off-white to pale yellow powder. It is soluble in methylene dichloride and insoluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive.
Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate equivalent to 62.5 mg of bosentan. Additionally, each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate equivalent to 125 mg of bosentan.
Inactive ingredients for the 62.5 mg and the 125 mg film-coated tablets consist of glyceryl dibehenate, magnesium stearate, Opadry (orange), povidone, pregelatinized starch, and sodium starch glycolate. The Opadry (orange) consists of hypromellose, iron oxide red, iron oxide yellow, talc, titanium dioxide and triacetin.

No data

Carcinogenesis and Mutagenesis
Two years of dietary administration of bosentan to mice produced an increased incidence of hepatocellular adenomas and carcinomas in males at doses as low as 450 mg/kg/day (about 8 times the maximum recommended human dose [MRHD] of 125 mg twice daily, on a mg/m basis). In the same study, doses greater than 2000 mg/kg/day (about 32 times the MRHD) were associated with an increased incidence of colon adenomas in both males and females. In rats, dietary administration of bosentan for two years was associated with an increased incidence of brain astrocytomas in males at doses as low as 500 mg/kg/day (about 16 times the MRHD). In a comprehensive battery of tests (the microbial mutagenesis assay, the unscheduled DNA synthesis assay, the V-79 mammalian cell mutagenesis assay, and human lymphocyte assay) and an mouse micronucleus assay, there was no evidence for any mutagenic or clastogenic activity of bosentan.
Impairment of Fertility/Testicular Function
The development of testicular tubular atrophy and impaired fertility has been linked with the chronic administration of certain endothelin receptor antagonists in rodents.
Treatment with bosentan at oral doses of up to 1500 mg/kg/day (50 times the MRHD on a mg/m basis) or intravenous doses up to 40 mg/kg/day had no effects on sperm count, sperm motility, mating performance or fertility in male and female rats. An increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/ day (about 4 times the MRHD and the lowest doses tested) for two years but not at doses as high as 1500 mg/kg/day (about 50 times the MRHD) for 6 months. Effects on sperm count and motility were evaluated only in the much shorter duration fertility studies in which males had been exposed to the drug for 4 to 6 weeks. An increased incidence of tubular atrophy was not observed in mice treated for 2 years at doses up to 4500 mg/kg/day (about 75 times the MRHD) or in dogs treated up to 12 months at doses up to 500 mg/kg/day (about 50 times the MRHD).

No data

Bosentan Tablets
62.5 mg tablets are supplied as a film-coated, round, biconvex, orange tablet, debossed with identification marking u201c54u201d on one side and u201c101u201d on the other side.
NDC 0054-0520-21: Bottle of 60 TabletsNDC 0054-0520-18: 30 Unit-Dose Tablets (For Hospital Use)
125 mg tablets are supplied as a film-coated, oval, biconvex, orange tablet, debossed with identification marking u201c54u201d on one side and u201c333u201d on the other side.
NDC 0054-0521-21: Bottle of 60 TabletsNDC 0054-0521-22: Bottle of 90 Tablets NDC 0054-0521-18: 30 Unit-Dose Tablets (For Hospital Use)
Store at 20u00baC to 25u00baC (68u00baF to 77u00baF). [See USP Controlled Room Temperature.]

Advise the patient to read the FDA-approved patient labeling ()
Restricted Access
Advise the patient that bosentan is only available through a restricted access program called the Bosentan REMS Program.
As a component of the Bosentan REMS Program, prescribers must review the contents of the bosentan Medication Guide with the patient before initiating bosentan.
Instruct patients that the risks associated with bosentan include:
Other Risks Associated with Bosentan
Instruct patients that the risks associated with bosentan also include the following:
Distr. by: n Eatontown, NJ 07724
10010267/05
Revised July 2019

No data

Bosentan Tablets, 62.5 mg
0054-0520-21, Rx only

Bosentan Tablets, 125 mg
0054-0521-21, Rx only

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Bosentan (Bosentan)

Trade Name : Bosentan

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Bosentan (Bosentan)

Trade Name : Bosentan

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?