Anastrozole (Anastrozole)

Trade Name : Anastrozole

Major Pharmaceuticals

TABLET

Strength 1 mg/1

ANASTROZOLE Aromatase Inhibitor [EPC],Aromatase Inhibitors [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 Anastrozole (Anastrozole) which is also known as Anastrozole and Manufactured by Major Pharmaceuticals. It is available in strength of 1 mg/1 per ml. Read more

Anastrozole (Anastrozole) 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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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
  • No data
  • u00a0
  • t5.4
  • Anastrozole is an aromatase inhibitor indicated for:
  • One 1 mg tablet taken once daily ( )
  • The tablets are white to off-white, round biconvex, film coated tablets, with u201cAHIu201d debossing on one side and plain on other side.
  • 1 mg tablets ( )
  • Hypersensitivity
  • Anastrozole is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria n
  • u2022
  • 4
  • No data
  • 5.1n- 6.1
  • 5.2n- t6.1
  • 5.3n- 6.1
  • 5.4n- 8.1
  • Serious adverse reactions with anastrozole occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling n
  • Common adverse reactions (occurring with an incidence of u226510%) in women taking anastrozole included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema.
  • In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the anastrozole group.
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • No data
  • 7.1n- 14.1
  • No data
  • Clinical trials have been conducted with anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
  • Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C H N and its structural formula is:
  • Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25u00b0C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile.
  • Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide.
  • No data
  • A conventional carcinogenesis study in rats at doses of 1.0u00a0tou00a025u00a0mg/kg/day (about 10 to 243 times the daily maximum recommended human dose on a mg/m basis) administered by oral gavage for up to 2 years revealed an increase in the incidence of hepatocellular adenoma and carcinoma and uterine stromal polyps in females and thyroid adenoma in males at the high dose. A dose-related increase was observed in the incidence of ovarian and uterine hyperplasia in females. At 25 mg/kg/day, plasma AUC levels in rats were 110 to 125 times higher than the level exhibited in postmenopausal volunteers at the recommended dose. A separate carcinogenicity study in mice at oral doses of 5 to 50 mg/kg/day (about 24 to 243u00a0times the daily maximum recommended human dose on a mg/m basis) for up to 2 years produced an increase in the incidence of benign ovarian stromal, epithelial and granulosa cell tumors at all dose levels. A dose-related increase in the incidence of ovarian hyperplasia was also observed in female mice. These ovarian changes are considered to be rodent-specific effects of aromatase inhibition and are of questionable significance to humans. The incidence of lymphosarcoma was increased in males and females at the high dose. At 50 mg/kg/day, plasma AUC levels in mice were 35 to 40 times higher than the level exhibited in postmenopausal volunteers at the recommended dose.
  • Anastrozole has not been shown to be mutagenic in tests (Ames and E. coli bacterial tests, CHO-K1 gene mutation assay) or clastogenic either (chromosome aberrations in human lymphocytes) or (micronucleus test in rats).
  • Oral administration of anastrozole to female rats (from 2u00a0weeks before mating to pregnancy day 7) produced significant incidence of infertility and reduced numbers of viable pregnancies at 1 mg/kg/day (about 10 times the recommended human dose on a mg/m basis and 9 times higher than the AUC found in postmenopausal volunteers at the recommended dose). Pre-implantation loss of ova or fetus was increased at doses equal to or greater than 0.02 mg/kg/day (about one-fifth the recommended human dose on a mg/m basis). Recovery of fertility was observed following a 5-week non-dosing period which followed 3 weeks of dosing. It is not known whether these effects observed in female rats are indicative of impaired fertility in humans.
  • Multiple-dose studies in rats administered anastrozole for 6u00a0months at doses equal to or greater than 1 mg/kg/day (which produced plasma anastrozole C and AUC that were 19 and 9 times higher than the respective values found in postmenopausal volunteers at the recommended dose) resulted in hypertrophy of the ovaries and the presence of follicular cysts. In addition, hyperplastic uteri were observed in 6-month studies in female dogs administered doses equal to or greater than 1 mg/kg/day (which produced plasma anastrozole C and AUC that were 22 times and 16 times higher than the respective values found in postmenopausal women at the recommended dose). It is not known whether these effects on the reproductive organs of animals are associated with impaired fertility in premenopausal women.
