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TriLegest Fe Tabs 5X28 By Teva Pharma.

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TriLegest Fe Tabs 5X28 By Teva Pharma.

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TriLegest Fe Tabs 5X28 By Teva Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4020228/RXB10043350/RXA307884
Size : 5X28
Selling UoM : EA
NDC: 00555-9032-70
UPC Barcode : 305559032701
Supplier: 0050001781 TEVA PHARMACEUTICALS USA
Supplier Material : 903270
Generic Code : 030493 NORETHINDRONE-E.ESTRADIOL-IRON ORAL TABL
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic

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Product Description.:

b, 711 or 712 or 713 or 247
tablet , multi-colored , round round
Flat-faced beveled-edge5 light pink (711) 7 light yellow (712) 9

ESTROSTEP? Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen.

ESTROSTEP Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.

Each white triangle-shaped tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] each white square-shaped tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol and each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each tablet also contains calcium stearate lactose microcrystalline cellulose and starch.

Each ESTROSTEP Fe tablet dispenser contains five white triangular tablets, seven white square tablets, nine white round tablets, and seven brown tablets. These tablets are to be taken in the following order: one triangular tablet each day for five days, then one square tablet each day for seven days, followed by one round tablet each day for nine days, and then one brown tablet each day for seven days.

INDICATIONS

ESTROSTEP Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

ESTROSTEP Fe is indicated for the treatment of moderate acne vulgaris in females, 15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. ESTROSTEP Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.

SIDE EFFECTS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

* Thrombophlebitis
* Arterial thromboembolism
* Pulmonary embolism
* Myocardial infarction
* Cerebral hemorrhage
* Cerebral thrombosis
* Hypertension
* Gallbladder disease
* Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

* Mesenteric thrombosis
* Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

* Nausea
* Vomiting
* Gastrointestinal symptoms (such as abdominal cramps and bloating)
* Breakthrough bleeding
* Spotting
* Change in menstrual flow
* Amenorrhea
* Temporary infertility after discontinuation of treatment
* Edema
* Melasma which may persist
* Breast changes: tenderness, enlargement, secretion
* Change in weight (increase or decrease)
* Change in cervical erosion and secretion
* Diminution in lactation when given immediately postpartum
* Cholestatic jaundice
* Migraine
* Rash (allergic)
* Mental depression
* Reduced tolerance to carbohydrates
* Vaginal candidiasis
* Change in corneal curvature (steepening)
* Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

* Pre-menstrual syndrome
* Cataracts
* Changes in appetite
* Cystitis-like syndrome
* Headache
* Nervousness
* Dizziness
* Hirsutism
* Loss of scalp hair
* Erythema multiforme
* Erythema nodosum
* Hemorrhagic eruption
* Vaginitis
* Porphyria
* Impaired renal function
* Hemolytic uremic syndrome
* Budd-Chiari syndrome
* Acne
* Changes in libido
* Colitis