Progesterone (Progesterone)

Trade Name : Progesterone

West-Ward Pharmaceuticals Corp

INJECTION

Strength 50 mg/1

PROGESTERONE Progesterone [CS],Progesterone [EPC]

Delivery Process

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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 West-Ward Pharmaceuticals Corp. It is available in strength of 50 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
  • Progesterone injection, USP,u00a0a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use.
  • Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils.
  • It has the following structural formula:
  • CHOu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. 314.47
  • Pregn-4-ene-3, 20-dione
  • Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s.
  • Transforms proliferative endometrium into secretory endometrium.
  • Inhibits (at the usual dose range) the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation.
  • This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
  • No data
  • The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
  • Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
  • Acute eosinophilic pneumonia has been reported in patients receiving progesterone in sesame oil. In reported cases associated with progesterone in sesame oil, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting progesterone in sesame oil and improved when progesterone in sesame oil was discontinued and a different formulation of progesterone and/or steroid therapy was initiated. Patients who develop these signs and symptoms while receiving progesterone in sesame oil should undergo prompt medical evaluation, and progesterone in sesame oil should be discontinued immediately.
  • No data
  • Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions (including eosinophilic pneumonia); mental depression; pyrexia; insomnia; nausea; and somnolence.
  • A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed.
  • There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.
  • The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness.
  • The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T uptake values.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp at 1-877-233-2001 or FDA at 1-800-FDA-1088 or .
  • Progesterone Injection, USPu00a0is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection.
  • Amenorrhea:
  • Functional Uterine Bleeding:
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
  • Progesterone Injection, USP,u00a050 mg/mL is available in 10 mL multiple dose vials, individually boxed.
  • (NDC 0143-9725-01)
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Manufactured By:
  • HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
  • Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, Portugal
  • Distributed by:
  • WEST-WARD
  • A HIKMA COMPANY
  • Arrayn- Array
  • Revised: August 2018
  • PIN258-WES/4
  • PROGESTERONE INJECTION, USP
  • IN SESAME OIL u2013 FOR INTRAMUSCULAR USE ONLY
  • Rx Only
  • FOR THE TREATMENT OF AMENORRHEA (ABSENCE OF MENSES IN WOMEN WHO HAVE PREVIOUSLY HAD A MENSTRUAL PERIOD) OR ABNORMAL UTERINE BLEEDING DUE TO HORMONAL IMBALANCE.
  • Please read this information carefully before you start to use progesterone injection and each time your prescription is renewed, in case anything has changed. This leaflet does not take the place of discussions with your doctor. If you still have any questions, ask your doctor or healthcare provider.
  • About progesterone injectionn
  • Understanding the role of progesterone injection in the treatment of your menstrual irregularities.n
  • When you do not produce enough progesterone, menstrual irregularities can occur.
  • Progesterone injection can provide you with the progesterone needed during a normal menstrual cycle.
  • Possible side effects of progesterone injectionn
  • *If you experience sleepiness, do not drive or operate machinery.
  • When you should not use progesterone injection
  • Risks of progesterone injection
  • Abnormal blood clotting. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.
  • Precautionsn
  • How progesterone injection worksn
  • Other information
  • How to use progesterone injectionn
  • How Suppliedn
  • Progesterone Injection should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Do not use progesterone injection after the expiration date which is printed on the vial label.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Manufactured By:
  • HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
  • Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, Portugal
  • Distributed by:
  • WEST-WARD
  • A HIKMA COMPANY
  • Eatontown, NJ 07724 USA
  • Revised: August 2018
  • PIN258-WES/4
  • NDC 0143-9725-01n n
  • NDC 0143-9725-01n
  • Arrayn- Array
  • Arrayn- Array
  • No data

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