Trade Names:Camila- Tablets norethindrone 0.35 mg
Trade Names:Errin- Tablets norethindrone 0.35 mg
Trade Names:Jolivette- Tablets norethindrone 0.35 mg
Trade Names:Micronor- Tablets norethindrone 0.35 mg
Trade Names:Nor-QD- Tablets norethindrone 0.35 mg
Trade Names:Nora-BE- Tablets norethindrone 0.35 mg
Thickens cervical mucus, interferes with implantation, lowers the midcycle luteinizing hormone and follicle-stimulating hormone peaks, alters endometrium, and may suppress ovulation.
Completely and rapidly absorbed. T max is approximately 1.2 h. C max and AUC are approximately 4,817 pg/mL and 21,233 pg•h/mL, respectively. Absolute bioavailability is approximately 65%.
Vd is 4 L/kg; 36% is bound to sex hormone–binding globulin (SHBG) and 61% to albumin.
Undergoes reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in circulation are sulfate, with the majority of urinary metabolites being glucuronides.
The t ½ is approximately 7.7 h. Less than 5% is excreted unchanged, while more than 50% and 20% to 40% is excreted as metabolites in urine and feces, respectively. Plasma Cl is approximately 600 L/day. Serum levels are near baseline within 24 h.
Prevention of pregnancy.
Active liver disease; benign or malignant liver tumors; hypersensitivity to any component of the product; known or suspected breast carcinoma; undiagnosed abnormal genital bleeding; known or suspected pregnancy.
PO 1 tablet daily. Administration is continuous with no interruption between pill packs.
If GI upset occurs, administer with food.
Store at 59° to 77°F.
Contraceptive effectiveness may be reduced when coadministered with antibiotics and/or anticonvulsants.Bosentan
Norethindrone plasma levels may be reduced, decreasing efficacy.Protease inhibitors
Significant changes (increase and decrease) in the plasma levels of progestins have been noted.Rifampin
Reduced plasma levels and pharmacologic effects of norethindrone.St. John's wort
May reduce the effectiveness of contraceptive steroids.
SHBG concentrations may be decreased; thyroxine concentrations may be reduced.
Androgenic adverse reactions (including acne and hirsutism).
Breast tenderness, frequent and irregular bleeding, long duration of bleeding episodes and amenorrhea, menstrual irregularities.
Carefully monitor blood glucose in prediabetic and diabetic women.
Category X .
Excreted in breast milk.
Use not indicated before menarche.
Increased risk of developing breast cancer has been reported with use of combined oral contraceptives.
Slight deterioration in glucose tolerance with increases in plasma insulin may occur.
If follicular development occurs, atresia of the follicle may be delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle.
Ectopic pregnancy has been reported with progestin-only oral contraceptives.
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
Increased risk of developing benign hepatic adenomas has been reported with use of combined oral contraceptives.
Irregular menstrual patterns are common.
HDL, HDL 2 , and apolipoprotein A-I and A-II may be decreased, while hepatic lipase may be increased.
Greatly increases the possibility of heart attacks or strokes; women who use oral contraceptives are strongly advised not to smoke.
No reports of serious effects.
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