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Progesterone (Progesterone)

Trade Name : Progesterone

Teva Pharmaceuticals USA, Inc.

CAPSULE, LIQUID FILLED

Strength 100 mg/1

PROGESTERONE Progesterone [CS],Progesterone [EPC]

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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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 Progesterone (Progesterone) which is also known as Progesterone and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Progesterone (Progesterone) 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
  • Cardiovascular Disorders and Probable Dementia
  • Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (see and and ).
  • The Womenu2019s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction 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 (see and ).
  • 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 (see and and ).
  • Breast Cancer
  • The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer (see and ).
  • 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.
  • Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Progesterone capsules contain micronized progesterone USP for oral administration. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126u00b0 and 131u00b0C. The structural formula is:
  • CHO M.W. 314.47
  • Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management.
  • Each progesterone capsule for oral administration contains either 100 mg or 200 mg of micronized progesterone USP and has the following inactive ingredients: black iron oxide, gelatin, glycerin, lecithin, peanut oil, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, and titanium dioxide. The 100 mg also contains red iron oxide. The 200 mg also contains yellow iron oxide.
  • Progesterone capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization.
  • No data
  • Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
  • Progesterone capsules should not be used in women with any of the following conditions:
  • 1.n
  • 2. Undiagnosed abnormal genital bleeding.
  • 3. Known, suspected, or history of breast cancer.
  • 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
  • 5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions.
  • 6. Known liver dysfunction or disease.
  • 7. Known or suspected pregnancy.
  • See .
  • No data
  • See , and .
  • 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 a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women. lists adverse reactions greater than or equal to 2 percent of women who received cyclic progesterone capsules, 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo.
  • No studies on overdosage have been conducted in humans. In the case of overdosage, progesterone capsules should be discontinued and the patient should be treated symptomatically.
  • No data
  • Progesterone Capsules, 100 mg are available as oval, soft gelatin, peach opaque capsules filled with white to off-white suspension imprinted in black ink u201cTVu201d over u201cA18u201d, containing 100 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5353-01).
  • Progesterone Capsules, 200 mg are available as oval, soft gelatin, pale yellow opaque capsules filled with white to off-white suspension imprinted in black ink u201cTVu201d over u201cA19u201d, containing 200 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5354-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Protect from excessive moisture.
  • Dispense in 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.
  • Manufactured By:
  • CATALENT PHARMA SOLUTIONS
  • St. Petersburg, FL 33716
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. B 5/2016
  • Progesterone Capsules
  • Rx only
  • Read this PATIENT INFORMATION before you start taking progesterone capsules and read what you get each time you refill your progesterone capsules prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • THIS PRODUCT CONTAINS PEANUT OIL AND SHOULD NOT BE USED IF YOU ARE ALLERGIC TO PEANUTS.
  • What are progesterone capsules?
  • Progesterone capsules contain the female hormone called progesterone.
  • What are progesterone capsules used for?
  • Arrayn- Treatment of Menstrual Irregularities
  • Progesterone capsules are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period) due to a decrease in progesterone. When you do not produce enough progesterone, menstrual irregularities can occur. If your healthcare provider has determined your body does not produce enough progesterone on its own, progesterone capsules may be prescribed to provide the progesterone you need.
  • Arrayn- Protection of the Endometrium (Lining of the Uterus)
  • Progesterone capsules are used in combination with estrogen-containing medications in a postmenopausal woman with a uterus (womb). Taking estrogen alone increases the chance of developing a condition called endometrial hyperplasia that may lead to cancer of the lining of the uterus (womb). The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • Who should not take progesterone capsules?
  • Do not start taking progesterone capsules if you:
  • Tell your healthcare provider:
  • How should I take progesterone capsules?
  • What are the possible side effects of progesterone capsules?
  • 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:
  • Some of the warning signs of serious side effects include:
  • Call your healthcare provider right away if you get any of these 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 progesterone capsules. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Teva Pharmaceuticals USA at 1-866-832-8537 or to FDA at 1-800-FDA-1088.
  • What can I do to lower my chances of getting a serious side effect with progesterone capsules?
  • General information about safe and effective use of progesterone capsules
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • This leaflet provides a summary of the most important information about progesterone capsules. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about progesterone capsules that is written for health professionals. You can get more information by calling the toll free number 1-888-838-2872.
  • What are the ingredients in progesterone capsules?
  • Active ingredient: 100 mg or 200 mg micronized progesterone USP
  • The inactive ingredients for progesterone capsules include: black iron oxide, gelatin, glycerin, lecithin, peanut oil, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, and titanium dioxide. The 100 mg also contains red iron oxide. The 200 mg also contains yellow iron oxide.
  • HOW SUPPLIED
  • Progesterone Capsules, 100 mg are available as oval, soft gelatin, peach opaque capsules filled with white to off-white suspension imprinted in black ink u201cTVu201d over u201cA18u201d, containing 100 mg of micronized progesterone USP, packaged in bottles 100 capsules.
  • Progesterone Capsules, 200 mg are available as oval, soft gelatin, pale yellow opaque capsules filled with white to off-white suspension imprinted in black ink u201cTVu201d over u201cA19u201d, containing 200 mg of micronized progesterone USP, packaged in bottles 100 capsules.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
  • Protect from excessive moisture.
  • Manufactured By:
  • CATALENT PHARMA SOLUTIONS
  • St. Petersburg, FL 33716
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. B 5/2016
  • No data
  • No data

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