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Ambrisentan (Ambrisentan)

Trade Name : Ambrisentan

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 5 mg/1

AMBRISENTAN Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]

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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 Ambrisentan (Ambrisentan) which is also known as Ambrisentan and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 5 mg/1 per ml. Read more

Ambrisentan (Ambrisentan) 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

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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.

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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.

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About GNH

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.

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.

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  • No data
  • Do not administer ambrisentan tablets to a pregnant female because they may cause fetal harm. Ambrisentan tablets are very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when they are administered to animals n
  • u00a0u00a0
  • Exclude pregnancy before the initiation of treatment with ambrisentan tablets. Females of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan tablets and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment n
  • u00a0u00a0
  • Because of the risk of embryo-fetal toxicity, for all female patients, ambrisentan tablets are only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Ambrisentan REMS n
  • WARNING: EMBRYO-FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • Do not administer ambrisentan tablets to a pregnant female because they may cause fetal harm (, , ).
  • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception (, ).
  • Because of the risk of embryo-fetal toxicity, for all female patients, ambrisentan tablets are only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Ambrisentan REMS ().
  • Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
  • Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
  • Ambrisentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
  • To improve exercise ability and delay clinical worsening.
  • Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) ().
  • No data
  • Ambrisentan Tablets are available containing 5 mg or 10 mg of ambrisentan.
  • Tablet: 5 mg and 10 mg ()
  • No data
  • No data
  • Clinically significant adverse reactions that appear in other sections of the labeling include:
  • u00a0u00a0u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u2022
  • 6.1
  • Multiple dose coadministration of ambrisentan and cyclosporine resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers; therefore, limit the dose of ambrisentan to 5 mg once daily when coadministered with cyclosporine n
  • Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily ().
  • No data
  • There is no experience with overdosage of ambrisentan tablets. The highest single dose of ambrisentan tablets administered to healthy volunteers was 100 mg, and the highest daily dose administered to patients with PAH was 10 mg once daily. In healthy volunteers, single doses of 50 mg and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea, and nasal congestion. Massive overdosage could potentially result in hypotension that may require intervention.
  • Ambrisentan tablets are an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. The chemical name of ambrisentan is (+)-(2)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of CHNO and a molecular weight of 378.42. It contains a single chiral center determined to be the configuration and has the following structural formula:
  • Ambrisentan is a white to off-white powder. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive.
  • Ambrisentan tablets are available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Each round, pink ambrisentan tablet contains 5 mg of ambrisentan. Each capsule shaped, pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored.
  • No data
  • Oral carcinogenicity studies of up to two years duration were conducted at starting doses of 10, 30, and 60 mg/kg/day in rats (8 to 48 times the maximum recommended human dose [MRHD] on a mg/m basis) and at 50, 150, and 250 mg/kg/day in mice (28 to 140 times the MRHD). In the rat study, the high- and mid-dose male and female groups had their doses lowered to 40 and 20 mg/kg/day, respectively, in week 51 because of effects on survival. The high-dose males and females were taken off drug completely in weeks 69 and 93, respectively. The only evidence of ambrisentan-related carcinogenicity was a positive trend in male rats, for the combined incidence of benign basal cell tumor and basal cell carcinoma of skin/subcutis in the mid-dose group (high-dose group excluded from analysis), and the occurrence of mammary fibroadenomas in males in the high-dose group. In the mouse study, high-dose male and female groups had their doses lowered to 150 mg/kg/day in week 39 and were taken off drug completely in week 96 (males) or week 76 (females). In mice, ambrisentan was not associated with excess tumors in any dosed group.
  • Positive findings of clastogenicity were detected, at drug concentrations producing moderate to high toxicity, in the chromosome aberration assay in cultured human lymphocytes. There was no evidence for genetic toxicity of ambrisentan when tested in bacteria (Ames test) or in rats (micronucleus assay, unscheduled DNA synthesis assay).
  • The development of testicular tubular atrophy and impaired fertility has been linked to the chronic administration of endothelin receptor antagonists in rodents. Testicular tubular degeneration was observed in rats treated with ambrisentan for two years at doses u2265 10 mg/kg/day (8-fold MRHD). Increased incidences of testicular findings were also observed in mice treated for two years at doses u2265 50 mg/kg/day (28-fold MRHD). Effects on sperm count, sperm morphology, mating performance, and fertility were observed in fertility studies in which male rats were treated with ambrisentan at oral doses of 300 mg/kg/day (236-fold MRHD). At doses of u2265 10 mg/kg/day, observations of testicular histopathology in the absence of fertility and sperm effects were also present.
  • No data
  • Ambrisentan Tablets are available containing 5 mg or 10 mg of ambrisentan.
  • The 5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4270-93bottles of 30 tablets
  • The 10 mg tablets are pink, film-coated, capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4271-93bottles of 30 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense only in original container.
  • PHARMACIST:
  • Advise patients to read the FDA-approved patient labeling ().
  • Embryo-fetal Toxicity:n- [see and ].
  • Ambrisentan Risk Evaluation and Mitigation Strategy (REMS):n- [see , ].
  • Inform female patients (and their guardians, if applicable) of the following notable requirements:
  • Ambrisentan tablets are available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product.
  • Hepatic Effects:
  • Hematological Change:
  • Other Risks Associated with Ambrisentan Tablets:
  • Administration:
  • u00a0
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • 75069501
  • Revised: 8/2019MX:AMBR:R5
  • NDC 0378-4270-97
  • Ambrisentann- Tabletsn- 5 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a010 Tablets
  • Each film-coated tablet contains:Ambrisentan 5 mg
  • Usual Dosage:
  • Do not split, crush or chew your tablets.
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4270AM
  • Dispense only in original container.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-4271-97
  • Ambrisentann- Tabletsn- 10 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a010 Tablets
  • Each film-coated tablet contains:Ambrisentan 10 mg
  • Usual Dosage:
  • Do not split, crush or chew your tablets.
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4271AM
  • Dispense only in original container.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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