Anastrozole (Anastrozole)

Trade Name : Anastrozole

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 1 mg/1

Storage and handling for Anastrozole

ANASTROZOLE Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]

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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 Teva Pharmaceuticals USA, Inc.. 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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About GNH

No data

Warnings and Precautions, Embryo-Fetal Toxicity (5.4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a012/2018n

Anastrozole tablets are an aromatase inhibitor indicated for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ()
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ()
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. ()

One 1 mg tablet taken once daily ()

Anastrozole Tablets USP are white to off-white, film-coated, unscored, round-shaped tablets, containing 1 mg of anastrozole; one side of the tablet is debossed with u201cTEVAu201d. The other side of the tablet is debossed with the number u201cA10u201d.
1 mg tablets ()

Hypersensitivity
Anastrozole tablets are 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

Patients with demonstrated hypersensitivity to anastrozole tablets or any excipient ()n

No data

In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with anastrozole tablet use compared to tamoxifen use. Consider risks and benefits. (, )
Decreases in bone mineral density may occur. Consider bone mineral density monitoring. (, )
Increases in total cholesterol may occur. Consider cholesterol monitoring. (, )
Embryo-Fetal Toxicity: Anastrozole tablets may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (, )

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 [].
Common adverse reactions (occurring with an incidence of u2265 10%) 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.
In the early breast cancer (ATAC) study, the most common (occurring with an incidence of u226510%) side effects occurring in women taking anastrozole tablets included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality. ()
In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking anastrozole tablets included: hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis and peripheral edema. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Tamoxifen: Do not use in combination with anastrozole tablets. No additional benefit seen over tamoxifen monotherapy. (, )
Estrogen-containing products: Combination use may diminish activity of anastrozole tablets. ()

No data

Lactation: Do not breastfeed. ()n
Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation of anastrozole tablets. ()
Pediatric patients: Efficacy has not been demonstrated for pubertal boys of adolescent age with gynecomastia or girls with McCune-Albright Syndrome and progressive precocious puberty. ()

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, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, u03b1, u03b1, u03b1', u03b1'-tetramethyl-5-(1-1,2,4-triazol-1-ylmethyl). Its structural formula is:
CHN M.W. 293.37
Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25u00b0C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile.
Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.

No data

A conventional carcinogenesis study in rats at doses of 1.0 to 25 mg/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 243 times 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 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 2 weeks 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 6 months 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 are available as follows:
1 mg u2013 White to off-white, film-coated, unscored, round-shaped tablets, debossed with u201cTEVAu201d on one side of the tablet and with u201cA10u201d on the other, in bottles of 30 (NDC 0093-7536-56).
Store at controlled room temperature, 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

See FDA approved patient labeling (Patient Information).
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 n
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 tablets use compared to tamoxifen use. Advise patients if new or worsening chest pain or shortness of breath occurs to seek medical attention immediately n
Bone Effects
Inform patients that anastrozole tablets lower 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 n
Cholesterol
Inform patients that an increased level of cholesterol might be seen while receiving anastrozole tablets n
Carpal Tunnel
Patients should be informed that if they experience tickling, tingling, or numbness they should notify their health care provider n
Tamoxifen
Patients should be advised not to take anastrozole tablets with tamoxifen n
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 anastrozole tablets 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 tablets .
Lactation
Advise women not to breastfeed during anastrozole tablets treatment and for at least 2 weeks after the last dose .
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Rev. J 1/2019

Anastrozole (an as' troe zole) Tablets
What is the most important information I should know about anastrozole tablets?
Anastrozole tablets may cause serious side effects including:
Get medical help right away if you have new or worsening chest pain or shortness of breath during treatment with anastrozole.
What are anastrozole tablets?
Anastrozole tablets are a prescription medicine used in women after menopause (u201cthe change of lifeu201d) for:
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 many 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. 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?
Keep anastrozole tablets and all medicines out of the reach of children.
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 they were not prescribed. Do not give anastrozole tablets to other people, even if they have the same symptoms that you have. They 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 call 1-888-838-2872.
What are the ingredients in anastrozole tablets?
Active ingredient: anastrozole
Inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Rev. E 1/2019
Arrayn- u00a0

NDCn- 7536
Anastrozoleu00a0n- Tablets USPn- 1 mg
PHARMACIST: PLEASE DISPENSEu00a0WITH ATTACHED PATIENTu00a0INFORMATION LEAFLET
Rx only
30 TABLETS
TEVA

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