Norethindrone Acetate And Ethinyl Estradiol (Jinteli)

Trade Name : Jinteli

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 15 mg/1ug/1

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]

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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 Norethindrone Acetate And Ethinyl Estradiol (Jinteli) which is also known as Jinteli and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1; 5 mg/1; ug/1 per ml. Read more

Norethindrone Acetate And Ethinyl Estradiol (Jinteli) 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
  • Arrayn- Estrogen Plus Progestin Therapy n
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia . n
  • The Womenu2019s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo . n
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .
  • Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer .n
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. n
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. n
  • Arrayn- Estrogen-Alone Therapy
  • Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding .
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia n n
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo n
  • The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women n
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA
  • See full prescribing information for complete boxed warning.
  • Estrogen Plus Progestin Therapy
  • Estrogen-Alone Therapy
  • u00a0u00a0n
  • Jinteli is an estrogen plus progestin indicated in a woman with a uterus for:
  • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ()
  • Prevention of Postmenopausal Osteoporosis ()
  • Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
  • One tablet taken orally once daily (2.1, 2.2)
  • Jinteli(Norethindrone Acetate and Ethinyl Estradiol Tablets USP) is available as:
  • 1 mg/5 mcg: Each white, round, flat-faced, beveled-edge, unscored tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; debossed with stylized on one side and 125 on the other side.
  • White, round, flat-faced, beveled edge, unscored tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol ()n
  • Jinteli is contraindicated in women with any of the following conditions:
  • Undiagnosed abnormal genital bleeding ()n
  • Known, suspected, or history of breast cancer (, 5.2)
  • Known or suspected estrogen-dependent neoplasia (, 5.2)
  • Active DVT, PE or a history of these conditions (, 5.1)
  • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, 5.1)
  • Known anaphylactic reaction or angioedema to Jinteli ()
  • Known liver impairment or disease (, 5.10)
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ()
  • Known or suspected pregnancy (, 8.1)
  • No data
  • Estrogens increase the risk of gallbladder disease (5.4)n
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10)
  • Monitor thyroid function in women on thyroid replacement therapy (5.11, 5.18)
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • Most common adverse reactions (incidence greater than or equal to 5 percent) are headache, abdominal pain, breast pain, and edema (generalized). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No drug-drug interaction studies have been conducted for Jinteli.
  • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1)n
  • No data
  • Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (8.3)n
  • Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Womenu2019s Health Initiative Memory ancillary studies of the Womenu2019s Health Initiative (5.3, 8.5)
  • Overdosage of estrogen plus progestin may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Jinteli with institution of appropriate symptomatic care.
  • Jinteli (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration.
  • Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17u03b1)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17u03b1)-]. Each tablet also contains the following ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.n
  • The structural formulas are as follows:n
  • Norethindrone Acetate, USPt Ethinyl Estradiol, USP
  • CHO M.W. 340.46 CHO M.W. 296.40
  • No data
  • Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
  • No data
  • No data
  • No data
  • See FDA-approved patient labeling (Patient Information)
  • Jintelin n
  • Read this Patient Information before you start taking Jinteli and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
  • What is Jinteli?
  • Jinteli is a prescription medicine that contains two kinds of hormones, an estrogen and a progestin.
  • What is Jinteli used for?
  • Jinteli is used after menopause to:
  • Estrogens are hormones made by a womanu2019s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the u201cchange of lifeu201d or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes u201csurgical menopauseu201d.n
  • When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (u201chot flashesu201d or u201chot flushesu201d). In some women the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe.
  • If you use Jinteli only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Jinteli.
  • Who should not take Jinteli?
  • Do not take Jinteli if you have had your uterus (womb) removed (hysterectomy).
  • Jinteli contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take Jinteli.
  • Do not take Jinteli if you:
  • Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Jinteli.
  • See the list of ingredients in Jinteli at the end of this leaflet.
  • Jinteli is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take Jinteli if the test is positive and talk to your healthcare provider.
  • What should I tell my healthcare provider before I take Jinteli?
  • Before you take Jinteli, tell your healthcare provider if you:
  • Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • Your healthcare provider will let you know if you need to stop taking Jinteli.
  • The hormones in Jinteli can pass into your breast milk.
  • Tell your healthcare provider about all the medicines you take,
  • including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Jinteli works. Jinteli may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take Jinteli?
  • What are the possible side effects of Jinteli?
  • Side effects are grouped by how serious they are and how often they happen when you are treated.
  • Serious, but less common side effects include:
  • Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
  • Less serious, but common side effects include:
  • These are not all the possible side effects of Jinteli. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • What can I do to lower my chances of a serious side effect with Jinteli?
  • Ask your healthcare provider for ways to lower your chances of getting heart disease.
  • How should I store Jinteli?
  • Keep Jinteli out of the reach of children.
  • General information about the safe and effective use of Jinteli.
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Jinteli for conditions for which it was not prescribed. Do not give Jinteli to other people, even if they have the same symptoms you have. It may harm them.
  • This leaflet summarizes the most important information about Jinteli. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about Jinteli that is written for health professionals.
  • For more information call 1-888-838-2872.
  • What are the ingredients in Jinteli?
  • Active Ingredients:
  • Inactive Ingredients:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454n
  • Rev. C 2/2016
  • No data
  • No data

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