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Trivora-28 Tablets 6X28 By Actavis Pharma

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Trivora-28 Tablets 6X28 By Actavis Pharma

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Trivora-28 Tablets 6X28 By Actavis Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2742971/RXB10008387/RXA314771
Size : 6X28
Selling UoM : EA
NDC: 52544-0291-28
UPC Barcode : 352544291285
Supplier: 0050000679 ACTAVIS PHARMA INC/GENERIC
Supplier Material : 029128
Generic Code : 003315 LEVONORGESTREL-ETHIN ESTRADIOL ORAL TABL
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Ge

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Product Description.:

WATSON, 50/30 or 75/40 or 125/30 or P1
tablet , multi-colored , round round
6 blue (50/30), 5 white (75/40), 10 pink (125/30), 7 peach (P1)

Trivora-28
(levonorgestrel and ethinyl estradiol)

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION

Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha- ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol) phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol then followed by 7 peach inert tablets. The inactive ingredients present in the blue, white and pink tablets are lactose monohydrate, magnesium stearate, povidone and starch (corn). Each blue tablet also contains FD&C Blue #1. Each pink tablet also contains FD&C Red #40.

INDICATIONS

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

SIDE EFFECTS

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

Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.

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 pain, cramps and bloating).
Breakthrough bleeding.
Spotting.
Change in menstrual flow.
Amenorrhea.
Temporary infertility after discontinuation of treatment.
Edema/fluid retention.
Melasma/chloasma which may persist.
Breast changes: tenderness, pain, enlargement, secretion.
Change in weight or appetite (increase or decrease).
Change in cervical erosion and secretion.
Diminution in lactation when given immediately postpartum.
Cholestatic jaundice.
Rash (allergic).
Mood changes, including depression.
Vaginitis, including candidiasis.
Change in corneal curvature (steepening).
Intolerance to contact lenses.
Mesenteric thrombosis.
Decrease in serum folate levels.
Exacerbation of systemic lupus erythematosus.
Exacerbation of porphyria.
Exacerbation of chorea.
Aggravation of varicose veins.
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

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

Congenital anomalies.
Premenstrual syndrome.
Cataracts.
Optic neuritis, which may lead to partial or complete loss of vision.
Cystitis-like syndrome.
Nervousness.
Dizziness.
Hirsutism.
Loss of scalp hair.
Erythema multiforme.
Erythema nodosum.
Hemorrhagic eruption.
Impaired renal function.
Hemolytic uremic syndrome.
Budd-Chiari syndrome.
Acne.
Changes in libido.
Colitis.
Sickle-cell disease.
Cerebral-vascular disease with mitral valve prolapse.
Lupus-like syndromes.
Pancreatitis.
Dysmenorrhea.