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TRI-NORINYL 28
Contraception
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Drug Name:

TRI-NORINYL 28 Rx

Generic Name and Formulations:
Norethindrone 0.5mg, ethinyl estradiol 35micrograms (7 tabs); norethindrone 1mg, ethinyl estradiol 35micrograms (9 tabs); norethindrone 0.5mg, ethinyl estradiol 35micrograms (5 tabs); inert (7 tabs).

Company:
Mayne Pharma US

Therapeutic Use:

Indications for TRI-NORINYL 28:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Not applicable.

Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Warnings/Precautions:

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid rentention. Monitor blood pressure. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tri-Norinyl prior to starting HCV regimen and restart 2wks after completion. Antagonized by rifampin, phenobarbital, phenytoin, carbamazepine, St. John's wort. Efficacy may be reduced by ampicillin, tetracycline, griseofulvin, phenylbutazone. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.

How Supplied:

Packs—3, 6

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