  • No data
  • Anastrozole tablets, USP 1 mg are white to off-white, round biconvex, film coated tablets, with u201cAHIu201d debossing on one side and plain on other side and are supplied as follows:
  • Bottle of 30 tablets, NDC 0904-6195-46
  • Storage
  • Store at controlled room temperature, 20 to 25u00b0C (68 to 77u00b0F) [see USP]. Preserve in tight container.
  • u201cSee FDA approved patient labeling (Patient Information).u201d
  • Hypersensitivity Reactions
  • Inform patients of the possibility of serious allergic reactions with swelling of the face, lips, tongue and/or throat (angioedema) which may cause difficulty in swallowing and/or breathing and to seek medical attention immediately .
  • Ischemic Cardiovascular Events
  • Patients with pre-existing ischemic heart disease should be informed that an increased incidence of cardiovascular events has been observed with anastrozole use compared to tamoxifen use. Advise patients if new or worsening chest pain or shortness of breath occurs to seek medical attention immediately .
  • Bone Effects
  • Inform patients that anastrozole lowers the level of estrogen. This may lead to a loss of the mineral content of bones, which might decrease bone strength. A possible consequence of decreased mineral content of bones is an increase in the risk of fractures .
  • Cholesterol
  • Inform patients that an increased level of cholesterol might be seen while receiving anastrozole .
  • Carpal Tunnel
  • Patients should be informed that if they experience tickling, tingling, or numbness they should notify their health care provider .
  • Tamoxifen
  • Patients should be advised not to take anastrozole with Tamoxifen .
  • Missed Doses
  • Inform patients that if they miss a dose, take it as soon as they remember. If it is almost time for their next dose, skip the missed dose and take the next regularly scheduled dose. Patients should not take two doses at the same time.
  • Embryo-Fetal Toxicity
  • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during ARIMIDEX therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with anastrozole .
  • Lactation
  • Advise women not to breastfeed during anastrozole treatment and for at least 2 weeks after the last dose .
  • Manufactured For:
  • Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA.
  • Manufactured By:
  • Intas Pharmaceuticals Limited, Ahmedabad u2013 380 054, INDIA.
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152 n
  • 10 2311 0 677194
  • Issued February 2019
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Patient Information
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Anastrozole Tablets u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 (an as' troe zole)
  • What is the most important information I should know about anastrozole tablet?
  • Get n- help right away if you have new or worsening chest pain or shortness of breath during
  • What is anastrozole tablet?
  • Anastrozole tablet is a prescription medicine used in women after menopause (u201cthe change of lifeu201d) for:
  • Anastrozole tablet does not work in women with breast cancer who have not gone through menopause (premenopausal women).
  • Who should not take anastrozole tablets?
  • Do not take anastrozole tablet if you:
  • What should I tell my healthcare provider before taking anastrozole tablets?
  • Before you take anastrozole tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take anastrozole tablets?
  • If you take too much anastrozole tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
  • What are the possible side effects of anastrozole tablets?
  • Anastrozole tablets may cause serious side effects including:
  • Common side effects in women taking anastrozole tablets include:
  • Anastrozole tablets may also cause you to have tickling, tingling or numbness of your skin.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of anastrozole tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store anastrozole tablets?
  • General information about the safe and effective use of anastrozole tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take anastrozole tablets for a condition for which it was not prescribed. Do not give anastrozole tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about anastrozole tablets that is written for health professionals.
  • For more information, visit or call Accord Healthcare Inc. at 1-866-941-7875.
  • What are the ingredients in anastrozole tablets?
  • Active ingredient: anastrozole
  • Inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured For:
  • Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA.
  • Manufactured By:
  • Intas Pharmaceuticals Limited, Ahmedabad u2013 380 054, INDIA.
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • 10 2311 0 677194
  • Issued February 2019
  • Anastrozole Tablets USP
  • 1 mg
  • 30 Tablets

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