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Mitotane (Lysodren)

Trade Name : LYSODREN

E.R. Squibb & Sons, L.L.C.

TABLET

Strength 500 mg/1

MITOTANE Cytochrome P450 3A4 Inducers [MoA]

Delivery Process

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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 Mitotane (Lysodren) which is also known as LYSODREN and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 500 mg/1 per ml. Read more

Mitotane (Lysodren) 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.

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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
  • In patients taking LYSODREN, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue LYSODREN until recovery .
  • WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR SEVERE TRAUMA
  • See full prescribing information for complete boxed warning.
  • LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.
  • LYSODREN is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma. n
  • u2022Initial dose: 2 g to 6 g orally daily, in three or four divided doses. n
  • u2022Increase dose incrementally to achieve a blood concentration of 14 to 20u00a0mg/L, or as tolerated. n
  • 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with u201cBLu201d over u201cL1u201d on the other side.
  • Tablets: 500 mg, scored n
  • None.
  • None n
  • No data
  • Central Nervous System (CNS) Toxicity: Plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity. n
  • Adrenal Insufficiency: Institute steroid replacement as clinically indicated. Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement. n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of reproductive potential of the potential risk to a fetus and use of effective contraception. (, , )
  • Ovarian Macrocysts in Premenopausal Women: Advise women to seek medical advice if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain. ()
  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • The following adverse reactions associated with the use of LYSODREN were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
  • Common adverse reactions occurring with LYSODREN treatment include:
  • Less common adverse reactions include: visual blurring, diplopia, lens opacity, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, generalized aching, and fever.
  • Common adverse reactions (u226515%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. n
  • Adjust dosage of concomitant coumarin-type anticoagulants as needed. n
  • No data
  • LYSODREN (mitotane) is an oral adrenal cytotoxic agent. The chemical name is (u00b1)-1,1-dichloro-2-(-chlorophenyl)-2-(-chlorophenyl) ethane (also known as o,pu2032-DDD). The chemical structure is:
  • Mitotane is a white granular solid composed of clear colorless crystals. It is tasteless and has a slight pleasant aromatic odor. It is soluble in ethanol and has a molecular weight of 320.05.
  • Inactive ingredients in LYSODREN are: microcrystalline cellulose, polyethylene glycol 3350, silicon dioxide, and starch.
  • No data
  • The carcinogenicity and mutagenicity of mitotane are unknown.
  • 1.u00a0u00a0 OSHA. n
  • LYSODREN tablets are supplied as 500u00a0mg white, round, biconvex, scored tablets, bisected on one side and impressed with u201cBLu201d over u201cL1u201d on the other side.
  • 100 tablets per bottle: NDC 0015-3080-60
  • Store bottles at 25u00b0C (77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F-86u00b0F).
  • Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures .
  • No data
  • Manufactured for:Bristol-Myers Squibb CompanyPrinceton, New Jersey 08543 USAn Revised: November 2019
  • See section for a complete list of available packages of LYSODREN.
  • NDC 0015-3080-60n- 100 TABLETSn- LYSODREN (mitotane tablets, USP)n- 500 mg n- Rx only

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